LONDON, Feb 25 (APM) - NICE on Wednesday published final guidance recommending National Health Service use of Gilead's Sovaldi (sofosbuvir) and Janssen's Olysio (simeprevir) as treatment options for some people with chronic hepatitis C.

Sofosbuvir has a marketing authorisation in the UK for use in combination with other medicinal products for treating chronic hepatitis C in adults. The guidance on sofosbuvir recommends its use in combination with ribavirin, with or without peginterferon alfa, as an option for some people with genotypes 1- 6 chronic hepatitis C, NICE said in a statement.

Simprevir is approved in the UK for use in combination with other medicinal products for treating adults with genotype 1 or 4 chronic hepatitis C. The guidance on simeprevir recommends its use, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

More data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who cannot tolerate or aren’t eligible for treatment with interferon is due to become available soon, NICE said. Therefore recommendations on this treatment combination will now be developed in separate guidance.

Carole Longson, director of the NICE Centre for Health Technology Evaluation, said in the statement: “Poor diagnosis rates - estimates suggest around 50% of people with the condition in England remain undiagnosed - combined with a high number of new infections annually make hepatitis C a major public health challenge. But even when people are diagnosed, the long duration and potentially unpleasant side-effects of current interferon-based treatments can discourage people with the disease from completing the full course, or even from seeking treatment in the first place.

“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.”

Following a request from NHS England and consultation with stakeholders, the period during which NHS England has to comply with the recommendations for sofosbuvir is extended to July 31.

The period during which NHS England has to comply with the recommendations for simeprevir has not been extended, it said.

The cost of sofosbuvir is 11,660.98 pounds (15,837 euros) per 28-tablet pack of 400 mg tablets. The cost of a 12-week course of treatment is 34,982.94 ( 47,760 euros) pounds and a 24-week course is 69,965.88 pounds (95,523 euros) (both excluding VAT), not including the cost for ribavirin and peginterferon alfa. Costs may vary in different settings because of negotiated procurement discounts.

NICE said an independent appraisal committee considered sofosbuvir plus peginterferon and ribavirin to be cost effective in treatment experienced patients compared with peginterferon and ribavirin, boceprevir plus peginterferon and ribavirin, and telaprevir plus peginterferon and ribavirin with incremental cost effectiveness ratios (ICERs) of approximately 12,600 pounds (17,202 euros), 700 pounds (955 euros) and 8,200 pounds (11,195 euros) per quality adjusted life year (QALY) gained respectively.

Sofosbuvir plus ribavirin was not recommended in people for whom interferon was unsuitable (regardless of previous treatment) because of the higher ICER compared with standard care (no treatment) which was in excess of 47,500 pounds (64,851 euros) per QALY gained in the combined population of people with and without cirrhosis.

nh/rs