Technology Appraisal Guidance No. 413
Source: National Institute for Health and Care Excellence
1.1 Elbasvir–grazoprevir is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1, only if the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit.
|Table 1 Elbasvir–grazoprevir for treating chronic hepatitis C in adults|
|Genotype||Treatment and duration|
|1a||Elbasvir–grazoprevir for 12 weeks.|
|Consider elbasvir–grazoprevir plus ribavirin for 16 weeks in people with a baseline hepatitis C virus RNA level of more than 800,000 IU/ml or specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir.|
|1b||Elbasvir–grazoprevir for 12 weeks.|
|4||Elbasvir–grazoprevir for 12 weeks.|
|Consider elbasvir-grazoprevir plus ribavirin for 16 weeks in people with a baseline hepatitis C virus RNA level of more than 800,000 IU/ml.|
1.2 It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at www.nice.org.uk/guidance/ta413
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
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Elbasvir–grazoprevir for treating chronic hepatitis C
Issue Date: October 2016