5. International comparison: How uniformly are non-drug interventions assessed on an international level?

From the perspective of patients, manufacturers, but also authorities, a globally uniform procedure for the assessment of new non-drug interventions with medical devices would have several advantages. In fact, however, the procedures differ considerably between countries - both in the certification or approval of new medical devices, and in their reimbursement. For example, a new treatment method may be reimbursed by health insurance in Germany but not in France, while in the USA it may not have even been approved.

The certification of medical devices is uniformly regulated, at least within the EU: Medical devices are tested by a confusing number of so-called notified bodies and awarded a CE certificate. In the United States, on the other hand, medical devices are approved centrally by the Food and Drug Administration (FDA), just like drugs. Since the FDA places higher demands on evidence of efficacy and safety, manufacturers generally conduct randomized controlled trials (RCTs). These studies are often only prepared for access to the US market, as they are not routinely required for market access in the EU. For the EU, small case series have sufficed up to now, even for the higher risk classes IIb and III. As a result, new medical devices enter the EU market on average three years earlier than the US market, but on the basis of much poorer evidence, because the results of studies with a high level of evidence are rarely available for assessment in the EU. Thus, it may only become clear through the studies conducted for the US market that a medical device has no benefit or even causes harm. For example, in 2010, a foam sealant for severely overinflated lung sections was certified in Europe, while this medical device never made it to market in the United States because it failed in the required studies due to side effects.

Whether and how a new non-drug intervention is offered and reimbursed in a healthcare system is decided by each EU member according to its own rules. Therefore, almost every country follows its own assessment process. Differences can be found in a wide range of areas, from the selection of topics (some countries conduct assessments, others do not), to the methodology (some countries assess the cost-benefit ratio, others do not), to the timing of the assessment (some countries assess shortly after CE certification, others years after or not at all).

The reasons for the differences are manifold: Even within Europe, healthcare systems differ, sometimes considerably, in legal, financial, organizational as well as social aspects. As a result, systems apply different benchmarks and conduct assessments in different ways at different times. Although in the EU some countries write their health technology assessments (HTAs) entirely in English, in other countries they are written in the national language, supplemented only by an English summary, making comprehensibility more difficult for other countries.

At the European level, efforts have been underway for years to standardize procedures, especially through the European Network for (EUnetHTA, read more: eunethta.eu), which was founded in 2006 and has over 80 participating institutions in 30 countries. Within the network, agreement has been reached in recent years on methodological principles and a common framework for HTA.

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At the beginning of 2018, the European Commission made a proposal as to how uniform HTAs of drugs and medical devices could be performed at the European level (read more: ec.europa.eu). However, this proposal faced a great deal of criticism, as it would in part interfere very strongly with national healthcare policies and oblige member states to adopt joint HTA reports and, as a consequence, no longer prepare their own additional assessments. A compromise was not reached until June 2021 (read more: europarl.europa.eu). Joint European HTAs will be implemented from 2025. Initially, they will be prepared for all new cancer drugs and for drugs containing living cells or tissue. In subsequent years, the assessments will be extended to all drugs. According to the EU HTA regulation, the European assessment of non-drug interventions (medical devices and in-vitro diagnostics) is expected to deliver initial results by 2027, but will remain limited to a few, particularly important high-risk medical devices (read more: eur-lex.europa.eu).

image: © PantherMedia / Golden Sikorka

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Jens Flintrop

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Susanne Breuer

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