This is the accessible text file for GAO report number GAO-13-46R 
entitled 'Medicare: High-Expenditure Part B Drugs' which was released 
on November 13, 2012. 

This text file was formatted by the U.S. Government Accountability 
Office (GAO) to be accessible to users with visual impairments, as 
part of a longer term project to improve GAO products' accessibility. 
Every attempt has been made to maintain the structural and data 
integrity of the original printed product. Accessibility features, 
such as text descriptions of tables, consecutively numbered footnotes 
placed at the end of the file, and the text of agency comment letters, 
are provided but may not exactly duplicate the presentation or format 
of the printed version. The portable document format (PDF) file is an 
exact electronic replica of the printed version. We welcome your 
feedback. Please E-mail your comments regarding the contents or 
accessibility features of this document to Webmaster@gao.gov. 

This is a work of the U.S. government and is not subject to copyright 
protection in the United States. It may be reproduced and distributed 
in its entirety without further permission from GAO. Because this work 
may contain copyrighted images or other material, permission from the 
copyright holder may be necessary if you wish to reproduce this 
material separately. 

GAO-13-46R: 

United States Government Accountability Office: 
Washington, DC 20548: 

October 12, 2012: 

The Honorable Herb Kohl: 
Chairman: 
Special Committee on Aging: 
United States Senate: 

The Honorable Dick Durbin: 
United States Senate: 

Subject: Medicare: High-Expenditure Part B Drugs: 

In 2010, the Medicare program and its beneficiaries spent about $19.5 
billion on Part B drugs[Footnote 1]--drugs that are commonly 
administered by a physician or under a physician's close supervision 
in physicians' offices and hospital outpatient departments.[Footnote 
2] Some of these drugs are particularly expensive for Medicare, either 
because they are used by a large number of beneficiaries or because 
their prices are high. These drugs generally differ from drugs 
beneficiaries obtain through Medicare Part D, which are usually self-
administered and for which Medicare, its beneficiaries, and the states 
spent $61.7 billion in 2010.[Footnote 3] 

Medicare bases its payments for most Part B drugs on the average sales 
price (ASP), which is calculated from data that manufacturers report 
quarterly to the Centers for Medicare & Medicaid Services (CMS), the 
agency within the Department of Health and Human Services that 
administers Medicare. ASP is the average price, after rebates and 
discounts, of all sales of a specified drug in the United States; 
consequently, Medicare's payment rates for Part B drugs are based on 
prices set by the private market. 

You asked us to analyze trends in utilization and expenditures for 
high-expenditure Part B drugs and to estimate Medicare's proportion of 
total U.S. expenditures for these high-expenditure drugs. This report 
examines (1) the Part B drugs for which Medicare expenditures were 
highest in 2010 and the utilization and spending trends for these high-
expenditure Part B drugs from 2008 to 2010, and (2) nationwide 
spending levels for the total U.S. population for these high-
expenditure Part B drugs in 2010 and Medicare's percentage of total 
U.S. spending. 

To identify the highest-expenditure Part B drugs in 2010 (the latest 
year for which data were available) and examine their utilization and 
spending trends, we used the CMS National Claims History 5 Percent 
Sample for physician, hospital outpatient, and durable medical 
equipment (DME) claims for 2008, 2009, and 2010.[Footnote 4] We 
calculated the total amount spent on each Part B-covered drug in 2010 
by the Medicare fee-for-service (FFS) program and by or on behalf of 
its beneficiaries and then ranked the drugs by total expenditures. 
[Footnote 5] We identified the 55 drugs with the highest total 2010 
Medicare expenditures--that is, expenditures by the Medicare program 
and expenditures by or on behalf of beneficiaries--and examined the 
number of beneficiaries using each of these drugs and the average 
annual cost per beneficiary.[Footnote 6] For these 55 drugs, we also 
examined changes in total expenditures, beneficiary utilization, and 
prices from 2008 to 2010. We obtained information on the purpose and 
other characteristics of these drugs from the Food and Drug 
Administration (FDA), the National Institutes of Health (NIH), and 
manufacturers. 

To estimate Medicare's share of total U.S. spending for these 55 high-
expenditure Part B drugs, we obtained estimates of total 2010 U.S. 
expenditures--excluding Medicare FFS--for each of the drugs from IMS 
Health, a company that collects and analyzes health care data. To make 
these estimates, IMS Health used its national claims database, which 
contains commercial health plan claims for more than 60 million unique 
patients from more than 80 health plans across the United States. 
[Footnote 7] IMS Health used claims for all beneficiaries who had been 
enrolled throughout 2010, but removed claims from Medicare 
supplemental health insurance policies to avoid double counting these 
claims, which were also included in the Medicare claims. IMS Health 
then used age-gender population information reported by the U.S. 
Census to project its claims data to the entire insured U.S. 
population, excluding the Medicare FFS population. To estimate total 
spending and utilization for the U.S. non-Medicare population, IMS 
Health made the assumption that beneficiaries not included in IMS 
Health's claims database, including those insured through certain 
government programs such as Medicaid, the Veterans Health 
Administration, and TRICARE,[Footnote 8] had expenditures similar to 
the commercially insured population of the same age and gender. We 
used these projections plus 2010 Medicare FFS claims to estimate the 
spending on each of the 55 drugs for the total U.S. insured population 
in 2010, thereby enabling us to estimate Medicare's share of spending 
for these drugs. 

While we believe our analytical approach allows us to achieve our 
objectives, our analysis has some limitations. IMS Health projected 
expenditures from a large national claims database but, by definition, 
projections are subject to error. Furthermore, according to IMS 
Health, hospital outpatient expenditures are underrepresented by an 
unknown amount. To the extent that Part B drugs may, in certain 
circumstances, be paid under Part A, Medicare expenditures and 
utilization are also underrepresented by an unknown amount in the 
estimates of total U.S. expenditures. 

We ensured the reliability of the Medicare claims data used in this 
report by performing appropriate electronic data checks and by 
interviewing agency officials who were knowledgeable about the data. 
We also checked total expenditures for the 55 highest-expenditure Part 
B drugs in the claims data against the published total expenditures 
for these drugs in CMS's Part B National Summary Files.[Footnote 9] 
IMS Health removed from its claims database cases where expenditure 
fields were not populated, and in cases where the paid amount was 
greater than the allowed amount, replaced the paid amount with the 
allowed amount. It also allowed only three claims per patient per day 
per code. When there were more than three, the three claims with the 
largest allowed amounts were retained. We found that the Medicare and 
IMS data were sufficiently reliable for the purposes of our analysis. 

We conducted our work from August 2011 through August 2012 in 
accordance with all sections of GAO's Quality Assurance Framework that 
are relevant to our objectives. The framework requires that we plan 
and perform the engagement to obtain sufficient and appropriate 
evidence to meet our stated objectives and to discuss any limitations 
to our work. We believe that the information and data obtained, and 
the analysis conducted, provide a reasonable basis for any findings 
and conclusions. 

Results in Brief: 

In 2010, the 55 highest-expenditure Part B drugs represented $16.9 
billion in spending, or about 85 percent of all Medicare spending on 
Part B drugs, which totaled $19.5 billion. The number of Medicare 
beneficiaries who received each of these drugs varied from 15.2 
million receiving the influenza vaccines to 660 hemophilia A patients 
receiving a group of biologicals known collectively as factor viii 
recombinant, which had the largest average annual cost per 
beneficiary--$217,000.[Footnote 10] Our analysis showed that most of 
the 55 drugs increased in expenditures, prices, and average annual 
cost per beneficiary from 2008 to 2010. The 5 drugs with the largest 
increase in Medicare expenditures over this time period also had the 
largest increase in the number of beneficiaries receiving each drug. 
Four of the 10 drugs which showed the greatest increase in 
expenditures were also among the 10 drugs showing the greatest price 
increases. 

Spending on Medicare beneficiaries accounted for the majority of 
estimated total U.S. spending for 35 of the 55 highest-expenditure 
Part B drugs in 2010. For 17 of the 35, Medicare spending accounted 
for more than two-thirds of total U.S. spending, defined as spending 
by the insured population in the United States. 

Background: 

Medicare Part B generally covers drugs and biologicals administered 
under a physician's direct supervision, including those administered 
in physician offices and in hospital outpatient departments that are 
not usually self-administered. These include drugs infused through 
DME, certain vaccines (influenza, pneumococcal, and hepatitis B) 
[Footnote 11], osteoporosis drugs, oral cancer drugs if the same drug 
is available in injectable form, antinausea drugs used as part of an 
anticancer chemotherapeutic regimen, erythropoiesis-stimulating 
agents,[Footnote 12] blood clotting factors for hemophilia patients, 
injectable drugs, and immunosuppressive drugs for transplant patients. 
The Medicare program pays 80 percent of the expenditures for Part B 
drugs and the beneficiary is responsible for the remaining 20 percent, 
which may be paid by supplemental coverage such as a Medicare 
supplemental health insurance policy,[Footnote 13] an employer-
sponsored retiree health plan, or Medicaid. As of 2009, nearly 90 
percent of Medicare Part B beneficiaries had some form of supplemental 
coverage. 

Payment to physicians is set at 106 percent of ASP for most Part B 
drugs they administer; however, payment for some Part B drugs is set 
on a different basis. Vaccines, infusion drugs furnished through DME, 
and blood products are paid at 95 percent of average wholesale price 
(AWP), which is the manufacturer's average price to wholesalers. 
[Footnote 14] In cases where the ASP of a new drug during the first 
quarter of sales is unavailable, payment may be set at 106 percent of 
the wholesale acquisition cost (WAC), which is the manufacturer's list 
price to wholesalers. If the WAC is not yet available for the new 
drug, payment is based on the invoice price. Payment for Part B drugs 
administered in hospital outpatient departments is determined based on 
ASP, though the rate can vary from year to year. In 2010, it was 104 
percent of ASP.[Footnote 15] 

Additionally, for certain drugs such as drugs used to treat cancer, 
some new drugs, and orphan drugs,[Footnote 16] which are drugs used to 
treat rare diseases, Medicare makes additional payments for some drugs 
administered in the hospital outpatient setting, known as transitional 
pass-through payments, which can be paid for 2 to 3 years.[Footnote 
17] For new drugs, pass-through status is intended to make the drugs 
accessible to beneficiaries while a pricing history is developed and 
the price is established. 

New drugs can be patented and, while under patent, can be manufactured 
or sold solely by the patent holder. Patents generally last for 20 
years from the date of application.[Footnote 18] After the patent 
expires and generic forms of the drug are marketed at significantly 
lower prices, the price of the original drug usually falls.[Footnote 
19] 

Orphan drug status is granted by FDA to drugs that treat rare 
diseases--those that affect fewer than 200,000 people in the United 
States or for which there is no reasonable expectation of recovering 
the costs of development and marketing--and confers several benefits 
on the drug sponsor, including a 7-year period of market exclusivity. 
[Footnote 20] 

The Highest-Expenditure Medicare Part B Drugs Represented Most Part B 
Drug Spending in 2010 and Most Showed Increases in Spending, 
Utilization, and Price from 2008 to 2010: 

The 55 highest-expenditure Part B drugs accounted for 85 percent of 
all Part B drug spending in 2010. Utilization and annual spending per 
beneficiary for these drugs varied widely, but, like spending, 
generally increased between 2008 and 2010. Enclosure I contains a 
complete list of the 55 highest-expenditure Part B drugs in 2010. 

Fifty-five Highest-Expenditure Part B Drugs Accounted for Three-
Quarters of Part B Drug Expenditures in 2010: 

In 2010, the 55 highest-expenditure Part B drugs represented $16.9 
billion in spending, or about 85 percent of all Medicare spending on 
Part B drugs, which totaled $19.5 billion. The 10 highest-expenditure 
Part B drugs accounted for about 45 percent of all Part B drug 
spending in 2010. Eight of the 10 most expensive were biological 
products as shown in table 1, and 4 of the 10 had orphan drug 
marketing exclusivity in 2010.[Footnote 21] None of the 10 highest-
expenditure drugs had a generic version approved by FDA in 2010. 
Enclosure II provides information on the expenditures, utilization, 
and average annual per beneficiary cost for the 55 Part B drugs. 
Enclosure III provides a list of all the 55 drugs that had orphan drug 
marketing exclusivity in 2010. Enclosure IV provides information on 
the generic availability of the 55 highest-expenditure Part B drugs. 

Table 1: Ten Highest-Expenditure Medicare Part B Drugs, 2010: 

2010 rank by total Medicare expenditures: 1; 
Brand name(s): Epogen/Procrit (ESRD use); 
Drug description: Epoetin alfa, ESRD[A]; 
Classification: Biological; 
Condition(s) treated: Anemia in end-stage renal disease (ESRD) 
patients; 
Total 2010 expenditures for Medicare beneficiaries: $2.0 billion. 

2010 rank by total Medicare expenditures: 2; 
Brand name(s): Rituxan[B]; 
Drug description: Rituximab injection; 
Classification: Biological; 
Condition(s) treated: Cancer; rheumatoid arthritis; 
Total 2010 expenditures for Medicare beneficiaries: $1.302 billion. 

2010 rank by total Medicare expenditures: 3; 
Brand name(s): Lucentis; 
Drug description: Ranibizumab injection; 
Classification: Biological; 
Condition(s) treated: Wet age-related macular degeneration (AMD); 
Total 2010 expenditures for Medicare beneficiaries: $1.180 billion. 

2010 rank by total Medicare expenditures: 4; 
Brand name(s): Avastin[B]; 
Drug description: Bevacizumab injection; 
Classification: Biological; 
Condition(s) treated: Cancer; wet AMD; 
Total 2010 expenditures for Medicare beneficiaries: $1.130 billion. 

