NICE process “not appropriate for a rapidly evolving virus”
We have submitted comments relating to NICE’s draft guidance on therapeutics for people with Covid-19, following the regulatory body’s draft decision to dramatically reduce the number of available treatments. We highlighted that the relevant evidence failed to consider the impact on high-risk patients while strongly advocating for the fast-tracking of Covid-19 treatments.
Kidney disease patients represent a unique population as the only treatment being offered by NICE – Paxlovid - is not suitable for them and may cause serious harm, leaving without any treatment options.
Following the release of the draft guidance, we have called on the Government to deliver Covid treatments in a similar manner to the original introduction of the Covid-19 vaccines by fast-tracking them into clinical practice. Within its formal response, we highlighted that the rigid structures of NICE approval lack the flexibility to deal with an ever-changing situation, often relying on already out-of-date information due to the emergence of new variants.
Alison Railton, head of policy and external affairs said: “Kidney patients have been horribly let down by this draft recommendation and we do not believe that the current NICE framework is the appropriate mechanism to deal with an evolving virus. Patients should not be forced once again to choose between withdrawing from society to shield from infection or risking severe outcomes from Covid-19 infection without adequate treatment options. The Government has a duty to treat immunosuppressed patients with the same urgency as the rest of the population and fast-track new antiviral treatments at a similar speed to which they successfully deployed mRNA vaccines.”
Alongside the call for greater urgency, we pointed to flaws in the evidence cited in the initial guidance. In particular, we highlighted that the studies used did not accurately reflect the population who would benefit most from the treatment, with recommendations based on evidence from a general hospitalised population rather than a group of immunosuppressed patients.
We also highlighted that other studies focusing on higher risk communities, such as OPENSAFELY and DISCOVER NOW, saw higher hospitalisation risks than in NICE’s analysis. We're now calling on NICE to conduct more sub-group analysis into at-risk groups before concluding their final recommendation.
Miranda Scanlon, kidney disease patient and chair of our Lay Advisory Group said: “As a kidney patient myself, I'm very concerned that the NICE draft guidance only recommends one treatment for Covid outside of hospital – a drug which many kidney patients are not able to take. We already know that our response to vaccines is reduced and now we are being denied effective treatment if we catch Covid. This leaves us once again vulnerable and abandoned.”