Download PDF - Hepatitis C (genotype 1) - boceprevir: final appraisal determination document
LONDON, March 9 |
Merck's hepatitis C drug wins UK cost endorsementLONDON, March 9 |
(Reuters) - U.S. drugmaker Merck & Co's new hepatitis C drug Victrelis was recommended for use within Britain's state health service on Friday, despite its hefty price tag.
The National Institute for Health and Clinical Excellence, which often spurns expensive new medicines on cost grounds, said significant improvements seen with Victrelis made it a cost-effective option.
The drug, also known as boceprevir, is designed for use in combination with peginterferon alfa and ribavirin for patients with liver disease due to genotype 1 chronic hepatitis C, the most common form.
It costs 30,800 pounds ($48,400) for a 44-week course, with the other two drugs increasing the bill by around 11,000 pounds.
The draft guidance from NICE is now open for consultation before the agency finally issues it.
NICE publishes final draft guidance on boceprevir for chronic hepatitis C
Source
Healthcare guidance body NICE has today (9 March) issued final draft guidance recommending boceprevir (Victrelis, Merck Sharp & Dohme) in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver diseasei.
Hepatitis C is a blood-borne virus that is transmitted by contact with contaminated blood (for example, through intravenous drug use). 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%, chronic infection will develop, which can cause significant damage to the liver and may eventually lead to liver cancer.
Figures from 2009 suggest that around 146,000 people in England and Wales 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 treatment 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.
Boceprevir inhibits the activity of the NS3/4A serine protease. 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. Clinical trials have demonstrated that treatment with boceprevir plus pegylated interferon and ribavirin produces higher sustained virological response rates (considered to be equivalent to a cure) than pegylated interferon and ribavirin combination therapy. The final draft guidance recommends boceprevir 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.
Commenting on the draft recommendations, Meindert Boysen, Programme Director Technology Appraisals at NICE, said: “The significant improvement in sustained virological response rates seen with boceprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone represents a major benefit for people with genotype 1 chronic hepatitis C. 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. We are therefore very pleased to be able to recommend boceprevir as a cost-effective use of NHS resources.”
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
2. Figures from 2009 suggest that around 250,000 people were infected with the hepatitis C virus, of who 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 concluded that the base-case 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.
6. 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).
7. NICE is also appraising telaprevir (Incivo, Janssen Cilag) for this indication. Further information about the appraisal is available on the NICE website at http://guidance.nice.org.uk/TA/Wave26/6
8. The SMC has published guidance on boceprevir for this condition: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/723_11_boceprevir_Victrelis/boceprevir_Victrelis_Naive and http://www.scottishmedicines.org.uk/SMC_Advice/Advice/722_11_boceprevir_Victrelis/boceprevir_Victrelis_Experienced
About NICE9. 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
10. 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.
11. 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
12. 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.
Hepatitis C is a blood-borne virus that is transmitted by contact with contaminated blood (for example, through intravenous drug use). 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%, chronic infection will develop, which can cause significant damage to the liver and may eventually lead to liver cancer.
Figures from 2009 suggest that around 146,000 people in England and Wales 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 treatment 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.
Boceprevir inhibits the activity of the NS3/4A serine protease. 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. Clinical trials have demonstrated that treatment with boceprevir plus pegylated interferon and ribavirin produces higher sustained virological response rates (considered to be equivalent to a cure) than pegylated interferon and ribavirin combination therapy. The final draft guidance recommends boceprevir 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.
Commenting on the draft recommendations, Meindert Boysen, Programme Director Technology Appraisals at NICE, said: “The significant improvement in sustained virological response rates seen with boceprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone represents a major benefit for people with genotype 1 chronic hepatitis C. 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. We are therefore very pleased to be able to recommend boceprevir as a cost-effective use of NHS resources.”
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
- 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.
- 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).
2. Figures from 2009 suggest that around 250,000 people were infected with the hepatitis C virus, of who 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 concluded that the base-case 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.
6. 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).
7. NICE is also appraising telaprevir (Incivo, Janssen Cilag) for this indication. Further information about the appraisal is available on the NICE website at http://guidance.nice.org.uk/TA/Wave26/6
8. The SMC has published guidance on boceprevir for this condition: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/723_11_boceprevir_Victrelis/boceprevir_Victrelis_Naive and http://www.scottishmedicines.org.uk/SMC_Advice/Advice/722_11_boceprevir_Victrelis/boceprevir_Victrelis_Experienced
About NICE9. 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
10. 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.
11. 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
12. 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: 08 March 2012
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