Therapeutic value of oncology products with a conditional approval from Health Canada: a cross-sectional study.

Abstract

Objectives: Investigate the additional therapeutic value compared to existing medicines of new oncology drugs given a conditional approval (Notice of Compliance with conditions, NOC/c) by Health Canada using therapeutic ratings from four independent organisations.

Design: A list of all new oncology drugs with an NOC/c from the start of the programme in 1998 to the end of 2023 was constructed. First-in-class and orphan drug status was determined for all drugs. Therapeutic ratings were obtained from the Canadian Patented Medicine Prices Review Board, the French drug bulletin Prescrire International, the French agency Haute Autorité de Santé and the German Institute for Quality and Efficiency in Health Care. If more than one organisation rated the drug, the highest rating was used.

Setting: Canada.

Participants: Oncology drugs with a conditional approval.

Main outcome measures: Additional therapeutic gain compared to existing products.

Results: Fifty-four oncology drugs were approved. Conditions were fulfilled for 29, fulfilment was still pending for 22 and 3 drugs were either discontinued by the manufacturer or placed on restricted access. Eighteen drugs had both orphan drug and first-in-class status. Therapeutic evaluations were available for 50 drugs, and the distribution of additional therapeutic value was examined for the entire group of 50 drugs, for 29 drugs that had fulfilled their conditions and for 18 drugs with both orphan drug and first-in-class status. In the three groups, 8.0%, 10.3% and 11.7%, respectively, offered major therapeutic improvement.

Conclusions: Few new oncology drugs approved through the NOC/c pathway offer major therapeutic improvements over existing drugs.