BMS flips negative NICE ruling on Opdivo, winning thumbs-up for preventing melanoma relapse

In September, Britain’s drug-cost watchdog, The National Institute for Health and Care Excellence (NICE), said Bristol-Myers Squibb did not make a convincing enough case that PD-1 blocker Opdivo should be covered for preventing relapses in melanoma patients after surgery. But the agency left the door open for BMS to try to change its committee members’ minds.

The company has succeeded in that mission—scoring an important win for a drug that’s seen its share of recent disappointments.

NICE initially expressed doubts about the cost effectiveness of Opdivo in patients who have undergone surgery because BMS didn’t present what it deemed sufficient data comparing the drug with routine surveillance. Clinical trials have shown improved recurrence-free survival with Opdivo, but studies comparing the drug with BMS’ other checkpoint inhibitor for melanoma, Yervoy, are still ongoing.

In its appeal of the preliminary decision, BMS made a good case that early data on recurrence-free and overall survival "are promising" and that there is "plausible potential" for the drug to be cost effective, according to NICE’s recommendation (PDF).

But there is a catch: The drug will only be covered by England’s Cancer Drugs Fund (CDF) for the next two years. To gain full coverage via the National Health Service after that, BMS will have to present further data comparing Opdivo with Yervoy and routine surveillance. That means Opdivo will be subject to NICE’s scrutiny yet again.

Still, the company sees the reversal as a positive.

"Today’s recommendation represents an important step forward in improving outcomes for melanoma patients by treating them with immunotherapy earlier as the first I-O treatment available in the U.K.," Veronique Walsh, general manager of Bristol-Myers Squibb U.K. and Ireland, said in a statement. She added that the company had been providing the drug to physicians in England who requested it for use in the post-surgery setting but that more people would have access to it with CDF reimbursement.

The NICE reversal could help calm sales worries about Opdivo, too. In October, BMS suffered two disappointments in a row that spooked investors. First, Merck’s rival drug Keytruda turned in impressive data from a kidney cancer combo trial, raising fears that BMS could soon gain some formidable competition in that market.

Then BMS disclosed that European regulators had asked for more survival data on its Opdivo-Yervoy combination for first-line lung cancer treatment. Considering that the FDA had also delayed its review of the combo in that indication, BMS is now way behind Merck, which has already grabbed significant market share in first-line lung cancer treatment. Investors pounded the company’s stock, knocking $5 billion off its market cap in the wake of the disappointments.

During BMS’ third-quarter earnings conference call shortly thereafter, CEO Giovanni Caforio said he was "aware of some of the frustration" investors have. Sales of Opdivo did grow 42% year over year to $1.79 billion for the quarter, but investors remain concerned about the product’s future.

Those concerns intensified earlier this week, when BMS announced that an Opdivo-Yervoy combo did not significantly extend life in a trial involving patients with small-cell lung cancer who had previously received platinum-based chemotherapy. Industry watchers had thought the trial could confirm an approval the FDA granted Opdivo back in August for previously treated SCLC. Now that approval could be in jeopardy.

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