Central Alerting System
View Alert

Originator: CMO Messaging

From: CMO Messaging

Issue date: Originally issued on 27-Jan-2022 16:24:21. This version was issued on 27-Jan-2022 16:24:21

This alert has been issued to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Foundation Trusts (England) - Chief Executive
  • NHS Trusts (England) - Medical Director
  • CMO Urgent Messages - Non-NHS Recipients on Public Health Link
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Consultants in Communicable Diseases
  • CMO Urgent Messages - Recipients on Public Health Link
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Community Pharmacy
  • Primary Care Networks

Action category: Action

Title: Antivirals or neutralising monoclonal antibodies (nMABs) for non-hospitalised patients with COVID-19

Broadcast content:
***The policy and linked clinical guide have been updated to capture exclusion criteria for remdesivir to mirror the SmPC (Summary of Product Characteristics)***

***3 February 2022: Update addition of date of SPS guidance and reference to Liverpool COVID-19 Drug Interaction Checker to footnote in Appendix 2.***

***31 January 2022: Update: correction to wording around exclusion criteria for molnupiravir.***

***27 January 2022: We have updated the Clinical Guide to rectify a broken link to the Remdesivir SmPC on page 3. We have also removed asterisk/footnotes on page 3 of the Clinical Guide and Appendix 1 of the Policy next to “corticosteroids”. No other changes have been made.***

The published policy, providing access to monoclonal antibodies or antivirals as treatment options for non-hospitalised patients at highest risk from COVID-19 infection, has been updated to include additional licensed antiviral treatment options – oral PF-07321332 (may also be known as nirmatrelvir) plus ritonavir (Paxlovid) as a new first-line treatment option, and intravenous remdesivir (Veklury) as a second-line treatment option. Intravenous sotrovimab (Xevudy) remains in the policy as a first-line treatment option. Oral molnupiravir (Lagevrio) remains a third-line option. Positive PCR tests or formally registered positive lateral flow tests may now be considered to meet the eligibility requirement on confirmed COVID infection. 

These changes are for implementation from Thursday 10 February 2022. 

This targeted NHS deployment for patients at highest risk sits alongside the PANORAMIC trial where a different and broader cohort of patients are able to access novel oral antivirals through a clinical study.

Additional information: NHS England and NHS Improvement Regional Offices: please cascade this alert to community pharmacy

Alert reference: CEM/CMO/2022/001


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency