NICE final guidance again rejects Sanofi’s Zaltrap for colorectal cancer

UK drugs watchdog the National Institute for Health and Care Excellence (NICE), today issued final guidance that does not recommend French pharma major Sanofi’s (Euronext: SAN) Zaltrap(aflibercept) treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin containing regimen, confirming an earlier negative draft guidance (The Pharma Letter June 21, 2013).

Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of National Health Service resources even when the patient access scheme submitted by the manufacturer was taken into account, the NICE asserted.

The Institute received an appeal on its final draft guidance for this appraisal from the manufacturer of aflibercept, Sanofi. The appeal was heard on January 23 this year and was dismissed on all points.

Commenting on the final guidance, Sir Andrew Dillon, chief executive of the NICE, said: “We have already recommended six treatments for various stages of colorectal cancer and are disappointed not to be able to add aflibercept as another treatment option for this stage of the disease. However, we have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them. Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of NHS funds.”

Pricing failed NICE criteria

The list price of a vial of 100mg aflibercept is £295.65 ($487.67), and £591.30 for the 200mg dose. The cost per patient will vary with dose adjustment and treatment duration. For this appraisal, the manufacturer of aflibercept (Sanofi) had agreed a patient access scheme with the Department of Health that would make aflibercept available with a discount. The size of the discount is commercial in confidence. The NICE Appraisal Committee therefore concluded that aflibercept did not meet the criteria for an end-of-life therapy as defined by NICE.