A Novel Approach to Equitable Distribution of Scarce Therapeutics: Institutional Experience Implementing a Reserve System for Allocation of COVID-19 Monoclonal Antibodies.
A Novel Approach to Equitable Distribution of Scarce Therapeutics: Institutional Experience Implementing a Reserve System for Allocation of COVID-19 Monoclonal Antibodies.
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稀缺治疗学的公平分布的一种新颖方法：实施储备系统的机构经验，用于分配Covid-19，单克隆抗体。
DOI：
10.1016/j.chest.2021.08.003
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发表时间：
2021-12
期刊：
影响因子：
9.6
通讯作者：
Ünver MU
中科院分区：
文献类型：
--
作者：
Rubin E;Dryden-Peterson SL;Hammond SP;Lennes I;Letourneau AR;Pathak P;Sonmez T;Ünver MU
2020年秋季，美国食品和药物管理局(FDA)发布了针对门诊新冠肺炎患者的单抗(MAb)疗法的紧急使用授权。马萨诸塞州联邦发布了指导意见，概述了在单抗稀缺的情况下使用抽签分配单抗的储备系统，该系统将优先考虑社会弱势患者20%的输液时段。随后，麻省总医院的布里格姆保健系统实施了这种后备系统。储备系统能否成功地部署在大型卫生系统中，以促进社会脆弱的新冠肺炎患者公平获得单抗治疗？我们对单抗治疗分配储备系统的运作进行了回顾，以确定转介是如何通过分配过程的，以及提供和接受单抗治疗的患者中有多大比例是社会弱势群体。尽管面临多项业务挑战，但分配单抗治疗储备系统的效果与预期的一样，以增加提供和接受单抗治疗的社会弱势患者的数量。接受单抗治疗的患者的社会弱势比例(27.0%)明显高于使用纯彩票系统分配输液预约而没有脆弱储备的患者(19.8%)，接受输液的患者的社会脆弱比例(25.3%)显著高于使用纯彩票系统分配输液预约的患者(17.6%)我们的卫生系统经验表明，当增加某些群体的获得性时，使用抽奖的储备系统是分发稀缺治疗药物的可行方式。
In fall 2020, the Food and Drug Administration issued emergency use authorization for monoclonal antibody (mAb) therapies for outpatients with COVID-19. The Commonwealth of Massachusetts issued guidance outlining the use of a reserve system with a lottery for allocation of mAbs in the event of scarcity that would prioritize socially vulnerable patients for 20% of the infusion slots. The Mass General Brigham health system subsequently implemented such a reserve system. Can a reserve system be deployed successfully in a large health system in a way that promotes equitable access to mAb therapy among socially vulnerable patients with COVID-19? We conducted a retrospective review of the operation of the reserve system for allocation of mAb therapies to identify how referrals moved through the allocation process and what proportion of patients who were offered and received mAb therapies were socially vulnerable. Notwithstanding multiple operational challenges, the reserve system for allocation of mAb therapy worked as intended to enhance the number of socially vulnerable patients who were offered and received mAb therapy. A significantly higher proportion of patients offered mAb therapy were socially vulnerable (27.0%) than would have been the case if the infusion appointments had been allocated using a pure lottery system without a vulnerable reserve (19.8%), and a significantly higher proportion of patient who received infusions were socially vulnerable (25.3%) than would have been the case if the infusion appointments had been allocated using a pure lottery system (17.6%) Our health system experience demonstrates that a reserve system with a lottery for tiebreaking is a viable way to distribute scarce therapeutics when enhancing access for certain groups is desirable.
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DOI：
10.1056/nejmoa2029849
发表时间：
2021-01-21
期刊：
The New England journal of medicine
影响因子：
--
作者：
Chen P;Nirula A;Heller B;Gottlieb RL;Boscia J;Morris J;Huhn G;Cardona J;Mocherla B;Stosor V;Shawa I;Adams AC;Van Naarden J;Custer KL;Shen L;Durante M;Oakley G;Schade AE;Sabo J;Patel DR;Klekotka P;Skovronsky DM;BLAZE-1 Investigators
通讯作者：
BLAZE-1 Investigators
影响因子：
2.4
作者：
Cooke, Marie;Richards, Julianne;Alcock, Mark
通讯作者：
Alcock, Mark
DOI：
10.1164/rccm.202010-3809cp
发表时间：
2021-02-01
影响因子：
24.7
作者：
White DB;Lo B
通讯作者：
Lo B
DOI：
10.1056/nejmoa2035002
发表时间：
2021-01-21
期刊：
The New England journal of medicine
影响因子：
--
作者：
Weinreich DM;Sivapalasingam S;Norton T;Ali S;Gao H;Bhore R;Musser BJ;Soo Y;Rofail D;Im J;Perry C;Pan C;Hosain R;Mahmood A;Davis JD;Turner KC;Hooper AT;Hamilton JD;Baum A;Kyratsous CA;Kim Y;Cook A;Kampman W;Kohli A;Sachdeva Y;Graber X;Kowal B;DiCioccio T;Stahl N;Lipsich L;Braunstein N;Herman G;Yancopoulos GD;Trial Investigators
通讯作者：
Trial Investigators