German benefit assessment

In late June 2019, the Federal Joint Committee (G-BA) took its first decision on the use of biomarker-based tests. Patients with breast cancer in the early stages, in which the risk of relapse cannot be determined with certainty, can be provided in the future with a biomarker test as a statutory health insurance (SHI) benefit.

The Federal Joint Committee (G-BA) has signed a further contract for scientific monitoring and implementation of a trial study for NYHA III heart failure therapy optimization by means of continuous blood pressure measurement and monitoring using an implanted sensor in the pulmonary artery.

The report includes an overview of funding framework and all (as of May 2019) decisions from ultimate payers and decisions makers in England (NHS England, one CCG), Germany (G-BA), Netherlands (Zorginstituut Nederland), Norway (“New Methods” framework) and Switzerland (Federal Office of Public Health). More than 1000 decisions are included.

On the 9th of May of 2018, the addendum H18-01 to the report H16-02C “Ultrasound-guided high-focused ultrasound (USgHIFU) therapy for malignant neoplasms of the pancreas” commissioned by the Federal Joint Committee (G-BA) at the beginning of March of 2018, was published by the Institute for Quality and Efficiency in Health Care (IQWiG) on its web-site.

The call for a tender to select an organization to run the pilot study “Liposuction for the treatment of lipedema” was announced by the Federal Joint Committee (G-BA) on the 8th of May of 2018. The deadline for the requests is the 26th of June, 2018, 14:00.

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has announced the call for a tender for the pilot study “Transcorneal Electrical Stimulation in Retinitis Pigmentosa” in the Official Journal of the European Union. The deadline for the requests is the 22nd of June, 2018, 14:00

On the 26th of April of 2018, the Federal Joint Committee (G-BA) has commissioned to the Institute for Quality and Efficiency in Health Care (IQWiG) to provide a rapid report regarding the current state of medical knowledge on synchronous balneophototherapy in atopic eczema. The identified results of the current state of medical knowledge would form the basis for the further G-BA’s assessment of adequacy, appropriateness and economic benefits of the researched method.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has published its final plan for the benefit assessment of motor-driven movement splints (CPM) after interventions on the knee joint and on the shoulder joint. IQWiG was commissioned with this task by the Federal Joint Committee (G-BA). Two manufacturers and relevant associations had used the opportunity of commenting on the preliminary project plan.

Shockwave Medical, the manufacturer of the Coronary Lithoplasty® System for the treatment of calcified coronary artery stenosis, requested a consultation by the Joint Federal Committee (G-BA) to find out whether their device requires an early benefit assessment according to §137h of the Social Code Book V (SGB V). The G-BA decided that the technology is highly invasive and innovative and therefore will need to undergo benefit assessment to be granted innovation funding.

A manufacturer (PQ Bypass) requested a consultation by the Joint Federal Committee (G-BA) about the eligibility of their medical device for an early benefit assessment according to §137h of the Social Code Book V (SGB V). The technology (PQ Bypass Stent Graft System) is a fully-percutaneous femoral-popliteal bypass procedure for peripheral arterial disease. The G-BA argued that the method is not based on the use of a high-risk medical device and therefore does not have to undergo a §137h assessment.

German Federal Joint Committee (G-BA) passed directives for co-funded trials to create evidence on two high-intensity focused ultrasound methods that showed potential benefit in the early benefit assessment process in relation to the innovation funding (NUB). Manufacturer refused to cover required contribution to trial costs and thereby risk exclusion of the methods from benefit catalogues in the German social health insurance.

The Joint Federal Committee (G-BA) resumes assessments of methods that have been intermitted due to missing evidence: LDR brachytherapy in localized prostate carcinoma and PET or PET/CT for malignant lymphomas as well as for interim staging in Hodgkin's lymphoma. Studies conducted in the meantime are expected to provide sufficient evidence base for the assessment about the inclusion of the methods into the social health insurance benefit catalogue in Germany.