加拿大早期肿瘤治疗的限时报销和临时准入流程:基于依可单抗经验的视角

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES
Chakrapani Balijepalli, Lakshmi Gullapalli, Swati Prasad, Nancy Paul Roc, Ana Rusu, Natalia Price, William Dempster, Stephane Barakat
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引用次数: 0

摘要

多年来,加拿大人在获得新药方面面临着漫长的等待时间。这些延误主要是由于复杂的卫生技术评估、旷日持久的价格谈判和旷日持久的省级上市决定。为了应对这些挑战,2023年11月,加拿大药品管理局(CDA)推出了第一个早期准入计划——限时报销建议(TLR),旨在加速对正在接受加拿大卫生部合规通知(NOC/c)流程的有前景药物的报销。与此同时,泛加拿大制药联盟制定了临时准入程序(pTAP),以支持通过CDA TLR途径的药物的价格谈判。艾伯维公司是第一家使用EPKINLY (epcoritamab)参与TLR和pTAP过程的公司,EPKINLY是一种治疗晚期淋巴瘤的新型药物。2024年6月18日,EPKINLY成为加拿大首个获得正面CDA TLR推荐的治疗药物,2024年7月19日,艾伯维和泛加拿大制药联盟成功完成了pTAP谈判。截至2024年11月1日,EPKINLY在9个省份上市,比标准流程的平均时间缩短了10.7个月,这对患者来说意义重大。这一成就证明了TLR和pTAP流程在改善患者药物获取时间表方面的潜力。然而,对2020年至2024年间从加拿大卫生部获得NOC/c状态的药物的分析显示,很少有药物符合当前严格的TLR受益资格标准,限制了这些计划的潜在收益。虽然TLR和pTAP是有希望的举措,但需要改进以最大限度地发挥其影响,并确保加拿大患者更快地获得挽救生命的治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Time-limited reimbursement and Temporary Access Process for early access to oncology treatments in Canada: a perspective based on the epcoritamab experience.

For years, Canadians have faced long wait times for access to new medicines. These delays are largely attributed to complex health technology assessments, extended price negotiations and protracted provincial listing decisions. To address these challenges, in November 2023, Canada's Drug Agency (CDA) introduced its first early access program - the time-limited reimbursement recommendation (TLR) - aimed at accelerating the reimbursement of promising drugs undergoing Health Canada's Notice of Compliance with Conditions (NOC/c) process. In conjunction, the pan-Canadian Pharmaceutical Alliance developed the Temporary Access Process (pTAP) to support price negotiations for drugs that go through CDA's TLR pathway. AbbVie corporation was the first company to participate in the TLR and pTAP processes with EPKINLY (epcoritamab) - a novel treatment for advanced lymphoma. On 18 June 2024, EPKINLY became the first therapy in Canada to receive a positive CDA TLR recommendation and on 19 July 2024, AbbVie and the pan-Canadian Pharmaceutical Alliance successfully concluded pTAP negotiations. As of 1 November 2024, EPKINLY was listed in nine provinces, achieving a 10.7 month faster time-to-patient than the average time for the standard process, which is significant and meaningful to patients. This achievement demonstrates the potential of the TLR and pTAP processes to improve medicine access timelines for patients. However, an analysis of drugs that received NOC/c status from Health Canada between 2020 and 2024 reveals that very few drugs would have met the current strict eligibility criteria required to benefit from the TLR, limiting the potential benefits of these programs. While TLR and pTAP are promising initiatives, refinements are needed to maximize their impact and ensure faster access to life-saving therapies for Canadian patients.

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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
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