背景：美国食品药品监督管理局（FDA）通过四个快速审查计划——优先审评，加速批准，快速通道和突破性治疗，加速了重要临床进展的批准速度。健康计划是否相对于FDA确定不符合这些计划条件的药物，优先考虑覆盖快速处理药物仍不清楚。目标：调查美国商业健康计划发放涉及不同数量的FDA快速处理计划中的药物的覆盖政策的速度。其次，研究药物被纳入FDA快速处理计划与保障覆盖范围之间的关联。方法：我们为每个研究目标使用单独的数据集。对于第一个目标，我们创建了一个由17个大型商业健康计划为2018年FDA批准的药物发放的政策数据集。包括政策在每种药物的FDA批准后的一年内正式生效。我们研究了政策发放速度与快速处理计划的数量之间的关系。我们控制了癌症和孤儿病症。对于第二个目标，我们分析了商业健康计划专科药物覆盖政策数据集。我们根据快速处理计划的数量（0、1或2个以上计划）对药物进行分类。覆盖政策被归类为是否超出了药物的FDA批准标签规定的限制，例如步骤疗法要求。我们使用回归分析来研究FDA快速审查和保障范围之间的关联，在控制其他相关因素（如替代品的可用性）的同时。结果：对于我们的第一个目标，计划中发放了62％（742/1,190）的政策，即药物获得FDA批准的一年之内发放。在未经调整的分析中，政策发放速度随着每个额外的快速处理计划而增加（风险比率=1.15；P＜0.01）。在控制了癌症和孤儿病症之后，快速处理计划的数量与更快的政策发放没有关联（风险比率=0.95；P=0.209）。对于我们的第二个目标，计划对FDA至少包括在1个FDA快速处理计划中的药物的政策中强制实施覆盖范围限制，覆盖范围限制的政策为33％（672/2,027），而对于FDA排除这些计划中的药物的政策，其覆盖范围限制的政策为51％（870/1,706）。在多变量回归中，我们没有发现FDA快速审查与保障限制之间的关联，同时控制了其他决策因素（包括疾病患病率、年度成本等）。结论：在控制其他决策因素之后，我们并未发现FDA快速批准与更快的保障政策发放之间的关联，也未发现计划为FDA快速处理计划中包括的药物提供的覆盖方式比排除在这些计划之外的药物提供的覆盖方式更为宽松。我们的研究结果引发了对为什么计划不为这些临床进展加速获得准入的问题。披露：本研究由詹森科学事务有限责任公司资助。英罕先生是詹森科学事务有限责任公司的雇员，也是强生公司的股东。查伯斯博士在研究过程中获得了詹森科学事务有限责任公司的拨款。

BACKGROUND: The US Food and Drug Administration (FDA) speeds approval of important clinical advancements through 4 expedited review programs: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Whether health plans prioritize coverage of expedited drugs relative to drugs that the FDA determined did not qualify from these programs is unclear. OBJECTIVES: To investigate how fast US commercial health plans issued coverage policies for drugs included in different numbers of FDA-expedited programs. Second, to examine the association between a drug's inclusion in an FDA-expedited program and plan coverage restrictiveness. METHODS: We used a separate dataset for each study objective. For the first objective, we created a dataset of policies issued by 17 large commercial health plans for 2018 FDA-approved drugs. Included policies were active exactly 1 year following each drug's FDA approval. We investigated the relationship between the speed of policy issuance and the number of expedited programs. We controlled for cancer and orphan indication. For the second objective, we analyzed a dataset of commercial health plan specialty drug coverage policies. We categorized drugs with respect to the number of expedited programs (0, 1, or 2+ programs). Coverage policies were categorized as whether plans imposed restrictions beyond a drug's FDA-approved labeling, for example, step therapy requirements. We used regression analysis to examine the association between FDA-expedited review and coverage restrictiveness when controlling for other relevant factors (eg, availability of alternatives). RESULTS: For our first objective, plans issued 62% (742/1,190) of policies within a year of a drug's FDA approval. In unadjusted analysis, policy issuance speed increased with each additional expedited program (hazard ratio=1.15; P<0.01). After controlling for cancer and orphan status, the number of expedited programs was not associated with faster policy issuance (hazard ratio=0.95; P=0.209). For our second objective, plans imposed coverage restrictions in 33% (672/2,027) of policies for drugs the FDA included in at least 1 FDA-expedited program vs 51% (870/1,706) of policies for drugs the FDA excluded from these programs. In multivariable regression, we did not find an association between FDA-expedited review and coverage restrictiveness after controlling for other decision-making factors (including disease prevalence, annual cost, etc). CONCLUSIONS: After controlling for other decision-making factors, we did not find that FDA-expedited approval was associated with faster coverage policy issuance, nor did we find that plans covered drugs the FDA included in expedited review programs less restrictively than drugs excluded from these programs. Our findings raise questions about why plans do not also accelerate access for these clinical advancements. DISCLOSURES: This study was funded by Janssen Scientific Affairs, LLC. Mr Ingham is an employee of Janssen Scientific Affairs, LLC, and is a stockholder of Johnson & Johnson. Dr Chambers reports grants from Janssen Scientific Affairs, LLC, during the conduct of the study.