NICE process “not appropriate for a rapidly evolving virus”
- In response to draft guidance on Covid-19 antivirals, Kidney Research UK argue that the rigid structures of NICE approvals are not appropriate for rapidly changing and life-threatening situations.
- Proposed NICE guidance would leave many renal patients with no effective treatment outside of hospital despite being at high risk of Covid-19.
- Kidney Research UK has called on the regulatory body to fast-track future Covid treatments in a similar manner to the mRNA vaccine roll-out.
London 12th December 2022: Kidney Research UK has submitted comments relating to NICE’s draft guidance on therapeutics for people with Covid-19, following the regulatory body’s draft decision to dramatically reduce the number of available treatments. The charity 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Following the release of the draft guidance, the charity has called on the Government to deliver Covid treatments in a similar manner to the original introduction of the Covid-19 vaccines by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, the charity 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structures of NICE approval lack the flexibility to deal with an ever-changing situation, often relying on already out-of-date information due to the emergence of new variants.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 at Kidney Research UK: “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, the research organisation pointed to flaws in the evidence cited in the initial guidance. In particular, it 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.
The charity 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. Kidney Research UK is 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 Kidney Research UK’s 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.”
About Kidney Research UK
As the largest kidney research charity in the UK, nothing is going to stop us in our urgent mission to end kidney disease. We’re here to be heard, to make a difference, to change the future. This is a disease that ruins and destroys lives. It must be stopped.
Over the past 60 years, our research has made an impact. But kidney failure is rising, as are the factors contributing to it, such as diabetes and obesity.
Today, we are more essential than ever.
Kidney disease affects three million people in the UK, treatments can be gruelling and currently there is no cure. Only research will end this.