NICE consults on draft guidance on the drug simeprevir (Olysio) for treating hepatitis C
17 September 2014
In draft guidance published today healthcare guidance body NICE has recommended simeprevir (Olysio, Janssen) as a treatment option for some people with chronic hepatitis C.
The draft guidance recommends simeprevir, in combination with peginterferon alfa and ribavirin as an option for treating genotype 1 chronic hepatitis C in adults.
Hepatitis C is a virus that infects the liver. 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.
Figures from 2012 suggest that around 160,000 people are chronically infected with the hepatitis C virus in England. More than half of people with chronic hepatitis C do not know they are infected because they only have mild symptoms or no symptoms at all for a long period of time. 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 also 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 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 cases. Genotype 4 hepatitis C accounts for around 4% of cases.
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Commenting on the draft guidance Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: "Chronic hepatitis C can have a significant impact on a person's quality of life, particularly if it progresses to the cirrhosis stages. One of the main challenges in treating hepatitis C is ensuring that people take the drugs they are prescribed. However, current treatment regimens, particularly interferon-based therapy, often have to be given over a long period of time and are associated with significant side effects that increase the likelihood that people may discontinue treatment, or not seek it in the first place."
"Simeprevir, like sofosbuvir which NICE provisionally recommended last month as an option for some patients, offers the possibility of a shortened course of interferon-based therapy. This could make it more likely that people will seek treatment for their condition. In turn this could have important benefits, not just for people with chronic hepatitis, but also in reducing transmission of the virus to people without the infection."
The independent Appraisal Committee was minded not to recommend the use of simprevir for treating genotype 4 chronic hepatitis C and has asked the company for more information on its use for this group of patients.
Because there was not enough robust evidence, the Committee did not recommend simeprevir in combination with sofosbuvir (with or without ribavirin), for treating genotype 1 or 4 chronic hepatitis C in adults.
Stakeholders are now able to comment on the draft recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee at the next meeting, and following this meeting the next draft guidance will be issued. The closing date for comments on the draft guidance is 9 October 2014.
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.
About the draft guidance
1. The draft guidance on simeprevir is available from the NICE website (from 00:01 on 18 September 2014). Consultation on the draft guidance closes on 9 October 2014.
2. The draft guidance states that:
· Simeprevir, in combination with peginterferon alfa and ribavirin, is recommended within its marketing authorisation as an option for treating genotype 1 chronic hepatitis C.
· The Committee is minded not to recommend simeprevir, in combination with peginterferon alfa and ribavirin, for treating genotype 4 chronic hepatitis C. The Committee recommends that NICE requests a detailed rationale from the company about whether the clinical effectiveness in people with genotype 1 hepatitis C virus (HCV) can be generalised to people with genotype 4 HCV.
· Simeprevir, in combination with sofosbuvir (with or without ribavirin) is not recommended within its marketing authorisation for treating genotype 1 or 4 chronic hepatitis C in.
· NICE recommends that clinical data, including genotype and sustained virological response at 12 weeks, is collected for all people treated with simeprevir in the NHS.
· People currently receiving treatment initiated within the NHS with simeprevir that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
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).
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.
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