2010 rank by total Medicare expenditures: 5; 
Brand name(s): Remicade[B]; 
Drug description: Infliximab injection; 
Classification: Biological; 
Condition(s) treated: Various autoimmune disorders; 
Total 2010 expenditures for Medicare beneficiaries: $900. 

2010 rank by total Medicare expenditures: 6; 
Brand name(s): Neulasta; 
Drug description: Injection, pegfilgrastim 6mg; 
Classification: Biological; 
Condition(s) treated: Prevent infection in chemotherapy patients; 
Total 2010 expenditures for Medicare beneficiaries: $888 million. 

2010 rank by total Medicare expenditures: 7; 
Brand name(s): Aranesp (non-ESRD use); 
Drug description: Darbepoetin alfa, non-ESRD; 
Classification: Biological; 
Condition(s) treated: Anemia in chemotherapy patients; 
Total 2010 expenditures for Medicare beneficiaries: $504 million. 

2010 rank by total Medicare expenditures: 8; 
Brand name(s): Epogen/Procrit (non-ESRD use); 
Drug description: Epoetin alfa, non-ESRD; 
Classification: Biological; 
Condition(s) treated: Anemia in chemotherapy and HIV patients; 
prevent blood loss in surgical patients; 
Total 2010 expenditures for Medicare beneficiaries: $443 million. 

2010 rank by total Medicare expenditures: 9; 
Brand name(s): Alimta[B]; 
Drug description: Pemetrexed injection; 
Classification: Drug; 
Condition(s) treated: Cancer; 
Total 2010 expenditures for Medicare beneficiaries: $394 million. 

2010 rank by total Medicare expenditures: 10; 
Brand name(s): Taxotere; 
Drug description: Docetaxel injection; 
Classification: Drug; 
Condition(s) treated: Cancer; 
Total 2010 expenditures for Medicare beneficiaries: $387 million. 

Brand name(s): Total; 
Total 2010 expenditures for Medicare beneficiaries: $9.128 billion. 

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data. 

[A] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[B] These products had orphan drug marketing exclusivity for specific 
FDA-approved indications in 2010. 

[End of table] 

Medicare spent most--$2 billion--on the drug Epogen/Procrit[Footnote 
22] for the treatment of anemia in end-stage renal disease (ESRD) 
patients.[Footnote 23] The second most expensive drug was Rituxan, 
which is used to treat non-Hodgkin's lymphoma, a type of cancer, and 
rheumatoid arthritis. Lucentis, the third most expensive drug, is used 
to treat wet age-related macular degeneration (AMD), an eye condition, 
and during this period Avastin, a cancer drug which was the fourth 
most expensive, also was used off-label to treat wet AMD.[Footnote 24] 
There was considerable interest by physicians and other experts in 
using Avastin for this purpose in part because the expenditure per 
treatment was significantly less than for Lucentis. However, it was 
not known whether Avastin was comparable to Lucentis in efficacy. A 
clinical trial determined that Avastin and Lucentis were equally 
effective, but the first trial results were not available until 2011, 
and so did not affect utilization in 2010. 

Of the 55 highest-expenditure Part B drugs, cancer and its side 
effects were treated by more drugs (23 drugs) than any other set of 
conditions in 2010. (See figure 1.) Other conditions that were treated 
by several drugs included immune system disorders such as rheumatoid 
arthritis (13 drugs) and chronic kidney disease (5 drugs). 

Figure 1: Conditions Treated by the 55 Highest-Expenditure Medicare 
Part B Drugs, 2010: 

[Refer to PDF for image: vertical bar graph] 

Condition treated: Cancer, side effects of cancer, and side effects of 
chemotherapy; 
Number of drugs: 23. 

Condition treated: Autoimmune|disorders and immunodeficiency; 
Number of drugs: 13. 

Condition treated: Cardiovascular disease testing and treatment; 
Number of drugs: 5. 

Condition treated: Chronic kidney|disease, including ESRD; 
Number of drugs: 5. 

Condition treated: Asthma and lung diseases; 
Number of drugs: 3. 

Condition treated: Prevention of organ transplant rejection; 
Number of drugs: 3. 

Condition treated: Other; 
Number of drugs: 15. 

Source: GAO analysis of CMS, NIH, and drug manufacturer data. 

Notes: The sum of the high-expenditure Medicare Part B drugs exceeds 
55 because some drugs were used to treat more than one type of 
condition. 

[A] Other includes conditions such as wet age-related macular 
degeneration, osteoarthritis of the knee, myelodysplastic syndrome, 
anemia in HIV and uterine fibroid patients, and prevention of 
influenza, pneumonia, and meningitis. 

[End of figure] 

Utilization of High-Expenditure Part B Drugs Ranged from Millions of 
Beneficiaries for Vaccines to Hundreds for Hemophilia Drugs in 2010: 

Utilization of the 55 highest-expenditure Part B drugs ranged from 
over 15 million beneficiaries who received the influenza vaccine to 
660 beneficiaries who used factor viii recombinant to treat hemophilia 
A.[Footnote 25] Although Epogen to treat beneficiaries with ESRD was 
Medicare's most expensive Part B drug in 2010, other drugs among the 
top 55 were used by more beneficiaries, including two vaccines 
(influenza and pneumococcal). Apart from the vaccines, the greatest 
number of beneficiaries (891,000) used Lexiscan, which is a chemical 
stress agent used to test heart function in patients who cannot take a 
stress test on a treadmill (see table 2). 

Table 2: Ten Most Utilized High-Expenditure Medicare Part B Drugs, 
2010: 

Brand name(s): Influenza Vaccine (various); 
Condition(s) treated: Prevent influenza; 
Utilization (number of unique Medicare beneficiaries): 15,229,920. 

Brand name(s): Pnuemovax 23, Pnu-Imune; 
Condition(s) treated: Prevent meningitis and pneumonia; 
Utilization (number of unique Medicare beneficiaries): 1,692,940. 

Brand name(s): Lexiscan; 
Condition(s) treated: Stress agent for myocardial perfusion imaging; 
Utilization (number of unique Medicare beneficiaries): 890,920. 

Brand name(s): Venofer; 
Condition(s) treated: Anemia in chronic kidney disease patients; 
Utilization (number of unique Medicare beneficiaries): 329,260. 

Brand name(s): Epogen/Procrit (ESRD use); 
Condition(s) treated: Anemia in end-stage renal disease (ESRD) 
patients[A]; 
Utilization (number of unique Medicare beneficiaries): 323,920. 

Brand name(s): Zemplar; 
Condition(s) treated: Hyperthyroidism in chronic kidney disease 
patients; 
Utilization (number of unique Medicare beneficiaries): 230,700. 

Brand name(s): Reclast; 
Condition(s) treated: Osteoporosis prevention and treatment; 
treat Paget's disease of bone; 
Utilization (number of unique Medicare beneficiaries): 218,060. 

Brand name(s): Avastin; 
Condition(s) treated: Cancer; 
wet age-related macular degeneration (AMD); 
Utilization (number of unique Medicare beneficiaries): 171,560. 

Brand name(s): Synvisc/Synvisc-One; 
Condition(s) treated: Osteoarthritis of the knee; 
Utilization (number of unique Medicare beneficiaries): 168,560. 

Brand name(s): Aloxi; 
Condition(s) treated: Prevent nausea and vomiting in chemotherapy and 
surgical patients; 
Utilization (number of unique Medicare beneficiaries): 164,000. 

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data. 

[A] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[End of table] 

Average Annual per Beneficiary Costs for 55 Highest-Expenditure 
Medicare Part B Drugs Ranged from over $200,000 to $13 in 2010: 

We also examined the average annual per beneficiary cost of each drug 
and found that factor viii recombinant, although used by the smallest 
number of Medicare beneficiaries, was the most costly drug on an 
average annual per beneficiary cost basis--the average annual cost was 
about $217,000 for each beneficiary who used it in 2010 (see table 3). 
The influenza vaccines had the lowest average annual per beneficiary 
cost ($13). The high average annual per beneficiary cost for factor 
viii recombinant drugs results in part from the complexity of the 
production process; consequently, even having several brand names 
available has not reduced the average annual per beneficiary cost for 
this drug. Remodulin and Ventavis follow with average annual per 
beneficiary costs of about $131,000 and $84,000, respectively; both 
are used to treat pulmonary hypertension (high blood pressure in the 
lungs due to narrowing of the pulmonary arteries). Primacor, at an 
average annual per beneficiary cost of about $63,000, is used to treat 
acute decompensated heart failure (a type of acute heart failure). 
Apart from these four drugs, no drug cost more than $26,000 per 
beneficiary per year in 2010. 

Table 3: Ten High-Expenditure Medicare Part B Drugs with Highest 
Average Annual Per Beneficiary Cost, 2010: 

Brand name(s): Factor viii recombinant (various); 
Condition(s) treated: Hemophilia A; 
Classification: Biological; 
Average annual cost per beneficiary (dollars): $216,833. 

Brand name(s): Remodulin; 
Condition(s) treated: Pulmonary arterial hypertension; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $130,772. 

Brand name(s): Ventavis; 
Condition(s) treated: Pulmonary arterial hypertension; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $84,205. 

Brand name(s): Primacor, Primacor in Dextrose; 
Condition(s) treated: Acute decompensated heart failure; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $62,790. 

Brand name(s): Erbitux; 
Condition(s) treated: Cancer; 
Classification: Biological; 
Average annual cost per beneficiary (dollars): $25,898. 

Brand name(s): Dacogen; 
Condition(s) treated: Myelodysplastic syndrome; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $25,858. 

Brand name(s): Herceptin; 
Condition(s) treated: Cancer; 
Classification: Biological; 
Average annual cost per beneficiary (dollars): $25,797. 

Brand name(s): Vidaza; 
Condition(s) treated: Myelodysplastic syndrome; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $22,957. 

Brand name(s): Sandostatin Lar Depot; 
Condition(s) treated: Acromegaly, diarrhea, and flushing caused by 
cancerous tumors and vasoactive intestinal peptide secreting adenomas; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $22,748. 

Brand name(s): Velcade; 
Condition(s) treated: Cancer; 
Classification: Drug; 
Average annual cost per beneficiary (dollars): $19,667. 

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data. 

[End of table] 

Most Changes in Expenditures, Utilization, and Price from 2008 to 2010 
Were Increases: 

Expenditures for drugs generally increased from 2008 to 2010, although 
some decreased. Medicare expenditures for 42 of the 55 most expensive 
Part B drugs increased from 2008 to 2010, while 12 decreased.[Footnote 
26] Changes in Medicare expenditures from 2008 to 2010 for the 55 
highest-expenditure Part B drugs in 2010 ranged from a 9,550 percent 
increase to a 40 percent decrease.[Footnote 27] Utilization also 
generally increased from 2008 to 2010. The drugs that showed the 
greatest increases in expenditures were Lexiscan (9,550 percent), 
Treanda (7,440 percent), Privigen (836 percent), Reclast (141 
percent), and Myfortic (107 percent); these drugs also showed the 
greatest increases in utilization (see table 4). Enclosure V provides 
information on the 55 highest-expenditure Medicare Part B drugs by 
changes in expenditures, utilization, and price. The first four of 
these drugs had been approved by FDA in 2007 or early 2008, and it 
took some months for their use to spread.[Footnote 28] Also, in late 
2008 and 2009 Reclast was approved for additional uses, such as for 
the treatment of osteoporosis in men. 

Most price changes from 2008 to 2010 were also increases but the range 
was smaller--from an increase in price of 51 percent to a decrease of 
38 percent.[Footnote 29] Four of the 10 that increased most in 
expenditures also were among the 10 that increased most in price. 
Ventavis increased the most (51 percent) followed by Pneumovax 23/Pnu-
Immune (36 percent), the vaccine used to prevent pneumonia. 

Table 4: Ten High-Expenditure Part B Drugs with Largest Changes in 
Expenditures, Utilization, and Average Price from 2008 to 2010: 

Change in expenditures, 2008-2010[A]: 

Brand name(s): Lexiscan; 
Percent change: 9,550.4%; 

Brand name(s): Treanda; 
Percent change: 7,440.2; 

Brand name(s): Privigen; 
Percent change: 836.3; 

Brand name(s): Reclast; 
Percent change: 140.7; 

Brand name(s): Myfortic; 
Percent change: 106.9; 

Brand name(s): Primacor, Primacor in Dextrose; 
Percent change: 94.0; 

Brand name(s): Ventavis; 
Percent change: 93.6; 

Brand name(s): Vidaza; 
Percent change: 81.9; 

Brand name(s): Gammagard Liquid; 
Percent change: 69.2; 

Brand name(s): Orencia; 
Percent change: 66.9. 

Change in utilization, 2008-2010: 

Brand name(s): Lexiscan; 
Percent change: 11,008.7%; 

Brand name(s): Treanda; 
Percent change: 3,271.4; 

Brand name(s): Privigen; 
Percent change: 381.1; 

Brand name(s): Reclast; 
Percent change: 136.8; 

Brand name(s): Myfortic; 
Percent change: 73.4; 

Brand name(s): Hectorol; 
Percent change: 71.1; 

Brand name(s): Flebogamma, Flebogamma DIF; 
Percent change: 46.7; 

Brand name(s): Orencia; 
Percent change: 45.4; 

Brand name(s): Vidaza; 
Percent change: 41.7; 

Brand name(s): Gamunex; 
Percent change: 36.7. 

Change in average price, 2008-2010[B]: 

Brand name(s): Ventavis; 
Percent change: 51.5%. 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Percent change: 36.0. 

Brand name(s): Myfortic; 
Percent change: 22.0. 

Brand name(s): Hycamtin; 
Percent change: 17.5. 

Brand name(s): Gammagard Liquid; 
Percent change: 15.4. 

Brand name(s): Doxil; 
Percent change: 14.1. 

