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NICE recommends simeprevir (Olysio) in combination with peginterferon alfa and ribavirin for treating hepatitis C in final draft guidance
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In final draft guidance published today NICE has recommended simeprevir (Olysio, Janssen) as a treatment option for some people with chronic hepatitis C.
Simeprevir has a marketing authorisation for treating two forms of hepatitis C, genotype 1 and genotype 4. Genotype 1 hepatitis C is the most common type of chronic hepatitis C in England, accounting for around 46% of diagnoses. Genotype 4 hepatitis C accounts for around 4% of diagnoses.
The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin, as an option for treating both genotypes 1 and 4 chronic hepatitis C in adults.
Hepatitis C is a virus that infects the liver and is thought that around 160,000 people are chronically infected with the virus in England. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to the liver, preventing it from working properly.
About 1 in 3 people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small percentage of people with chronic hepatitis C and cirrhosis may require a liver transplant and some may develop liver cancer.
The 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.
Simeprevir is administered orally and works by inhibiting the replication of the hepatitis C virus.
Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "The previous draft guidance did not recommend simeprevir for treating genotype 4 chronic hepatitis C and asked the company for more information on its use for this group of patients.
"Based on the information received the independent Appraisal Committee concluded that simeprevir, in combination with peginterferon alfa and ribavirin, is a cost effective treatment option for people with genotypes 1 and 4 chronic hepatitis C."
More data on the use of simeprevir in combination with sofosbuvir to treat chronic hepatitis C in people who can't tolerate or aren't eligible for treatment with interferon is due to become available soon. Therefore recommendations on this treatment combination will now be developed in separate guidance.
The draft guidance is now with consultees, who have the opportunity to appeal against it.
This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
Final guidance on simeprevir in combination with peginterferon alfa and ribavirin for chronic hepatitis C is due to be published in February 2015.
Ends
For further information, please contact the NICE press office on 0300 323 0142 / pressoffice@nice.org.uk or out of hours on 07775 583 813.
Notes to Editors
About the draft guidance
1. The draft guidance on simeprevir is available from the NICE website (from 00:01 on 16 January 2015).
2. This guidance gives recommendations for simeprevir in combination with peginterferon alfa and ribavirin. Simeprevir also has a marketing authorisation in combination with sofosbuvir. Recommendations for the combination with sofosbuvir will be developed in separate guidance.
3. The draft guidance states that:
1.1 Simeprevir, in combination with peginterferon alfa and ribavirin, is recommended within its marketing authorisation as an option for treating genotype 1 and 4 chronic hepatitis C in adults.
1. As part of this appraisal the Committee originally considered the effectiveness of simeprevir in combination with sofosbuvir. In the appraisal consultation document the Committee concluded that the true magnitude of the effect of simeprevir in combination with sofosbuvir could not be robustly estimated in people who cannot tolerate or are not eligible to have interferon treatment. At its second meeting, the Committee heard that mature observational data for simeprevir in combination with sofosbuvir would become available in the near future, and that this would include data on people who cannot tolerate or are not eligible to have interferon treatment. The Committee considered that it would be more appropriate to postpone making a decision on this combination until the more mature data become available. To avoid postponing the recommendations for the combination of simeprevir with peginterferon alfa and ribavirin for treating genotype 1 and 4 hepatitis C, the Committee recommended that this appraisal be split. Therefore, this appraisal no longer includes a recommendation for simeprevir in combination with sofosbuvir with or without ribavirin for treating people with genotype 1 and 4 HCV who are intolerant or ineligible for treatment with interferon.
2. Following a request from NHS England to extend the period during which funding must be made available, NICE consulted on a proposal to grant an extension to the deferred funding period until 31 July 2015. Following consideration of comments received during the consultation on a decision to amend the deferred funding, the NICE Guidance Executive decided that no extension to the normal period was required for simeprevir in combination with peginterferon alpha and ribavirin. This is because simeprevir will be used in the same way as boceprevir and telaprevir. Both these interventions have been funded by the NHS since the publication of NICE appraisal guidance in early 2012. The resources and arrangements for safe delivery of treatment are already in place as a result of the availability of telaprevir and boceprevir. Therefore, additional resources or training are not required to support the implementation of simeprevir. In addition, simeprevir treatment is less complex to administer than telaprevir and boceprevir, and the additional small patient population with genotype 4, for whom simeprevir is licensed is not expected to constitute a substantial challenge to the implementation. Consequently, section 5 of the FAD states that clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities are required to comply with the recommendations in this appraisal within 3 months of its date of publication.
