Focused Ultrasound Treatment for Essential Tremor Now Reimbursed in Germany

Written by Thomas Andreae, PhD

An important change in reimbursement for German patients with essential tremor has occurred. On April 21, 2022, the German Federal Joint Committee governing healthcare in Germany (Gemeinsamer Bundesausschuss or G-BA) favorably amended its ruling on patient eligibility for focused ultrasound treatment and reimbursement.

Originally, on May 20, 2021, the G-BA concluded that focused ultrasound could provide a benefit for patients who were not suitable for deep brain stimulation (DBS); the ruling stated there were not enough data on whether focused ultrasound could also benefit patients who were suitable for DBS. The G-BA stated that there would be a potential of a benefit (an important aspect in the process), but that the benefit would need to be verified with a clinical trial. Because of this initial decision, the G-BA put out a draft directive for a randomized controlled trial (RCT) comparing focused ultrasound with unilateral DBS.

Focused ultrasound physicians at the University Hospital in Kiel worked together with a consulting firm – Institut TakeCare (ITC) GmbH in Berlin – to unite all seven German neurology and neurosurgery specialty societies. The physicians wrote and signed a joint statement and commented on the draft directive. They argued that an RCT would be unfeasible or, in the least, very difficult to recruit because:

  • The efficacy of both procedures is sufficiently demonstrated and comparable to a large degree. This also applies to patients who were suitable for DBS. There are not enough data available to compare the safety profile of both procedures. Therefore, the objective of the study should be to understand the adverse events, which are rare and require a large sample size.
  • Neurosurgeons rarely perform unilateral DBS anymore; most treatments are now bilateral. Hence, there would be only about 5 (five) eligible DBS patients per year in Germany, not enough to complete the trial in a meaningful timeframe.
  • Patients often come with a clear preference for their treatment, especially if the alternatives are invasive brain surgery versus a noninvasive treatment. Patients initially willing to be randomized may reconsider after being randomized to DBS and the study needs to account for a high dropout and crossover rate.
  • The estimated number of patients eligible and willing to participate in such a study over a period of 3 years was estimated to be 10 (ten).

This consensus statement, along with statements from the vendor and the German medtech industry association, BVMed, convinced the G-BA to skip the trial and accept that patients who would be suitable for but are not willing to undergo DBS should be eligible for MR-guided focused ultrasound (MRgFUS) after careful diagnosis and discussion with the treating physician. Or, in the words of the G-BA in their supporting reasons for the decision:

“If these patients make a therapeutic decision against treatment with DBS and in favor of MRgFUS after being fully informed about the state of medical knowledge and the existing relevant treatment alternatives in joint decision-making with the attending physician, they are also considered patients who are not eligible for DBS within the meaning of the decision clauses of May 20, 2021, for the evaluation of the present procedure according to Section 137h SGB V.”

Of note: This is the first time the G-BA has accepted patient preference as indication for a reimbursable focused ultrasound procedure – or any other procedure, for that matter.

This is all public information, and it is available on the G-BA website (in German with elaborate bureaucratic language). All statements can be found in the Anlage zur Zusammenfassenden Dokumentation.

Focused ultrasound for essential tremor is available at the university hospitals in Bonn and Kiel, and a new treatment site is planning to open in Kassel.

Regulatory and reimbursement processes are different in every country, but organizing stakeholders (treating physicians, medical specialty societies, and regulatory experts) to build consensus around a treatment can be a successful model that ultimately helps the patients who most need the treatment and advocacy.