Yan Kevin, Balijepalli Chakrapani, Druyts Eric
Pharmalytics Group, Vancouver, BC, Canada.
Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada.
Front Digit Health. 2021 Jun 9;3:667016. doi: 10.3389/fdgth.2021.667016. eCollection 2021.
Historically healthcare has been delivered offline (e.g., physician consultations, mental health counseling services). It is widely understood that healthcare lags behind other industries (e.g., financial, transportation) whom have already incorporated digital technologies in their workflow. However, this is changing with the recent emergence of digital therapeutics (DTx) helping to bring healthcare services online. To promote adoption, healthcare providers need to be educated regarding the digital therapy to allow for proper prescribing. But of equal importance is affordability and many countries rely on reimbursement support from the government and insurance agencies. Here we briefly explore how national reimbursement agencies or non-profits across six countries (Canada, United States of America, United Kingdom, Germany, France, Australia) handle DTx submissions and describe the potential impact of digital therapeutics on current health technology assessment (HTA) frameworks. A targeted review to identify HTA submissions and guidelines from national reimbursement agencies or non-profits was conducted. We reviewed guidelines from the Institute for Clinical and Economic Review (ICER) in the USA, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK), the Institute for Quality and Efficiency in Health Care (IQWIG) in Germany, Haute Autorité de Santé (HAS) in France, and the Pharmaceutical Benefits Advisory Committee (PBAC) in Australia. Our review identified one set of guidelines developed by NICE in the UK. The guidelines by NICE outlined an evidence standards framework for digital health technologies (DHT). Depending on the organizational impact, financial commitment, and economic risk for the payer, different economic analyses are required. Economic analyses levels are separated into 3 categories, basic, low financial commitment, and high financial commitment. All economic analyses levels require a budget impact analysis. A cost-utility analysis is recommended for DHTs categorized in the high financial commitment category. Whereas, for DHTs that are in the low financial commitment category, a cost-consequence analysis is typically recommended. No HTA guidelines for DTx submissions were identified for the remaining countries (Canada, USA, Germany, France, and Australia).
从历史上看，医疗保健一直是线下提供的（例如，医生咨询、心理健康咨询服务）。人们普遍认为，医疗保健行业落后于其他行业（例如，金融、交通），这些行业已经在其工作流程中采用了数字技术。然而，随着数字疗法（DTx）的最近出现，这种情况正在发生变化，数字疗法有助于将医疗服务带到线上。为了促进数字疗法的采用，医疗保健提供者需要接受有关数字疗法的教育，以便进行正确的开方。但同样重要的是可承受性，许多国家依赖政府和保险机构的报销支持。在此，我们简要探讨六个国家（加拿大、美利坚合众国、英国、德国、法国、澳大利亚）的国家报销机构或非营利组织如何处理数字疗法的提交，并描述数字疗法对当前卫生技术评估（HTA）框架的潜在影响。我们进行了一项有针对性的审查，以确定国家报销机构或非营利组织的HTA提交材料和指南。我们审查了美国临床和经济审查研究所（ICER）、加拿大卫生技术评估局（CADTH）、英国国家卫生与临床优化研究所（NICE）、德国卫生保健质量与效率研究所（IQWIG）、法国高等卫生管理局（HAS）以及澳大利亚药品福利咨询委员会（PBAC）的指南。我们的审查发现了英国NICE制定的一套指南。NICE的指南概述了数字健康技术（DHT）的证据标准框架。根据对付款人的组织影响、财务承诺和经济风险，需要进行不同的经济分析。经济分析水平分为3类，基本、低财务承诺和高财务承诺。所有经济分析水平都需要进行预算影响分析。对于归类为高财务承诺类别的DHT，建议进行成本效用分析。而对于归类为低财务承诺类别的DHT，通常建议进行成本后果分析。其余国家（加拿大、美国、德国、法国和澳大利亚）未发现数字疗法提交的HTA指南。
