Dive Brief:
- In an unexpectedly fast decision, the U.K.'s National Institute for Health and Care Excellence (NICE) approved use of a combination therapy of Bristol Myers-Squibb's Yervoy and Opdivo for treatment of melanoma.
- The decision is based on evidence from clinical trials in which the Yervoy/Opdivo combo shrunk tumors—even the most deadly and aggressive—by 69%. However, the approval is contingent on Bristol-Myers providing Yervoy with an agreed-upon discount through its patient-access program.
- NICE rejected another combination treatment of melanoma from Roche a day before its decision on Bristol-Myers' drugs, citing cost-effectiveness reasons.
Dive Insight:
NICE is notorious for saying rejecting new drugs for being too costly, which is why this speedy approval took some by surprise. In addition, as this combo was recently approved by the E.U. for treatment of melanoma, NICE's decision mean that melanoma patients in the UK will be among the first to get the combo.
Opdivo blocks PD- 1 activity, while Yervoy turns off the CTLA-4 receptor. thereby dismantling the key drivers of the cancer in some patients.
The Yervoy/Opdivo combo was approved in the U.S. last year for treatment of melanoma, and made headlines because of its high list cost. NICE, however, has already wrangled discounts from Bristol-Myers.
Around 1300 patients in the U.K. will be able to access the combination therapy each year, Reuters reported citing NICE estimates.