Lexchin Joel
School of Health Policy and Management, York University, Toronto, ON, Canada.
Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
JRSM Open. 2025 Mar 19;16(3):20542704251325314. doi: 10.1177/20542704251325314. eCollection 2025 Mar.
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.
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.
Canada.
Oncology drugs with a conditional approval.
Additional therapeutic gain compared to existing products.
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.
Few new oncology drugs approved through the NOC/c pathway offer major therapeutic improvements over existing drugs.
利用四个独立组织的治疗评级，调查加拿大卫生部有条件批准（合规通知，NOC/c）的新型肿瘤药物相对于现有药物的额外治疗价值。
构建了一份从1998年该计划启动至2023年底所有获得NOC/c的新型肿瘤药物清单。确定了所有药物的首创药物和孤儿药地位。从加拿大专利药品价格审查委员会、法国药品公告《Prescrire International》、法国卫生高级管理局和德国医疗质量与效率研究所获得治疗评级。如果有多个组织对该药物进行评级，则采用最高评级。
加拿大。
有条件批准的肿瘤药物。
相对于现有产品的额外治疗获益。
54种肿瘤药物获得批准。29种药物的条件已满足，22种药物的条件仍在等待满足，3种药物已被制造商停产或被限制使用。18种药物同时具有孤儿药和首创药物地位。对50种药物进行了治疗评估，并对全部50种药物、29种已满足条件的药物以及18种同时具有孤儿药和首创药物地位的药物的额外治疗价值分布进行了检查。在这三组中，分别有8.0%、10.3%和11.7%的药物带来了重大治疗改善。
通过NOC/c途径批准的新型肿瘤药物中，很少有能比现有药物带来重大治疗改善的。
