Nice rejects AstraZeneca’s Tagrisso for lung cancer in preliminary recommendation
pharmafile | June 24, 2016 | News story | Medical Communications, Research and Development | AstraZeneca, CDF, NICE, lung cancer, regulation
UK drugmaker AstraZeneca (LSE: AZN) said the National Institute for Health and Care Excellence (Nice) has rejected Tagrisso (osimertinib) to treat non-small cell lung cancer (NSCLC) in a preliminary recommendation.
The committee also concluded that, at this stage, osimertinib does not meet the criteria to be considered for inclusion in the Cancer Drug Fund (CDF).
Lisa Anson, Country President, AstraZeneca UK and Ireland said: “It is disappointing that Nice has not been able to exercise more flexibility with regard to the degree of acceptable uncertainty around the overall survival data for osimertinib, especially given its recognition as a medical breakthrough. We will add the latest data to our Nice submission and are hopeful that osimertinib will eventually qualify as an end-of-life medicine and be made available routinely to UK patients. This delay in access could have significant consequences for NHS patients who are relying on the system to enable swift access to innovative medicines like osimertinib.”
Every year in the UK, about 39,000 people are diagnosed with lung cancer, and about 87% of these cases are NSCLC. Ten percent of people with NSCLC will have tumours harbouring EGFR mutations.
Osimertinib was given Accelerated Assessment by the European Medicines Agency. The drug was granted expedited conditional marketing authorisation by the European Commission (EC) in February 2016.
The regulator determined that until further data confirming a survival benefit are available, the standard Nice cost-effectiveness threshold of £30,000 per quality-adjusted life year (QALY) should be used rather than the £50,000/QALY threshold considered appropriate for end-of-life medicines. The AstraZeneca submission to Nice showed a conservatively-estimated ICER of just under £43,000 per QALY for osimertinib, which is comfortably within the threshold for end-of-life medicines, but higher than the standard threshold.
AstraZeneca will submit additional analyses and updated data on osimertinib as part of the ACD consultation process, which closes on July 14.
Anjali Shukla
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