An analysis of the top 200 drugs by prescriptions dispensed and total sales reveals key trends in today's pharmaceutical market.
Prescription drug sales in the United States in 2011 demonstrated both a continuation of recent market trends and important new developments in the treatment of several disease states.
Growth in spending has been slow over recent years, and 2011 was no exception. Total health care spending reached $320 billion, an increase of approximately $50 billion since 2006 and $125 billion since 2002.1,2
This represents an increase in nominal spending of 3.7%, which falls in line with the trend of annual growth of 5% or less since 2007. When adjusted for gross domestic product and population growth, this is a per capita increase of 0.5%. Factors contributing to the minimal growth in spending include declining volume growth, decreased spending on new drugs, and the continued shift from branded to generic products.1
Sales within 5 leading therapy areas accounted for nearly one-third of total spending in 2011.1
Oncologics accounted for $23.2 billion in spending, an increase of 4.2%. Respiratory agents grew by 8.8% to $21 billion, with anti-asthmatics accounting for two-thirds of class spending. Lipid regulators earned $20.1 billion, a 7.2% increase.1
Lipitor (atorvastatin) was the single largest earning source in this class, but nearly 60% of prescriptions were switched to a generic alternative when the patent expired in November 2011.1,3
Spending on antidiabetic agents reached $19.6 billion, up 10.7%. Antipsychotics garnered $18.2 billion in spending, although 2 top-performing agents in the class face patent loss: Zyprexa (olanzapine) in October 2011 and Seroquel (quetiapine) in early 2012.1,4
Spending increased significantly in several areas, including multiple sclerosis (22.5%), attention-deficit/hyperactivity disorder (ADHD) (17%), and non- HIV–targeting antivirals (14.8%).1
Overall medication utilization per capita declined, along with total office visits and non-emergency department hospital admissions. Medication use per person dropped by 1.1%, whereas prescription usage in the retail setting declined in 41 states, largely due to a reduction in chronic medication use.
Conversely, the number of emergency department admissions increased significantly in 2011, possibly as a consequence of the high number of long-term unemployed people without insurance. These trends demonstrate a shift from lowercost, nonemergency medical care towards more costly emergency care, which is likely to contribute to the rising overall costs of the US health care system.1
Prescription Volume Comparisons
Seniors continued to be the largest consumers of prescription medications, although the total number of prescriptions for patients 65 years of age and older declined for a second straight year. Prescription volume dropped by 2.7% in 2010 and by 3.1% in 2011, a sharp contrast to the average volume increase of about 4% seen in the preceding years. The largest declines in prescription volume among patients 65 years and older were seen in antihypertensive medications, osteoporosis medications, and lipid regulators.1
Alternatively, prescription use increased among individuals aged 19 to 25 years, “which coincides with the first full year of implementation of the provision of the ACA [Affordable Care Act] allowing individuals under 26 years ofage to remain on their parents’ health insurance.”1,5
Therapies with the largest increases among this age group included ADHD and antidepressants.1
Out-of-pocket medication spending fell for the first time on record, declining by approximately $1.8 billion in 2011. Patients insured by commercial thirdparty companies paid roughly 78% of the total out-of-pocket costs. The average copay was $10 or less for 75% of all retail prescriptions. Copays for branded products cost up to $40 on average, and although brands only accounted for about 18% of total prescription volume, they represented 46% of out-of-pocket costs. Use of copay coupons and vouchers increased as well, helping to offset some of the higher costs associated with branded products.
Total spending among Medicaid patients and commercially insured patients remained relatively flat compared with 2010; however, spending by Medicare Part D beneficiaries decreased from $11.5 billion to $9.7 billion. This is largely a result of the “donut-hole” subsidy provided by the ACA.1,5
Brand Versus Generics
Use of branded medications continued to decline, whereas generic alternatives grew to represent 80% of total prescriptions dispensed. Several key patent expirations contributed to a reduction of about $14.9 billion in spending on branded products.1
Major products affected by patent loss in 2011 include Lipitor, Advair Diskus (fluticasone propionate and salmeterol), Zyprexa, Levaquin (levofloxacin injection), and Concerta (methylphenidate). Each of these products had accounted for more than $1 billion in annual spending in the 12 months prior to their patent expiry.1,4
The total savings in health care costs attributed to patent expiries, known as the “patent dividend,” grew to $65.2 billion since 2007.1,5
This number does not fully reflect savings associated with patent expiries that occurred late in the year, and more adequately reflects savings from expiries that occurred in late 2010 and early 2011, including Lovenox (enoxaparin injection), Aricept (donepezil), and Effexor XR (venlafaxine hydrochloride).
Major upcoming patent expiries include Actos (pioglitazone), Singulair (montelukast), and Nexium (esomeprazole) (Table).1,4
Spending on branded medications represented 73% of total spending in the United States. Declining volume in brands resulted in a reduction of $5.6 billion in spending. This number was offset by a pricing increase of $18.5 billion, or an estimated $12.6 billion after adjusting for discounts and rebates. Spending on new brands (products available for less than 24 months) increased from $7.5 billion in 2009 to $12.2 billion in 2011.
