Compile Ke 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 terms of helping patients to extend their life, it showed a significant improvement of 7.
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 agency added that it is unclear how long patients should continue to take the drug.
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.
However, the NICE committee pointed out that data from the Javelin trial showed that after the two-year time point, more patients are still taking the drug.
In addition, there is no provision about stopping treatment in the product description.
As the clinical director of the Cancer Drug Fund of the United Kingdom said, Merck's hypothesis of treatment time has not been realized.
The Committee of Drug Cost Regulators concluded that in this case, there is no evidence to support Bavencio's stopping rule.
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.
But NICE still believes that this is unlikely to be cost-effective, and that "further data collection is not an option.
According to NICE estimates, approximately 750 people are eligible for Bavencio treatment in this disease environment.
"We are committed to working with pharmaceutical companies to help them resolve the issues identified by the Cost Regulatory Commission, which are highlighted in this draft guideline.
" Meindert Boysen, director of the NICE Health Technology Evaluation Center, said in a statement on Friday.
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