- Bristol-Myers Squibb's cancer immunotherapy was rejected by the United Kingdom's healthcare cost agency for use in treating a type of kidney cancer, according to guidance published Tuesday.
- The National Institute for Health and Care Excellence (NICE) found Opdivo to be too pricey when discounts for competing drugs were taken into account and also raised concerns about the drug's long term benefits for patients with renal cell carcinoma.
- Opdivo just won NICE's endorsement for treatment of melanoma in combination with Bristol's other drug Yervoy, but has previously been rejected for use in lung cancer.
Even as Opdivo continues its march towards blockbuster status, Bristol-Myers has run into difficulties in winning over NICE, which notorious for its stringent reviews.
The European Medicines Agency has approved Opdivo for use in patients with melanoma, non-small call lung cancer and advanced renal cell carcinoma. But with this new draft recommendation, NICE has now recommended against covering the drug for two of those three indications.
In this case, NICE considered Opdivo as a second-line treatment in previously-treated patients with renal cell carcinoma.
Although NICE agreed the drug extended overall survival compared to everolimus, the agency expressed concerns that the survival benefit might not hold up over time.
"The committee concluded that the most robust results came from the large CheckMate 025 trial, which showed that nivolumab [Opdivo] extended life by a median of 5.4 months compared with everolimus, but that there was substantial uncertainty about the extent of the survival benefit when measured over the long term," the document said.
Furthermore, NICE determined that Opdivo's price exceeded its cost-effectiveness range, costing more than £50,000 per quality-adjusted life years after taking into account discounts for the chemotherapy axitinib, which is commonly used in a second-line setting.
Axitinib's discount proved to be crucial in pushing Opdivo out of NICE's acceptable range, suggesting a discount on Opdivo could help win a positive recommendation.
NICE also noted the data presented to support Opdivo was "immature," as the key Checkmate 025 trail was stopped early due to positive results. This further fed into the agency's concerns over the proof of the drug's long term benefit in kidney cancer.
Opdivo costs £439 per 40-mg vial in the U.K., according to NICE. At a dosing schedule of 3 mg/kg every 2 weeks, the drug's list price per year adds up to over $90,000 a year for a male of average weight.
The guidance is open for comments until July 26. NICE will then meet again on August 4 to weigh input and issue final guidance.