Osimertinib (Tagrisso; AstraZeneca) has become the first new drug to be recommended for inclusion in the revamped cancer drugs fund (CDF) by the National Institute for Health and Care Excellence (NICE).
In draft guidance issued on 4 October 2016, NICE recommends that the drug is funded by the CDF because of promising evidence that it is effective in the long term and represents value for money.
Inclusion in the CDF would allow osimertinib to be used as a managed access product for patients with metastatic EGFR and T790M mutation-positive non-small-cell lung cancer. Its manufacturer would have to continue to provide evidence to support its long-term use and cost effectiveness.
Carole Longson, director of NICE’s health technology evaluation centre, says: “For the first time, we are able to give patients access to a promising new cancer treatment whilst more evidence is gathered on its effectiveness. This is the system working as it should.”
A NICE appraisal committee first considered osimertinib in May 2016. The drug showed early promise but the committee was unconvinced that it was cost effective. Fresh evidence presented by the drug company from ongoing studies and new analysis of existing data has been enough to persuade NICE to make the drug available via the CDF pending its final recommendation.
Between December 2015 and February 2016, the drug was provided free of charge by AstraZeneca after being granted a positive opinion via the government’s early access to medicines scheme (EAMS), which recognises the potential of a medicine to address unmet clinical need.
Its EAMS status was lifted in February 2016 after its conditional marketing authority by the European Medicines Agency was approved by the European Commission following a fast-track assessment.