Wednesday, April 25, 2012

NICE has given its final recommendation for two new hepatitis C pills in an expedited review.

Published on 25/04/12 at 02:19pm

NICE has given its final recommendation for two new hepatitis C pills in an expedited review.

Janssen’s Incivo (telaprevir) and MSD’s Victrelis (boceprevir), in combination with Roche’s injectable treatments Copegus and Pegasys, have both been recommended as options for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

The drugs have bypassed the preliminary NICE stages and have been recommended months ahead of NICE’s normal schedule.

The guidance for Victrelis recommends the drug as an option for the treatment of people with genotype 1 chronic hepatitis C, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or in whom previous treatment has failed.

The guidance for Incivo recommends the drug as an option for the treatment of genotype 1 chronic hepatitis C, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease who are previously untreated.

It can also be used in patents who have had previous treatment with peginterferon alfa alone or in combination with ribavirin has failed, including people whose condition has relapsed, partially responded or did not respond.

Both drugs inhibit the activity of the NS3/4A serine protease. Activity of this protease is essential for viral replication and may be partially responsible for the ability of the hepatitis C virus to evade clearance by the host immune system.

Carole Longson, NICE health technology evaluation centre director, said: “Chronic hepatitis C can have a significant impact on a person’s quality of life, particularly if it progresses to the cirrhosis stages. Fear of transmitting the disease is also a concern, particularly for women of child-bearing age for whom there is a risk of transmitting the disease to their unborn child.

“In the past, patients have declined treatment because the perceived chance of a sustained virological response with peginterferon alfa plus ribavirin was too low for them to accept the associated side effects.

“The significant improvement in sustained virological response rates seen with boceprevir plus peginterferon alfa and ribavirin, and telaprevir plus peginterferon alfa and ribavirin, compared to peginterferon alfa and ribavirin alone represents a major benefit for people with chronic hepatitis C.
“The Committee also acknowledged the significant public health impact that a sustained virological response can have in reducing transmission of the hepatitis C virus to uninfected people.
“We are pleased to be able to recommend boceprevir and telaprevir as a cost effective use of NHS resources,” she added.

Janssen’s drug is priced at £1866.50 for a 1-week, 42-tablet pack - this means that the maximum cost to the NHS would be £22,398 for a 12-week course of therapy.
Merck’s drug is priced at £2,800 for a 28-day, 336-tablet pack and costs £30,800 for a 44-week course.
Both treatments will also need to be used alongside Roche’s injectable drugs, which add around £11,000 to the overall cost of each treatment.
Ben Adams

http://www.inpharm.com/news/172359/two-new-hep-c-pills-recommended-nice

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