Europe in its broadest, geographical definition is comprised of approximately 50 countries, each with its own legislation and healthcare system. Even within the biggest block of countries – the European Union with 27 member states – healthcare delivery and related funding is organized on a national level, and in some countries (e.g., Italy, Spain, and Scandinavian countries), even on a regional level. With this, a view on focused ultrasound-based procedure reimbursement in Europe becomes a look at individual countries and their respective healthcare governance.

Europe mapThe decision-making process for introducing new technologies in each country reflects the organization of its healthcare system. Countries with a national healthcare system, like the United Kingdom (UK), France, or Germany, have central institutions that base their approval decisions on health technology assessments and clinical evidence (preferably from multiple randomized controlled trials, which are thus far not available for most focused ultrasound procedures). In countries with local or regional healthcare governance, criteria are not always clear, and the decision-making process may not be fully transparent.

Below is a breakdown of the current reimbursement processes and status in the UK, Germany, France, Italy, Spain, Israel, and Scandinavia.

In the UK, the National Institute for Health and Care Excellence (NICE) provides health technology assessments for new clinical procedures. These assessments are used as guidance for access to the procedure within the National Health Service (NHS). The NHS is the public, tax-funded healthcare system that provides health care services to every citizen. A positive NICE guidance does not automatically result in NHS coverage. Below is an overview of NICE guidance in the three dimensions of safety, efficacy, and use, and available NHS coverage for focused ultrasound procedures where such data are available.

Reimbursement landscape in Europe chart October 2020

Overview NICE guidance and NHS coverage:
Safety: RED – Current evidence is inadequate in quantity and quality and there may be serious safety concerns; YELLOW – Well-known risks for complications the user needs to mitigate; GREEN – Evidence raises no major safety concerns.
Efficacy: RED – Current evidence is inadequate in quantity and quality; YELLOW – Evidence is limited in quantity and quality; GREEN – Current evidence appears adequate.
Use: RED – Should not be used; YELLOW – Should only be used in the context of research; GREEN – Used with normal or special arrangements for clinical governance, consent, and audit in place.
Coverage: RED – No coverage; YELLOW – Coverage in consideration, decision pending; GREEN – Coverage in place
* Efficacy for MRI-guided Uterine Fibroid FUS: Short-term evidence is adequate (GREEN), although further treatment may be required (YELLOW).

With no agreed NHS access except for prostate cancer, focused ultrasound treatments in the UK are limited to either private out-of-pocket pay or grant funded research. The reimbursement for focused ultrasound treatment of prostate cancer is marginal and requires using multiparametric MRI and transperineal biopsy for diagnosis as a prerequisite.

Germany has a universal dual-arm health insurance system with a statutory public arm covering about 89 percent of the population and a private arm covering the remaining 11 percent. Instead of being a state-run public health service like in the UK (the NHS and all its hospitals belong to the state and are funded by the state). In Germany, the federal government sets the framework for all relevant stakeholders to cooperate, which are independently operating physicians, hospitals, insurance companies, diagnostic laboratories, and related services.

The German Operation and Procedure Code base for the statutory health insurance system has a number of focused ultrasound-specific procedure codes for treating a broad range of indications. These codes are linked to a standard payment for hospital in-patient procedures. Additionally, there are generic codes that include some general language that specifies either percutaneous, local destruction or thermal ablation, and these are applicable to focused ultrasound and accepted for payment. Reimbursement is determined based on procedural cost, which does not include amortization of capital equipment, making return-on-investment calculation for costly devices challenging. There is no outpatient reimbursement for focused ultrasound so focused ultrasound patients must spend at minimum one night in a hospital.

In addition to the statutory/compulsory public health insurance system in Germany, there is a private system, which serves higher salaried employees, public servants and entrepreneurs/private businesspeople. Private health insurance is provided by profit-based insurance companies using a cost reimbursement principle. Private payers are more forthcoming to agree on attractive payments (two to three times public tariff) as a way to differentiate themselves in a highly competitive market.

Other countries in Europe
The situation regarding FUS reimbursement in other countries is far less structured and mainly based on out-of-pocket payments and/or site-specific arrangements with local health authorities or insurance companies. Some examples:

Insurance companies can only pay what is in the “big code book,” and no special agreements are allowed; there is currently no code for any focused ultrasound procedure in the book. The process by which new procedures can get into the code book is called Forfait Innovation. This is a clinical trial with government-agreed protocol and patient treatment costs are covered by the public health insurance system. So far, no focused ultrasound procedure has completed the process.

Healthcare in Italy is governed within each of the 20 regions. There is some coverage for prostate focused ultrasound across many regions in place with reasonable payment. Additionally, there is reimbursement for uterine fibroids, bone metastases, osteoid osteoma, essential tremor, tremor-dominant Parkinson’s disease, and neuropathic pain in some regions.

Healthcare in Spain is governed within each of the 17 autonomous regions. There are no known focused ultrasound-specific codes or payments. However, special negotiations and agreements by individual HCPs on a regional level are in place.

Reimbursement is established for essential tremor, bone metastases, and uterine fibroids.

The Nordic countries of Denmark, Sweden, Norway, Iceland, and Finland are known for their comprehensive public healthcare system. Hospitals typically run on a budget controlled by the municipality or region. Physicians are on salary rather than a payment per treatment, which substantially reduces turf discussions between medical specialties. Decision-making includes all stakeholders and is very much consensus driven. Once the group decides focused ultrasound is a valuable addition to the hospital’s service, respective equipment is purchased, and operating expenses become part of the budget. For context, FUS in Scandinavia includes one site in Sweden (uterine fibroids); one site in Finland (uterine fibroids, prostate, bone metastases) and three sites in Norway (uterine fibroids, prostate, research) – all in university hospitals.

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