SPY423.11+2.25 0.53%
DIA339.45+0.67 0.20%
IXIC14,253.27+111.79 0.79%

UK's NICE Provisionally Rejects Coverage Of Pfizer-Merck KGaA's Bavencio As First-Line Therapy For Bladder Cancer

05/10/2021 14:48
  • England’s drug-cost watchdog has shown a cold-shoulder to Pfizer Inc (NYSE: PFE) and Merck KGaA’s (OTC:MKGAF) Bavencio (avelumab) as first-line maintenance therapy for urothelial cancer after platinum-based chemo.
  • The PD-L1 inhibitor, therefore, won’t be able to enjoy routine NHS reimbursement or coverage through the more complicated and restrictive Cancer Drugs Fund, said the National Institute for Health and Care Excellence (NICE).
  • Bavencio showed in the Phase 3 Javelin Bladder 100 trial that it could cut the risk of death by 31% compared with best supportive care when used after one chemo cycle. It demonstrated a significant 7.1-month improvement in helping patients live longer.
  • In the draft guidance, drug reviewers at NICE recognized that no maintenance treatment is routinely available for metastatic bladder cancer that has responded to chemo. They did not challenge the clinical finding that patients on Bavencio live longer than if they had the best supportive care.
  • But Bavencio didn’t meet NICE’s criteria to be considered “a life-extending treatment at the end of life,” they said. It’s unclear how long patients will remain on the drug, they added.
  • The drug’s current price is £768 per 200 mg/10 ml solution. But NICE still thinks it’s unlikely to be cost-effective and that “further data collection is not an option.”
  • The company has a commercial arrangement that makes avelumab available to the NHS with a discount. It would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence.
  • The agency is collecting comments on the draft report until May 27 and will hold a second appraisal meeting in mid-June before making a formal recommendation.
  • Price Action: PFE shares are up 1.07% at $40, and MKGAF shares are up 1.15% at $176 during the market trading session on the last check Monday.