doctor holding a tablet with a heart monitor being shown and a hospital sign

As healthcare authorities around the world continue to grapple with rising healthcare costs, attempts to rein in health spending are inevitably gaining ground. A survey of the global market access landscape for medical devices reveals the medtech sector is no exception to this trend. With the growing emphasis on value, healthcare decision makers are increasingly turning to health technology assessment (HTA) when making decisions about medtech pricing and reimbursement. HTA involves rigorous review of new technologies, not just in terms of their added clinical utility but also often with an eye toward cost-effectiveness. With governments solidifying their cost containment stance, manufacturers will need to approach the market armed with strong evidence, both clinical and economic, to make the case for adoption of their products.

Already well established among pharmaceutical market access pathways, medtech HTA is making notable inroads across the globe, often building off of existing drug evaluation capabilities. The United Kingdom’s gold standard National Institute for Health and Care Excellence (NICE) has widened its focus to selected novel devices in recent years and its Medical Technologies Evaluation Programme (MTEP) offers opportunities for innovative devices to speed market access, albeit via non-binding recommendations. Meanwhile, Germany’s highly developed pharmaceutical HTA capacity has paved the way for greater use of medtech HTA in recent years.

In France, formal HTA has become a prerequisite for access to reimbursement for most innovative devices. Further, in October 2013, health economic evaluation became mandatory for new devices offering a major to moderate added clinical value (ASA; amélioration du service attendu) or with the potential to significantly impact public health insurance spending. These health economic evaluations occur in parallel with clinical evaluations and are also used to inform eventual pricing negotiations.

HTA is also gaining steam in Italy and increasingly factors into pricing and reimbursement decisions for medical devices. While the National Agency for Regional Health Services (AGENAS; Agenzia Nazionale per i Servizi Sanitari Regionali) produces only select evaluations, regional and local HTAs are widespread and the country is moving closer to national framework guidelines for HTA.

In the United States, evaluating medical treatments on the basis of cost-effectiveness is viewed less favorably and national-level HTAs are reserved for clinical effectiveness and risk-benefit analyses. Nevertheless, select state-level HTA bodies do consider costs when reviewing devices for incorporation into public programs such as Medicaid, as increasingly do private payors.

In the Asia Pacific region, both Australia and South Korea also continue to integrate HTA into their medtech pricing and reimbursement decisions. And notably, Japan has begun movement toward the establishment of its first formal HTA body, with targets as early as 2016.

What’s striking about the spread of medtech HTA is its growth not only among the most developed healthcare systems but also in emerging markets like Brazil and India. These countries have recognized that their goals of rapidly improving access and quality of care can work hand-in-hand with efforts to contain costs by emphasizing relative value. Hence, we see in India the early signs of the development of an official HTA agency even as the country takes its first steps toward substantive medical device regulation. They’re not waiting to walk before they run; when it comes to preparing for the demands of HTA, medtech manufacturers won’t want to either.

Interested in learning more? View our Spectrum Report on Going Global.

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