NICE Issues Final Draft Approval For Incivo

The UK’s National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending Janssen Cilag’s Incivo (telaprevir), in combination with Roche’s peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

The final draft guidance recommends the drug as an option for the treatment of such patients who are previously untreated or in where previous treatment has failed, including people whose condition has relapsed, partially responded or did not respond.

The drug has bypassed the preliminary NICE stages and has gone straight to final draft guidance, with a verdict anticipated by June.

Janssen’s rival drug Victrelis (boceprevir), produced by Merck, also received a speedy review from NICE, and has been recommended for backing for the same licence.

Both drugs have impressed in Phase III trials, and demonstrated that they can clear a higher percentage of the virus in conjunction with Copegus and Pegasus, compared to using the drugs on their own.

Commenting on the endorsements, Meindert Boysen, programme director for technology appraisals at NICE, noted that chronic hepatitis C can have substantial impact on the quality of life, particularly if it progresses to the fibrosis and 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,” he added.

“The significant improvement in sustained virological response rates seen with telaprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone, and its potential for shortening the treatment time… represents a major benefit for people with chronic hepatitis C,” added Mr Boysen.

Graham Foster, professor of hepatology at Barts and the London School of Medicine and Dentistry, welcomed the National Institute for Health and Clinical Excellence’s positive endorsement for Incivo’s clinical and cost-effectiveness.

“We have approved new treatments which significantly increase these patients’ chances of clearing the virus and offers some patients a shorter treatment duration.  We must now ensure that patients are in a position to access the new antiviral treatments which offer them a very good chance of clearing the virus,” stated Professor Foster.

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

Figures from 2009 suggest that roughly 146,000 people were chronically infected with the hepatitis C virus.  Genotype 1 is the most common subtype of hepatitis C in England and Wales, affecting 40%-50% of people with hepatitis, and is the most resistant to treatment.

The final draft guidance is now with consultees, who have the chance to appeal against it.  NICE has not yet provided any final guidance to the NHS.


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