Patients with extensive-stage small cell lung cancer don’t have a lot of options. When the FDA last March approved Roche’s Tecentriq to treat new patients, it was the first new option for that group in more than 20 years.
But that fact didn’t convince England’s cost watchdogs to foot the bill for the drug, which they say is too pricey to be cost-effective for NHS patients.
The National Institute for Health and Care Excellence (NICE) shot down the Roche drug in draft guidance Tuesday, pointing to its high price.
The Swiss drugmaker had already served up a confidential discount on the product—which bears a list price of £3,807.69 per 1,200 mg vial in England, bringing the mean cost for a course of SCLC treatment to £32,905.46. But it wasn’t steep enough to appease the agency.
One reason? NICE has seen Roche’s data, which showed adding Tecentriq to chemo could extend patients’ lives by a median 12.3 months, two months longer than chemo. But it’s not sure (PDF) about the PD-L1 inhibitor's long-term effectiveness, it said.
Roche has trailed behind Merck’s Keytruda—which currently dominates the non-small cell lung cancer landscape—in the race for lung cancer market share. It’s looked to niche areas, such as small cell, to make up revenue, and it was the first PD-1/PD-L1 drugmaker to score an indication in that arena.
Analysts predicted the go-ahead could land the company blockbuster sales, but if Roche wants to max out its potential around the world, it’ll need to change minds at NICE. It has until Jan. 28 to appeal the gatekeeper’s recommendation and negotiate a price NICE finds acceptable.
Roche has another reason to make haste, too. AstraZeneca’s rival therapy Imfinzi is rocketing toward an SCLC approval of its own; in the U.S., it bagged an FDA priority review early last month.