Hepatitis C: Weighing the Price of a Cure

John Watson

Disclosures

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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....