A total of 34 new molecular entities were launched in 2011, the largest number in the past decade. A variety of new treatments became available, targeting diseases affecting millions of chronically ill patients as well as orphan diseases that affect fewer than 200,000 individuals. Notable developments include agents targeting hepatitis C (boceprevir, telaprevir), multiple sclerosis (fingolimod), stroke prevention (dabigatran, rivaroxaban), melanoma (ipilimumab, vemurafenib), prostate cancer (sipuleucel-T), and nonsmall cell lung cancer (crizotinib). These new treatment options may impact the care of more than 20 million patients with existing conditions as well as the estimated 2.5 million patients who are newly diagnosed each year.1
Several key elements within the current political and economic climate of the United States will significantly influence the growth of medication spending over the next few years. The ACA, for instance, is a highly controversial law that has dramatically affected out-ofpocket spending, access to health care, and the brand/generic shift. Although the US Supreme Court ruled in favor of upholding the ACA, the debate will remain a central issue during the 2012 government elections.5,6 Likewise, the thus-far slow economic recovery, high unemployment levels, and limited access to affordable health insurance are closely tied to overall health care spending and will remain key variables in the drug sales market.1
Although 2011 showed promise with the introduction of many novel therapy options, manufacturers face growing pressure to find new products to offset the loss of top performers. “This is a sobering reversal for an industry that just a few years ago was the world’s most profitable business sector but is now under pressure to reinvent itself and shed its dependence on blockbuster drugs,” reported Doug Wilson of The New York Times
And it casts a spotlight on the problems drug companies now face: a drought of big drug breakthroughs and research discoveries; pressure from insurers and the government to hold down prices; regulatory vigilance and government investigations; and thousands of layoffs in research and development.”7
But despite all obstacles, companies including Pfizer, Merck, Eli Lilly, and Teva posted higher-than-expected earnings for the first quarter of 2012, proving that growth is still possible in a tough market.3,8,9
It remains to be seen whether this growth can be sustained in the months ahead.
Click on the image below to download a printable PDF of the Top 200 Products of 2011 by Total Dollars:
Click on the image below to download a printable PDF of the Top 200 Products of 2011 by Total Prescriptions:
Dr. Bartholow is a clinical pharmacist in the VA Southern Nevada Healthcare System in Las Vegas, Nevada.
1. IMS Institute for Healthcare Informatics. The Use of Medicines in the United States: Review of 2011. IMS Institute for Healthcare Informatics Web Site. June 2012. http://www.imshealth.com/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.pdf. Accessed June 23, 2012.
2. Bartholow, M. Top 200 prescription drugs of 2010. Pharmacy Times Web site. June 2012. http://www.pharmacytimes.com/publications/issue/2011/May2011/Top-200-Drugs-of-2010. Accessed June 23, 2012.
3. Pierson, R. Pfizer profits solid despite Lipitor loss. Reuters.com Web Site. May 1, 2012. http://www.reuters.com/article/2012/05/01/us-pfizer-idUSBRE8400KJ20120501. Accessed June 25, 2012.
4. Alazraki, M. The 10 Biggest-Selling Drugs That Are About to Lose Their Patent. DailyFinance Web Site. February 27, 2011. http://www.dailyfinance.com/2011/02/27/top-selling-drugs-are-about-to-lose-patent-protection-ready/. Accessed June 23, 2012.
5. Affordable Care Act. HealthCare.gov website. http://www.healthcare.gov/law/index.html. Access June 23, 2012.
6. Chan, S. Updates on Supreme Court Health Care Ruling. Seattle Times Web Site. June 28, 2012. http://seattletimes.nwsource.com/html/edcetera/2018550273_updates-supreme-court-health-care.html. Accessed June 28, 2012.
7. Wilson, D. Drug Firms Face Billions in Losses in ’11 as Patents End. New York Times Web Site. March 6, 2011. http://www.nytimes.com/2011/03/07/business/07drug.html?_r=1&pagewanted=all. Accessed June 25, 2012.
8. Teva profit beats forecasts on U.S. drug sales. Reuters.com Web Site. May 9, 2012. http://www.reuters.com/article/2012/05/09/us-teva-idUSBRE8480A520120509. Accessed June 25, 2012.
9. Fontevecchia, A. Merck Beats As Singulair Rakes In The Cash, But Patents Expire Soon. Forbes Web Site. April 27, 2012. http://www.forbes.com/sites/afontevecchia/2012/04/27/merck-beats-as-singulair-brings-in-the-cash-but-patents-expire-soon/. Accessed June 25, 2012.
10. FDA Listing of Authorized Generics as of January 9, 2012. FDA Web Site. January 9, 2012. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM183605.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=concerta%20generic&utm_content=11. Accessed June 23, 2012.
11. UPDATE 1-Watson Pharma signs generic drug deal with JNJ unit. Reuters Web Site. November 2, 2010. http://www.reuters.com/article/2010/11/02/watsonpharma-idUSSGE6A10IX20101102. Accessed June 23, 2012.
12. AstraZeneca Settles US Nexium Patent Litigation with Ranbaxy. Drugs.com Web Site. April 15, 2008. http://www.drugs.com/news/astrazeneca-settles-us-nexium-patent-litigation-ranbaxy-8072.html. Accessed June 22, 2012.
13. FDA News Release. FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder . FDA Web Site. June 29, 2010.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm217624.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=effexor&utm_content=6. Accessed June 22, 2012.
14. FDA News Release. FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections. FDA Web Site. June 20, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm259951.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=levaquin%20generic&utm_content=1. Accessed June 22, 2012.
15. FDA News Release. FDA Approves First Generic Enoxaparin Sodium Injection. FDA Web Site. July 23, 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm220092.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=lovenox%20generic&utm_content=1. Accessed June 22, 2012.