NICE Rejects Bavencio as First-Line Maintenance Therapy for Urothelial Carcinoma Post-Platinum Chemotherapy

Compiled by Keke

The UK’s National Institute for Health and Care Excellence (NICE) stated on Friday that the country’s drug cost watchdog had rejected Bavencio, co-developed by Pfizer and Merck KGaA, refusing to endorse it as a first-line maintenance therapy for urothelial carcinoma following platinum-based chemotherapy.

This indicates that Bavencio will not be eligible for routine reimbursement or coverage under the UK’s National Health Service (NHS) through the more complex and restrictive Cancer Drugs Fund.

The Phase III Javelin Bladder 100 clinical trial of Bavencio demonstrated that, compared with best supportive care, the use of Bavencio after one cycle of chemotherapy reduced the risk of death by 31% in patients with urothelial carcinoma. Furthermore, it showed a significant improvement of 7.1 months in overall survival.

In a draft guideline (PDF), NICE’s drug evaluators acknowledged that for patients with metastatic urothelial carcinoma who respond to chemotherapy, there is no standard maintenance therapy, and they did not challenge the previous clinical study results indicating that patients taking Bavencio indeed lived longer than those receiving best supportive care.

However, Bavencio does not meet NICE’s criteria and is not considered a “life-extending treatment at the end of life.” The agency further stated that it remains unclear how long patients should continue taking the drug.

The draft report from NICE states that Merck assumed in an economic model that 95% of patients would discontinue Bavencio treatment within two years, regardless of whether their disease had progressed. However, the NICE committee pointed out that data from the Javelin trial showed that more patients were still taking the drug after the two-year mark. Additionally, there are no provisions for discontinuing treatment in the product description.

As stated by the clinical lead of the UK Cancer Drugs Fund, the treatment duration assumptions provided by Merck were not realized. The committee of the drug cost regulatory agency concluded that, in this context, there is no evidence to support the stopping rule for Bavencio.

More importantly, because patients cannot receive another immunotherapy after Bavencio, NICE is concerned that clinicians may continue treatment for an extended duration, even beyond disease progression.

It is reported that Merck has indeed offered a confidential discount on top of its current list price of £768 per 200 mg/10 mL vial. However, NICE still considers it unlikely to be cost-effective and stated that “further data collection is not an option.”

NICE estimates that approximately 750 patients are eligible for treatment with Bavencio in this disease context. “We are committed to working with pharmaceutical companies to help them address the issues identified by the Cost and Outcomes Committee, which were highlighted in this draft guidance,” said Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, in a statement on Friday.

The agency will collect comments on the draft report by May 27, hold a second evaluation meeting in mid-June, and then issue formal recommendations.

Reference: Pfizer, Merck KGaA's Bavencio hits NICE roadblock in bladder cancer coverage