Pathways' Pick of the Week: The WHO and EU Address HTAs

The World Health Organization circulated a new guide for public consultation this week on conducting health technology assessments for medical devices. The goal of the document is to advance the use of HTA and to strengthen evidence-based decision-making for devices, especially in low-to-middle-income countries. WHO lays out strategies for developing HTAs, including the prospect of “adapting” HTAs conducted by one country to the local context of another country. The draft guide includes a distinct chapter on “international collaboration in HTA” that outlines existing global and regional efforts to share HTA resources. That section in particular is in an “early stage of development” and needs more input from international organizations, WHO underscores. WHO defines HTA broadly, explaining that it bridges regulatory approval, policies around coverage and reimbursement, and management of day-to-day use of device technologies. Comments on the document, which would update a 2011 guide, are due July 17.

EU guides.Meanwhile, the EU is accelerating efforts to stand up a Union-wide HTA program by January 1 under the EU Health Technology Assessment Regulation. The European Commission published two guidance document last week to support that effort. One document addresses procedures for defining and fulfilling outcomes for the EU joint clinical assessments (JCAs) that will be conducted under the new regulation to inform country-level market access decision-making. The second guidance digs into more details on handling statistical challenges in the analysis of JCAs.

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