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ledipasvir/sofosbuvir (Harvoni®)


Reference No. 1887

Publication date:
12/08/2015


Appraisal information

ledipasvir/sofosbuvir (Harvoni®) 90 mg/400 mg film-coated tablet


Company: Gilead Sciences Ltd
BNF category: Infections
NMG meeting date: 18/03/2015
AWMSG meeting date: 22/04/2015
   
   
Submission Type: Full Submission
Status: Superseded
Advice No: 0915
Ministerial ratification: 12/08/2015

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

AWMSG ADVICE SUPERSEDED BY NICE GUIDANCE (TA363) NICE GUIDANCE ISSUED NOVEMBER 2015 (Refer to NICE website for full guidance on NICE recommendations, including any specific restrictions on the use of the technology). Ledipasvir/sofosbuvir (Harvoni®) is recommended as an option for restricted use within NHS Wales for the treatment of chronic hepatitis C in adults with hepatitis C virus genotype 1 and 4 without cirrhosis or with compensated cirrhosis for up to 12 weeks. Ledipasvir/sofosbuvir (Harvoni®) is not recommended for use within NHS Wales outside of this subpopulation/these circumstances. Key factor(s) influencing the recommendation: The cost effectiveness data presented in the submission were insufficient for AWMSG to recommend use beyond 12 weeks. No economic data were provided for genotype 1 or 4 patients with decompensated cirrhosis or who are pre-/post liver transplant. Similarly, no economic data were provided for genotype 3 patients with cirrhosis and/or prior treatment failure.
Final Appraisal Recommendation (FAR)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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