Decisions on whether licensed medicines should be recommended for routine National Health Service funding are made independently by the National Institute for Health and Care Excellence (NICE), on the basis of the evidence of the costs and benefits. The Department has no plans to speak to the NICE about offering Paxlovid to all people over the age of 50 years old.

NICE guidance recommends Paxlovid, which contains nirmatrelvir and ritonavir, as an option for treating COVID-19 in adults only if they do not need supplemental oxygen for COVID-19 and if they are or have any of the following:

• an increased risk for progression to severe COVID-19, as defined in the guidance;
• are aged 70 years old and over;
• a body mass index of 35 kilograms per meter squared of height, or more;
• diabetes; or
• heart failure.

The NICE has agreed to NHS England’s proposal to a phased implementation of its recommendations on Paxlovid, to allow more time for the NHS to put in place the capacity and infrastructure needed for full rollout to all eligible patients. Paxlovid is currently available to NHS patients at highest risk of severe COVID-19, in line with the approach to the rollout set out in the NICE’s guidance.

The Department has made no such assessment, as the National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations on whether medicines can be recommended for routine use on the National Health Service. NICE’s recommendations are based on a thorough assessment of the available evidence and developed through a rigorous process that includes extensive engagement with stakeholders.

NICE published guidance in March 2023 that recommends Paxlovid for patients at highest risk of developing serious illness from COVID-19. Paxlovid is now routinely available to NHS patients in line with NICE’s guidance. NICE issued final draft guidance on 11 January 2024 that expands its recommendation of Paxlovid to include other higher risk groups, including people aged 70 years and over, or with a body mass index of 35 or more, diabetes, or heart failure.

The Department procured stock of Paxlovid during the pandemic and has set up a distribution network to both primary and secondary care in England so that all eligible patients can access the treatment in line with recommendations from the National Institute for Health and Care Excellence (NICE).

NICE is in the process of developing recommendations for the National Health Service on the potential expanded use of Paxlovid. NICE published final draft guidance that recommends expanded use of Paxlovid in August 2023. Following discussions between the Department, NHS England and NICE, NICE has recently consulted on an NHS England proposal to vary the funding requirement that normally applies three months after the publication of NICE guidance to allow a phased rollout to all eligible patients, considering the capacity of the NHS to implement NICE’s recommendations in full.

The Department recognises that implementation of the updated National Institute for Health and Care Excellence (NICE) recommendations on nirmatrelvir plus ritonavir (Paxlovid) within the standard three-month timescale that applies to NICE’s recommendations would be challenging for the National Health Service. The Department supports NICE’s consultation on NHS England’s proposal to phase rollout to the expanded cohort of patients over a 12-month period. NHS England’s proposal would ensure that the NHS has sufficient time to put in place the capacity necessary to support access to treatment and consider how to ensure the availability of testing in way that provides value for money, whilst continuing to ensure access for patients at highest risk of serious illness from COVID-19.

NICE will carefully consider the comments received in response to the consultation in making its final recommendations.

The National Institute for Health and Care Excellence (NICE) has been developing recommendations for the National Health Service on whether licensed antivirals for COVID-19 should be routinely funded by the NHS based on an assessment of their costs and benefits. NICE published guidance in March 2023 that recommends the antiviral Paxlovid for those at highest risk of serious illness from COVID-19 and the NHS is now legally required to fund treatment in line with NICE’s recommendations. The Department procured stock of Paxlovid during the pandemic and has set up a distribution network to both primary and secondary care in England, as the devolved administrations have their own arrangements, so that all eligible patients can access the treatment.

NICE is developing recommendations for the NHS on the use of the antivirals molnupiravir and remdesivir, and is also developing guidance for the NHS on the potential expanded use of Paxlovid. NICE published final draft guidance that recommends expanded use of Paxlovid in August 2023. Following discussions between the Department, NHS England and NICE, NICE has recently consulted on an NHS England proposal to vary the funding requirement that normally applies three months after the publication of NICE guidance to allow a phased rollout to all eligible patients. NICE will carefully consider the comments received in response to the consultation in making its final recommendations.

