LONDON, Jan 16 (APM) - NICE on Friday extended its recommendation in final draft guidance for National Health Service use of Janssen's Olysio (simeprevir) for chronic hepatitis C, genotypes 1 and 4, as it said data on the drug in combination with Gilead's Sovaldi (sofosbuvir) will be due out soon.

NICE's draft guidance for Olysio in September excluded genotype 4 (APMHE 39727) but quoted in a statement on Friday, professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said the U.S. group had met the cost effectiveness body's call for more data showing value for money in genotype 4.

“Based on the information received ... simeprevir, in combination with peginterferon alfa and ribavirin, is a cost-effective treatment option for people with genotypes 1 and 4 chronic hepatitis C.”

The draft guidance, which is now likely to become binding on NHS next month, recommends simeprevir, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.

It is thought that around 160,000 people are chronically infected with hepatitis C in England. Genotype 1 is the most common chronic hepatitis C in England, accounting for around 46% of diagnoses compared to around 4% for genotype 4, NICE noted.

NICE said more data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who cannot tolerate or are not eligible for treatment with interferon is due to become available soon.

NICE said a course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 24 weeks) costs 27,220 pounds (35,383 euros).

A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 48 weeks) costs 32,155 pounds (41,798 euros).

A course of simeprevir plus sofosbuvir (both for 12 weeks) for people with genotype 1 or 4 HCV who cannot tolerate or are not eligible for interferon-based treatment costs 57,381 pounds (74,589 euros). Costs may vary in different settings because of negotiated procurement discounts, NICE added.

For treating genotype 1 HCV, the incremental cost-effectiveness ratios (ICERs) for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone was between 14,200 pounds (18,472 euros) and 9,800 pounds (12,748 euros) per QALY. Simeprevir dominated both telaprevir and boceprevir (both with peginterferon alfa and ribavirin), that is simeprevir was less expensive and provided more quality adjusted life years (QALYs).

"The committee noted that, in all scenarios for genotype 4 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin remained below 20,000 pounds (26,018 euros) per QALY gained," NICE said.

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