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NICE approves Sovaldi

Published on 16/01/15 at 07:49am
Sovaldi image

NICE has recommended Sovaldi in final draft guidance and extended its scope, despite concerns over the price of the blockbuster hepatitis C drug.

Solvaldi (sofosbuvir) from Gilead is a highly-effective treatment for hep C, with trials showing it can effectively cure the liver disease in over 90% of patients in just 12 weeks.

Its sales have reflected this, bringing in revenues of $8.4 billion in its first nine months on the market – making it the most successful drug launch ever.

The draft guidance now recommends the drug in combination with pegylated interferon and ribavirin in patients with hep C genotypes 1, 3, 4, 5 and 6, and in combination with ribavirin alone in patients with genotypes 2 and 3 – making up the majority of patients with the disease in England and Wales.

However, at the request of NHS England the deadline for services and funding to be in place for the treatment has been extended until the end of July.

"Current interferon-based treatments for chronic hepatitis C, which often need to be given for a long period of time, are associated with a number of often unpleasant side-effects such as chronic fatigue, neuropsychological effects and flu-like symptoms,” says Carole Longson, director of the NICE centre for health technology evaluation.

“As a result many people with the disease either don't complete the full course, or are reluctant to seek treatment in the first place. New treatments, like sofosbuvir, can shorten the duration of interferon-based therapy and in some cases don't need to be taken with interferon at all.”

Such is the drug’s impact that NHS England set up a silo fund for to pay for it while it went through NICE. The only other such fund in the country is the cancer drugs fund (CDF). Solvaldi is already approved by the Scottish Medicines Consortium.

A costly treatment

Sovaldi has faced a rocky road through the watchdog’s processes, though. It initially faced rejection when NICE asked Gilead for more clinical data. The body later issued positive draft recommendations for the drug, but the future of that decision looked to be in jeopardy when internal NHS documents showed that some in the health service considered the £35,000 per-patient cost to be unaffordable.

Gilead has faced similar criticism for its pricing in the US where the treatment costs $84,000 per course of treatment, much to the chagrin of insurers and payers. One company has even filed a lawsuit against the firm after spending $2.4 million on Sovaldi for its employees.

Gilead has maintained that the benefits of the drug outweigh its costs, as it could dramatically reduce the need for costly liver transplants.

The US firm says that it welcomes the final draft guidance but is ‘disappointed’ that NICE has extended the NHS deadline.

“Under this guidance patients will not be offered treatment with sofosbuvir until August 2015, a full 18 months following approval by the European Medicines Agency in January 2014,” the company notes in a statement.

Sovaldi is just the first of many new highly effective hep C drugs in the pipeline, with firms including BMS, Merck and AbbVie also developing similar treatments that could soon challenge Gilead’s market dominance.

In fact, on the same day that it recommended Sovaldi, NICE also approved Olysio (simeprevir) from Janssen. The drug is being offered under a novel ‘pay if you clear’ scheme, where the NHS will only pay for those patients that it cures – but it has slightly lower cure rates than Gilead’s drug at around 80 per cent.

George Underwood

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