College of Pharmacy, University of Iowa, Iowa City.
J Manag Care Spec Pharm. 2023 May;29(5):449-463. doi: 10.18553/jmcp.2023.29.5.449.
Specialty drugs are identified by high monthly costs and complexity of administration. Payers use utilization management strategies, including prior authorization and separate tiers with higher cost sharing, to control spending. These strategies can negatively impact patients' health outcomes through treatment initiation delays, medication abandonment, and nonadherence. To examine the effect of patient cost sharing on specialty drug utilization and the effect of prior authorization on treatment delay and specialty drug utilization. We conducted a literature search in the period between February 2021 and April 2022 using PubMed for articles published in English without restriction on date of publication. We included research papers with prior authorization and cost sharing for specialty drugs as exposure variables and specialty drug utilization as the outcome variable. Studies were reviewed by 2 independent reviewers and relevant information from eligible studies was extracted using a standardized form and approved by 2 reviewers. Review papers, opinion pieces, and projects without data were excluded. Forty-four studies were included in this review after screening and exclusions, 9 on prior authorization and 35 on cost sharing. Patients with lower cost sharing via patient support programs experienced higher adherence, fewer days to fill prescriptions, and lower discontinuation rates. Similar outcomes were noted for patients on low-income subsidy programs. Increasing cost sharing above $100 was associated with up to 75% abandonment rate for certain specialty drugs. This increased level of cost sharing was also associated with higher discontinuation rates and odds. At the same time, decreasing out-of-pocket costs increased initiation of specialty drugs. However, inconsistent results on impact of cost sharing on medication possession ratio (MPR) and proportion of days covered (PDC) were reported. Some studies reported a negative association between higher costs and MPR and PDC; however, MPR and PDC of cancer specialty drugs did not decrease with higher costs. Significant delays in prescription initiation were reported when prior authorization was needed. Higher levels of patient cost sharing reduce specialty drug use by increasing medication abandonment while generally decreasing initiation and persistence. Similarly, programs that reduce patient cost sharing increase initiation and persistence. In contrast, cost sharing had an inconsistent and bidirectional effect on MPR and PDC. Prior authorization caused treatment delays, but its effects on specialty drug use varied. More research is needed to examine the effect of cost sharing and prior authorization on long-term health outcomes.
特殊药物的特点是每月费用高且给药方式复杂。支付方采用利用管理策略,包括事先授权和更高自付额的单独层级,以控制支出。这些策略可能通过延迟治疗开始、药物放弃和不遵医嘱来对患者的健康结果产生负面影响。本研究旨在考察患者自付额对特殊药物使用的影响,以及事先授权对治疗延迟和特殊药物使用的影响。我们在 2021 年 2 月至 2022 年 4 月期间在 PubMed 上进行了文献检索,检索了没有出版日期限制的英文文章。我们纳入了以事先授权和特殊药物自付额为暴露变量、特殊药物使用为结局变量的研究论文。由 2 名独立评审员对研究进行评审,并使用标准化表格提取合格研究的相关信息,由 2 名评审员进行审核。排除综述文章、观点文章和无数据的项目。经过筛选和排除后,本综述共纳入 44 项研究,其中 9 项研究涉及事先授权,35 项研究涉及自付额。通过患者支持计划降低自付额的患者具有更高的依从性、更少的处方填写天数和更低的停药率。在享受低收入补贴计划的患者中也观察到了类似的结果。对于某些特殊药物,自付额增加到 100 美元以上,导致弃用率高达 75%。这种更高水平的自付额也与更高的停药率和可能性相关。与此同时,降低自付额会增加特殊药物的使用。然而,关于自付额对药物持有率(MPR)和覆盖率(PDC)的影响报告结果不一致。一些研究报告称,较高的费用与 MPR 和 PDC 呈负相关;然而,随着费用的增加,癌症特殊药物的 MPR 和 PDC 并未降低。需要事先授权时,会报告处方开始的显著延迟。较高的患者自付额水平通过增加药物弃用而减少特殊药物的使用,同时普遍减少开始和持续使用。同样,降低患者自付额的计划会增加开始和持续使用。相比之下,自付额对 MPR 和 PDC 的影响不一致且具有双向性。事先授权会导致治疗延迟,但对特殊药物使用的影响则有所不同。需要更多的研究来考察自付额和事先授权对长期健康结果的影响。