OBJECTIVES

: As digital therapeutic companies gradually receive regulatory approval, the next step is to gain widespread adoption. To promote adoption a key determinant relies on reimbursement support from the government and insurance agencies. To assess the potential impact on the current health technology assessment process (HTA) framework, we conducted a review to identify HTA submissions and guidelines from national reimbursement agencies or non-profits across six countries (Canada, USA, United Kingdom, Germany, France, Australia).

METHODS

: Reimbursement related documents and guidelines surrounding digital health technologies across the Canadian Agency for Drugs and Technologies in Health (CADTH), Institute for Clinical and Economic Review (ICER), National Institute for Health and Care Excellence (NICE), Institute for Quality and Efficiency in Health Care (IQWIG), Haute Autorité de Santé (HAS), and Pharmaceutical Benefits Advisory Committee (PBAC) were reviewed.

RESULTS

: Of the six agencies/non-profits reviewed, only NICE has issued extensive guidance outlining evidence standards surrounding digital therapeutics. Guidance included evidence standards for not only potentially regulated digital therapeutics but also for all other general digital health technologies (ex. electronic prescribing systems). CADTH’s Evidence Bundle focusing on digital health have conducted reviews on clinical effectiveness and HTA assessments related to digital technologies. Meanwhile, ICER in collaboration with industry and payers have outlined a scoping document to assess digital apps for opioid use disorder. Both CADTH and ICER have not issued any evidence standards to evaluate digital therapeutics. IQWIG, HAS, and PBAC has yet to release any HTA documents related to digital therapeutics.

CONCLUSIONS

: Reimbursement agencies are moving towards developing standards for evaluating digital therapeutics. Due to its novelty, agencies across the world are at different steps in this process. However, it appears NICE is the furthest ahead in issuing publicly transparent evidence requirements for HTA approval.