U.K.'s NICE says yes to Opdivo for advanced skin cancer

Last month the U.K. drug cost watchdog nixed Bristol-Myers Squibb's ($BMY) immunotherapy Opdivo for use against lung cancer, saying in draft guidance that it just cost too much to justify approval. But NICE feels differently when it comes to using Opdivo against skin cancer, today recommending it for approval without even extracting a price cut.

Carole Longson

The final draft guidance from the National Institute for Health and Care Excellence (NICE) recommends Opdivo for patients with advanced (unresectable or metastatic) melanoma.

In a statement, Professor Carole Longson, Health Technology Evaluation Center director pointed out that statistics show more than 13,000 people in the U.K. were diagnosed with melanoma in 2011 and that the disease leads to more deaths than all other skin cancers combined. "I am sure this will be welcome news to patients and healthcare professionals alike," she said.

NICE said Opdivo is priced at £439 ($623) for a 40-milliliter vial and £1,097 ($1,572) for a 10-milliliter vial. According to Bloomberg, Bristol-Myers didn't have to offer a discount to snag the approval. NICE said it figures the drug will likely cost less than £30,000 per quality-adjusted life year threshold.

But price was a stumbling block when the cost watchdog last month decided against approving Opdivo for treating lung cancer. In draft guidance, NICE said that the drug is too expensive to justify, despite substantial clinical benefits compared with the only other alternative for relapsed patients, Sanofi's ($SNY) Taxotere (docetaxel). According to NICE's calculations, Opdivo would cost £86,599 ($130,090) per patient per year.

Opdivo has been approved for treating non-small cell lung cancer by the FDA, which reached its decision just 37 days after its recommendation. It also has won four other approvals in the U.S. including as a treatment against advanced melanoma for patients who no longer respond to other drugs.

- here's the NICE announcement
- read the Bloomberg story

Special Reports: The top 10 most expensive drugs of 2013 | Top 15 Drug Launch Superstars - Kadcyla - Roche/Genentech | Top 10 best-selling cancer drugs of 2013 | The new drug approvals of 2014 | Opdivo