Brand name(s): Tysabri; 
Percent change: 12.3. 

Brand name(s): Vidaza; 
Percent change: 11.6. 

Brand name(s): Gamunex; 
Percent change: 11.3. 

Brand name(s): Xolair; 
Percent change: 11.2. 

Source: GAO analysis of CMS and FDA data. 

Notes: Our analysis excludes expenditures and utilization in 2008 that 
were reported using a not otherwise classified code, which may have 
artificially increased the changes shown for new drugs, including 
Lexiscan and Treanda. 

[A] We removed factor viii recombinant biologicals from our analysis 
of change in expenditures from 2008-2010 because Medicare claims 
expenditures for 2008 were lower than values in CMS's Part B National 
Summary Files and we were not confident that the reported expenditures 
for 2008 were valid. 

[B] The change in price analysis was based on the unweighted average 
ASP across four quarters in each year, and does not include prices for 
drugs when supplied through infusion equipment. 

[End of table] 

Medicare Beneficiaries Accounted for the Majority of Total U.S. 
Spending for Most of the Highest-Expenditure Medicare Part B-Covered 
Drugs in 2010: 

Spending on Medicare beneficiaries accounted for the majority of 
estimated total U.S. spending for 35 of the 55 highest-expenditure 
Part B drugs in 2010. For 17 of these drugs, Medicare spending 
accounted for more than two-thirds of total U.S. spending (see table 
5). Of the $16.9 billion Medicare spent for the 55 highest-expenditure 
Part B drugs, $11.0 billion, or 65 percent, was spent on drugs for 
which spending for Medicare beneficiaries accounted for the majority 
of total U.S. expenditures. Enclosure VI provides information on the 
percentage spent on Medicare beneficiaries for the 55 highest-
expenditure Part B drugs. 

Table 5: High-Expenditure Medicare Part B Drugs for Which Spending on 
Medicare Beneficiaries Exceeded Two-thirds of Total U.S. Spending, 
2010: 

2010 rank by total Medicare expenditures: 47; 
Brand name(s): Myfortic; 
Condition(s) treated: Prevent transplant kidney rejection; treat 
Crohn's disease; 
Spending on Medicare beneficiaries: $80 million; 
Spending on total U.S. insured population: $86 million; 
Percentage spent on Medicare beneficiaries: 92.2%. 

2010 rank by total Medicare expenditures: 18; 
Brand name(s): Prograf; 
Condition(s) treated: Prevent transplant organ rejection; treat 
fistulizing Crohn's disease; 
Spending on Medicare beneficiaries: $267 million; 
Spending on total U.S. insured population: $290 million; 
Percentage spent on Medicare beneficiaries: 92.1%. 

2010 rank by total Medicare expenditures: 52; 
Brand name(s): Brovana; 
Condition(s) treated: Symptoms of chronic obstructive pulmonary 
disease; 
Spending on Medicare beneficiaries: $70 million; 
Spending on total U.S. insured population: $77 million; 
Percentage spent on Medicare beneficiaries: 91.3%. 

2010 rank by total Medicare expenditures: 22; 
Brand name(s): Pulmicort; 
Condition(s) treated: Prevent wheezing, shortness of breath, and 
troubled breathing in asthma and lung disease patients; 
Spending on Medicare beneficiaries: $245 million; 
Spending on total U.S. insured population: $273 million; 
Percentage spent on Medicare beneficiaries: 89.6%. 

2010 rank by total Medicare expenditures: 33; 
Brand name(s): Aranesp (ESRD use); 
Condition(s) treated: Anemia in end-stage renal disease (ESRD) 
patients[A]; 
Spending on Medicare beneficiaries: $162 million; 
Spending on total U.S. insured population: $182 million; 
Percentage spent on Medicare beneficiaries: 88.7%. 

2010 rank by total Medicare expenditures: 45; 
Brand name(s): Primacor, Primacor in Dextrose; 
Condition(s) treated: Acute decompensated heart failure; 
Spending on Medicare beneficiaries: $87 million; 
Spending on total U.S. insured population: $101 million; 
Percentage spent on Medicare beneficiaries: 85.6%. 

2010 rank by total Medicare expenditures: 40; 
Brand name(s): Cellcept; 
Condition(s) treated: Prevent transplant organ rejection; treat 
Crohn's disease; 
Spending on Medicare beneficiaries: $113 million; 
Spending on total U.S. insured population: $133 million; 
Percentage spent on Medicare beneficiaries: 84.9%. 

2010 rank by total Medicare expenditures: 1; 
Brand name(s): Epogen/Procrit (ESRD use); 
Condition(s) treated: Anemia in ESRD patients; 
Spending on Medicare beneficiaries: $2.000 billion; 
Spending on total U.S. insured population: $2.381 billion; 
Percentage spent on Medicare beneficiaries: 84.0%. 

2010 rank by total Medicare expenditures: 14; 
Brand name(s): Zemplar; 
Condition(s) treated: Hyperthyroidism in chronic kidney disease 
patients; 
Spending on Medicare beneficiaries: $324 million; 
Spending on total U.S. insured population: $389 million; 
Percentage spent on Medicare beneficiaries: 83.3%. 

2010 rank by total Medicare expenditures: 3; 
Brand name(s): Lucentis; 
Condition(s) treated: Wet age-related macular degeneration (AMD); 
Spending on Medicare beneficiaries: $1.180 billion; 
Spending on total U.S. insured population: $1.486 billion; 
Percentage spent on Medicare beneficiaries: 79.5%. 

2010 rank by total Medicare expenditures: 44; 
Brand name(s): Dacogen; 
Condition(s) treated: Myelodysplastic syndrome; 
Spending on Medicare beneficiaries: $100 million; 
Spending on total U.S. insured population: $130 million; 
Percentage spent on Medicare beneficiaries: 77.1%. 

2010 rank by total Medicare expenditures: 28; 
Brand name(s): Vidaza; 
Condition(s) treated: Myelodysplastic syndrome; 
Spending on Medicare beneficiaries: $187 million; 
Spending on total U.S. insured population: $245 million; 
Percentage spent on Medicare beneficiaries: 76.3%. 

2010 rank by total Medicare expenditures: 48; 
Brand name(s): Ventavis; 
Condition(s) treated: Pulmonary arterial hypertension; 
Spending on Medicare beneficiaries: $79 million; 
Spending on total U.S. insured population: $104 million; 
Percentage spent on Medicare beneficiaries: 76.1%. 

2010 rank by total Medicare expenditures: 19; 
Brand name(s): Venofer; 
Condition(s) treated: Anemia in chronic kidney disease patients; 
Spending on Medicare beneficiaries: $257 million; 
Spending on total U.S. insured population: $350 million; 
Percentage spent on Medicare beneficiaries: 73.5%. 

2010 rank by total Medicare expenditures: 8; 
Brand name(s): Epogen/Procrit (non-ESRD use); 
Condition(s) treated: Anemia in chemotherapy and HIV patients; prevent 
blood loss in surgical patients; 
Spending on Medicare beneficiaries: $443 million; 
Spending on total U.S. insured population: $609 million; 
Percentage spent on Medicare beneficiaries: 72.7%. 

2010 rank by total Medicare expenditures: 42; 
Brand name(s): Hectorol; 
Condition(s) treated: Hyperthyroidism in chronic kidney disease 
patients; 
Spending on Medicare beneficiaries: $105 million; 
Spending on total U.S. insured population: $150 million; 
Percentage spent on Medicare beneficiaries: 69.8%. 

2010 rank by total Medicare expenditures: 7; 
Brand name(s): Aranesp (non-ESRD use); 
Condition(s) treated: Anemia in chemotherapy patients; 
Spending on Medicare beneficiaries: $504 million; 
Spending on total U.S. insured population: $755 million; 
Percentage spent on Medicare beneficiaries: 66.7%. 

Source: GAO analysis of CMS, FDA, NIH, drug manufacturer, and IMS 
Health data. 

[A] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[End of table] 

Treatment of cancer and its side effects, autoimmune disorders and 
immunodeficiency, and chronic kidney disease were the most common uses 
of the 35 drugs for which Medicare spending was the majority of U.S. 
spending. Twenty-nine percent of these 35 drugs were biologicals, 
compared to 42 percent of all 55 drugs. 

Agency Comments: 

CMS provided us with technical comments, which we incorporated as 
appropriate. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies to the CMS 
Administrator and other interested congressional committees. In 
addition, the report will be available at no charge on the GAO website 
at [hyperlink, http://www.gao.gov]. 

If you or your staff have any questions regarding this report, please 
contact me at (202) 512-7114 or cosgrovej@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. Individuals making key contributions 
to this report include Phyllis Thorburn, Assistant Director; Zhi Boon; 
Linda Galib; and Andrew Johnson. 

Signed by: 

James C. Cosgrove: 
Director, Health Care: 

[End of section] 

Enclosure I: 

General Information on the 55 Highest-Expenditure Medicare Part B 
Drugs, 2010: 

Brand name(s): Abraxane; 
Drug description: Paclitaxel protein bound; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9264; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Alimta; 
Drug description: Pemetrexed injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9305; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Aloxi; 
Drug description: Palonosetron HCI; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2469; 
Classification: Drug; 
Condition(s) treated: Prevent nausea and vomiting in chemotherapy and 
surgical patients. 

Brand name(s): Aranesp (non-ESRD use)[B]; 
Drug description: Darbepoetin alfa, non-ESRD; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0881; 
Classification: Biological; 
Condition(s) treated: Anemia in chemotherapy patients. 

Brand name(s): Aranesp (ESRD use); 
Drug description: Darbepoetin alfa, ESRD; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0882; 
Classification: Biological; 
Condition(s) treated: Anemia in end-stage renal disease (ESRD) 
patients. 

Brand name(s): Avastin; 
Drug description: Bevacizumab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
C9257, J9035, Q2024; 
Classification: Biological; 
Condition(s) treated: Cancer; 
wet age-related macular degeneration (AMD). 

Brand name(s): Botox; 
Drug description: OnabotulinumtoxinA injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0585; 
Classification: Biological; 
Condition(s) treated: Various conditions. 

Brand name(s): Brovana; 
Drug description: Arformoterol non-comp unit; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7605; 
Classification: Drug; 
Condition(s) treated: Symptoms of chronic obstructive pulmonary 
disease. 

Brand name(s): Cellcept; 
Drug description: Mycophenolate mofetil oral; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7517; 
Classification: Drug; 
Condition(s) treated: Prevent transplant organ rejection; 
treat Crohn's disease. 

Brand name(s): Dacogen; 
Drug description: Decitabine injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0894; 
Classification: Drug; 
Condition(s) treated: Myelodysplastic syndrome. 

Brand name(s): Doxil; 
Drug description: Doxorubicin HCI liposome injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9001; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Drug description: Leuprolide acetate suspension; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9217; 
Classification: Drug; 
Condition(s) treated: Prostate cancer; 
various other conditions. 

Brand name(s): Eloxatin; 
Drug description: Oxaliplatin; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9263; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Epogen/Procrit (ESRD use); 
Drug description: Epoetin alfa, ESRD; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
Q4081; 
Classification: Biological; 
Condition(s) treated: Anemia in ESRD patients. 

Brand name(s): Epogen/Procrit (non-ESRD use); 
Drug description: Epoetin alfa, non-ESRD; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0885; 
Classification: Biological; 
Condition(s) treated: Anemia in chemotherapy and HIV patients; 
prevent blood loss in surgical patients. 

Brand name(s): Erbitux; 
Drug description: Cetuximab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9055; 
Classification: Biological; 
Condition(s) treated: Cancer. 

Brand name(s): Faslodex; 
Drug description: Fulvestrant injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9395; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Flebogamma, Flebogamma DIF; 
Drug description: Immune Globulin Intravenous (Human); 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1572; 
Classification: Biological; 
Condition(s) treated: Primary immunodeficiency. 

Brand name(s): Gammagard Liquid; 
Drug description: Immune Globulin Intravenous (Human); 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1569; 
Classification: Biological; 
Condition(s) treated: Primary humoral immunodeficiency; 
multifocal motor neuropathy. 

Brand name(s): Gamunex; 
Drug description: Immune Globulin Intravenous (Human); 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1561; 
Classification: Biological; 
Condition(s) treated: Primary humoral immunodeficiency; 
chronic inflammatory demyelinating polyneuropathy; 
idiopathic thrombocytopenic purpura. 

Brand name(s): Gemzar; 
Drug description: Gemcitabine HCI injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9201; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Hectorol; 
Drug description: Doxercalciferol injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1270; 
Classification: Drug; 
Condition(s) treated: Hyperthyroidism in chronic kidney disease 
patients. 

Brand name(s): Herceptin; 
Drug description: Trastuzumab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9355; 
Classification: Biological; 
Condition(s) treated: Cancer. 

Brand name(s): Hyalgan, Supartz; 
Drug description: Solution of sodium hyaluronate; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7321; 
Classification: Drug; 
Condition(s) treated: Osteoarthritis of the knee. 

Brand name(s): Hycamtin; 
Drug description: Topotecan injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9350, J9351; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Lexiscan; 
Drug description: Regadenoson injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
C9244, J2785; 
Classification: Drug; 
Condition(s) treated: Stress agent for myocardial perfusion imaging. 

Brand name(s): Lucentis; 
Drug description: Ranibizumab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2778; 
Classification: Biological; 
Condition(s) treated: Wet AMD. 

Brand name(s): Myfortic; 
Drug description: Mycophenolic acid; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7518; 
Classification: Drug; 
Condition(s) treated: Prevent transplant kidney rejection; 
treat Crohn's disease. 

Brand name(s): Neulasta; 
Drug description: Injection, pegfilgrastim 6mg; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2505; 
Classification: Biological; 
Condition(s) treated: Prevent infection in chemotherapy patients. 

