It is not news that the medical technology industry is one of the most innovative in the world, launching on average one new product every 50 minutes in Europe. Nonetheless, on top of all the usual challenges to justify prices and enter markets, international reimbursement authorities have recently become stricter in terms of requirements and processes. In short, 2016 is the year when all medical companies will have to revisit their reimbursement strategies.

Fortunately, healthcare authorities also decided to look for efficient ways to keep pace with innovation and ensure that promising technologies have accelerated mechanisms to reach patients who truly need them even before substantial clinical evidence is in place. Welcome to Conditional Reimbursement, or Coverage with Evidence Development (CED), one of the strongest healthcare market trends across Europe, US and other markets.

Through these mechanisms, healthcare authorities select technologies with significant potential benefits and provide funds to offer the treatment to a select patient group via a clinical study, which will then generate evidence around the technology. For companies, this represents a straightforward process to enter markets, generate sales and create strong evidence that is completely in line with decision-makers.

In this series of posts we will review some examples of Conditional Reimbursement in Europe, starting with Germany.

Germany – Testing examination and treatment methods, in accordance with SGB V, section 137e

Until recently, the German Federal Joint Committee (G-BA) had no means to find additional evidence or even take corrective actions when promising technologies were presented with insufficient evidence. This has changed with the Healthcare Provision Act, or GKV-Versorgungsstrukturgesetz.

Among other things, the act established the new testing examination and treatment methods, allowing the G-BA to finance and initiate clinical studies of “promising technologies” to generate sufficient evidence for reimbursement decisions. The G-BA defines “promising technologies” as those that can “replace other methods that are more complicated or costly, more invasive for the patient, or not successfully applicable on certain patients, or if the method has fewer side effects, optimizes treatment, or can facilitate better treatment in another manner.”

Either the G-BA or medical companies can apply for the examination. Within three months after the application has been submitted, the G-BA must decide whether the application will be accepted. However, a positive decision does not constitute immediate funding. This is because the G-BA determines only once per year, as part of the budget planning for the following year, which applications will be funded via the testing examination and treatment methods program.

Medical companies and German hospitals should also consider this program in contrast to the new examination and treatment methods (NUB). This is because the new NUB process, which started this year, will include assessment of clinical evidence by the G-BA. Although such assessments had never been part of the NUB process before, they have become central for the NUB decision. As a consequence, most NUB applications will need to include strong clinical data, which significantly increases the complexity of the process. There are open questions concerning the Testing examination and treatment methods. For example, it appears that similar technologies could obtain the same reimbursement once the first product is evaluated and approved. However, the potential of establishing an entry door in Europe’s largest market far outweighs any doubts about this process, and we look forward to more companies applying for it.

Stay tuned, in the next post we will review the Accelerated Access Review from the National Institute for Health and Care Excellence (NICE) in England.

There is much more happening with Conditional Reimbursement and Accelerated Funding for Medical Innovations in Europe, United States and internationally. Want to know if your technology could fit within any of these mechanisms? Contact us at and subscribe to our newsletter.