PDF(Pubmed)
Abstract：
UNASSIGNED: Preapproval information exchange (PIE) has increased between biopharma companies and health care decision-makers (HCDMs) over the last several years. However, there still exists a gap in what HCDMs need and what biopharma companies are providing.
UNASSIGNED: To assess trends in the utilization of preapproval information by HCDMs and identify resources that may best support organizations in evaluating product information for formulary coverage prior to US Food and Drug Administration approval.
UNASSIGNED: A double-blinded, web-based survey was fielded to a research panel of HCDMs from FormularyDecisions from May 16, 2022, to May 23, 2022.
UNASSIGNED: A total of 30 advisors were invited to take the survey and 17 responded to the survey, with representation largely from health plans (41%), pharmacy benefit managers (24%), and integrated delivery networks (12%) across commercial, Medicare, and Medicaid lines of business. Of the respondents, 47% noted that the availability of preapproval information has shortened the time to make a formulary decision. Almost all respondents (90%) ranked the availability of clinical and economic information in a timely manner to evaluate budget impact as a top benefit for PIE. Respondents noted that Academy of Managed Care Pharmacy (AMCP) preapproval dossiers (88%), AMCP PIE webinars (76%), preapproval presentations/videos (65%), and posters and abstracts of clinical trials results (59%) were the main resources used to facilitate PIE.
UNASSIGNED: The availability of preapproval information for HCDMs (particularly content related to anticipated place in therapy and product pricing) has an impact on shortening formulary decision-making timelines.
UNASSIGNED: To assess trends in the utilization of preapproval information by HCDMs and identify resources that may best support organizations in evaluating product information for formulary coverage prior to US Food and Drug Administration approval.
UNASSIGNED: A double-blinded, web-based survey was fielded to a research panel of HCDMs from FormularyDecisions from May 16, 2022, to May 23, 2022.
UNASSIGNED: A total of 30 advisors were invited to take the survey and 17 responded to the survey, with representation largely from health plans (41%), pharmacy benefit managers (24%), and integrated delivery networks (12%) across commercial, Medicare, and Medicaid lines of business. Of the respondents, 47% noted that the availability of preapproval information has shortened the time to make a formulary decision. Almost all respondents (90%) ranked the availability of clinical and economic information in a timely manner to evaluate budget impact as a top benefit for PIE. Respondents noted that Academy of Managed Care Pharmacy (AMCP) preapproval dossiers (88%), AMCP PIE webinars (76%), preapproval presentations/videos (65%), and posters and abstracts of clinical trials results (59%) were the main resources used to facilitate PIE.
UNASSIGNED: The availability of preapproval information for HCDMs (particularly content related to anticipated place in therapy and product pricing) has an impact on shortening formulary decision-making timelines.
摘要：
■在过去几年中，生物制药公司和医疗保健决策者（HCDM）之间的预先批准信息交换（PIE）有所增加。然而,在HCDM需要什么和生物制药公司提供什么方面仍然存在差距。
■评估HCDM对预先批准信息的利用趋势，并确定在美国食品和药物管理局批准之前，可以最好地支持组织评估产品信息的资源。
■双盲，从2022年5月16日至2022年5月23日，对FormularyDecisions的HCDM研究小组进行了基于网络的调查。
■共有30位顾问获邀参与调查,17位顾问回应调查,代表主要来自健康计划(41%)，药房福利经理（24%），和整个商业的集成交付网络(12%)，Medicare,和医疗补助业务。在受访者中，47%的人指出，预先批准信息的可用性缩短了做出处方决定的时间。几乎所有受访者（90％）都及时将临床和经济信息的可用性列为PIE的最大收益，以评估预算影响。受访者指出，管理式护理药房学院(AMCP)预先批准的档案(88%)，AMCPPIE网络研讨会（76%），预先批准演示文稿/视频（65%），临床试验结果的海报和摘要（59％）是用于促进PIE的主要资源。
■HCDM的预先批准信息（特别是与治疗和产品定价的预期位置相关的内容）的可用性对缩短处方决策时间有影响。
■评估HCDM对预先批准信息的利用趋势，并确定在美国食品和药物管理局批准之前，可以最好地支持组织评估产品信息的资源。
■双盲，从2022年5月16日至2022年5月23日，对FormularyDecisions的HCDM研究小组进行了基于网络的调查。
■共有30位顾问获邀参与调查,17位顾问回应调查,代表主要来自健康计划(41%)，药房福利经理（24%），和整个商业的集成交付网络(12%)，Medicare,和医疗补助业务。在受访者中，47%的人指出，预先批准信息的可用性缩短了做出处方决定的时间。几乎所有受访者（90％）都及时将临床和经济信息的可用性列为PIE的最大收益，以评估预算影响。受访者指出，管理式护理药房学院(AMCP)预先批准的档案(88%)，AMCPPIE网络研讨会（76%），预先批准演示文稿/视频（65%），临床试验结果的海报和摘要（59％）是用于促进PIE的主要资源。
■HCDM的预先批准信息（特别是与治疗和产品定价的预期位置相关的内容）的可用性对缩短处方决策时间有影响。
