Pfizer is facing tough ALK-positive lung-cancer competition with Xalkori, and the latest move from England’s cost watchdogs isn’t making it any easier for the company to branch out.
The National Institute for Health and Care Excellence (NICE) has turned down the drug for routine NHS use in ROS1-positive advanced non-small cell lung cancer for a couple of key reasons, it said on Wednesday. It doesn’t recommend Xalkori (crizotinib) for previously treated patients because its cost-effectiveness estimates are higher than what it normally considers acceptable for therapies it deems “end-of-life” treatments. But it’s not clearing the drug to treat those who have yet to receive treatment, either.
“Although one cost-effectiveness estimate is possibly within the range that NICE normally considers acceptable for end-of-life treatments, it is highly uncertain,” the body wrote in draft guidance.
The uncertainty, as NICE sees it, stems from the fact that Pfizer used a “small single arm study that included mostly people with previously treated disease” to show that Xalkori could shrink tumors and slow disease progression in the ROS1-positive population.
“The lack of data comparing crizotinib with ‘standard care’ makes any assessment of relative effectiveness very challenging,” it said.
That doesn’t mean all doors are closed to Pfizer. NICE still believes Xalkori may have potential in ROS1-positive lung cancer, and as a result, it’s invited the pharma giant to consider submitting a proposal for including Xalkori on England’s Cancer Drugs Fund (CDF).
“Using crizotinib in the Cancer Drugs Fund would provide important data” that right now NICE feels is lacking in untreated patients, it wrote.
NICE will also take public comments until Feb. 7, ahead of a second appraisal meeting on Feb. 21.
Pfizer, for its part, said in a statement that it was "disappointed" with NICE's recommendations but that it was "continuing to work with NICE to find a solution so that patients with ROS1-positive advanced non-small cell lung cancer can routinely access crizotinib on the NHS."
"This is a particularly rare and largely unknown type of lung cancer which therefore presents challenges in the NICE appraisal process, but we are committed to ongoing collaboration with all parties to reach a positive outcome," a company spokeswoman said by email.
Pfizer has been here with Xalkori before. NICE initially rejected it back in 2013 based on price, despite a discount offer from the company. But the New York drugmaker eventually changed minds at the cost-effectiveness gatekeeper by offering up an additional price break.
Meanwhile, Pfizer is feeling the heat in the first-line ALK space, where Novartis’ Zykadia and Roche’s Alecensa made waves last year. In June, Alecensa posted phase 3 Xalkori-topping data for the second time, and a first-line green light from the FDA followed in November. Zykadia won its own first-line go-ahead in May.