Nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication (29 March 2023).

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has COVID‑19 and the doctor responsible for their care thinks that sotrovimab or tocilizumab is the right treatment, it should be available for use, in line with NICE's recommendations.

In Scotland, the advice will have the same status for health board consideration as other Scottish Medicines Consortium advice on new medicines.

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards (ICBs), NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication. For people with an increased risk for progression to severe COVID‑19, as defined in section 5, this is 3 months after 29 March 2023. For people who are aged 70 years and over, or who have a body mass index (BMI) of 35 kg/m² or more, diabetes or heart failure, the normal period of compliance has been extended to 15 months to 1 June 2025. This is because NHS England, on behalf of ICBs, submitted a funding variation request for this expanded population, which was accepted by NICE after a period of public consultation. NHS England's justification for the funding variation request is that ICBs will need time beyond the usual 3 month implementation period to put in place the necessary treatment pathways and ensure the necessary capacity, knowledge and expertise is in place to support equitable access for the expanded population.

During the period of the variation (that is, within 3 months of publishing final guidance), the NHS will rollout access to treatment to the following groups if they test positive for COVID‑19:

• people aged 85 years and over

• people with end-stage heart failure who have a long-term ventricular assistance device

• people on the organ transplant waiting list

• people aged 70 years and over, or who have a BMI of 35 kg/m² or more, diabetes or heart failure, and:

  • are resident in a care home, or

  • are already hospitalised.

NICE has recommended nirmatrelvir plus ritonavir for people aged 70 years and over, or who have a BMI of 35 kg/m² or more, diabetes or heart failure because it is clinically and cost effective. Having done so, NICE should be cautious about introducing any delay in patients gaining access to treatments from which they may benefit. However, it should also avoid placing the NHS in a position of confronting substantial demand from patients for access to care that it has told NICE it cannot provide. To do so would risk sub-optimal treatment decisions and may subject the current NHS services to undue stress.

The responsibility for securing care for the NHS in England rests with NHS England and ICBs. NICE should be cautious and sure of its judgement before requiring NHS England and ICBs to provide services that they do not consider that they can provide, or provide safely and efficiently. In effect, NICE would have to conclude that NHS England and ICBs were mistaken. NHS England has indicated that not all ICBs have in place the arrangements that it considers necessary to provide nirmatrelvir plus ritonavir, to the full extent recommended in this guidance, within 3 months. This is based on a consultation will ICBs and regional Senior Responsible Officers for COVID‑19 treatments. Although the company has identified that some ICBs would be ready to implement the recommendation, NHS England, in setting out what it believes other ICBs need to do to put the necessary arrangements in place, has credibility. NICE needs to be wary of substituting its judgement for NHS England's in this respect.

NICE put to NHS England the question raised in consultation of whether ICBs that did consider they could implement the full recommendations sooner than the end of the funding variation period would be able to do so. NHS England responded that it did not consider that an approach during the variation, which sees some areas providing access sooner than others, is equitable or practicable. Such an approach would mean access was based on where someone lives. This could lead to confusion for patients and clinicians and would likely lead to an avoidable increase in pressure on services. In addition, access to testing would not be available. In the short term, NHS England is extending the arrangements already in place for the highest risk cohort, but will need to introduce new models to allow access for the full population. This will take the time requested in the funding variation and cannot be done in a phased way. NICE accepts these explanations.

NHS England provided an equality impact assessment that noted that the funding variation request could impact some groups. However, NHS England considers that the proposal to continue to provide access to nirmatrelvir plus ritonavir to treat mild COVID‑19 in the highest risk groups and to expand access to people aged over 85 years, people in care homes and hospital inpatients is a proportionate means of:

• Protecting those at highest risk of severe COVID‑19 outcomes and patients with protected characteristics who require primary care services for other health conditions. It is known from previous COVID‑19 waves that risk of hospitalisation and death are closely associated with age.

• Achieving the legitimate aim of maximising public health in the context of the availability of vaccination for the patients covered by this recommendation and of other COVID‑19 treatments for hospital inpatients.

• Ensuring access is provided in an equitable way across the whole NHS and not determined either by where someone lives or their ability to pay for a COVID‑19 test.

• Supporting the NHS to prepare for the implementation of NICE guidance in full as required by the legal funding requirement.

NICE fully understands the concerns put forward by consultees who object to the proposed extension to the funding period. Any additional delay in accessing recommended treatments is undesirable. However, NHS England's request on behalf of ICBs reflects a real concern that the current arrangements expose existing services and other services to substantial risks from overwhelming demand.

An extension of the funding period is therefore granted under section 7(5) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance. For people who are aged 70 years and over, or who have a BMI of 35 kg/m² or more, diabetes or heart failure, the normal period of compliance has been extended to 15 months to 1 June 2025. This is for the reasons explained in section 4.1.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has COVID‑19 and the doctor responsible for their care thinks that nirmatrelvir plus ritonavir is the right treatment, it should be available for use, in line with NICE's recommendations.

The Scottish Medicines Consortium collaborated with NICE on this guidance. In Scotland, the advice will have the same status for health board consideration as other Scottish Medicines Consortium advice on new medicines. Information on implications of the funding variation in Scotland will be issued by Scottish Government.