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Gilead's Sovaldi wins NICE approval but faces access delay

The Institute also recommends Janssen's hepatitis C drug Olysio

Gilead HQ 

NICE has issued final guidance recommending two new innovative hepatitis C drugs - Gilead's Sovaldi (sofosbuvir) and Janssen's Olysio (simeprevir) - but patients will not be able to access Gilead's treatment until the summer.  

Sovaldi is eligible, in combination with the injectable drugs ribavirin and peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C. 

But while it is now NICE-approved, the drug will not actually be paid for by the NHS until August, more than two months later than this would usually happen.

This is because healthcare bodies in England are concerned about the high cost of the drug, which comes with a price tag of around £35,000 and could cost the health service £1bn per year if all eligible patients are treated with the pill. 

To try and prepare for this, NHS England has asked NICE for the guidance to be delayed until July 31.

Meanwhile, Janssen's Olysio has also been backed by NICE, again in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hep C. In this case, NHS England has not asked for this drug to have its funding delayed. 

But Olysio faces a different limitation as NICE has not given the go ahead for the drug in combination with Sovaldi to treat chronic hep C in people who can't tolerate, or aren't eligible for treatment, with interferon.

Data for this is “due to become available soon”, according to the Institute. Therefore, its recommendation on this treatment combination will now be “developed in separate guidance”, says NICE. 

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “New treatments, like sofosbuvir and simeprevir, can shorten the length of interferon-based therapy and in some situations don't need to be taken with interferon at all. Both drugs can also be given to people who have previously been treated but did not clear the virus, in people whose condition has relapsed, or in people who have become re-infected after treatment. 

“Sofosbuvir and simeprevir could therefore be valuable treatment options for people with chronic hepatitis C. This is good news, not just for people with chronic hepatitis C, but also because having more effective treatments for the condition could reduce the spread of the virus.”

Article by
Ben Adams

26th February 2015

From: Sales



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