During my first year of residency, I had to complete a required rotation in “pharmacy administration.” Our residency group had another name for it, which I won’t mention, but we basically rallied around the poor soul going through the 6 weeks of organized torture in support of their rite of passage to completion. The majority of the rotation was focused on money…and lots of grunt work. Neither of these things can compare with going on rounds or seeing your own patients in clinic. I could handle the grunt work, but the money part was the thing that annoyed me the most. Who cares what the drugs cost? It didn’t matter to me. I wasn’t there to control costs. I was there to do clinical work. The cost part was for someone else.
Fast forward (ahem) years later to 2014. Aside from my classroom teaching, I work in the area of infectious diseases and enjoy caring for patients with infections. One of the most emerging areas in our practice is Hepatitis C Virus (HCV) treatment. There are an estimated 3 million individuals in the US with HCV infection.1 Up until recently, patients with genotype 1 infection (the most common and difficult to treat type), had to endure long courses of treatment with difficult to tolerate side effects; 40% of patients would be cured with this.2-5 Great odds for feeling crummy and not-so-great odds for getting cured. However, in recent months, 2 new drugs, Sovaldi (Sofosbuvir) and Olysio (Simeprevir) have been approved, with amazingly high response rates (over 90%), carry few side effects, and a short duration of therapy (12-24 weeks).6 So, what’s the big deal, you ask? These new drugs come at a MUCH higher cost. Sovaldi, manufactured by Gilead, goes for about $1,000 per pill! A course of therapy can cost anywhere from $65,000-150,000!7 Yes, this jaw dropping price tag has caused quite a stir.
As one would imagine, it is no small feat getting access to these drugs. And, during my residency days, I probably would have said, “Why does it really matter to me?” Well, it does matter if your patient can’t get access to it because their insurance doesn’t want to cover it. Last week, we had a patient who was severely ill from hepatitis get started on a regimen containing Sovaldi. The patient’s copayment was over $8,000 for a bottle of 28 tablets. When I’m called in to help out, I can’t say “Not It!”
Steve Miller, the Chief Medical Officer of Express Scripts, one of the country’s top pharmacy benefits manager, is pointing a finger at Gilead, claiming unfair pricing. And, he’s not alone! It’s easy to blame Gilead, especially when their first quarter earnings from Sovaldi alone exceeded $2 billion ($2.27 billion to be exact)!
On the other hand, Gilead maintains their pricing is fair, since the cure rates are extremely high, reducing the costs of care for patients with HCV by avoiding events, such as cancer, liver transplant and death. After all, supporting innovation is critical to new drug development, and after so many years without highly effective therapy, there must be some reward for innovation.
With newer agents expected to be approved this fall, the pricing set by Gilead has many concerned about what is to come. Medicaid and the Veterans Affairs, despite receiving price rebates, still had major concerns over budgetary constraints by covering these drugs. The VA, for example, has coverage restrictions for the sickest patients. The state Medicaid program is doing the same thing.
Another complicating factor is that these agents are currently recommended as the treatment of choice for HCV. American Association for The Study of Liver Diseases and Infectious Diseases Society of America recommend these drugs, as does the World Health Organization8,9. However, even the agencies have been criticized for recommending agents that so many aren’t able to afford. As quoted in a story by Kaiser Health News, Gary Davis, a panel co-chairman and hepatitis expert said,
“We just put down the best regimen for the individual. We recognize cost issues are really important, but we are clinicians, not the people who should be addressing that.”
We can point the blame for the problem in ANY of these directions, but at least pick a game to play. If you want to play the Price is Right, at least you’re contributing to some cause. I think the important game to stop playing is Not It!
References
- Denniston MM, Jiles RB, Drobenluc J, Klevens RM, et al. Chronic Hepatitis C Virus Infection in the United States, National Health and Nutrition Examination Survey 2003-2010. Ann Intern Med 2014;160:293-300.
- McHutchinson JG, Lawitz EJ, Schiffman ML, et al. Peginterferon alfa 2b or alfa 2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361:580-93.
- Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa 2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347:975-82
- McHutchinson J, Gordon SC, Schiff E, et al. Interferon alfa 2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med 1998;339:1485-92.
- Manns MP, McHutchinson JG, Gordon SC, et al. Peginterferon alfa 2b plus ribavirin compared with interferon alfa 2b plus ribaviring for initial treatment of chronic hepatitis C: a randomized trial. Lancet 2001;358:958-65.
- Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013b;368(20):1878-1887.
- Tice JA, Ollendorf DA, and Pearson SD. Institute for Clinical and Economic Review. The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection. Draft Report for March 10, 2014 Meeting. Available from: http://ctaf.org/sites/default/files/assessments/CTAF_Hep_C_Draft_021214.pdf
- American Association for The Study of Liver Diseases and Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. Updated March 2014. Available from: http://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/26/hiv-hcv
- World Health Organization. Guidelines for the screening, care and treatment ofpersons with hepatitis C infection. Accessed 10 June 2014. Available from: http://apps.who.int/iris/bitstream/10665/111747/1/9789241548755_eng.pdf?ua=1&ua=1
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