As pandemic abates, NICE issues new COVID drug guidance

UK cost-effectiveness agency NICE has published guidance on the use of COVID-19 therapies that can be used for at-risk patients, focusing on three drugs that can be used outside of the pandemic.

The draft guidance recommends three therapies – Pfizer’s Paxlovid (nirmatrelvir/ritonavir), GSK’s Xevudy (sotrovimab), and Roche’s RoActemra (tocilizumab) – that can be used to protect vulnerable people, such as those who are immunosuppressed, from developing severe COVID-19 symptoms.

NICE said it is the first health technology assessment (HTA) body in the world to look at the clinical and cost-effectiveness of COVID treatments outside of their use during the pandemic, as the transmission of SARS-CoV-2 starts to take on more endemic characteristics.

Cases of COVID still remain fairly high in the UK, at almost 58,000 in the week to 20th February, but are down by a fifth on the prior week. There were still more than 500 deaths attributed to COVID during that period, however, pointing to the continued need for drug treatment.

Those deaths are likely to be in people who are at risk of complications from SARS-CoV-2 infection, such as those with heart disease, respiratory disease, diabetes, or neurological conditions, in addition to people whose immune systems are not working as they should.

Paxlovid, Xevudy, and RoActemra can be administered either at home or in hospital under the new guidance, which notes that the drugs still have “some evidence” of efficacy in COVID, despite the emergence of new variants.

Pfizer’s drug is recommended for adults with milder symptoms who do not need supplemental oxygen for COVID, with Xevudy coming into play if Paxlovid is contraindicated or unsuitable.

It is the first time GSK’s antibody has been recommended by NICE, coming after “more clinical evidence and productive discussions with the company,” said the HTA ‘s director of medicines evaluation, Helen Knight.

RoActemra, meanwhile, is recommended for sicker adults with COVID who need systemic corticosteroids and supplemental oxygen or mechanical ventilation.

The new guidance comes a few days after NICE rejected AstraZeneca’s Evusheld (tixagevimab/cilgavimab) for COVID prevention, in a blow to immunocompromised individuals who cannot get protection through vaccination.

Rapid review process out for comment in April

NICE also provided an update on its planned speedier review process for COVID treatments, which comes after the agency has been criticised for taking too long to carry out its cost-effectiveness appraisals, with emerging variants reducing the efficacy of therapies before they have a chance to be fully deployed.

It will be launching a public consultation on proposals for the new rapid update process from 3rd April. A surveillance programme to spot emerging new variants and evidence that medicines work against them is already in place, and NICE says it has the ability to run an update as a pilot during the consultation period.