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Two Hepatitis C Treatments (Boceprevir, Telaprevir) Win U.K. Health-Cost Agency Backing
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Merck & Co. (MRK) (MRK)'s Victrelis and Johnson & Johnson (JNJ) (JNJ)'s Incivo won the backing of the U.K.'s health-cost adviser in final guidance on the treatment of hepatitis C, a virus that causes illness in 85 percent of infected people.
Each of the two drugs offers a cost-effective option for the most common form of the infection when used with older drugs peginterferon alfa and ribavirin, the National Institute for Health and Clinical Excellence said today in an e-mailed statement. The agency advises the state-run National Health Service on which products represent value for money.
Merck, based in Whitehouse Station, New Jersey, won approval to market Victrelis in Europe in July. J&J of New Brunswick, New Jersey, won European approval for Incivo in September.
NICE publishes final guidance on two new drugs for chronic hepatitis C
Healthcare guidance body NICE has today (25 April) issued final guidance recommending boceprevir (Victrelis, Merck Sharp & Dohme) and telaprevir (Incivo, Janssen Cilag), in combination with peginterferon alfa and ribavirin, as options for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver diseasei.
Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver. Transmission is by contact with infected blood primarily as a result of exposure through the skin to contaminated blood (for example, through intravenous drug use). The virus can cause inflammation of, and sometimes significant damage to, the liver and affect the ability of the liver to perform its many, varied and essential functions. Hepatits C infections can be categorised into 2 stages: firstly an acute infection (the first 6 months following initial infection) and secondly a chronic infection.
Figures from 2009 suggest that around 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 the most resistant to treatment. Poor diagnosis rates, low compliance rates and a high annual incidence of new infection mean that chronic hepatitis C presents a major public health challenge, despite the availability of treatments that provide the opportunity to address this challenge.
The primary aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Current NICE guidanceii recommends pegylated interferon and ribavirin combination therapy for people with genotype 1 chronic hepatitis C.
Administered orally, boceprevir and telaprevir 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 virusto evade clearance by the host immune system. The guidance for boceprevir 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 telaprevir 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 or in whom 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.
Commenting on the final recommendations, Professor 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."
References and explanation of terms
i. Chronic hepatitis C infection causes initial inflammation of the liver that progresses through to gradual scarring (fibrosis) and then hardening of liver tissue (cirrhosis). Cirrhosis commonly occurs in two stages, compensated and decompensated. In the first stage of cirrhosis, the liver can compensate for the damage and still has the ability to function normally. When extensive damage occurs and the liver can no longer function normally, decompensation occurs.
ii. NICE has published the following related guidance on hepatitis C:
a. Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of NICE technology appraisal guidance 75 and 106). NICE technology appraisal guidance 200 (2010). Available from www.nice.org.uk/guidance/TA200
b. Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis
C. NICE technology appraisal guidance 106 (2006). Available from www.nice.org.uk/guidance/TA106
c. Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C (2004). Available from www.nice.org.uk/TA75
About the guidance
2. The final guidance for boceprevir will be available at http://guidance.nice.org.uk/TA253 from 25 April 2012. The final guidance for telaprevir will be available at http://guidance.nice.org.uk/TA252 from 25 April 2012. Please contact the NICE press office for an embargoed copy of the guidance.
3. Out of 100 people infected with hepatitis C, approximately 15% will naturally clear the virus from their body and experience no long-term effects from the infection. However, for the remaining 85% a chronic infection will develop. 80% (68 people) of those who develop a chronic infection will remain stable but the remaining 20% (17 people) will go on to develop liver cirrhosis, of whom 25% (4 people) will either progress to hepatocellular carcinoma, require a liver transplant, or die.
4. Figures from 2009 suggest that around 250,000 people were infected with the hepatitis C virus in England and Wales, of whom 146,000 were chronically infected. Hepatitis C is more common in men and in people aged 25-44 years. In England, prevalence studies suggest that people of South Asian family origin are at an increased risk of having hepatitis C infection.
5. In 2008, the Department of Health estimated that 68,000 patients with hepatitis C infection had been diagnosed and 4,800 had been treated.
6. The aims of treatment are:
· To eradicate the hepatitis C virus in the individual
· To prevent progression of liver disease and development of liver cancer
· To prevent transmission of hepatitis C virus
7. The Committee accepted that the most plausible ICERs for boceprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone for the treatment-naive and previously treated populations were robust to sensitivity analyses and were all below 20,000 per QALY gained, demonstrating that boceprevir represents a cost-effective use of NHS resources for patients with genotype 1 chronic hepatitis C.
8. Boceprevir is priced at 2800 for a 28-day, 336-tablet pack (excluding VAT; 'Monthly Index of Medical Specialities' [MIMS] January 2012) and costs 30,800 for a 44-week course. The recommended duration of treatment with boceprevir may be shorter (24 weeks or 32 weeks) depending on patient and disease characteristics. The marketing authorisation states that boceprevir should be given in combination with peginterferon alfa and ribavirin, which has an estimated additional cost of around 11,000 (see 'Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C' [NICE technology appraisal guidance 200] for details). Costs may vary in different settings because of negotiated procurement discounts.
9. The Committee accepted that the most plausible ICERs for telaprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone were 18,000 and 10,000 per QALY gained for previously untreated and previously treated patients respectively.
10. Telaprevir is priced at priced at 1866.50 for a 1-week, 42-tablet pack (excluding VAT; 'Monthly Index of Medical Specialities' [MIMS] January 2012). This equates to a maximum of 22,398 for a 12-week course of therapy. Costs may vary in different settings because of negotiated procurement discounts.
11. The SMC has published guidance on telaprevir for this condition: telaprevir (Incivo) Exp and telaprevir (Incivo) Naive
12. The SMC has also published guidance on boceprevir for this condition: boceprevir (Victrelis) Naive Patients and boceprevir (Victrelis) Experienced Patients
About NICE
13. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
14. NICE produces guidance in three areas of health:
· public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
· health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
· clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
15. NICE produces standards for patient care:
· quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
· Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
16. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
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