A number of new drugs for the estimated 3.2 million people in the US living with chronic Hepatitis C virus infection have been launched over the past year, with Abbvie’s drug, Viekira Pak, the latest following its approval by the US Food and Drug Administration (FDA) last month.
The drug combines three active pharmaceutical ingredients (API): an NS5A inhibitor, ombitasvir; NS3/4A protease inhibitor, paritaprevir; and non-nucleoside NS5B polymerase inhibitor, ritonavir.
The triple-action mechanism goes further than Gilead’s two HCV treatments launched in the last year:
Sovaldi (sofosbuvir), a nucleotide analog that inhibits the polymerase enzyme that the hepatitis C virus uses to replicate its RNA, and Harvoni, a combination of sofosbuvir and the drug ledipasvir, which inhibits the viral phosphoprotein, NS5A, involved in viral replication, assembly, and secretion.
These drugs, along with J&J’s Olysio approved in November 2013, can be taken without the need for co-administration of interferon and offer sufferers heightened cure rates with fewer side effects than conventional treatments. Furthermore, the oral delivery method improves patient adherence and compliance.
The impact of these new treatments has already affected sales of other hepatitis C drugs, such as Merck & Co.’s Victrelis - approved for use in combination with peginterferon alfa and ribavirin – which had Q3 2014 sales of $27m, 78% less than the same period 2013.
Similarly, Codexis, which supplies intermediates and biocatalysts for hepatitis C drugs including Victrelis, blamed a 60% drop in sales last August on the impact of Sovaldi.
However, the benefits of these new drugs come at a cost and Gilead has been hit with criticism regarding its pricing, $84,000 for a 12-week course of Sovaldi, equating to $1,000 a pill, with Harvoni costing even more.
While Viekira Pak has been similarly priced ($83,319), within days of approval AbbVie signed a deal with Express Scripts, the largest Pharmacy Benefit Manager (PBM) in the US, to supply the drug exclusively to HCV sufferers enrolled through its healthcare plan.
ISI analyst Mark Schoenebaum said such a deal coupled with a number of “basically interchangeable” drugs in an “intensively competitive” sector could start a price war between AbbVie and Gilead.
Despite this, he told in-Pharmatechnologist.com the discount AbbVie had offered to gain access with Express Scripts was most likely less than 30% and would only have a “modest” impact on Gilead’s US business.
But yesterday, in what fellow ISI analyst Ross Muken described as “unsurprising but timely,” Gilead announced it too had struck an exclusive deal with the PBM CVS for Harvoni/Sovaldi to be given preferred formulary status.
Describing Gilead’s offerings as more attractive due to the potentially shorter regimen, more convenient dosing, and less drug-to-drug interaction issues, Muken added CVS was likely able to “garner an attractive discount for its members.”
In the UK, the cost of a 12-week course of Sovaldi is £34,983 ($53,155) while in 91 developing countries, a course of the drug will be available for a cost as low as $300 thanks to a tech transfer deal Gilead recently signed with seven Indian generic drugmakers.