Coronavirus: Drugs
The question
To ask the Secretary of State for Health and Social Care, whether he has had discussions with NICE on the potential use of PEMGARDA to protect clinically vulnerable people against covid-19 in emergency situations.
Answered by Karin Smyth
It is critical that medicines used in the United Kingdom are safe and effective and as such, medicines cannot be marketed in the UK without a marketing authorisation. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA) which assesses all medicines with regard to their quality, safety, and efficacy. Pemivibart, sold under the brand name Pemgarda, for use in the prophylaxis of COVID-19 does not yet have a marketing authorisation. It is the responsibility of the company to apply to the MHRA for the relevant marketing authorisation. Should an application for it be received, the MHRA will consider this accordingly.
In England, the National Institute for Health and Care Excellence (NICE) considers all newly licenced medicines, those that have received a marketing authorisation, to determine whether they represent a clinically and cost-effective use of National Health Service resources. If the manufacturer of Pemgarda seeks a licence from the MHRA, then the NICE may consider it through its technology appraisal programme.
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