Brand name(s): Neupogen; 
Drug description: Filgrastim injection, 300 and 480 mcg; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1440, J1441; 
Classification: Biological; 
Condition(s) treated: Prevent infection in cancer, bone marrow 
transplant, chronic neutropenia, and HIV patients; 
prepare blood for leukapheresis in chemotherapy patients. 

Brand name(s): Orencia; 
Drug description: Abatacept injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J0129; 
Classification: Biological; 
Condition(s) treated: Rheumatoid arthritis. 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Drug description: Pneumococcal vaccine; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
90732; 
Classification: Biological; 
Condition(s) treated: Prevent meningitis and pneumonia. 

Brand name(s): Primacor, Primacor in Dextrose; 
Drug description: Milrinone lactate 5 mg injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2260; 
Classification: Drug; 
Condition(s) treated: Acute decompensated heart failure. 

Brand name(s): Privigen; 
Drug description: Immune Globulin Intravenous (Human); 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1459, Q4097; 
Classification: Biological; 
Condition(s) treated: Primary humoral immunodeficiency; 
chronic immune thrombocytopenic purpura. 

Brand name(s): Prograf; 
Drug description: Tacrolimus oral per 1 MG; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7507; 
Classification: Drug; 
Condition(s) treated: Prevent organ transplant rejection; 
treat fistulizing Crohn's disease. 

Brand name(s): Pulmicort; 
Drug description: Budesonide non-comp unit; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7626; 
Classification: Drug; 
Condition(s) treated: Prevent wheezing, shortness of breath, and 
troubled breathing in asthma and lung disease patients. 

Brand name(s): Reclast; 
Drug description: Zoledronic acid; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J3488; 
Classification: Drug; 
Condition(s) treated: Osteoporosis prevention and treatment; 
treat Paget's disease of bone. 

Brand name(s): Remicade; 
Drug description: Infliximab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1745; 
Classification: Biological; 
Condition(s) treated: Various autoimmune disorders. 

Brand name(s): Remodulin; 
Drug description: Treprostinil injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J3285; 
Classification: Drug; 
Condition(s) treated: Pulmonary arterial hypertension. 

Brand name(s): Rituxan; 
Drug description: Rituximab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9310; 
Classification: Biological; 
Condition(s) treated: Cancer; 
rheumatoid arthritis. 

Brand name(s): Sandostatin Lar Depot; 
Drug description: Octreotide injection, depot; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2353; 
Classification: Drug; 
Condition(s) treated: Acromegaly; 
diarrhea and flushing caused by carcinoid tumors and vasoactive 
intestinal peptide secreting adenomas. 

Brand name(s): Synvisc, Synvisc-One; 
Drug description: Hylan GF 20; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7322, J7325; 
Classification: Drug; 
Condition(s) treated: Osteoarthritis of the knee. 

Brand name(s): Taxotere; 
Drug description: Docetaxel injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9170, J9171; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Treanda; 
Drug description: Bendamustine HCI injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
C9243, J9033; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Tysabri; 
Drug description: Natalizumab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2323; 
Classification: Biological; 
Condition(s) treated: Multiple sclerosis; 
Crohn's disease. 

Brand name(s): Various brand names; 
Drug description: Influenza vaccine; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
90655, 90656, 90657, 90658, 90662, Q2035, Q2036, Q2037, Q2038; 
Classification: Biological; 
Condition(s) treated: Prevent influenza. 

Brand name(s): Various brand names; 
Drug description: Factor viii recombinant; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J7192; 
Classification: Biological; 
Condition(s) treated: Hemophilia A. 

Brand name(s): Various brand names; 
Drug description: Immune globulin, powder; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1566; 
Classification: Biological; 
Condition(s) treated: Primary defective antibody synthesis; 
primary immunodeficiency diseases; 
B-cell chronic lymphocytic leukemia; 
idiopathic thrombocytopenic purpura; 
Kawasaki syndrome. 

Brand name(s): Velcade; 
Drug description: Bortezomib injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9041; 
Classification: Drug; 
Condition(s) treated: Cancer. 

Brand name(s): Venofer; 
Drug description: Iron sucrose injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J1756; 
Classification: Drug; 
Condition(s) treated: Iron deficiency anemia in chronic kidney disease 
patients. 

Brand name(s): Ventavis; 
Drug description: Iloprost non-comp unit dose; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
Q4074, Q4080; 
Classification: Drug; 
Condition(s) treated: Pulmonary arterial hypertension. 

Brand name(s): Vidaza; 
Drug description: Azacitidine injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J9025; 
Classification: Drug; 
Condition(s) treated: Myelodysplastic syndrome. 

Brand name(s): Xolair; 
Drug description: Omalizumab injection; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2357; 
Classification: Drug; 
Condition(s) treated: Asthma. 

Brand name(s): Zemplar; 
Drug description: Paricalcitol; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J2501; 
Classification: Drug; 
Condition(s) treated: Hyperparathyroidism in chronic kidney disease 
patients. 

Brand name(s): Zometa; 
Drug description: Zoledronic acid; 
Healthcare Common Procedure Classification System (HCPCS) code(s)[A]: 
J3487; 
Classification: Drug; 
Condition(s) treated: High calcium levels and bone disease in cancer 
patients. 

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data. 

[A] Healthcare Common Procedure Coding System (HCPCS) is a standard 
coding system developed to ensure that health care claims are 
processed in an orderly and consistent manner by Medicare and other 
health insurance programs. 

[B] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[End of table] 

[End of section] 

Enclosure II: 

Fifty-Five Highest-Expenditure Medicare B Drugs Ranked by Total 
Expenditures, Utilization, and Average Annual Per Beneficiary Cost, 
2010: 

Brand name(s): Epogen/Procrit (ESRD use)[A]; 
Total expenditures, 2010: 
Total: $2.000 billion; 
Rank by total Medicare expenditures: 1; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 323,920; 
Rank by beneficiary utilization: 5; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $6,175; 
Rank: by annual cost per beneficiary: 32. 

Brand name(s): Rituxan; 
Total expenditures, 2010: 
Total: $1.302 billion; 
Rank by total Medicare expenditures: 2; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 67,520; 
Rank by beneficiary utilization: 21; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $19,281; 
Rank: by annual cost per beneficiary: 11. 

Brand name(s): Lucentis; 
Total expenditures, 2010: 
Total: $1.180 billion; 
Rank by total Medicare expenditures: 3; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 115,760; 
Rank by beneficiary utilization: 17; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $10,196; 
Rank: by annual cost per beneficiary: 27. 

Brand name(s): Avastin; 
Total expenditures, 2010: 
Total: $1.130 billion; 
Rank by total Medicare expenditures: 4; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 171,560; 
Rank by beneficiary utilization: 8; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $6,585; 
Rank: by annual cost per beneficiary: 31. 

Brand name(s): Remicade; 
Total expenditures, 2010: 
Total: $900 million; 
Rank by total Medicare expenditures: 5; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 59,640; 
Rank by beneficiary utilization: 23; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $15,084; 
Rank: by annual cost per beneficiary: 20. 

Brand name(s): Neulasta; 
Total expenditures, 2010: 
Total: $888 million; 
Rank by total Medicare expenditures: 6; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 98,460; 
Rank by beneficiary utilization: 18; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $9,015; 
Rank: by annual cost per beneficiary: 28. 

Brand name(s): Aranesp (non-ESRD use); 
Total expenditures, 2010: 
Total: $504 million; 
Rank by total Medicare expenditures: 7; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 137,980; 
Rank by beneficiary utilization: 14; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $3,651; 
Rank: by annual cost per beneficiary: 38. 

Brand name(s): Epogen/Procrit (non-ESRD use); 
Total expenditures, 2010: 
Total: $443 million; 
Rank by total Medicare expenditures: 8; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 154,720; 
Rank by beneficiary utilization: 12; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $2,862; 
Rank: by annual cost per beneficiary: 40. 

Brand name(s): Alimta; 
Total expenditures, 2010: 
Total: $394 million; 
Rank by total Medicare expenditures: 9; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 20,740; 
Rank by beneficiary utilization: 31; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $18,990; 
Rank: by annual cost per beneficiary: 13. 

Brand name(s): Taxotere; 
Total expenditures, 2010: 
Total: $387 million; 
Rank by total Medicare expenditures: 10; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 44,560; 
Rank by beneficiary utilization: 28; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $8,690; 
Rank: by annual cost per beneficiary: 29. 

Brand name(s): Herceptin; 
Total expenditures, 2010: 
Total: $375 million; 
Rank by total Medicare expenditures: 11; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 14,540; 
Rank by beneficiary utilization: 35; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $25,797; 
Rank: by annual cost per beneficiary: 7. 

Brand name(s): Zometa; 
Total expenditures, 2010: 
Total: $350 million; 
Rank by total Medicare expenditures: 12; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 90,260; 
Rank by beneficiary utilization: 19; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $3,881; 
Rank: by annual cost per beneficiary: 37. 

Brand name(s): Gemzar; 
Total expenditures, 2010: 
Total: $349 million; 
Rank by total Medicare expenditures: 13; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 44,660; 
Rank by beneficiary utilization: 27; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $7,820; 
Rank: by annual cost per beneficiary: 30. 

Brand name(s): Zemplar; 
Total expenditures, 2010: 
Total: $324 million; 
Rank by total Medicare expenditures: 14; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 230,700; 
Rank by beneficiary utilization: 6; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,406; 
Rank: by annual cost per beneficiary: 46. 

Brand name(s): Velcade; 
Total expenditures, 2010: 
Total: $297 million; 
Rank by total Medicare expenditures: 15; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 15,120; 
Rank by beneficiary utilization: 34; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $19,667; 
Rank: by annual cost per beneficiary: 10. 

Brand name(s): Eloxatin; 
Total expenditures, 2010: 
Total: $290 million; 
Rank by total Medicare expenditures: 16; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 27,260; 
Rank by beneficiary utilization: 30; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $10,649; 
Rank: by annual cost per beneficiary: 26. 

Brand name(s): Erbitux; 
Total expenditures, 2010: 
Total: $275 million; 
Rank by total Medicare expenditures: 17; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 10,620; 
Rank by beneficiary utilization: 38; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $25,898; 
Rank: by annual cost per beneficiary: 5. 

Brand name(s): Prograf; 
Total expenditures, 2010: 
Total: $267 million; 
Rank by total Medicare expenditures: 18; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 61,280; 
Rank by beneficiary utilization: 22; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $4,351; 
Rank: by annual cost per beneficiary: 35. 

Brand name(s): Venofer; 
Total expenditures, 2010: 
Total: $257 million; 
Rank by total Medicare expenditures: 19; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 329,260; 
Rank by beneficiary utilization: 4; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $782; 
Rank: by annual cost per beneficiary: 50. 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Total expenditures, 2010: 
Total: $256 million; 
Rank by total Medicare expenditures: 20; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 159,700; 
Rank by beneficiary utilization: 11; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,600; 
Rank: by annual cost per beneficiary: 44. 

Brand name(s): Reclast; 
Total expenditures, 2010: 
Total: $245 million; 
Rank by total Medicare expenditures: 21; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 218,060; 
Rank by beneficiary utilization: 7; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,122; 
Rank: by annual cost per beneficiary: 48. 

Brand name(s): Pulmicort; 
Total expenditures, 2010: 
Total: $245 million; 
Rank by total Medicare expenditures: 22; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 142,440; 
Rank by beneficiary utilization: 13; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,717; 
Rank: by annual cost per beneficiary: 43. 

Brand name(s): Orencia; 
Total expenditures, 2010: 
Total: $240 million; 
Rank by total Medicare expenditures: 23; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 20,040; 
Rank by beneficiary utilization: 32; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $11,953; 
Rank: by annual cost per beneficiary: 24. 

Brand name(s): Sandostatin Lar Depot; 
Total expenditures, 2010: 
Total: $210 million; 
Rank by total Medicare expenditures: 24; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 9,220; 
Rank by beneficiary utilization: 40; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $22,748; 
Rank: by annual cost per beneficiary: 9. 

Brand name(s): Influenza Vaccine (various); 
Total expenditures, 2010: 
Total: $193 million; 
Rank by total Medicare expenditures: 25; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 15,229,920; 
Rank by beneficiary utilization: 1; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $13; 
Rank: by annual cost per beneficiary: 55. 

Brand name(s): Gammagard Liquid; 
Total expenditures, 2010: 
Total: $191 million; 
Rank by total Medicare expenditures: 26; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 10,880; 
Rank by beneficiary utilization: 37; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $17,543; 
Rank: by annual cost per beneficiary: 15. 

Brand name(s): Aloxi; 
Total expenditures, 2010: 
Total: $190 million; 
Rank by total Medicare expenditures: 27; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 164,000; 
Rank by beneficiary utilization: 10; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,161; 
Rank: by annual cost per beneficiary: 47. 

Brand name(s): Vidaza; 
Total expenditures, 2010: 
Total: $187 million; 
Rank by total Medicare expenditures: 28; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 8,160; 
Rank by beneficiary utilization: 43; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $22,957; 
Rank: by annual cost per beneficiary: 8. 

Brand name(s): Lexiscan; 
Total expenditures, 2010: 
Total: $181 million; 
Rank by total Medicare expenditures: 29; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 890,920; 
Rank by beneficiary utilization: 3; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $204; 
Rank: by annual cost per beneficiary: 53. 

Brand name(s): Treanda; 
Total expenditures, 2010: 
Total: $181 million; 
Rank by total Medicare expenditures: 30; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 9,440; 
Rank by beneficiary utilization: 39; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $19,218; 
Rank: by annual cost per beneficiary: 12. 

