HTA for Medical Devices

FOREWORD BY MECOMED

In the Middle East and Africa (MEA) region, the implementation of health technology assessment (HTA) is in its nascent stages. Among countries in the region, there are differing levels of understanding of how health technologies should be evaluated, while guidelines on the HTA of medical devices, including in-vitro diagnostics(IVDs), are largely absent.

At Mecomed, we contend that it is important to participate in and support efforts to establish HTA policies in our industries that inform decision-making in order to promote an equitable, efficient and high-quality health system.

As such, we embarked on a study to investigate the evidence related to best practices in HTA of medical devices, understand what lessons can be learned from the pharmaceutical industry, and identify which of these best practices can be adopted by the medical device industry.

FOR THE PURPOSE OF THIS STUDY, THE TERM “MEDICAL DEVICES” REFER TO ANY INSTRUMENT, APPARATUS, IMPLEMENT, MACHINE, APPLIANCE, IMPLANT, REAGENT FOR IN-VITRO USE, SOFTWARE OR MATERIAL INTENDED BY THE MANUFACTURER TO BE USED FOR A MEDICAL PURPOSE, AS PER THE WORLD HEALTH ORGANIZATION’S DEFINITION.

This paper, “Towards Health Technology Assessment of Medical Devices in the Middle East and Africa Region”, produced in collaboration with VI Research, documents the results of the study which describe the HTA process for medical devices globally; identifies the differences between HTA for pharmaceuticals and medical devices; provides examples of best practice HTAs of medical devices and provides guidance on the applicability of HTA of medical devices; and proposes alternative solutions where HTA is not applicable.

The study consisted of a literature review using Pubmed as well as grey literature; structured interviews with Mecomed members with a particular interest and understanding of HTA conducted on medical devices; as well as interviews with several industry stakeholders, policymakers, HTA agencies in the Kingdom of Saudi Arabia, United Arab Emirates, and Egypt, and other global experts. The interviews aimed to elicit information on the knowledge, attitudes and practices of the experts.