Bristol-Myers' Opdivo falls short at NICE, thanks to Pfizer's Inlyta discount


England’s cost-effectiveness watchdogs have a love-hate relationship with Opdivo, the hot Bristol-Myers Squibb immuno-oncology treatment.

Last month, a cocktail pairing Opdivo (nivolumab) and fellow Bristol-Myers med Yervoy won a quick thumbs up in melanoma from the National institute for Health and Care Excellence. But now, NICE’s gatekeepers have stiff-armed the drug in kidney cancer.

The good news for Bristol-Myers? NICE’s analysis hints that Opdivo’s cost-effectiveness rating would stack up to its competitors’ if the company offered a discount.

NICE's decisions are influential not only in England and Wales, where they determine which meds are routinely covered by the National Health Service, but in other countries that use NICE's deliberations as guidance for their own coverage decisions.

Up for a NICE nod in advanced kidney cancer that’s returned after one previous treatment, Opdivo came into the argument with data from the Checkmate-025 study, which showed that the drug beat Novartis’ standard treatment Afinitor (everolimus) at prolonging patients’ lives.

But the NICE committee took issue with some of the company’s analyses of that data, along with other studies. For one thing, the appraisers questioned whether Opdivo’s overall survival numbers--a median of 25 months versus 19.6 for Afinitor--were “mature,” given the fact that the trial was stopped early. They also suggested that Opdivo’s survival results in kidney cancer might show a “long tail,” that is, a few patients might survive for a very long time, while most patients die sooner.

The committee also took issue the required cost-effectiveness model, not an unusual occurrence at NICE. And what tripped Opdivo up on the cost side, however, was a discount Pfizer had extended on its rival treatment Inlyta.

Opdivo is pricey--its list price is more than £91,000 in England, NICE says--compared with Afinitor at about £39,000 and about £46,000 for Pfizer’s Inlyta. But Opdivo’s effectiveness score, or quality-adjusted life year (QALY) was 2.3, versus 1.69 for Afinitor, the next best treatment. Calculating out the costs per QALY--a common measure of cost-effectiveness--put Opdivo in line with its rivals.

That is, until NICE considered that pesky Inlyta discount. Pfizer’s deal with NICE catapulted Opdivo’s comparative costs-per-QALY far ahead of the other kidney cancer treatments.

Bottom line? “The committee agreed that nivolumab was an innovative treatment,” the committee’s appraisal noted. But, the cost-effectiveness numbers were “substantially above the range that could be considered a cost-effective use of NHS resources.”

It’s not unusual for NICE to kick back at a pricey cancer drug, particularly on the first round of appraisals. This draft guidance is just that--and Bristol-Myers and others can comment on it till July 26. After that, the agency will weigh the evidence again before coming up with a final recommendation. If Bristol-Myers’ comments include a deal on price, NICE’s final say-so might well be different.

The kidney cancer "No" follows that "Yes" for Opdivo and Yervoy in melanoma, and another "No," handed down in May, for Opdivo in lung cancer. NICE backed Opdivo for solo melanoma treatment in January.

- see the NICE documents

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