HTA For Medical Devices

Towards HTA for Medical Devices in the Middle East and Africa.

Dr Tienie Stander, Managing Director, VI Research FZ LLC
Dr Inna Nadelwais, Executive Director, MECOMED

Mecomed is actively engaging in building MEA region’s capacity building and advancing the devices HTA knowledge base at all stakeholder levels. This will pave the way for constructive partnerships between HTA agencies and industry.

Below is the abstract of the white paper, summarizing our research and covering various aspects of the HTA opportunities and challenges for the MedTech in the MEA region. Please stay tuned for the full paper to be released shortly…

There is a progressive move towards value-based healthcare and the optimization of healthcare budgets and spending in the Middle East and Africa, as well as globally. This poses significant challenges to the healthcare ecosystem. Although health technology assessment (HTA) is mature and well-established in the pharmaceutical field, it is still expanding in the field of medical technology. Given this, Mecomed embarked on a study to explore the differences between HTA for pharmaceuticals and medical technologies/devices.

The study consisted of a literature review as well as interviews with several industry stakeholders, policymakers, HTA agencies in the Kingdom of Saudi Arabia, United Arab Emirates and Egypt, and global experts. The industry respondents, with an average of 22 years of experience, were very knowledgeable in healthcare: 78% of them have graduate and post-graduate qualifications in health economics or related subjects.

Throughout this study, core themes emerged, highlighting the unique elements of HTA for medical devices. One such theme includes the difference in evidence generation. Often, comparative effectiveness evidence is lacking for medical devices at launch compared to the typical phase three evidence gathered in clinical trials of pharmaceuticals. Furthermore, randomized controlled trials are not conducted for many medical devices. This poses the question: what evidence could support claims of efficacy, safety, and quality? This has been debated extensively in other regions of the world. One solution includes a flexible approach towards evidence generation using real-world data (RWD).

Another important difference is the learning curve effect observed in many medical devices where there is a device-operator interaction. Commonly, the operator (healthcare professional) becomes more proficient in performing procedures over time. For example, theatre time for robotic surgery would initially be longer as the operator builds experience, however, over time, with improved proficiency, theatre time would be shorter than that of conventional surgery. The question then arises of how one should approach this learning curve effect when performing economic modelling. One solution is to follow a lifecycle approach by considering the economic impact at different stages in the device’s lifecycle.

Incremental innovation is yet another important difference that needs to be considered. Not all innovations in medical devices are breakthrough innovations. Many are incremental innovations or small enhancements. This makes the product lifecycle very short compared to pharmaceuticals. Often these incremental innovations cannot be directly attributed to health outcomes as they might be of benefit to the operator. Given the high rate of innovation in medical devices, it is not feasible to do an HTA submission for each incremental innovation.

Some other important differences include the dynamic pricing mechanisms seen in devices (capital investment, rental, lease, etc.) and the organizational impact of implementing some medical devices in a facility (staff, space, etc.).

Overall, the study showed that there is a significant evidence base supporting the challenges faced in performing HTA for medical devices. It is imperative to work towards addressing the potential risk that HTA could create an additional hurdle in ensuring access to innovation to patients in need and to ensure that HTA is the tool for enabling rewarding real-world innovation. Capacity building and advancing the HTA knowledge base for devices should start early, at all stakeholder levels. This will pave the way for constructive partnerships between HTA agencies and industry.

Evidence from the study further highlights that one of the key attributes of successful, mature HTA agencies is their bias towards transparency, inclusiveness, communication, and procedural justice. This should be the aim of all HTA agencies.

Collaboration at a regional and global level with more mature HTA agencies is needed to ensure that the adopted processes and policies are not only scientifically robust but also consider individual health system realities.

The study confirmed that the devices industry is diverse and faces unique challenges related to HTA implementation and that significant opportunities exist for collaboration between different stakeholders. One of the early imperatives will be to invest in the education of stakeholders to ensure the adoption of HTA policies and processes that support population health outcomes.