US regulators have approved AbbVie’s multi-pill hepatitis C regimen Viekira Pak for the treatment of chronic Genotype 1, which looks set to give Gilead’s market giant Harvoni (ledipasvir and sofosbuvir) a bit of a run for its money.
Viekira Pak contains three new drugs - ombitasvir, paritaprevir and dasabuvir - that inhibit growth of the hepatitis C virus, as well as the booster ritonavir, but the combo can also can be used alongside ribavirin in certain circumstances. Clinical trials showed 95%-100% cure rates and a good tolerability profile, which saw more than 98% of patients completing a full course of therapy.
However, while efficacy the therapy’s efficacy is considered similar to Harvoni’s, the latter has the edge on convenience, consisting of just one daily pill versus Viekira Pak’s baseline four, which is expected to give it a much stronger foothold in the market.
Nevertheless, it seems Viekira Pak could claw back some market share through background pricing strategies. While listed at around $83,319 per course, pharmacy benefit manager Express Scripts said it has secured a significant discount, enough for it to declare that, from January 1, AbbVie’s offering will be the “exclusive option” for patients covered by its National Preferred Formulary.
"For the first time, a pharmaceutical manufacturer and a pharmacy benefit manager have created an agreement to deliver on the promise of a curative therapy for hepatitis C patients,” said Steve Miller, Express Scripts’ chief medical officer, adding that it “marks a fundamental change in how sustainable access and affordability will be delivered” to patients.
Gilead has reportedly been resistant to offering such discounts on its HCV medicines Sovaldi (sofosbuvir) and Harvoni despite criticisms over their “unaffordability” from private insurers, insisting that in the long-run they will save huge amounts of cash. Current predictions are that the total annual direct medical costs of HCV in the US will top $85 billion in the next 20 years.