With healthcare authorities cutting costs across Europe, gaining reimbursement for your medical device is harder than ever before. We look at how medtech companies can address these challenges and develop a successful reimbursement strategy to obtain reimbursement for their new products.
Developing a reimbursement strategy in Europe is tricky to say the least. The regulatory structure for medical devices differs from country to country. In Germany it’s administered by Der Gemeinsame Bundesausschuss (G-BA), while in France it’s the Haute Autorite de Sante (HAS) and in Britain it’s the National Health Service (NHS). And just as individual countries have their own regulatory structures, they have their own reimbursement structures as well.
To make things even more complex, there are different reimbursement mechanisms (how and who pays you) within the individual countries, which are based upon the setting in which the device is used. For example, a heart monitor may be used in an inpatient setting (in a hospital), in a doctor’s surgery or in a patient’s home. Different settings mean different coverage criteria, different codes, different payment rates and for you – the medtech company – different strategies.
This is just the start. From here you’ll need to determine whether your device can use an existing reimbursement mechanism or develop a new one, neither of which is as quick and easy as it used to be. As reimbursement expert Lea Koelemeijer explains, the requirements to obtain reimbursement are harder than ever before.
‘You have to provide more and more clinical evidence. You have to provide more and more health economics studies. The levels of evidence required are much higher, especially when it comes to more expensive products.’
Due to higher costs and longer waits for treatments, healthcare authorities across Europe have restricted available reimbursement to costly medical devices. How well you address the current reimbursement restrictions and requirements will ultimately determine whether you successfully market your device or not.
Consider reimbursement from the payer’s perspective (both private and public). Their aim is to provide maximum coverage to the population, while also keeping healthcare costs as low as possible. As a result, payers are highly selective when deciding on which devices will be granted reimbursement. As for the providers, they expect payers to provide maximum coverage in order to maximise payments, while the payers expect the providers to use high quality and cost-effective procedures.
An in-depth knowledge of what the different reimbursement mechanisms are, of how they work, and how they’re granted (especially in the current climate), is essential to being able to engage with payers, providers and doctors, and to identify the main decision maker for the commercialisation of your device. If your device can use an existing reimbursement mechanism, you should focus your efforts on providers and doctors rather than payers.
If you need to develop a new reimbursement mechanism, you will need to work with payers as well, and convince them of the clinical and economic benefits of using your device instead of the alternatives currently available. For example, if you were developing a new mechanism for your device for use in German hospitals, you would need to work Institute for the Hospital Payment System (InEK). If it were for use in the patient’s home, you would work with the Association of Statutory Health Insurance (SHI). It’s also important to note that the evidence required to develop a new mechanism can vary significantly across Europe, as Koelemeijer explains.
‘(Establishing a new mechanism) depends on the requirements of the evidence. Different healthcare authorities at the national level have established their own guidelines as to what a good level of clinical evidence is.’
When you’ve established who your decision makers are, it’s best to develop your reimbursement strategy with their perspective in mind. Whereas a doctor may be interested in the benefit for some patients, a payer may be interested in the benefit for many patients. In order to gain such perspective, it’s advisable to involve the decision makers from the product development stage to understand whether your devices are feasible or not.
Finally, given the increased requirements to obtain reimbursement it’s essential that you formulate your clinical development plan with reimbursement in mind. If new reimbursement mechanisms need to be developed, it’s advisable to use any upcoming clinical studies to generate the data required by the relevant decision makers. Remember, the clinical data that is of interest to doctors and healthcare authorities may not be enough to support an application for a new code, coverage criteria, or a payment rate. That said, developing such required data might be included in a company’s clinical study designed to obtain regulatory approval.
Developing a reimbursement strategy is not easy, especially in Europe at this time. However, the more you understand the different mechanisms, requirements and perspectives that exist in each individual country – and actively engage with their key decision-makers – the more likely it is that you’ll be able to successfully market your device.
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