On appeal, Pfizer and Merck KGaA convince England's NICE to back Bavencio in bladder cancer

Last year, Pfizer and Merck KGaA suffered a cold rejection from England’s drug cost watchdog in a bid to win coverage for Bavencio in bladder cancer. Now, the partners have successfully persuaded the appraisers to overturn their previous decision.

Bavencio now has routine NHS coverage as a front-line maintenance treatment of bladder cancer that hasn’t progressed after platinum-based chemotherapy, the National Institute for Health and Care Excellence said in a new recommendation (PDF).

Pfizer and Merck KGaA won over NICE after revising their patient access scheme and offering confidential discounts for subsequent treatments. As a result, NICE said Bavencio falls within the range to be considered a cost-effective use of NHS resources. The list price for Bavencio is 768 pounds (about $1,000) for a 200mg/10ml vial before any discount.

The new deal makes Bavencio available to eligible bladder cancer patients in England, Wales and Northern Ireland. The PD-L1 inhibitor has previously won coverage in Scotland in August 2021.

Bavencio proved its case in the phase 3 JAVELIN Bladder 100 study. At an interim analysis, Bavencio’s addition to best supportive care reduced the risk of death in the front-line maintenance setting by 31%. A longer-term follow-up showed the drug cut the same risk by 24%; patients on Bavencio lived a median 23.8 months, versus 15 months for the control group. The median duration of treatment was 25.3 weeks for the updated analysis.

During the appeal, Pfizer and Merck KGaA convinced the NICE appraisal committee that Bavencio is indeed a life-extending treatment. Under conventional treatment methods, 65% of bladder cancer patients didn’t survive after 24 months, according to a life expectancy model.

Bavencio is covered for a maximum five years of treatment or up to the point of disease progression, whichever comes first.

Last year, NICE also rejected Merck & Co.’s PD-1 inhibitor Keytruda for second-line treatment of bladder cancer after progression on chemotherapy.