About chronic hepatitis C
1. There are 6 major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically.
2. Genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43% respectively).
3. People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.
4. For people with mild disease, a 'watchful waiting' approach may be agreed, on an individual basis, between the patient and clinician.
5. Although 15 to 20% of people infected with the hepatitis C virus naturally clear their infections within 6 months, the remainder develop chronic hepatitis which can be life-long.
6. Current NICE guidance (NICE technology appraisal 75 and NICE technology appraisal 106) recommends that standard treatment for the majority of people with chronic hepatitis C is peginterferon alfa and ribavirin combination therapy. Monotherapy with peginterferon alfa-2a or peginterferon alfa-2b is recommended for patients who are unable to tolerate ribavirin or for whom ribavirin is contraindicated.
7. Other NICE guidance on hepatitis C (NICE technology appraisal 200) also recommends that people who have been previously treated with peginterferon alfa and ribavirin or with peginterferon alfa monotherapy have an option to receive further courses of peginterferon alfa and ribavirin.
8. Shortened courses of peginterferon alfa and ribavirin are also recommended as an option for certain patient subgroups (NICE technology appraisal 200).
9. For people with genotype 1 chronic hepatitis C, who have not been previously treated or who have been previously treated, NICE guidance also recommends telaprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 252) or boceprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 253).
About simeprevir
1. Simeprevir (Olysio, Janssen) is a protease inhibitor; it inhibits the NS3/4A enzyme that the hepatitis C virus (HCV) depends on to replicate. Simeprevir is administered orally.
2. Simeprevir has a UK marketing authorisation in the UK for use in combination with peginterferon alfa and ribavirin or in combination with sofosbuvir (with or without ribavirin) for treating adults with genotype 1 or 4 chronic hepatitis C, including people with or without cirrhosis, and people with HIV.
3. For people who have not had previous treatment or whose disease has responded to previous treatment but subsequently relapsed, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 12 weeks of peginterferon alfa and ribavirin alone.
4. For other people, the course of simeprevir is the same, but the course of pegylated interferon and ribavirin is longer than 24 weeks; specifically, for people whose disease did not respond to previous treatment, and for people with HIV who also have cirrhosis, simeprevir in combination with peginterferon alfa and ribavirin is indicated for 12 weeks, followed by 36 weeks of peginterferon alfa and ribavirin alone.
5. Simeprevir in combination with sofosbuvir (with or without ribavirin) is indicated for 12 weeks for people with genotype 1 or 4 HCV who cannot tolerate or are not eligible for interferon therapy, and are in urgent need of treatment, regardless of previous treatment history. According to the summary of product characteristics, treatment can be extended up to 24 weeks, considered on an individual basis.
6. Simeprevir costs 1866.50 per pack of 7x150 mg tablets (excluding VAT, MIMS online, accessed July 2014). A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 24 weeks) costs 27,220. A course of simeprevir (for 12 weeks) plus peginterferon alfa and ribavirin (both for 48 weeks) costs 32,155. A course of simeprevir plus sofosbuvir (both for 12 weeks) for people with genotype 1 or 4 HCV who cannot tolerate or are not eligible for interferon-based treatment costs 57,381. Costs may vary in different settings because of negotiated procurement discounts.
7. For treating genotype 1 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone was between 14,200 and 9800 per QALY. Simeprevir dominated both telaprevir and boceprevir (both with peginterferon alfa and ribavirin), that is simeprevir was less expensive and provided more QALYs.
8. The Committee noted that, in all scenarios for genotype 4 HCV, the ICERs for simeprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin remained below 20,000 per QALY gained.
About NICE
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