The Department procured stock of Paxlovid during the pandemic and has set up a distribution network to both primary and secondary care in England so that all eligible patients can access the treatment in line with recommendations from the National Institute for Health and Care Excellence (NICE). The Department is in regular contact with NHS England about demand for and distribution of the centrally procured stocks, including for the potential expanded use of Paxlovid following the publication of NICE’s final draft guidance on Paxlovid published in August 2023.

Of the nirmatrelvir+ritonavir (Paxlovid) received, none has expired. Currently 1,095,954 courses held in central warehouses will expire within the next six months. The latest shelf-life approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 26 October 2022 is 24 months from initial manufacture. The Department is working with Pfizer to extend the use-by period of the unused stock received through batch-specific variation applications. This will align existing stock with the MHRA’s latest approved shelf-life, therefore it is anticipated none of the nirmatrelvir+ritonavir held will expire in the next six months. Any shelf-life extension is subject to the MHRA’s review and approval of the product’s continued safety and effectiveness.

Of the nirmatrelvir+ritonavir (Paxlovid) received, none has expired. Currently 1,095,954 courses held in central warehouses will expire within the next six months. The latest shelf-life approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 26 October 2022 is 24 months from initial manufacture. The Department is working with Pfizer to extend the use-by period of the unused stock received through batch-specific variation applications. This will align existing stock with the MHRA’s latest approved shelf-life, therefore it is anticipated none of the nirmatrelvir+ritonavir held will expire in the next six months. Any shelf-life extension is subject to the MHRA’s review and approval of the product’s continued safety and effectiveness.

No doses are due to reach the expiry date in the next two months.

Nirmatrelvir+ritonavir was granted a conditional marketing authorisation on 31 December 2021 and received an initial shelf life of 12 months from manufacture. Of nirmatrelvir+ritonavir received, none will expire in the next three months, 400,000 courses will expire in the next six months and 1,075,000 courses will expire in the next nine months. The Department continues to consider options for extending the shelf-life of COVID-19 antiviral treatments which have been received and not yet used.

The pharmaceutical companies producing antivirals have not made these treatments commercially available to the private health care sector in the United Kingdom. The supply of the COVID-19 oral antiviral treatments approved by the Medicines and Healthcare products Regulatory Agency is commercially available to the Government for National Health Service patients and the devolved administrations. Pharmaceutical companies are responsible for the commercial decisions on the availability of their products.

The Merk Sharp and Dohme clinical trial of molnupiravir showed that the drug reduces the relative risk of hospitalisation or death by 30%. Pfizer’s trial of nirmatrelvir+ritonavir showed an 89% reduction in hospitalisation or death compared to a placebo. The PANORAMIC national study will inform our understanding on how oral antiviral treatments perform in the UK, where the majority of the population is vaccinated. This will inform future decisions on access for patients in the UK.

The Government has secured 4.98 million patient courses of oral antiviral treatments. As a result, there are supplies of oral antivirals molnupiravir and nirmatrelvir+ritonavir held in the United Kingdom with regular deliveries to ensure sufficient treatment for patients. These are available to eligible patients in the community at highest risk of developing severe disease through COVID Medicines Delivery Units in England and equivalent arrangements in Scotland, Wales and Northern Ireland. In addition, nirmatrelvir + ritonavir is available to eligible patients who contract COVID-19 whilst in hospital.

We continue to monitor clinical trial results to understand which patient cohorts may benefit from oral antivirals, including the PANORAMIC national study. The results will inform our understanding of the performance of oral antivirals where the majority of the population is vaccinated and future decisions on patient access in the UK.

The supply of COVID-19 oral antivirals is not yet commercially available, with the current United Kingdom stocks held by the Government. As there is no commercial supply of antivirals, private physicians are not able to prescribe antivirals to non-hospitalised patients.

Community pharmacies dispense prescriptions issued by general practice. COVID-19 treatments, including the oral antiviral treatments molnupiravir and nirmatrelvir (Paxlovid), are not currently available for general practice prescribing. In England, these treatments are prescribed by a clinician within a COVID Medicine Delivery Unit. Where an oral antiviral treatment is prescribed, this can be collected from a named pharmacy usually in a hospital, or alternatively sent directly to the patient’s home.

Community pharmacies are not able to stock and sell COVID-19 treatments, including molnupiravir or PF-07321332+ritonavir, co-packaged as Paxlovid. Updates on accessing these medications will be provided in due course.