Brand name(s): Neupogen; 
Total expenditures, 2010: 
Total: $171 million; 
Rank by total Medicare expenditures: 31; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 53,020; 
Rank by beneficiary utilization: 24; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $3,232; 
Rank: by annual cost per beneficiary: 39. 

Brand name(s): Remodulin; 
Total expenditures, 2010: 
Total: $170 million; 
Rank by total Medicare expenditures: 32; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 1,300; 
Rank by beneficiary utilization: 53; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $130,772; 
Rank: by annual cost per beneficiary: 2. 

Brand name(s): Aranesp (ESRD use); 
Total expenditures, 2010: 
Total: $162 million; 
Rank by total Medicare expenditures: 33; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 31,800; 
Rank by beneficiary utilization: 29; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $5,086; 
Rank: by annual cost per beneficiary: 34. 

Brand name(s): Factor viii recombinant (various); 
Total expenditures, 2010: 
Total: $143 million; 
Rank by total Medicare expenditures: 34; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 660; 
Rank by beneficiary utilization: 55; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $216,833; 
Rank: by annual cost per beneficiary: 1. 

Brand name(s): Gamunex; 
Total expenditures, 2010: 
Total: $142 million; 
Rank by total Medicare expenditures: 35; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 8,420; 
Rank by beneficiary utilization: 42; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $16,862; 
Rank: by annual cost per beneficiary: 17. 

Brand name(s): Tysabri; 
Total expenditures, 2010: 
Total: $139 million; 
Rank by total Medicare expenditures: 36; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 7,340; 
Rank by beneficiary utilization: 46; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $18,978; 
Rank: by annual cost per beneficiary: 14. 

Brand name(s): Botox; 
Total expenditures, 2010: 
Total: $136 million; 
Rank by total Medicare expenditures: 37; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 67,860; 
Rank by beneficiary utilization: 20; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $2,008; 
Rank: by annual cost per beneficiary: 42. 

Brand name(s): Abraxane; 
Total expenditures, 2010: 
Total: $128 million; 
Rank by total Medicare expenditures: 38; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 7,520; 
Rank by beneficiary utilization: 44; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $16,989; 
Rank: by annual cost per beneficiary: 16. 

Brand name(s): Synvisc, Synvisc-One; 
Total expenditures, 2010: 
Total: $126 million; 
Rank by total Medicare expenditures: 39; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 168,560; 
Rank by beneficiary utilization: 9; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $746; 
Rank: by annual cost per beneficiary: 51. 

Brand name(s): Cellcept; 
Total expenditures, 2010: 
Total: $113 million; 
Rank by total Medicare expenditures: 40; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 48,740; 
Rank by beneficiary utilization: 25; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $2,322; 
Rank: by annual cost per beneficiary: 41. 

Brand name(s): Xolair; 
Total expenditures, 2010: 
Total: $110 million; 
Rank by total Medicare expenditures: 41; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 7,420; 
Rank by beneficiary utilization: 45; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $14,774; 
Rank: by annual cost per beneficiary: 21. 

Brand name(s): Hectorol; 
Total expenditures, 2010: 
Total: $105 million; 
Rank by total Medicare expenditures: 42; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 127,440; 
Rank by beneficiary utilization: 16; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $820; 
Rank: by annual cost per beneficiary: 49. 

Brand name(s): Doxil; 
Total expenditures, 2010: 
Total: $103 million; 
Rank by total Medicare expenditures: 43; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 9,160; 
Rank by beneficiary utilization: 41; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $11,195; 
Rank: by annual cost per beneficiary: 25. 

Brand name(s): Dacogen; 
Total expenditures, 2010: 
Total: $100 million; 
Rank by total Medicare expenditures: 44; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 3,860; 
Rank by beneficiary utilization: 51; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $25,858; 
Rank: by annual cost per beneficiary: 6. 

Brand name(s): Primacor, Primacor in Dextrose; 
Total expenditures, 2010: 
Total: $87 million; 
Rank by total Medicare expenditures: 45; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 1,380; 
Rank by beneficiary utilization: 52; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $62,790; 
Rank: by annual cost per beneficiary: 4. 

Brand name(s): Immune globulin, powder (various); 
Total expenditures, 2010: 
Total: $80 million; 
Rank by total Medicare expenditures: 46; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 6,120; 
Rank by beneficiary utilization: 47; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $13,139; 
Rank by annual cost per beneficiary: 22. 

Brand name(s): Myfortic; 
Total expenditures, 2010: 
Total: $80 million; 
Rank by total Medicare expenditures: 47; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 19,280; 
Rank by beneficiary utilization: 33; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $4,131; 
Rank by annual cost per beneficiary: 36. 

Brand name(s): Ventavis; 
Total expenditures, 2010: 
Total: $79 million; 
Rank by total Medicare expenditures: 48; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 940; 
Rank by beneficiary utilization: 54; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $84,205; 
Rank by annual cost per beneficiary: 3. 

Brand name(s): Privigen; 
Total expenditures, 2010: 
Total: $78 million; 
Rank by total Medicare expenditures: 49; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 5,100; 
Rank by beneficiary utilization: 49; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $15,335; 
Rank by annual cost per beneficiary: 19. 

Brand name(s): Hycamtin; 
Total expenditures, 2010: 
Total: $75 million; 
Rank by total Medicare expenditures: 50; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 5,840; 
Rank by beneficiary utilization: 48; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $12,768; 
Rank by annual cost per beneficiary: 23. 

Brand name(s): Pnuemovax-23, Pnu-Imune; 
Total expenditures, 2010: 
Total: $73 million; 
Rank by total Medicare expenditures: 51; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 1,692,940; 
Rank by beneficiary utilization: 2; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $43; 
Rank by annual cost per beneficiary: 54. 

Brand name(s): Brovana; 
Total expenditures, 2010: 
Total: $70 million; 
Rank by total Medicare expenditures: 52; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 45,920; 
Rank by beneficiary utilization: 26; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $1,528; 
Rank by annual cost per beneficiary: 45. 

Brand name(s): Faslodex; 
Total expenditures, 2010: 
Total: $70 million; 
Rank by total Medicare expenditures: 53; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 11,700; 
Rank by beneficiary utilization: 36; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $5,959; 
Rank by annual cost per beneficiary: 33. 

Brand name(s): Hyalgan, Supartz; 
Total expenditures, 2010: 
Total: $69 million; 
Rank by total Medicare expenditures: 54; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 132,620; 
Rank by beneficiary utilization: 15; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $520; 
Rank by annual cost per beneficiary: 52. 

Brand name(s): Flebogamma, Flebogamma DIF; 
Total expenditures, 2010: 
Total: $63 million; 
Rank by total Medicare expenditures: 55; 
Beneficiary utilization, 2010: 
Number of unique beneficiaries: 4,020; 
Rank by beneficiary utilization: 50; 
Per beneficiary cost, 2010: 
Average annual cost per beneficiary: $15,684; 
Rank by annual cost per beneficiary: 18. 

Source: GAO analysis of CMS and FDA data. 

[A] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[End of table] 

[End of section] 

Enclosure III: 

High-Expenditure Medicare Part B Drugs with Orphan Marketing 
Exclusivity during 2008 to 2010: 

2010 rank by total Medicare expenditures: 2; 
Brand name(s) of orphan drug: Rituxan; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
02-18-2010: Treatment of patients previously untreated for CD20-
positive chronic lymphocytic leukemia in combination with fludarbine 
and cyclophosphamide; 
04-19-2011: For the use of Rituxan (rituximab) in combination with 
glucocorticoids for the treatment of patients with Wegener's 
Granulomatosis and Microscopic Polyangiitis; 
Year(s) of orphan exclusivity expiration: 2017, 2018. 

2010 rank by total Medicare expenditures: 4; 
Brand name(s) of orphan drug: Avastin; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-05-2009: Treatment of glioblastoma with progressive disease 
following prior therapy; 
07-31-2009: Treatment of renal cell carcinoma in combination with 
interferon alfa; 
Year(s) of orphan exclusivity expiration: 2016. 

2010 rank by total Medicare expenditures: 5; 
Brand name(s) of orphan drug: Remicade; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-19-2006: For reducing signs and symptoms and inducing and 
maintaining clinical remission in pediatric patients with moderately 
to severely active Crohn's disease who have had an inadequate response 
to conventional therapy; 
09-23-2011" For reducing signs and symptoms and inducing and 
maintaining clinical remission in pediatric patients 6 years of age 
and older with moderately to severely active ulcerative colitis who 
have had an inadequate response to conventional therapy; 
Year(s) of orphan exclusivity expiration: 2013, 2018. 

2010 rank by total Medicare expenditures: 9; 
Brand name(s) of orphan drug: Alimta; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
02-04-2004: Treatment of patients with malignant pleural mesothelioma 
whose disease is either unresectable or who are otherwise not 
candidates for curative surgery; 
Year(s) of orphan exclusivity expiration: 2011. 

2010 rank by total Medicare expenditures: 11; 
Brand name(s) of orphan drug: Herceptin; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
10-20-2010: Treatment of patients with humana epidermal growth factor 
receptor 2 overexpressing metastatic gastric or gastroesophageal 
junction adenocarcinoma, who have not received prior treatment for 
metastatic disease; 
Year(s) of orphan exclusivity expiration: 2017. 

2010 rank by total Medicare expenditures: 12; 
Brand name(s) of orphan drug: Zometa; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
08-20-2001: Treatment of hypercalcemia of malignancy; 
Year(s) of orphan exclusivity expiration: 2008. 

2010 rank by total Medicare expenditures: 15; 
Brand name(s) of orphan drug: Velcade; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-13-2003: Treatment of multiple myeloma patients who have received 
at least two prior therapies and have demonstrated disease progression 
on the last therapy; 
12-08-2006: Treatment of patients with mantile cell lymphoma who have 
received at least one prior therapy; 
Year(s) of orphan exclusivity expiration: 2010, 2013. 

2010 rank by total Medicare expenditures: 17; 
Brand name(s) of orphan drug: Erbitux; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
03-01-2006: For use in combination with radiation therapy, for the 
treatment of locally or regionally advanced squamous cell carcinoma of 
the head and neck (SCCHN) and for use as a single agent for the 
treatment of patients with recurrent or metastatic SCCHN for whom 
prior platinum-based therapy has failed; 
Year(s) of orphan exclusivity expiration: 2013. 

2010 rank by total Medicare expenditures: 18; 
Brand name(s) of orphan drug: Prograf; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
03-29-2006: Prophylaxis of organ rejection in patients receiving 
allogenic heart transplants; 
Year(s) of orphan exclusivity expiration: 2013. 

2010 rank by total Medicare expenditures: 28; 
Brand name(s) of orphan drug: Vidaza; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-19-2004: Treatment of patients with the following myelodysplastic 
syndrome subtypes: refractory anemia or refractory anemia with ringed 
sideroblasts (if accompanied by neutropenia or thrombocytopenia and 
requiring transfusions), refractory anemia with excess blasts, 
refractory anemia with excess blasts in transformation, and chronic 
myelomonocytic leukemia; 
Year(s) of orphan exclusivity expiration: 2011. 

2010 rank by total Medicare expenditures: 30; 
Brand name(s) of orphan drug: Treanda; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
03-20-2008: Treatment of patients with chronic lymphocytic leukemia; 
Year(s) of orphan exclusivity expiration: 2015. 

2010 rank by total Medicare expenditures: 32; 
Brand name(s) of orphan drug: Remodulin; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-21-2002: Treatment of pulmonary arterial hypertension; 
Year(s) of orphan exclusivity expiration: 2009. 

2010 rank by total Medicare expenditures: 35; 
Brand name(s) of orphan drug: Gamunex; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
09-12-2008: Treatment of chronic inflammatory demyelinating 
polyneuropathy to improve neuromuscular disability and impairment and 
for maintenance therapy to prevent relapse; 
Year(s) of orphan exclusivity expiration: 2015. 

2010 rank by total Medicare expenditures: 43; 
Brand name(s) of orphan drug: Doxil; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-17-2007: For use in combination with bortezomib for the treatment 
of patients with multiple myeloma who have not previously received 
bortezomib and have at least one prior therapy; 
Year(s) of orphan exclusivity expiration: 2014. 

2010 rank by total Medicare expenditures: 44; 
Brand name(s) of orphan drug: Dacogen; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
05-02-2006: for treatment of patients with myelodysplastic syndromes 
(MDS) including previously treated and untreated, de novo and 
secondary MDS of all French-American-British subtypes (refractory 
anemia, refractory anemia with ringed sideroblasts, refractory anemia 
with excess blasts, refractory anemia with excess blasts in 
transformation, and chronic myelomonocytic leukemia) and intermediate-
1, intermediate-2, and high-risk International Prognostic Scoring 
System groups; 
Year(s) of orphan exclusivity expiration: 2013. 

2010 rank by total Medicare expenditures: 48; 
Brand name(s) of orphan drug: Ventavis; 
Orphan exclusivity in 2008-2010: Yes; 
Orphan exclusivity start date(s) and indication(s), 2008-present: 
12-29-2004: Treatment of pulmonary arterial hypertension in patients 
with symptoms of moderate or severe heart failure; 
Year(s) of orphan exclusivity expiration: 2011. 

Source: GAO analysis of CMS and FDA data. 

Note: Upon approval by FDA for specific orphan indications, orphan 
drugs receive marketing exclusivity for a period of 7 years. Other 
drugs in our analysis have been designated as orphan drugs by FDA, but 
did not have orphan marketing exclusivity at any point during 2008 to 
2010. In addition to the drugs listed above, one drug in our analysis, 
Gammagard Liquid, has an orphan exclusivity start date of June 22, 
2012, for an indication of maintenance therapy to improve muscle 
strength and disability in adult patients with multifocal motor 
neuropathy. 

