Graff Jennifer S
Innov8 Health Policy, LLC, Washington, DC.
J Manag Care Spec Pharm. 2024 Aug;30(8):854-859. doi: 10.18553/jmcp.2024.30.8.854.
The rapid growth of digital health tools, including digital applications, wearables, sensors, diagnostics, digital therapeutics (DTx), and prescription DTx, offers new ways to treat patients and close gaps in care. Payers need transparent, credible, and efficient processes to differentiate products for potential reimbursement from the larger universe of digital health products.
To identify areas of agreement, disagreement, and rationale for payers to determine which digital health products should be evaluated for formulary consideration and to develop generalizable criteria for health care decision-makers developing policies and approaches for digital health products.
Experts from the Academy of Managed Care Pharmacy DTx Advisory Group Payer Evaluation subcommittee rated whether a pharmacy and therapeutics committee, health technology assessment group, or an innovation center within a health plan or pharmacy benefit manager should consider 14 hypothetical products for potential formulary coverage. Using a 4-step modified Delphi approach, experts rated whether it was appropriate for a payer to evaluate each product on a scale of 1 (strongly disagree) to 9 (strongly agree). Quantitative agreement was assessed using terciles of responses, medians, and the distribution of appropriateness scores. The corresponding discussions are summarized to identify generalizable criteria for payers to consider as they develop approaches to determine which digital health products to evaluate.
Among the 14 hypothetical products, 4 achieved quantitative agreement that payers evaluate the product. 5 products had quantitative disagreement, and the remaining were indeterminant. Payers were most likely to review a product if it (1) was reviewed by the US Food and Drug Administration, (2) required a prescription, (3) was intended to be paid for using premium dollars, (4) treated rather than diagnosed or monitored a clinical condition, (5) had a low clinical opportunity cost, and (6) could address population health metrics.
The rapid availability of digital health and DTx options can be daunting for health care decision-makers when determining which products to evaluate. These generalizable criteria can help payers develop a more efficient process.
包括数字应用程序、可穿戴设备、传感器、诊断工具、数字疗法（DTx）和处方数字疗法在内的数字健康工具迅速发展，为治疗患者和弥合护理差距提供了新途径。支付方需要透明、可靠且高效的流程，以便从众多数字健康产品中区分出有潜在报销资格的产品。
确定支付方在决定哪些数字健康产品应进行医保目录考虑时的共识、分歧及理由，并为制定数字健康产品政策和方法的医疗保健决策者制定通用标准。
管理式医疗药房数字疗法咨询小组支付方评估小组委员会的专家对药房与治疗学委员会、卫生技术评估小组或健康计划或药房福利管理机构内的创新中心是否应考虑14种假设产品以获得潜在医保目录覆盖范围进行评分。采用四步改良德尔菲法，专家们根据1（强烈反对）至9（强烈同意）的评分标准，对支付方评估每种产品是否合适进行评分。使用响应三分位数、中位数和适宜性得分分布来评估定量共识。总结相应讨论，以确定支付方在制定确定评估哪些数字健康产品的方法时应考虑的通用标准。
在14种假设产品中，4种产品在支付方评估该产品方面达成了定量共识。5种产品存在定量分歧，其余产品情况不确定。如果产品（1）经过美国食品药品监督管理局审查，（2）需要处方，（3）打算使用保费资金支付，（4）用于治疗而非诊断或监测临床状况，（5）临床机会成本较低，以及（6）能够解决人群健康指标问题，支付方最有可能对其进行审查。
在确定评估哪些产品时，数字健康和数字疗法选项的快速涌现可能让医疗保健决策者望而却步。这些通用标准有助于支付方制定更高效的流程。
