Hepatitis C: Weighing the Price of a Cure

John Watson


May 21, 2015

In This Article

From Cure to Controversy

In 2014, the medical community marked 25 years since the hepatitis C virus (HCV) was discovered through a partnership of government and industry researchers. In contrast to other clinical areas where anniversaries often serve as a cruel reminder of the slow pace of progress, practitioners treating HCV actually had something to celebrate: the emergence of a genuine breakthrough in the form of Gilead Sciences' direct-acting antiviral agent sofosbuvir (Sovaldi®).

With 16-week cure rates approaching 95% in certain disease genotypes and limited side effects noted in several pivotal phase 3 studies, a once-daily tablet of sofosbuvir quickly established itself as an unprecedented breakthrough.[1] The positive news was compounded when an uncommonly productive drug-development pipeline produced other FDA-approved HCV agents in quick succession, most notably Gilead's ledipasvir/sofosbuvir combination (Harvoni®)[2] and AbbVie's ombitasvir/paritaprevir/ritonavir/dasabuvir tablet combination (Viekira Pak™).[3]

Yet just as quickly, the story changed when the wholesale acquisition price tags for these 12-week treatments were revealed: $83,319 for Viekira Pak, $84,000 for Sovaldi, and $94,500 for Harvoni.[4] These prices rise further when one factors in other agents that could be delivered alongside them and the general cost of care. That the issue could be boiled down to a media-friendly "$1000-a-day pill" headline only heightened the controversy, which eventually led to a December Senate hearing on the issue.[5]

The process by which drug manufacturers set their prices remains unclear. A spokesman for Gilead responded to a query by Medscape with the following statement: "We believe the price of Sovaldi and Harvoni reflects the value of these medicines. Unlike long-term or indefinite treatments for other chronic diseases, Sovaldi and Harvoni offer a cure with as little as eight weeks of treatment for many patients taking Harvoni."

Similarly, a spokeswoman for AbbVie also cited the fact that these drugs are offering a "high certainty of a cure with notably low rates of discontinuation and relapse." She further stated in an email exchange that the company took a number of factors into account when determining the treatment's price, "including the benefits of the therapy to patients, overall market dynamics, cost-effectiveness of treatment, and the value that it brings to off-setting short-term and long-term healthcare costs."

The resulting impact of these treatment costs on the healthcare system was immediately apparent. New HCV drugs were reported to have led to a 13.1% rise in prescription drug spending in 2014.[6] An analysis in the Annals of Internal Medicine found the new drugs to be cost-effective in most patients, but also concluded that they would cost an additional $65 billion over the next 5 years in comparison with earlier treatments.[7] Various states reported problems funding the drugs through their Medicaid programs, which required them to restrict access or, in the case of Texas, deciding not to pay for Sovaldi entirely.[8] Collectively, these reports spoke to larger concerns about whether the price of a cure was something that the US economy could afford.


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