US FDA approves Gilead's $1,125 a pill combination Hep C drug

By Dan Stanton contact

- Last updated on GMT

US OK for Gilead's HCV combo
US OK for Gilead's HCV combo
Gilead says its hepatitis C combination drug Harvoni will deliver significant healthcare savings in the long-term despite its $1,150 (€885) a pill price tag.

Last week, the US Food and Drug Administration (FDA) approved Gilead’s Harvoni, the first combination drug to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni consists of the inhibitor drug ledipasvir which is combined with sofosbuvir, the active ingredient in Gilead’s Sovaldi approved in December 2013​.

Like Sovaldi, Harvoni treats HCV without the administration of interferon or ribavirin. However, Sovaldi has been subject to criticism over its price which in the US equates to around $1,000 a pill​, and analysts have speculated Harvoni could cost even more.

“The WAC [Wholesale Acquisition Cost] price for Harvoni is $63,000 for 8 weeks and $94,500 for 12 weeks of treatment,”​ ISI analyst Mark Schoenebaum said in a note, equating to $1,125 a pill.

“Based on Gilead’s prior comments that it expects 45% of GT1 patients would likely receive 8 weeks of therapy [thus the other 55% receive 12 weeks], we estimate that the average price per GT1 patient for Harvoni would be approximately $80,000.”

In-Pharmatechnologist.com contacted Gilead for justification of the cost and spokesperson Sonia Choi told us the price of Harvoni is a reflection of the value of the drug.

“Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant healthcare savings to the healthcare system over the long-term.”

She added the drug delivers a cure rate of between 94 and 99 percent and eliminates the need for both peg-interferon and ribavirin. Furthermore, treatment time is reduced and administration is simplified to taking just one tablet a day, compare to other HCV treatments.

Choi did not comment on the manufacturing process of Harvoni, but according to SEC filings​ the company uses a combination of third-parties manufacture the majority of its active pharmaceutical ingredients and solid dose products, licensing out its technology platforms.

Cheaper options

Last month the firm announced it would license its manufacturing technology to seven India-based generic companies​ in order to provide cheaper Sovaldi to up to 100 million people living with HCV in 91 developing countries.

Under the agreement, Gilead also permits the manufacture of Harvoni by the generic firms. “Ensuring patient access to Harvoni – and to all our medicines – is a top priority for Gilead,” Choi said.

Furthermore, she added: “We have programs in place to ensure that HCV patients in the US with limited or no health insurance options can access Harvoni, and that patients will not be burdened with high insurance co-payments.”

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