The National Institute of Health and Care Excellence (NICE) has ruled against AstraZeneca’s non-small cell lung cancer drug Tagrisso (osimertinib).
NICE provisionally recommended against covering Tagrisso in the treatment of locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive NSCLC last year. The ruling led to an appeal by AstraZeneca, which argued the appraisal committee’s decisions about which data to use in the analysis of the value of Tagrisso were unreasonable and unfair.
However, while the NICE appeal panel agreed it was unfair to consider “information from the submission of another company in a separate appraisal” when assessing Tagrisso, it dismissed all the other points made by AstraZeneca.
AstraZeneca’s failure to convince the appeal panel of the perceived failings of the original decision have led to final NICE guidance that hews closely to the UK cost watchdog’s draft position.
The headline conclusions are that Tagrisso “does not meet NICE's criteria to be considered a life-extending treatment at the end of life”
and is associated with cost-effectiveness estimates that “are above what NICE normally considers an acceptable use of NHS resources”. In light of those findings, NICE recommended against the use of Tagrisso.
AstraZeneca’s problems stemmed, in part, from the comparators used in clinical trials of Tagrisso.
NICE accepted that data suggest patients who take Tagrisso live longer than their peers who receive Roche’s Tarceva (erlotinib) or AstraZeneca’s own Iressa (gefitinib). However, AstraZeneca was unable to share data from a randomised clinical trial comparing Tagrisso to Boehringer Ingelheim’s Gilotrif (afatinib).
That was a problem for NICE. Gilotrif is the first-choice EGFR tyrosine kinase inhibitor in the UK and, in the view of NICE, may be more effective than the comparators used in the Tagrisso clinical trials.
In the absence of clinical data showing Tagrisso is better than Gilotrif, NICE calculated the pairwise incremental cost-effectiveness ratio for AstraZeneca’s challenger compared to Boehringer’s incumbent product was greater than £30,000 ($39,000) per quality adjusted life year gained.
The ruling is a blow to AstraZeneca’s efforts to grow sales of Tagrisso but fast-rising demand in other markets mean the drug is still well positioned. Tagrisso sales over the first nine months of 2019 came in at $2.3bn, up more than 80% over the same period of the prior year.
Triple-digit growth in emerging markets contributed to the performance after China put Tagrisso on the reimbursement list as a second-line treatment for EGFR-mutated NSCLC.