Lilly will have to be content marketing Alimta for its current lung cancer uses in England and Wales after it was turned down for an expanded indication in the disease.
The National Institute for Health and Care Excellence (NICE), which assesses the cost-effectiveness of drugs for NHS use, issued final draft guidance which does not recommend use of Alimta (pemetrexed) as maintenance therapy for certain people with non-small-cell lung cancer (NSCLC).
This negative recommendation covers patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed immediately following induction therapy with Alimta and the chemotherapy cisplatin.
The drug is already available as a maintenance therapy on the NHS, although in combination with gemcitabine, paclitaxel or docetaxel and only after platinum-based chemotherapy.
However, NICE’s chief executive Sire Andrew Dillon said Alimta “did not offer sufficient benefit to justify the costs” when used in combination with cisplatin in this indication.
This is despite Alimta being recommend in combination with cisplatin as a first-line treatment option for NSCLC.
The latest final draft guidance is in fact the second final draft guidance NICE has published for Alimta in this indication.
The watchdog had already announced a negative recommendation for the drug in June last year, but had to retract this decision just two months later when it admitted a procedural error had been uncovered during Lilly’s appeal.
At the time, NICE said the error related to the “handling of the technology appraisal” for Alimta, with specific regard to the “release of the evidence review group’s exploratory amendments to the manufacturer’s model”.
This means the final draft guidance has been published more than a year after initial draft guidance.
The new final draft guidance is now up for consultation, after which NICE will issue final guidance.