The U.K.’s drug cost watchdog has endorsed Bristol Myers Squibb’s Opdivo to treat certain bladder cancer patients, though the recommendation is couched by several caveats.
The National Institute for Health and Care Excellence (NICE) gave a thumbs-up to Opdivo in muscle-invasive urothelial cancer patients whose disease is at high risk of returning after surgery. The recommendation focuses specifically on adults whose tumors express PD-L1 at a level of 1% or more.
NICE’s recommendation relies on two conditions: First, NICE is only recommending BMS’ drug in patients who aren’t a good fit for adjuvant treatment with platinum-based chemotherapy. Second, the endorsement hinges on BMS providing Opdivo under a special commercial arrangement with the U.K.’s National Health Service (NHS).
A 240 mg per 24-ml vial of Opdivo costs 2,633 pounds sterling in the U.K. before discounts, NICE says. That said, BMS has a pact in place with NHS that provides the drug at an undisclosed lower price.
“It is the company's responsibility to let relevant NHS organisations know details of the discount,” NICE added.
Patient experts polled by NICE suggested Opdivo is a “valued” treatment option for muscle-invasive bladder cancer patients whose disease comes back. Standard care after radical resection surgery is platinum-based chemotherapy, though many patients opt out of chemotherapy because its benefits are small and it carries a high level of toxicity that can be hard for patients to endure, NICE explained.
Opdivo, by comparison, was “generally well tolerated,” plus its short infusion time versus chemotherapy was viewed as an “advantage.”
NICE based its recommendation on Opdivo’s phase 3 CheckMate 274 study, which found that roughly 68% of patients on the BMS drug post-radical resection were still alive and disease free after 12 months, versus 46% of patients who received best supportive care.
Still, BMS’ study didn’t compare Opdivo to platinum-based chemotherapy. Instead, NICE said it provided an “indirect treatment comparison” that the agency branded “highly uncertain.” What’s more, overall survival data from the trial isn’t yet available, NICE pointed out. For this reason, Opdivo is only cost effective “when platinum-based adjuvant chemotherapy was not appropriate,” the drug cost watchdog said.
Opdivo has recorded both wins and losses in recent months. As for the positive, the drug in late May snagged simultaneous FDA approvals in tandem with chemotherapy or BMS’ Yervoy to treat newly diagnosed, advanced esophageal squamous cell carcinoma (ESCC) patients.
Earlier that same month, however, Opdivo and Yervoy missed the mark in a late-stage trial in newly diagnosed bladder cancer patients—an area where rivals from Roche and Merck have also struggled.