Defining the value of innovative treatment methods in Germany

January 2019

Healthcare innovators would see accelerated adoption of new methods for treatment provided through the Statutory Health Insurance (SHI) program in Germany if a recent proposal by Jens Spahn, Federal Minister for Health, to limit the decision-making power of the Joint Federal Committee (G-BA) is approved.

The proposal seeks to transfer power of attorney to the Ministry from the G-BA to bring innovative treatment methods to the public health system faster, even for those treatment methods that have not received a formal assessment by the G-BA.

Under current regulations, assessments and processes for including new therapies into the reimbursement catalogue are lengthy and challenging to navigate, holding implications for manufacturers, patients, and providers.

A key driver to Spahn’s proposal is the potential that liposuction holds for the treatment of lipedema. Prior discussion on the inclusion of this treatment in the reimbursement catalogue was based on insufficient evidence to prove value. A reimbursement decision has been pending since 2014 and, in July of last year, the G-BA decided to support a clinical trial, with expected inclusion of patients in 2020 and results for decision making after 2024.

If Spahn succeeds, barriers for the consideration of innovative products as potential treatment alternatives would be lowered, removing the requirement for national associations of SHI funds and SHI accredited physicians to determine method assessment. The change would also impact the G-BAs excessive clinical evidence demands through randomized controlled trials (RCTs), and promote new evidence approaches for healthcare decision making, like real-world evidence (RWE), for example.

Liposuction in the treatment of lipedema serves as a strong example for the ministry to request authorization to establish this therapy as a SHI benefit. In the planned changes in legislation, Spahn intends not only to be authorized for the inclusion of treatments in the benefit catalogue but also to regulate quality requirements for the provision of services and specifications for remuneration.

The G-BA is the highest decision-making body for coverage of treatments in the German SHI and also specifies measures for quality assurance for inpatient and outpatient areas of the health care system. The joint self-government of physicians, dentists, hospitals, and health insurance funds also issue directives for the benefit catalogue for reimbursement.

Spahn’s request has intensified the discussion about the role of the G-BA and the problems with the introduction of innovative therapies and diagnostics in the German SHI system.

New developments across Germany’s healthcare industry provide significant opportunities for global digital health, medical device, and diagnostics innovators, however many hurdles and barriers to entry still exist. If you are interested in learning more about gaining access to Germany’s healthcare market, please contact us.

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