NICE Publishes Final Draft Guidance on telaprevir for Chronic Hepatitis C

Healthcare guidance body NICE has today (16 March) issued final draft guidance recommending telaprevir (Incivo, Janssen Cilag), in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease [1].

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 its ability to perform its many, varied and essential functions. A hepatits C infection 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 and compliance rates and a high annual incidence of new infection mean that CHC 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 guidance [2] recommends pegylated interferon and ribavirin combination therapy for people with genotype 1 chronic hepatitis C.

Telaprevir inhibits 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. The drug is administered orally. The final draft guidance for telaprevir recommends the drug as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease who are previously untreated or in whom previous treatment with peginterferon alfa and ribavirin has failed, including people whose condition has relapsed, partially responded or did not respond.

Commenting on the draft recommendations, Meindert Boysen, Programme Director Technology Appraisals at NICE, said: "Chronic hepatitis C can have a significant impact on a person's quality of life, particularly when if it progresses to the fibrosis and cirrhosis stage. 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. The Committee heard that the current treatment regimen for chronic hepatitis C is often lengthy and that the side effects of treatment themselves can have a significant impact on daily life.

"The significant improvement in sustained virological response rates seen with telaprevir plus peginterferon alfa and ribavirin compared to peginterferon alfa and ribavirin alone, and its potential for shortening the treatment time from the full 48 week course needed for a virological response therefore 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 teleprevir as a cost effective use of NHS resources, alongside boceprevir for which positive draft guidance was published last week."

The draft guidance is now with consultees, who have the opportunity to appeal against it.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

Ends

Notes to Editors
References and explanation of terms
[1] 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.

[2] NICE has published the following related guidance on hepatitis C:

•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).
•Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C. NICE technology appraisal guidance 106 (2006).
•Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C. NICE technology appraisal guidance 75 (2004).
About the draft guidance
1. Approximately 15% of those infected with hepatitis C virus 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) of those who develop a chronic infection will remain stable but the remaining 20% (17) will go on to develop liver cirrhosis, of whom 25% (4) will either progress to hepatocellular carcinoma, require a liver transplant, or die.

2. Figures from 2009 suggest that around 250,000 people were infected with the hepatitis C virus, 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.

3. In 2008, the Department of Health estimated that 68,000 patients with hepatitis C infection had been diagnosed and 4,800 had been treated.

4. 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
5. 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 the previously untreated and previously treated patients.

6. 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.

7. NICE is also appraising boceprevir (Victrelis, Merck Sharp & Dohme) for this indication.

8. The SMC has published guidance on telaprevir for this condition: www.scottishmedicines.org.uk/SMC_Advice/Advice/742_11_telaprevir_Incivo_experienced_patients/telaprevir_Incivo and www.scottishmedicines.org.uk/SMC_Advice/Advice/743_11_telaprevir_Incivo_naive_patients/telaprevir_Incivo

About NICE
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

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.
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
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.

This page was last updated: 13 March 2012
 

Posted: March 2012


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