The Institute of Cancer Research (ICR) has criticised the National Institute for Health and Care Excellence (NICE) for having “passed up a golden opportunity to ensure its evaluation methods support approval of the most innovative, potentially game-changing drugs”. According to the ICR, NICE’s updated methods and processes for evaluating new drugs (read more about the changes here) fall short of what is needed and could even make access to cancer drugs worse.
In a statement the ICR said that it welcomes some of the changes, but that it wants to “see further consideration and movement in several important areas”:
Greater recognition of the barriers for rare diseases
Generating the statistical evidence needed for approval is challenging for drugs to treat rare diseases. Whilst NICE takes this into account for extremely rare diseases, the ICR maintains it should be doing so for a wider range of rare diseases, such as cancers in children.
Risks of removing the end-of-life modifier
NICE’s end-of-life criteria have allowed many cancer patients to access life-extending drugs. For this reason the ICR is calling on NICE to carry out a pilot of the impact of switching end-of-life criteria for a disease severity modifier to ensure there are no unintended consequences for cancer patients.
Prioritising innovative medicines
The ICR notes that it is positive that NICE will now allow more flexibility when considering uncertainty in the evidence base for a new treatment. But the ICR argues that NICE should be willing to accept uncertainty in data, or a higher price, when evaluating drugs that are innovative in their mechanism of action.
Using surrogate measures of survival
Whilst the ICR acknowledges that NICE has taken some steps towards recognising the importance of wider sources of data (rather than relying on overall survival data), it maintains that it is disappointing that the Institute will not seek to establish ‘surrogate’ measures of overall survival which can help predict whether a new treatment is likely to help patients live longer. Surrogate measures can help approve cancer drugs more quickly, based on earlier trial data, notes the ICR.
Commenting, Professor Kristian Helin, Chief Executive of the ICR, said “We are disappointed that in many areas NICE is making minor tweaks rather than bold reforms. We want to see an appraisal system that incentivises the discovery and development of cutting-edge new treatments and technologies, and provides hope for patients with cancers that are rare or especially hard to treat.
“We believe that NICE should be favouring the most scientifically innovative drugs, and levelling the playing field by making it easier for children with cancer, and other patients with rare diseases, to gain access to new treatments. And NICE should be establishing early measures that help to predict longer survival, so it can make innovative new treatments available to patients more quickly”.
- www.icr.ac.uk, “NICE misses golden opportunity to enhance access to innovative cancer drugs”, 7th February 2022