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CompileKe Ke
The National Institute of Health and Healthcare Excellence (NICE) said on Friday that the British drug cost monitoring agency rejected Bavencio, a joint research and development of Pfizer and Merck, and did not endorse it as a first-line maintenance therapy for urothelial cancer after platinum-based chemotherapy.
This shows that Bavencio will not be able to enjoy the regular reimbursement or coverage of the British National Health Service (NHS) through the more complex and restrictive cancer drug fund.
Bavencio's Phase III clinical trial Javelin Bladder 100 showed that compared with the best supportive treatment, the use of Bavencio after a cycle of chemotherapy can reduce the risk of death in patients with urothelial cancer by 31%.
In a draft guideline (PDF), NICE's drug reviewers admitted that there is no routine maintenance treatment for patients with metastatic urothelial cancer who have responded to chemotherapy, and they did not question the results of previous clinical studies, that is, taking Bavencio patients do live longer than those who receive the best supportive care.
But Bavencio does not meet NICE's standards and is not considered a "life-prolonging therapy at the end of life.
The draft NICE report states that Merck has assumed in an economic model that 95% of patients will stop receiving Bavencio treatment within two years, regardless of whether their disease has progressed.
As the clinical director of the Cancer Drug Fund of the United Kingdom said, Merck's hypothesis of treatment time has not been realized.
More importantly, since patients cannot receive another immunotherapy after Bavencio, NICE is worried that doctors will allow patients to receive treatment for a longer period of time, even beyond the progression of the disease.
It is reported that Merck does offer a confidential discount above 768 pounds per 200mg/10ml specification based on its current listing price.
According to NICE estimates, approximately 750 people are eligible for Bavencio treatment in this disease environment.
The agency will collect comments on the draft report before May 27, and will hold a second evaluation meeting in mid-June before making formal recommendations.
Reference source: Pfizer, Merck KGaA's Bavencio hits NICE roadblock in bladder cancer coverage
