NICE to reject Bristol Myers' Opdivo in head and neck cancer after 3 years of restricted coverage

opdivo
NICE is poised to reject Bristol Myers Squibb's Opdivo in previously treated head and neck cancer. (Bristol Myers Squibb)

Three years after offering Bristol Myers Squibb’s Opdivo limited coverage in head and neck cancer, England’s cost watchdog is poised to back away entirely.

After reviewing new evidence, the National Institute for Health and Care Excellence (NICE) concluded that Opdivo’s not worthy of coverage for recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy, according to draft guidance published (PDF) Thursday.

The PD-1 inhibitor is currently available for those patients under the Cancer Drugs Fund, which allows physicians to apply for coverage on a case-by-case basis. The tentative recommendation is now open for comments, and if NICE remains unconvinced, the CDF channel will also be closed, meaning no NHS coverage whatsoever for Opdivo in the indication.

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NICE originally rejected Opdivo in head and neck cancer in early 2017, citing a lack of long-term survival and quality of life data. But in October that year, it offered Bristol Myers a chance to prove its worth through CDF.

Over the years, data have been collected on real-world patients who got Opdivo through the CDF program and from clinical trial participants in the CheckMate-141 study. Now, NICE’s drug appraisers have concluded that the new evidence still doesn’t support Opdivo’s use.

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Specifically, Opdivo has shown it could help previously treated patients live up to nine months longer than those who got Merck KGaA’s Erbitux—sold by Eli Lilly in the U.S.—or the chemotherapies docetaxel or methotrexate. But it’s unclear whether the PD-1 drug extends life for longer than three months when compared specifically with docetaxel or for people with a low PD-L1 score, NICE noted.

The appraisal committee members argued that docetaxel is the most appropriate comparator in this setting because Erbitux, with coverage for recurrent or metastatic head and neck cancer, is used earlier in the treatment line. Plus, Merck’s Keytruda just won NICE backing in October for previously untreated patients with PD-L1-positive tumors.

That Keytruda coverage essentially leaves Opdivo with second-line patients whose tumors have a very low PD-L1 score, the NICE experts said. In addition, among the different chemotherapies available in England, the clinical experts agreed that docetaxel is the standard of care.

RELATED: Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK

However, the Checkmate-141 trial was not powered to detect a difference between Opdivo and solo docetaxel. The experts also concluded that the drug’s benefit in PD-L1-low cancers was less certain than in the high score group.

Currently, Opdivo’s list price is £439 for a 40-mg vial, £1,097 per 100-mg vial and £2,633 per 240-mg vial. Bristol Myers offers NHS a confidential discount for the head and neck cancer indication.

Comments on the draft guidance is open until Jan. 28. After that, the appraisal committee will meet again before making the final recommendation.