Dr Samantha Roberts
National Institute for Health and Care Excellence
2nd Floor, 2 Redman Place, London
Dear Dr Samantha Roberts,
As kidney patient organisations and funders of medical research and quality improvement, we are committed to and proud of our health system. We recognise that the MHRA and NICE are internationally respected bodies in assessing the safety and effectiveness of new medicines. However, we are deeply concerned that a return to ‘business as normal’ for evaluating new Covid-19 treatments is not appropriate, for patients or the National Health Service.
We welcome the announcement from NICE that a new process will be consulted on for reviewing the latest evidence for existing treatments for Covid-19. It is a positive step towards recognising the unprecedented uncertainty facing treatments for a rapidly evolving virus, and we thank NICE for meeting with us recently to discuss this in further depth. However, we remain concerned about the assessment process for new treatments for Covid-19 that have not yet been through a health technology assessment.
We are reassured that NICE appreciate the need to address this issue, however we need to see firm proposals for reforming the way we appraise new treatments for Covid-19 to ensure the process is expedited. These should be developed alongside all stakeholders, including patients and patient organisations, to ensure its feasibility. A revised process should then be documented and shared with all stakeholders in a timely manner to ensure all relevant groups can effectively input.
Covid-19 is a rapidly evolving virus, and we recognise the significant challenge this creates for regulatory bodies. We need a system which understands that an ever-evolving virus causes a level of data uncertainty that may not be seen with other treatments, and that there is subsequently a need for flexibility to ensure there are adequate appropriate treatment options available to all NHS patients. A lack of flexibility could leave us with a two-tier healthcare system, where those most at risk are those left with the least treatment options available.
Addressing the risk of Covid-19 to those who are immunocompromised must be prioritised. As we know, vaccination can be less effective in transplant recipients. The importance of the vaccination and booster programme is undoubted, but we must continue to push for more effective strategies and review new data promptly – including for new treatments.
Regulators and reimbursement bodies must commit to rapidly reviewing and providing access to safe and effective new treatments. Following traditional health technology assessment routes restricts the opportunity to promptly utilise effective treatments, with a prolonged period of assessment leaving vulnerable patients without potentially life-saving treatment options during periods of high infection rates. This has been exemplified by the process for evaluating tixagevimab plus cilgavimab (Evusheld). Following procurement of the prophylaxis treatment across many European countries, the UK started its own review process in June 2022. We are only just now at the end of its health technology assessment. Efficacy against new variants of the virus has waned, but many lives could have been transformed by access to the treatment during its highest period of efficacy during the summer of 2022. The UK ‘missed the boat’, and high-risk kidney patients, a significant number of whom remain shielding, have paid the price.
The threat of Covid-19 is not over for everyone in our society. While we have made remarkable progress, some people have remained shielding for three years. Shielding has taken a significant toll on the physical, emotional, and financial well-being of kidney patients. We must not forget them by being inflexible in how we approach new treatments for Covid-19.
We would be keen to meet with you to discuss the matters we have brought to your attention in this letter and look forward to working together in the future.
Fiona Loud - Director of policy, Kidney Care UK
Alison Railton – Head of policy and external effairs, Kidney Research UK