[End of table] 

[End of section] 

Enclosure IV: 

Nine of the 55 Highest-Expenditure Medicare Part B Drugs with Generic 
Products Approved: 

2010 rank by total Medicare expenditures: 10; 
Brand name(s): Taxotere; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 3/8/2011[A]. 

2010 rank by total Medicare expenditures: 13; 
Brand name(s): Gemzar; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 11/15/2010. 

2010 rank by total Medicare expenditures: 14; 
Brand name(s): Zemplar; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 7/27/2011[A]. 

2010 rank by total Medicare expenditures: 16; 
Brand name(s): Eloxatin; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 8/7/2009. 

2010 rank by total Medicare expenditures: 18; 
Brand name(s): Prograf; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 8/10/2009. 

2010 rank by total Medicare expenditures: 22; 
Brand name(s): Pulmicort; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 11/18/2008. 

2010 rank by total Medicare expenditures: 40; 
Brand name(s): Cellcept; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 7/29/2008. 

2010 rank by total Medicare expenditures: 45; 
Brand name(s): Primacor, Primacor in Dextrose; 
Generic version approved by FDA: Yes (however, some versions of this 
drug are listed as discontinued); 
Date of first generic approval: 5/28/2002. 

2010 rank by total Medicare expenditures: 50; 
Brand name(s): Hycamtin; 
Generic version approved by FDA: Yes; 
Date of first generic approval: 11/29/2010. 

Source: GAO analysis of CMS and FDA data. 

Notes: The date of first generic approval does not necessarily 
indicate the date on which a generic version was available on the 
market. 

[A] A generic version was approved after 2010, the most recent year of 
our analysis. 

[End of table] 

[End of section] 

Enclosure V: 

Fifty-Five Highest-Expenditure Medicare Part B Drugs Ranked Highest to 
Lowest by Change in Expenditures, Change in Number of Beneficiaries, 
and Change in Average Price, 2008 to 2010: 

Change in expenditures, 2008-2010: 

Brand name(s): Lexiscan; 
Percent change: 9,550.4%; 

Brand name(s): Treanda; 
Percent change: 7,440.2%; 

Brand name(s): Privigen; 
Percent change: 836.3; 

Brand name(s): Reclast; 
Percent change: 140.7%; 

Brand name(s): Myfortic; 
Percent change: 106.9%; 

Brand name(s): Primacor, Primacor in Dextrose; 
Percent change: 94.0%; 

Brand name(s): Ventavis; 
Percent change: 93.6%; 

Brand name(s): Vidaza; 
Percent change: 81.9%; 

Brand name(s): Gammagard Liquid; 
Percent change: 69.2%; 

Brand name(s): Orencia; 
Percent change: 66.9%; 

Brand name(s): Gamunex; 
Percent change: 66.5%; 

Brand name(s): Flebogamma, Flebogamma DIF; 
Percent change: 62.3%; 

Brand name(s): Velcade; 
Percent change: 56.9%; 

Brand name(s): Lucentis; 
Percent change: 56.6%; 

Brand name(s): Xolair; 
Percent change: 55.8%; 

Brand name(s): Tysabri; 
Percent change: 50.5%; 

Brand name(s): Alimta; 
Percent change: 49.7%; 

Brand name(s): Brovana; 
Percent change: 48.0%; 

Brand name(s): Hectorol; 
Percent change: 47.1%; 

Brand name(s): Remodulin; 
Percent change: 40.7%; 

Brand name(s): Synvisc, Synvisc-One; 
Percent change: 36.0%; 

Brand name(s): Venofer; 
Percent change: 33.4%; 

Brand name(s): Sandostatin Lar Depot; 
Percent change: 29.2%; 

Brand name(s): Faslodex; 
Percent change: 27.7%; 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Percent change: 26.1%; 

Brand name(s): Dacogen; 
Percent change: 24.6%; 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Percent change: 24.3%; 

Brand name(s): Herceptin; 
Percent change: 22.1%; 

Brand name(s): Botox; 
Percent change: 20.8%; 

Brand name(s): Abraxane; 
Percent change: 20.4%; 

Brand name(s): Aloxi; 
Percent change: 18.7%; 

Brand name(s): Doxil; 
Percent change: 16.9%; 

Brand name(s): Avastin; 
Percent change: 15.5%; 

Brand name(s): Epogen/Procrit (ESRD use); 
Percent change: 11.6%; 

Brand name(s): Rituxan; 
Percent change: 8.7%; 

Brand name(s): Remicade; 
Percent change: 8.6%; 

Brand name(s): Gemzar; 
Percent change: 8.5%; 

Brand name(s): Neulasta; 
Percent change: 6.5%; 

Brand name(s): Zometa; 
Percent change: 6.0%; 

Brand name(s): Hycamtin; 
Percent change: 5.1%; 

Brand name(s): Neupogen; 
Percent change: 3.8%; 

Brand name(s): Prograf; 
Percent change: 0.3%; 

Brand name(s): Influenza Vaccine (various); 
Percent change: -0.6%; 

Brand name(s): Erbitux; 
Percent change: -2.7%; 

Brand name(s): Taxotere; 
Percent change: -4.2%; 

Brand name(s): Epogen/Procrit (non-ESRD use); 
Percent change: -6.4%; 

Brand name(s): Aranesp (ESRD use); 
Percent change: -9.1%; 

Brand name(s): Zemplar; 
Percent change: -16.2%; 

Brand name(s): Pulmicort; 
Percent change: -16.5%; 

Brand name(s): Hyalgan, Supartz; 
Percent change: -17.4%; 

Brand name(s): Aranesp (non-ESRD use); 
Percent change: -27.8%; 

Brand name(s): Immune globulin, powder (various); 
Percent change: -28.1%; 

Brand name(s): Eloxatin; 
Percent change: -39.5%; 

Brand name(s): Cellcept; 
Percent change: -40.3%; 

Brand name(s): Factor viii recombinant (various)[G]; 
Percent change: N/A. 

Change in beneficiaries, 2008-2010: 

Brand name(s): Lexiscan; 
Percent change: 11,008.7%; 

Brand name(s): Treanda; 
Percent change: 3,271.4%; 

Brand name(s): Privigen; 
Percent change: 381.1%; 

Brand name(s): Reclast; 
Percent change: 136.8%; 

Brand name(s): Myfortic; 
Percent change: 73.4%; 

Brand name(s): Hectorol; 
Percent change: 71.1%; 

Brand name(s): Flebogamma, Flebogamma DIF; 
Percent change: 46.7%; 

Brand name(s): Orencia; 
Percent change: 45.4%; 

Brand name(s): Vidaza; 
Percent change: 41.7%; 

Brand name(s): Gamunex; 
Percent change: 36.7%; 

Brand name(s): Velcade; 
Percent change: 35.5%; 

Brand name(s): Tysabri; 
Percent change: 34.9%; 

Brand name(s): Gammagard Liquid; 
Percent change: 32.0%; 

Brand name(s): Alimta; 
Percent change: 30.3%; 

Brand name(s): Lucentis; 
Percent change: 29.6%; 

Brand name(s): Brovana; 
Percent change: 28.8%; 

Brand name(s): Synvisc, Synvisc-One; 
Percent change: 27.8%; 

Brand name(s): Primacor, Primacor in Dextrose; 
Percent change: 27.8%; 

Brand name(s): Venofer; 
Percent change: 27.0%; 

Brand name(s): Sandostatin Lar Depot; 
Percent change: 22.9%; 

Brand name(s): Remodulin; 
Percent change: 22.6%; 

Brand name(s): Xolair; 
Percent change: 20.5%; 

Brand name(s): Prograf; 
Percent change: 19.5%; 

Brand name(s): Abraxane; 
Percent change: 16.8%; 

Brand name(s): Avastin; 
Percent change: 14.0%; 

Brand name(s): Zemplar; 
Percent change: 8.6%; 

Brand name(s): Aloxi; 
Percent change: 7.2%; 

Brand name(s): Botox; 
Percent change: 6.7%; 

Brand name(s): Epogen/Procrit (ESRD use); 
Percent change: 6.0%; 

Brand name(s): Influenza Vaccine (various); 
Percent change: 5.6%; 

Brand name(s): Herceptin; 
Percent change: 4.3%; 

Brand name(s): Zometa; 
Percent change: 4.3%; 

Brand name(s): Cellcept; 
Percent change: 2.8%; 

Brand name(s): Rituxan; 
Percent change: 2.8%; 

Brand name(s): Eloxatin; 
Percent change: 0.5%; 

Brand name(s): Aranesp (ESRD use); 
Percent change: 0.0%; 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Percent change: -0.5%; 

Brand name(s): Gemzar; 
Percent change: -0.8%; 

Brand name(s): Faslodex; 
Percent change: -1.5%; 

Brand name(s): Remicade; 
Percent change: -2.3%; 

Brand name(s): Doxil; 
Percent change: -2.3%; 

Brand name(s): Dacogen; 
Percent change: -3.0%; 

Brand name(s): Taxotere; 
Percent change: -4.1%; 

Brand name(s): Neulasta; 
Percent change: -4.9%; 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Percent change: -5.5%; 

Brand name(s): Neupogen; 
Percent change: -5.5%; 

Brand name(s): Ventavis; 
Percent change: -7.8%; 

Brand name(s): Pulmicort; 
Percent change: -9.3%; 

Brand name(s): Hycamtin; 
Percent change: -12.0%; 

Brand name(s): Hyalgan, Supartz; 
Percent change: -12.8%; 

Brand name(s): Erbitux; 
Percent change: -14.4%; 

Brand name(s): Epogen/Procrit, (non-ESRD use); 
Percent change: -17.4%; 

Brand name(s): Immune globulin, powder (various); 
Percent change: -32.5%; 

Brand name(s): Aranesp (non-ESRD use); 
Percent change: -33.6%; 

Brand name(s): Factor viii recombinant (various)[G]; 
Percent change: N/A. 

Changes in average price 2008-2010[A]: 

Brand name(s): Ventavis; 
Percent change: 51.5%; 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Percent change: 36.0%; 

Brand name(s): Myfortic; 
Percent change: 22.0%; 

Brand name(s): Hycamtin; 
Percent change: 17.5%; 

Brand name(s): Gammagard Liquid; 
Percent change: 15.4%; 

Brand name(s): Doxil; 
Percent change: 14.1%; 

Brand name(s): Tysabri; 
Percent change: 12.3%; 

Brand name(s): Vidaza; 
Percent change: 11.6%; 

Brand name(s): Gamunex; 
Percent change: 11.3%; 

Brand name(s): Xolair; 
Percent change: 11.2%; 

Brand name(s): Velcade; 
Percent change: 11.1%; 

Brand name(s): Neulasta; 
Percent change: 11.1%; 

Brand name(s): Rituxan; 
Percent change: 11.0%; 

Brand name(s): Hectorol; 
Percent change: 10.6%; 

Brand name(s): Herceptin; 
Percent change: 10.5%; 

Brand name(s): Gemzar; 
Percent change: 10.0%; 

Brand name(s): Dacogen; 
Percent change: 9.7%; 

Brand name(s): Alimta; 
Percent change: 9.5%; 

Brand name(s): Taxotere[B]; 
Percent change: 9.2%; 

Brand name(s): Aloxi; 
Percent change: 8.6%; 

Brand name(s): Flebogamma, Flebogamma DIF; 
Percent change: 7.7%; 

Brand name(s): Sandostatin Lar Depot; 
Percent change: 7.1%; 

Brand name(s): Immune globulin, powder (various); 
Percent change: 6.9%; 

Brand name(s): Abraxane; 
Percent change: 6.4%; 

Brand name(s): Orencia; 
Percent change: 6.3%; 

Brand name(s): Remicade; 
Percent change: 6.3%; 

Brand name(s): Brovana; 
Percent change: 6.0%; 

Brand name(s): Epogen/Procrit (non-ESRD use)[C]; 
Percent change: 5.9%; 

Brand name(s): Epogen/Procrit (ESRD use); 
Percent change: 5.8%; 

Brand name(s): Pulmicort; 
Percent change: 5.5%; 

Brand name(s): Zometa; 
Percent change: 4.7%; 

Brand name(s): Privigen; 
Percent change: 3.8%; 

Brand name(s): Botox; 
Percent change: 3.4%; 

Brand name(s): Lexiscan[D]; 
Percent change: 2.8%; 

Brand name(s): Reclast; 
Percent change: 2.6%; 

Brand name(s): Venofer; 
Percent change: 2.4%; 

Brand name(s): Factor viii recombinant (various); 
Percent change: 2.1%; 

Brand name(s): Faslodex; 
Percent change: 1.6%; 

Brand name(s): Aranesp (non-ESRD use); 
Percent change: 1.1%; 

Brand name(s): Aranesp (ESRD use); 
Percent change: 1.1%; 

Brand name(s): Remodulin; 
Percent change: 1.0%; 

Brand name(s): Avastin[E]; 
Percent change: 1.0%; 

Brand name(s): Erbitux; 
Percent change: -0.1%; 

Brand name(s): Lucentis; 
Percent change: -0.1%; 

Brand name(s): Treanda[D]; 
Percent change: -0.4%; 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Percent change: -0.5%; 

Brand name(s): Zemplar; 
Percent change: -7.4%; 

Brand name(s): Hyalgan, Supartz; 
Percent change: -9.0%; 

Brand name(s): Prograf; 
Percent change: -13.4%; 

Brand name(s): Primacor, Primacor in Dextrose; 
Percent change: -17.6%; 

Brand name(s): Cellcept; 
Percent change: -38.1%; 

Brand name(s): Eloxatin; 
Percent change: -38.2%; 

Brand name(s): Influenza Vaccine (various)[F]; 
Percent change: N/A; 

Brand name(s): Neupogen[F]; 
Percent change: N/A; 

Brand name(s): Synvisc, Synvisc-One[F]; 
Percent change: N/A. 

