In a bad week for Roche, cancer drug Avastin (bevacizumab) has received negative opinions from both NICE and the CHMP.
Preliminary recommendations published by NICE state that the use of bevacizumab for metastatic colorectal cancer is not a cost-effective use of NHS resources, while the CHMP has issued a negative opinion for the drug in glioblastoma (GBM), an aggressive type of brain cancer.
Commenting on the NICE draft guidance, Health Technology Evaluation Centre Director Dr Carole Longson said: “Before making these preliminary recommendations, the independent Advisory Committee considered the manufacturer’s cost-effectiveness estimates, the proposed patient access scheme and the published evidence on the effectiveness of bevacizumab in treating metastatic colorectal cancer.
“The Committee recognised that bevacizumab may provide benefits in terms of clinical effectiveness. However, the uncertainties in the economic analysis provided by the manufacturer and, in particular, the proposed patient access scheme led the Committee to conclude that the high cost of bevacizumab relative to the benefits it brings means that it is not a cost-effective use of NHS resources for the treatment of metastatic colorectal cancer.“
She added that the proposed patient access scheme was too complex, did not reflect routine clinical practice and would have high administration costs.
The CHMP’s negative opinion related to the approval of Avastin alone or in combination with irinotecan chemotherapy for the treatment of relapsed or progressive GBM.
The major objection from the CHMP was the lack of a comparator arm without Avastin in the BRAIN study, an investigational Phase II trial. Although the CHMP usually bases its approval decisions on Phase III studies only, Roche chose to submit this data set based on what it felt was remarkable clinical activity on the part of Avastin.
“We are very disappointed with the CHMP opinion, which will result in a delay to patients receiving an important new treatment option. We strongly believe that Avastin is a new treatment option for physicians within the EU which would bring hope to GBM patients and their families as it is today in the US and other countries,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
“Relapsed glioblastoma is a rare condition and represents a very high unmet medical need. These patients deserve effective additional therapies to manage this devastating disease,” he continued.
NICE’s draft guidance on bevacizumab is now out for consultation.