1 Recommendations

There is a funding variation for nirmatrelvir plus ritonavir (see section 4). In addition to people with an increased risk for progression to severe COVID-19 as defined in section 5, the full recommendation would provide access 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.

During the funding variation period, that is, from within 3 months of guidance publication (13 March 2024) to 1 June 2025, the NHS will expand access to nirmatrelvir plus ritonavir for the following groups:

  • 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.

1.1

Nirmatrelvir plus ritonavir is recommended as an option for treating COVID‑19 in adults, only if they:

  • do not need supplemental oxygen for COVID‑19 and

  • they have any of the following:

    • an increased risk for progression to severe COVID‑19, as defined in section 5

    • age 70 years and over

    • a body mass index (BMI) of 35 kg/m2 or more

    • diabetes

    • heart failure.

1.2

Sotrovimab is recommended as an option for treating COVID‑19 in adults and young people aged 12 years and over and weighing at least 40 kg, only if:

  • they do not need supplemental oxygen for COVID‑19 and

  • they have an increased risk for progression to severe COVID‑19, as defined in section 5 and

  • nirmatrelvir plus ritonavir is contraindicated or unsuitable.

    Sotrovimab is only recommended if the company provides it according to the commercial arrangement.

1.3

Tocilizumab is recommended, within its marketing authorisation, as an option for treating COVID‑19 in adults who:

  • are having systemic corticosteroids and

  • need supplemental oxygen or mechanical ventilation.

    Tocilizumab (branded or biosimilar) is only recommended if the companies provide it according to the commercial arrangement.

Why the committee made these recommendations

About this evaluation

This evaluation reviews the clinical and cost effectiveness of:

  • nirmatrelvir plus ritonavir and sotrovimab for mild COVID‑19

  • tocilizumab for severe COVID‑19.

Most of the clinical evidence for these treatments is highly uncertain because it comes from studies done before the dominant Omicron variants of SARS‑CoV‑2 (the virus that causes COVID‑19).

The cost-effectiveness estimates are highly dependent on how well each treatment works compared with standard care, and hospitalisation and mortality rates. Hospitalisation and mortality rates are lower with Omicron variants than earlier variants in the pandemic. These lower rates increase the cost-effectiveness estimates.

Clinical and cost effectiveness

Clinical evidence suggests that:

  • nirmatrelvir plus ritonavir is effective at treating mild COVID‑19 compared with standard care

  • sotrovimab is likely to be effective at treating mild COVID‑19 compared with standard care but some of the evidence is uncertain

  • tocilizumab is effective at treating severe COVID‑19 compared with standard care.

The independent advisory group report commissioned by the Department of Health and Social Care defines people with the highest risk of progression to severe COVID‑19 (see section 5). Nirmatrelvir plus ritonavir is recommended in these groups because the likely cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources. The cost-effectiveness estimates for sotrovimab in these groups are also within what NICE considers an acceptable use of NHS resources, but only for people for whom nirmatrelvir plus ritonavir is contraindicated or unsuitable. So, sotrovimab is recommended in this group.

The Therapeutics Clinical Review Panel modelling group findings on risk of severe COVID-19 outcomes identify additional groups of people with an increased risk of severe COVID‑19. Nirmatrelvir plus ritonavir is also recommended for some of these groups (age 70 years and over, BMI of 35 kg/m2 or more, diabetes, and heart failure) because the likely cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources.

Tocilizumab is recommended because the likely cost-effectiveness estimates are within what NICE considers an acceptable use of NHS resources.

  • National Institute for Health and Care Excellence (NICE)