Source: GAO analysis of CMS and FDA data. 

Notes: Our analysis excludes expenditures and utilization in 2008 that 
were reported using a not otherwise classified code, which may have 
had an impact on our analysis of new drugs, including Lexiscan and 
Treanda. 

[A] The change in price analysis was based on the unweighted average 
ASP across four quarters in each year, and does not include prices for 
drugs when supplied through infusion equipment. 

[B] Our analysis of the change in average price for Taxotere includes 
an adjustment for a change in dosage between 2008 and 2010. 

[C] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[D] Our analysis of changes in price for Lexiscan and Treanda only 
includes changes from 2009-2010 as 2008 ASP information was not 
available. 

[E] Our analysis of Avastin only includes changes in price for 
Healthcare Common Procedure Classification System (HCPCS) code J9035 
due to dosage differences for other codes used to identify Avastin. 
Code J9035 accounted for the vast majority of Avastin expenditures in 
2010. 

[F] Change in average price could not be analyzed for the influenza 
vaccine, Neupogen, or Synvisc/Synvisc-One because the multiple HCPCS 
codes that are associated with these drugs have different units or 
dosage amounts. 

[G] We removed factor viii recombinant from our analysis of change in 
expenditures from 2008-2010 because we were not confident that the 
expenditures for 2008 were valid. 

[End of table] 

[End of section] 

Enclosure VI: 

Fifty-Five Highest-Expenditure Medicare Part B Drugs by Percentage 
Spent on Medicare Beneficiaries, 2010: 

Brand name(s): Myfortic; 
Condition(s) treated: Prevent transplant kidney rejection; 
treat Crohn's disease; 
Spending on Medicare beneficiaries: $80 million; 
Spending on total U.S. insured population: $86 million; 
Percent spent on Medicare beneficiaries: 92.2%; 
2010 rank by total Medicare expenditures: 47. 

Brand name(s): Prograf; 
Condition(s) treated: Prevent transplant organ rejection; 
treat fistulizing Crohn's disease; 
Spending on Medicare beneficiaries: $267 million; 
Spending on total U.S. insured population: $290 million; 
Percent spent on Medicare beneficiaries: 92.1%; 
2010 rank by total Medicare expenditures: 18. 

Brand name(s): Brovana; 
Condition(s) treated: Symptoms of chronic obstructive pulmonary 
disease; 
Spending on Medicare beneficiaries: $70 million; 
Spending on total U.S. insured population: $77 million; 
Percent spent on Medicare beneficiaries: 91.3%; 
2010 rank by total Medicare expenditures: 52. 

Brand name(s): Pulmicort; 
Condition(s) treated: Prevent wheezing, shortness of breath, and 
troubled breathing in asthma and lung disease patients; 
Spending on Medicare beneficiaries: $245 million; 
Spending on total U.S. insured population: 273 million; 
Percent spent on Medicare beneficiaries: 89.6%; 
2010 rank by total Medicare expenditures: 22. 

Brand name(s): Aranesp (ESRD use); 
Condition(s) treated: Anemia in end-stage renal disease (ESRD) 
patients[A]; 
Spending on Medicare beneficiaries: $162 million; 
Spending on total U.S. insured population: $182 million; 
Percent spent on Medicare beneficiaries: 88.7%; 
2010 rank by total Medicare expenditures: 33. 

Brand name(s): Primacor, Primacor in Dextrose; 
Condition(s) treated: Acute decompensated heart failure; 
Spending on Medicare beneficiaries: $87 million; 
Spending on total U.S. insured population: $101 million; 
Percent spent on Medicare beneficiaries: 85.6%; 
2010 rank by total Medicare expenditures: 45. 

Brand name(s): Cellcept; 
Condition(s) treated: Prevent transplant organ rejection; 
treat Crohn's disease; 
Spending on Medicare beneficiaries: $113 million; 
Spending on total U.S. insured population: $133 million; 
Percent spent on Medicare beneficiaries: 84.9%; 
2010 rank by total Medicare expenditures: 40. 

Brand name(s): Epogen/Procrit (ESRD use); 
Condition(s) treated: Anemia in ESRD patients; 
Spending on Medicare beneficiaries: $2.000 billion; 
Spending on total U.S. insured population: $2.381 billion; 
Percent spent on Medicare beneficiaries: 84.0%; 
2010 rank by total Medicare expenditures: 1. 

Brand name(s): Zemplar; 
Condition(s) treated: Hyperparathyroidism in chronic kidney disease 
patients; 
Spending on Medicare beneficiaries: $324 million; 
Spending on total U.S. insured population: $389 million; 
Percent spent on Medicare beneficiaries: 83.3%; 
2010 rank by total Medicare expenditures: 14. 

Brand name(s): Lucentis; 
Condition(s) treated: Wet age-related macular degeneration (AMD); 
Spending on Medicare beneficiaries: $1.180 billion; 
Spending on total U.S. insured population: $1.486 billion; 
Percent spent on Medicare beneficiaries: 79.5%; 
2010 rank by total Medicare expenditures: 3. 

Brand name(s): Dacogen; 
Condition(s) treated: Myelodysplastic syndrome; 
Spending on Medicare beneficiaries: $100 million; 
Spending on total U.S. insured population: $130 million; 
Percent spent on Medicare beneficiaries: 77.1%; 
2010 rank by total Medicare expenditures: 44. 

Brand name(s): Vidaza; 
Condition(s) treated: Myelodysplastic syndrome; 
Spending on Medicare beneficiaries: $187 million; 
Spending on total U.S. insured population: $245 million; 
Percent spent on Medicare beneficiaries: 76.3%; 
2010 rank by total Medicare expenditures: 28. 

Brand name(s): Ventavis; 
Condition(s) treated: Pulmonary arterial hypertension; 
Spending on Medicare beneficiaries: $79 million; 
Spending on total U.S. insured population: $104 million; 
Percent spent on Medicare beneficiaries: 76.1%; 
2010 rank by total Medicare expenditures: 48. 

Brand name(s): Venofer; 
Condition(s) treated: Iron deficiency anemia in chronic kidney disease 
patients; 
Spending on Medicare beneficiaries: $257 million; 
Spending on total U.S. insured population: $350 million; 
Percent spent on Medicare beneficiaries: 73.5%; 
2010 rank by total Medicare expenditures: 19. 

Brand name(s): Epogen/Procrit (non-ESRD use); 
Condition(s) treated: Anemia in chemotherapy and HIV patients; 
prevent blood loss in surgical patients; 
Spending on Medicare beneficiaries: $443 million; 
Spending on total U.S. insured population: $609 million; 
Percent spent on Medicare beneficiaries: 72.7%; 
2010 rank by total Medicare expenditures: 8. 

Brand name(s): Hectorol; 
Condition(s) treated: Hyperthyroidism in chronic kidney disease 
patients; 
Spending on Medicare beneficiaries: $105 million; 
Spending on total U.S. insured population: $150 million; 
Percent spent on Medicare beneficiaries: 69.8%; 
2010 rank by total Medicare expenditures: 42. 

Brand name(s): Aranesp (non-ESRD use); 
Condition(s) treated: Anemia in chemotherapy patients; 
Spending on Medicare beneficiaries: $504 million; 
Spending on total U.S. insured population: $755 million; 
Percent spent on Medicare beneficiaries: 66.7%; 
2010 rank by total Medicare expenditures: 7. 

Brand name(s): Eligard, Lupron Depot, Lupron Depot-PED; 
Condition(s) treated: Prostate cancer; 
various other conditions; 
Spending on Medicare beneficiaries: $256 million; 
Spending on total U.S. insured population: $410 million; 
Percent spent on Medicare beneficiaries: 62.4%; 
2010 rank by total Medicare expenditures: 20. 

Brand name(s): Lexiscan; 
Condition(s) treated: Stress agent for myocardial perfusion imaging; 
Spending on Medicare beneficiaries: $181 million; 
Spending on total U.S. insured population: $299 million; 
Percent spent on Medicare beneficiaries: 60.7%; 
2010 rank by total Medicare expenditures: 29. 

Brand name(s): Reclast; 
Condition(s) treated: Osteoporosis prevention and treatment; 
treat Paget's disease of bone; 
Spending on Medicare beneficiaries: $245 million; 
Spending on total U.S. insured population: $408 million; 
Percent spent on Medicare beneficiaries: 60.0%; 
2010 rank by total Medicare expenditures: 21. 

Brand name(s): Faslodex; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $70 million; 
Spending on total U.S. insured population: $117 million; 
Percent spent on Medicare beneficiaries: 59.6%; 
2010 rank by total Medicare expenditures: 53. 

Brand name(s): Alimta; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $394 million; 
Spending on total U.S. insured population: $673 million; 
Percent spent on Medicare beneficiaries: 58.5%; 
2010 rank by total Medicare expenditures: 9. 

Brand name(s): Treanda; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $181 million; 
Spending on total U.S. insured population: $313 million; 
Percent spent on Medicare beneficiaries: 58.0%; 
2010 rank by total Medicare expenditures: 30. 

Brand name(s): Velcade; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $297 million; 
Spending on total U.S. insured population: $527 million; 
Percent spent on Medicare beneficiaries: 56.5%; 
2010 rank by total Medicare expenditures: 15. 

Brand name(s): Zometa; 
Condition(s) treated: High calcium levels and bone disease in cancer 
patients; 
Spending on Medicare beneficiaries: $350 million; 
Spending on total U.S. insured population: $630 million; 
Percent spent on Medicare beneficiaries: 55.6%; 
2010 rank by total Medicare expenditures: 12. 

Brand name(s): Erbitux; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $275 million; 
Spending on total U.S. insured population: $495 million; 
Percent spent on Medicare beneficiaries: 55.5%; 
2010 rank by total Medicare expenditures: 17. 

Brand name(s): Gemzar; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $349 million; 
Spending on total U.S. insured population: $629 million; 
Percent spent on Medicare beneficiaries: 55.5%; 
2010 rank by total Medicare expenditures: 13. 

Brand name(s): Neupogen; 
Condition(s) treated: Prevent infection in cancer, bone marrow 
transplant, chronic neutropenia, and HIV patients; 
prepare blood for leukapheresis in chemotherapy patients; 
Spending on Medicare beneficiaries: $171 million; 
Spending on total U.S. insured population: $309 million; 
Percent spent on Medicare beneficiaries: 55.5%; 
2010 rank by total Medicare expenditures: 31. 

Brand name(s): Hycamtin; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $75 million; 
Spending on total U.S. insured population: $134 million; 
Percent spent on Medicare beneficiaries: 55.5%; 
2010 rank by total Medicare expenditures: 50. 

Brand name(s): Remodulin; 
Condition(s) treated: Pulmonary arterial hypertension; 
Spending on Medicare beneficiaries: $170 million; 
Spending on total U.S. insured population: $308 million; 
Percent spent on Medicare beneficiaries: 55.1%; 
2010 rank by total Medicare expenditures: 32. 

Brand name(s): Doxil; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $103 million; 
Spending on total U.S. insured population: $188 million; 
Percent spent on Medicare beneficiaries: 54.4%; 
2010 rank by total Medicare expenditures: 43. 

Brand name(s): Pneumovax 23, Pnu-Imune; 
Condition(s) treated: Prevent meningitis and pneumonia; 
Spending on Medicare beneficiaries: $73 million; 
Spending on total U.S. insured population: $135 million; 
Percent spent on Medicare beneficiaries: 54.2%; 
2010 rank by total Medicare expenditures: 51. 

Brand name(s): Rituxan; 
Condition(s) treated: Cancer; 
rheumatoid arthritis; 
Spending on Medicare beneficiaries: $1.302 billion; 
Spending on total U.S. insured population: $2.490 billion; 
Percent spent on Medicare beneficiaries: 52.3%; 
2010 rank by total Medicare expenditures: 2. 

Brand name(s): Sandostatin Lar Depot; 
Condition(s) treated: Acromegaly; 
diarrhea and flushing caused by carcinoid tumors and vasoactive 
intestinal peptide secreting adenomas; 
Spending on Medicare beneficiaries: $210 million; 
Spending on total U.S. insured population: $403 million; 
Percent spent on Medicare beneficiaries: 52.1%; 
2010 rank by total Medicare expenditures: 24. 

Brand name(s): Flebogamma, Flebogamma DIF; 
Condition(s) treated: Primary immunodeficiency; 
Spending on Medicare beneficiaries: $63 million; 
Spending on total U.S. insured population: $124 million; 
Percent spent on Medicare beneficiaries: 50.7%; 
2010 rank by total Medicare expenditures: 55. 

Brand name(s): Avastin; 
Condition(s) treated: Cancer; wet AMD; 
Spending on Medicare beneficiaries: $1.130 billion; 
Spending on total U.S. insured population: $2.527 billion; 
Percent spent on Medicare beneficiaries: 44.7%; 
2010 rank by total Medicare expenditures: 4. 

Brand name(s): Abraxane; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $128 million; 
Spending on total U.S. insured population: $289 million; 
Percent spent on Medicare beneficiaries: 44.2%; 
2010 rank by total Medicare expenditures: 38. 

Brand name(s): Hyalgan, Supartz; 
Condition(s) treated: Osteoarthritis of the knee; 
Spending on Medicare beneficiaries: $69 million; 
Spending on total U.S. insured population: $159 million; 
Percent spent on Medicare beneficiaries: 43.4%; 
2010 rank by total Medicare expenditures: 54. 

Brand name(s): Orencia; 
Condition(s) treated: Rheumatoid arthritis; 
Spending on Medicare beneficiaries: $240 million; 
Spending on total U.S. insured population: $564 million; 
Percent spent on Medicare beneficiaries: 42.4%; 
2010 rank by total Medicare expenditures: 23. 

