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  • 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

1.1

Molnupiravir is not recommended, within its marketing authorisation, for treating mild to moderate COVID-19 in adults who have:

  • a positive SARS-CoV-2 test, and

  • 1 or more risk factors for developing severe COVID-19.

Why the committee made these recommendations

Usual treatment for mild to moderate COVID-19 in people at risk of developing severe COVID-19 includes nirmatrelvir plus ritonavir, or sotrovimab when nirmatrelvir plus ritonavir is unsuitable. There are no other treatment options when these medicines cannot be used.

The company asked for molnupiravir to be considered only in the community setting for people with mild to moderate COVID-19 who are at risk of developing severe COVID-19 and cannot have nirmatrelvir plus ritonavir, or sotrovimab. This does not include everyone it is licensed for.

Some results from clinical trials and real-world evidence for the people molnupiravir is licensed for suggest that it reduces the likelihood of hospitalisation or death compared with no treatment. But results from the UK do not show clinically meaningful effects with molnupiravir compared with no treatment. The evidence the company submitted is not specific to people with the highest risk of developing severe COVID-19. Also, who this includes is uncertain.

Because of these uncertainties, it is not possible to determine the most likely cost-effectiveness estimates for molnupiravir. So, molnupiravir is not recommended.