Novartis melanoma combination wins key thumbs-up from cost watchdog NICE after Opdivo shut out

Novartis headquarters
Novartis has negotiated two cancer approvals from the U.K.'s NICE this month, guaranteeing coverage for the products in that region. (Wikimedia Commons / Andrew / Flickr)

Just one week after Bristol-Myers Squibb failed to gain a recommendation for coverage in the U.K. for Opdivo in adjuvant melanoma, Novartis has one-upped its rival with an approval in the same setting.

The National Institute for Health and Care Excellence (NICE) has given its blessing to the combination of Novartis’ Tafinlar and Mekinist in patients with stage III BRAF V600 mutation-positive melanoma after surgery. The agency cited a lack of adjuvant treatment options and the effectiveness of the combination in lowering the chance of the cancer spreading. The decision comes two years after NICE recommended the combination as a first-line treatment for advanced melanoma patients who are not eligible for surgery.

NICE didn't reveal what the price would be for Tafinlar plus Mekinist in the adjuvant setting, saying only that it negotiated a confidential discount with Novartis. The list price of 28 doses of Tafinlar in the U.K. is £1,400 ($1,839), while 30 tablets of Mekinist sell for £4,800 ($6,306).

The U.K. agency based its decision on a clinical trial showing a 53% lower risk of relapse or death in patients taking the Novartis combo vs. those taking a placebo, according to the guidance document (PDF). The agency then projected long-term relapse-free survival and determined that the incremental cost-effectiveness ratio for every year of quality life gained by patients on the treatment would be around £20,000 ($26,279)—making the treatment acceptable for coverage by the U.K.’s National Health Service (NHS).

RELATED: NICE nixes Opdivo as postsurgery melanoma therapy but leaves door open

The decision stands in stark contrast to NICE’s rejection of BMS’ Opdivo in adjuvant melanoma last week. In that case, NICE said a lack of trials comparing Opdivo with the standard of care made it difficult to determine cost effectiveness. And overall survival is also hard to predict because that’s still being studied, the agency said. There is a small chance NICE could reverse the decision, as it will consider comments or an offer of a price cut from BMS until the end of September, but the delay was considered a setback.

Even though BMS and Novartis aren’t direct rivals in the adjuvant melanoma setting—Opdivo is a type of immunotherapy, while Tafinlar and Mekinist work by targeting a tumor mutation and cancer-promoting protein respectively—NICE’s back-to-back verdicts will give Novartis a head start in a wide open market. The current treatment for advanced melanoma post-surgery in the U.K. is routine surveillance. The recommendation of the Novartis combo marks “an important development in the management of melanoma,” said Mirella Marlow, deputy director for the NICE Centre for Health Technology Evaluation, in a statement. Novartis has estimated that there are about 400 people in the U.K. who are immediately eligible to receive the treatment.

RELATED: After snubbing Gilead, British cost watchdogs give thumbs-up to Novartis’ CAR-T Kymriah

Novartis is on a bit of a winning streak in the U.K. Earlier this month, NICE approved the company’s CAR-T engineered cell treatment, Kymriah, for the treatment of children and young adults with B-cell acute lymphoblastic leukemia (ALL). The agency greenlighted the treatment shortly after rejecting Gilead’s CAR-T, Yescarta.

Novartis did have to bend on price, though. Kymriah is listed at £282,000 ($361,000) in the U.K., which is significantly lower than the U.S. price of $475,000 for the treatment of ALL.