Mixed news for drugmakers as NICE rules on HCV drugs

Patients with hepatitis C virus (HCV) infection in England and Wales will be able to get treatment with Gilead Sciences’ Sovaldi and Janssen’s Olysio under the NHS, according to cost-effectiveness watchdog NICE.

It was not all good news for the pharma companies, however, as NHS funding for Sovaldi (sofosbuvir) will be delayed for several months and Olysio (simeprevir) has not been backed in all its approved indications.

The two drugs were approved last year as part of a new wave of oral, directly-acting antivirals that have made it possible to treat HCV without using interferon alfa injections, which have a significant side effect burden. However, their premium pricing has raised concerns about the ability of healthcare systems to pay for the treatment.

NICE delivered draft guidance last year indicating it was “minded not to recommend” Sovaldi because of its high price of £69,966 per course, although it backed the drug after further discussions with the company.

Since then, it has emerged that Gilead has been prepared to negotiate on price, with France recently announcing it had agreed a discounted price of €41,000 (£31,000) per course. Details of the price offered to the NHS have not been disclosed.

NICE said it has acceded to NHS England’s request for a delay (to 1st August) to the deadline for making sure NHS units can provide access to the drug, so Gilead will have to wait before prescribing of the drug moves into a higher gear.

Commenting on the verdict – which is not final and could be appealed – Gilead’s UK and Ireland general manager Stelios Karagiannoglou said: “We are disappointed that the majority of patients will not gain access to this important medicine until later this year.”

However, in some more good news for the company, NICE said it had decided Sovaldi should be made available to patients with HCV genotypes 4, 5 and 6, in addition its earlier backing of genotypes 1 and 3.

Meanwhile, NICE recommended approval of Olysio in combination with peginterferon alfa and ribavirin for genotypes 1 and 4 HCV – effectively precluding it from use in all-oral treatment regimens. The final guidance is in line with an earlier draft that declined to recommend the drug for use alongside Sovaldi in patients who are unable to tolerate an interferon alfa-based regimen.

Janssen has said that indication could still be backed if ongoing efforts to collect real-world data on the combination prove fruitful. The Scottish Medicines Consortium (SMC) backed the use of Olysio with both interferon and Sovaldi last October.

In an unusual (but separate) move, Janssen recently offered to reimburse the NHS for the cost of therapy with Olysio if patients taking the drug do not clear HCV after 12 weeks, as well as free access to a diagnostic test designed to identify patients most likely to benefit from the treatment.

Pricing war starts in US

Meanwhile, the high price of the new HCV therapies is also resulting in a dogfight across the Atlantic, with AbbVie drawing first blood after pharmacy benefits manager Express Scripts announced it would only include its four-drug Viekira Pak (ombitasvir/paritaprevir/ritonavir plus dasabuvir) regimen – which has just been approved in Europe – on its formulary.

This week, it emerged that Gilead had retaliated with an exclusive arrangement with rival PBM Humana for Harvoni, thank to an undisclosed discount on the drug’s list price.

Image courtesy of Shutterstock/decade3d


NICE asks for more cost data on Sovaldi

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