Brand name(s): Synvisc, Synvisc-One; 
Condition(s) treated: Osteoarthritis of the knee; 
Spending on Medicare beneficiaries: $126 million; 
Spending on total U.S. insured population: $314 million; 
Percent spent on Medicare beneficiaries: 40.0%; 
2010 rank by total Medicare expenditures: 39. 

Brand name(s): Neulasta; 
Condition(s) treated: Prevent infection in chemotherapy patients; 
Spending on Medicare beneficiaries: $888 million; 
Spending on total U.S. insured population: $2.254 billion; 
Percent spent on Medicare beneficiaries: 39.4%; 
2010 rank by total Medicare expenditures: 6. 

Brand name(s): Taxotere; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $387 million; 
Spending on total U.S. insured population: $1.041 billion; 
Percent spent on Medicare beneficiaries: 37.2%; 
2010 rank by total Medicare expenditures: 10. 

Brand name(s): Privigen; 
Condition(s) treated: Primary humoral immunodeficiency; 
chronic immune thrombocytopenic purpura; 
Spending on Medicare beneficiaries: $78 million; 
Spending on total U.S. insured population: $224 million; 
Percent spent on Medicare beneficiaries: 34.9%; 
2010 rank by total Medicare expenditures: 49. 

Brand name(s): Aloxi; 
Condition(s) treated: Prevent nausea and vomiting in chemotherapy and 
surgical patients; 
Spending on Medicare beneficiaries: $190 million; 
Spending on total U.S. insured population: $553 million; 
Percent spent on Medicare beneficiaries: 34.4%; 
2010 rank by total Medicare expenditures: 27. 

Brand name(s): Immune globulin, powder (various); 
Condition(s) treated: Primary defective antibody synthesis; 
primary immunodeficiency diseases; B-cell chronic lymphocytic leukemia; 
idiopathic thrombocytopenic purpura; Kawasaki syndrome; 
Spending on Medicare beneficiaries: $80 million; 
Spending on total U.S. insured population: $234 million; 
Percent spent on Medicare beneficiaries: 34.4%; 
2010 rank by total Medicare expenditures: 46. 

Brand name(s): Eloxatin; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $290 million; 
Spending on total U.S. insured population: $868 million; 
Percent spent on Medicare beneficiaries: 33.4%; 
2010 rank by total Medicare expenditures: 16. 

Brand name(s): Influenza Vaccine (various); 
Condition(s) treated: Prevent influenza; 
Spending on Medicare beneficiaries: $193 million; 
Spending on total U.S. insured population: $603 million; 
Percent spent on Medicare beneficiaries: 32.0%; 
2010 rank by total Medicare expenditures: 25. 

Brand name(s): Botox; 
Condition(s) treated: Various conditions; 
Spending on Medicare beneficiaries: $136 million; 
Spending on total U.S. insured population: $429 million; 
Percent spent on Medicare beneficiaries: 31.8%; 
2010 rank by total Medicare expenditures: 37. 

Brand name(s): Herceptin; 
Condition(s) treated: Cancer; 
Spending on Medicare beneficiaries: $375 million; 
Spending on total U.S. insured population: $1.257 billion; 
Percent spent on Medicare beneficiaries: 29.8%; 
2010 rank by total Medicare expenditures: 11. 

Brand name(s): Gamunex; 
Condition(s) treated: Primary humoral immunodeficiency; 
chronic inflammatory demyelinating polyneuropathy; 
idiopathic thrombocytopenic purpura; 
Spending on Medicare beneficiaries: $142 million; 
Spending on total U.S. insured population: $481 million; 
Percent spent on Medicare beneficiaries: 29.5%; 
2010 rank by total Medicare expenditures: 35. 

Brand name(s): Xolair; 
Condition(s) treated: Asthma; 
Spending on Medicare beneficiaries: $110 million; 
Spending on total U.S. insured population: $374 million; 
Percent spent on Medicare beneficiaries: 29.3%; 
2010 rank by total Medicare expenditures: 41. 

Brand name(s): Remicade; 
Condition(s) treated: Various autoimmune disorders; 
Spending on Medicare beneficiaries: $900 million; 
Spending on total U.S. insured population: $3.229 billion; 
Percent spent on Medicare beneficiaries: 27.9%; 
2010 rank by total Medicare expenditures: 5. 

Brand name(s): Factor viii recombinant (various); 
Condition(s) treated: Hemophilia A; 
Spending on Medicare beneficiaries: $143 million; 
Spending on total U.S. insured population: $526 million; 
Percent spent on Medicare beneficiaries: 27.2%; 
2010 rank by total Medicare expenditures: 34. 

Brand name(s): Gammagard Liquid; 
Condition(s) treated: Primary humoral immunodeficiency; 
multifocal motor neuropathy; 
Spending on Medicare beneficiaries: $191 million; 
Spending on total U.S. insured population: $770 million; 
Percent spent on Medicare beneficiaries: 24.8%; 
2010 rank by total Medicare expenditures: 26. 

Brand name(s): Tysabri; 
Condition(s) treated: Multiple sclerosis; Crohn's disease; 
Spending on Medicare beneficiaries: $139 million; 
Spending on total U.S. insured population: $588 million; 
Percent spent on Medicare beneficiaries: 23.7%; 
2010 rank by total Medicare expenditures: 36. 

Source: GAO analysis of CMS, FDA, NIH, and drug manufacturer data. 

[A] End-stage renal disease (ESRD) is also known as stage 5 chronic 
kidney disease. 

[End of table] 

[End of section] 

Footnotes: 

[1] Medicare Part B covers certain physician, outpatient hospital, 
laboratory and other services, and medical equipment and supplies. 
Under certain circumstances, drugs that are usually administered to 
outpatients may be administered to inpatients and covered by Medicare 
Part A. 

[2] In this report the terms "drugs" refers to chemically synthesized 
drugs and biologicals unless otherwise specified. Biologicals are 
products derived from living sources, including humans, animals, and 
microorganisms. 

[3] Medicare Part D is a voluntary program through which Medicare 
covers outpatient prescription drugs. The estimate of total 
expenditures includes beneficiary payments for premiums but excludes 
beneficiary expenditure-sharing. 

[4] For each claim type, the CMS National Claims History 5 Percent 
Sample file contains a random sample of all claims paid by Medicare. 

[5] Our ranking of highest-expenditure Part B drugs is a snapshot of 
total spending in 2010. The list of highest-expenditure Part B drugs 
will change over time as new drugs enter the market and drug 
utilization changes. CMS has noted that, while outside the scope of 
our analysis, several extremely expensive injectable products entered 
the market during or after 2010, including Provenge, Jevtana, 
Benlysta, and others. 

[6] For the remainder of this report, we use the term Medicare 
spending to refer to spending by the Medicare program and spending by 
or on behalf of Medicare beneficiaries. 

[7] IMS Health's national claims data base is called the LifeLink 
Health Plan Claims Database. 

[8] TRICARE is the Department of Defense's health care system for 
active duty and retired uniformed service members and their families. 

[9] This check resulted in the removal of one drug (factor viii 
recombinant) from our 2008 analyses of utilization and expenditures 
due to low reported expenditures in the 2008 Medicare claims data. 

[10] Hemophilia A is a hereditary bleeding disorder caused by a lack 
of blood clotting factor viii. Without enough factor viii, the blood 
cannot clot properly to stop bleeding. 

[11] Influenza, pneumococcal, and hepatitis B vaccines for certain 
individuals are covered only under Medicare Part B, regardless of the 
setting in which they are furnished (for example, even when provided 
to an inpatient during a hospital stay covered under Medicare Part A). 
Other vaccines, such as the shingles vaccine, are covered under 
Medicare Part D. 

[12] Erythropoiesis-stimulating agents are used to stimulate the bone 
marrow to produce red blood cells. 

[13] A Medicare supplemental health insurance policy is health 
insurance sold by private insurers that covers Medicare deductibles 
and copayments as well as some services that Medicare FFS does not 
cover. 

[14] The prices used to determine payment rates for the vaccines and 
blood products are updated to reflect current AWPs. For DME infusion 
drugs, payment is based on the AWP in effect on October 1, 2003. 

[15] Part B drugs in the hospital outpatient setting are paid 
separately if the per day expenditure of the drug exceeds a certain 
threshold set by CMS each year. In 2010, this threshold was $65 per 
day. 

[16] Orphan drug status is granted by FDA to drugs and biologics that 
treat rare diseases. FDA provides this designation to medications 
intended to prevent, diagnose, or treat conditions that affect fewer 
than 200,000 people in the United States or to those that affect more 
than 200,000 persons, but whose sponsors have no reasonable 
expectation of recovering the costs of developing and marketing a 
treatment drug. 

[17] In 2010, Medicare paid for pass-through drugs at 106 percent of 
ASP. The additional pass-through payment amount for 2010, therefore, 
was the difference between this amount and the usual payment limit of 
104 percent of ASP for non-pass-through drugs in the hospital 
outpatient setting in 2010. 

[18] Patents may be applied for and granted at any time during the 
development and testing of the drug. As a consequence, a sponsor may 
have fewer than 20 years to market the drug exclusively under the 
patent. 

[19] Biological products do not have generic equivalents, but 
biosimilars or follow-on biologics serve a similar function. A 
biosimilar is a biological product that is highly similar to an 
already approved biological product, notwithstanding minor differences 
in clinically inactive components, and for which there are no 
clinically meaningful differences between the biosimilar and the 
approved biological product in terms of the safety, purity, and 
potency. 

[20] During this 7-year period, FDA may not approve applications to 
market other versions of the same drug for the same diseases or 
conditions. See 21 U.S.C. § 360cc. This period can run concurrently 
with a patent term or not. It is granted for FDA-approved uses of a 
drug. Other benefits of orphan status may include a tax credit of 50 
percent of the cost of conducting human clinical testing, research 
grants for clinical testing of new therapies to treat orphan diseases, 
and exemption from the fees that are typically charged when sponsors 
submit NDAs for FDA's review. 

[21] Rtiuxan, Avastin, Remicade, and Almita had orphan drug marketing 
exclusivity. 

[22] Epogen/Procrit for the treatment of anemia in non-ESRD patients 
was the eighth most expensive Part B drug in 2010. ESRD is also known 
as stage 5 chronic kidney disease. 

[23] Beginning in 2011, CMS implemented bundled payments for drugs and 
services to Medicare dialysis facilities, which treat ESRD, in part to 
discourage excessive use of separately billable drugs such as Epogen. 
Since then, Medicare has not paid separately for 5 of the 55 drugs in 
our analysis when they are used to treat chronic kidney disease: 
Epogen/Procrit, Aranesp, Zemplar, Venofer, and Hectorol. 

[24] Off-label use refers to using a drug for a condition or patient 
population for which the drug has not been approved by FDA or in a 
manner that is inconsistent with the information found in the drug's 
labeling that has been approved by FDA. We did not separate 
expenditures on Avastin for cancer and for wet AMD. 

[25] Hemophilia A is a hereditary bleeding disorder caused by a lack 
of blood clotting factor viii. Without enough factor viii, the blood 
cannot clot properly to stop bleeding. 

[26] We removed factor viii recombinant from our analysis of change in 
expenditures from 2008-2010 because we were not confident that the 
expenditures for 2008 were valid. 

[27] Percent change in expenditures is calculated as the difference 
between 2010 and 2008 expenditures as a percentage of 2008 
expenditures. 

[28] Our analysis excludes expenditures and utilization in 2008 that 
were reported using a not otherwise classified code, which may have 
artificially increased the changes shown for new drugs, including 
Lexiscan and Treanda. 

[29] Percent change in average price is calculated as the difference 
between 2010 and 2008 average prices as a percentage of the 2008 
average price. 

[End of section] 

GAO’s Mission: 

The Government Accountability Office, the audit, evaluation, and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the 
performance and accountability of the federal government for the 
American people. GAO examines the use of public funds; evaluates 
federal programs and policies; and provides analyses, recommendations, 
and other assistance to help Congress make informed oversight, policy, 
and funding decisions. GAO’s commitment to good government is 
reflected in its core values of accountability, integrity, and 
reliability. 

Obtaining Copies of GAO Reports and Testimony: 

The fastest and easiest way to obtain copies of GAO documents at no 
cost is through GAO’s website [hyperlink, http://www.gao.gov]. Each 
weekday afternoon, GAO posts on its website newly released reports, 
testimony, and correspondence. To have GAO e-mail you a list of newly 
posted products, go to [hyperlink, http://www.gao.gov] and select 
“E-mail Updates.” 

Order by Phone: 

The price of each GAO publication reflects GAO’s actual cost of 
production and distribution and depends on the number of pages in the 
publication and whether the publication is printed in color or black 
and white. Pricing and ordering information is posted on GAO’s 
website, [hyperlink, http://www.gao.gov/ordering.htm]. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 
TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card, 
MasterCard, Visa, check, or money order. Call for additional 
information. 

Connect with GAO: 

Connect with GAO on facebook, flickr, twitter, and YouTube.
Subscribe to our RSS Feeds or E mail Updates. Listen to our Podcasts.
Visit GAO on the web at [hyperlink, http://www.gao.gov]. 

To Report Fraud, Waste, and Abuse in Federal Programs: 

Contact: 
Website: [hyperlink, http://www.gao.gov/fraudnet/fraudnet.htm]; 
E-mail: fraudnet@gao.gov; 
Automated answering system: (800) 424-5454 or (202) 512-7470. 

Congressional Relations: 

Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-4400
U.S. Government Accountability Office, 441 G Street NW, Room 7125
Washington, DC 20548. 

Public Affairs: 
Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800
U.S. Government Accountability Office, 441 G Street NW, Room 7149 
Washington, DC 20548. 

[End of document]