| |
NICE Simeprevir Report
|
| |
| |
https://www.nice.org.uk/guidance/gid-tag455/resources/hepatitis-c-chronic-simeprevir-id668-appraisal-consultation-document
Hepatitis C (chronic) - simeprevir [ID668] -
https://www.nice.org.uk/Guidance/InDevelopment/GID-TAG455/Documents
Appraisal Committee's preliminary recommendations
1.1 Simeprevir, in combination with peginterferon alfa and ribavirin, is recommended within its marketing authorisation as an option for treating genotype 1 chronic hepatitis C.
1.2 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.
1.3 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.
1.4 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.
1.5 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.
-----------------------
Janssen Responds To Initial Reaction From NICE On Olysio (Simeprevir) For Hepatitis C Patients With Genotypes 1 And 4
September 22nd, 2014
High Wycombe, UK, 22 September 2014 ĞResponding to the Appraisal Consultation Document1 (ACD) from the National Institute of Health and Care Excellence (NICE) for the use of Olysio¨ (simeprevir), Janssen has expressed mixed feelings.
Janssen is pleased that the NICE Appraisal Consultation Document for simeprevir has recommended its use for the treatment of chronic hepatitis C genotype 1 infection; however, it is extremely disappointed that it has not recommended its use in the other two of its three licenced indications.
Data from clinical studies have demonstrated the efficacy of simeprevir in patients with genotype 4 infection, when used in combination with pegylated interferon and ribavirin. Simeprevir is also licenced in combination with sofosbuvir, thus providing a much needed treatment option for patients who are unable to tolerate interferon-containing regimens. Each of these patient groups includes a small number of patients who have an unmet medical need for alternative treatment options.
By not recommending the use of simeprevir with sofosbuvir, patients who are unable to tolerate an interferon-based regimen with genotypes 1 or 4 hepatitis C, will not have access to an effective, new therapy. These patients will have to wait further until new therapy combinations are approved, during which time their disease may progress, with the potential development of permanent liver damage such as cirrhosis or cancer. Additionally, successful clearing of the virus reduces the risk of onward transmission of hepatitis C to others.
At this stage the decision by NICE is still preliminary, and we will therefore continue to work with NICE and other stakeholders to find a solution that will make simeprevir available for these patients.
Peter Barnes, Medical Director at Janssen, commented: "We are pleased that simeprevir has been recommended for the treatment of patients with genotype 1 hepatitis C when used in combination with peginterferon and ribavirin. However, we are disappointed with the preliminary recommendations from NICE for genotype 4 patients and those who are intolerant to interferon, and could therefore benefit from the use of a treatment regime that does not include it.
We believe there is an unmet need in these patient groups that simeprevir can help address and that our submission to NICE demonstrates the cost-effectiveness of its use. However, we will attempt to address NICE's concerns around this evidence, and hope its position will change."
The public consultation has now started and interested parties may submit a response through the NICE website. The deadline for response is the 9th October 20141
About simeprevir
Simeprevir is an NS3/4A protease inhibitor (antiviral drug) developed jointly by Janssen R&D Ireland and Medivir AB. It prevents viral replication by binding to the enzyme responsible for HCV replication thus rendering it inactive.
Simeprevir is indicated for the treatment of chronic hepatitis C infection in combination with peginterferon alfa-2a (pegIFN) and ribavirin (RBV) in genotype 1 and genotype 4 HCV-infected patients with compensated (a diseased liver that is still functioning) liver disease, including all stages of liver fibrosis.2 Simeprevir is also licensed for use as part of an all oral 12-week interferon-free Direct Acting Antiviral (DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.
The licence for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal Phase 3 studies, with over 1,000 patients. The trials; QUEST-1, QUEST-24 and PROMISE5, explored the use of simeprevir in combination with PegIFN/RBV in treatment-na•ve patients and patients who have relapsed after prior interferon-based treatment. All three studies met their primary endpoints and demonstrated that simeprevir, in combination with PegIFN/RBV, achieves significant viral clearance rates when compared with PegIFN/RBV alone.
Simeprevir is taken once-daily for 12 weeks, with treatment-na•ve and prior-relapser patients receiving pegylated interferon and ribavirin for 24 weeks, and for 48 weeks total by those shown to be prior non-responder patients (including partial and null responders). It is generally well tolerated, with the most common adverse events reported in clinical trials (incidence ³ 5%) including nausea, rash, pruritus, dyspnoea, hyperbilirubinemia and photosensitivity reaction.6
About hepatitis C
Hepatitis C is a treatable blood-borne virus that can lead to damage of the liver, and potentially result in liver conditions such as cirrhosis (destruction of normal liver tissue) and liver cancer.2 It is regarded as a public health issue that leads to significant morbidity and mortality and burden to the NHS, with Public Health England (PHE) estimating there are 215,000 people in the UK infected with hepatitis C3.
Despite being a curable disease, hepatitis C is often dubbed a 'silent killer' as symptoms may go unnoticed for many years, and only 3% of people with hepatitis C receive treatment each year3.
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit www.janssen.co.uk for more information.
Olysio SmPC
http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+cap... Accessed September 2014
|
|
| |
| |
|
|
|
