How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

1 Recommendations

Open for comments Open until   Request commenting lead permission

We have updated this service so that members of the same organisation can now collaborate on a joint online response.

Read our blog to learn more.

2 Information about resmetirom

Anticipated marketing authorisation indication

2.1

This draft guidance is being issued for consultation before resmetirom (Rezdiffra, Madrigal Pharmaceuticals) has a marketing authorisation for this indication in the UK. The committee considered resmetirom within the anticipated marketing authorisation wording: 'indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic MASH with moderate-to-advanced liver fibrosis (consistent with fibrosis stages F2 to F3)'. Any recommendations or conclusions in this document are provisional and dependent on the granting of a marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). The evaluation and consultation processes do not pre-empt, influence or replace the MHRA's independent regulatory assessment. Final guidance will only be published when a marketing authorisation is granted.

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for resmetirom.

Price

2.3

The list price of resmetirom is currently confidential because resmetirom does not yet have a marketing authorisation in the UK.

Sustainability

2.4

Information on the Carbon Reduction Plan for UK carbon emissions for Madrigal Pharmaceuticals will be included here when guidance is published.