Germany

Following the request of a patient organization, the Joint Federal Committee (G-BA) evaluated the newborn screening for tyrosinemia type I by tandem mass spectrometry and decided to include the method into the relevant guideline. Before the method can be applied and reimbursed in the statutory health insurance (SHI) in Germany, the Genetic Diagnostics Act requires approval by the Genetic Diagnostics Commission (GEKO).

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.

After successful trial application by the manufacturer (Okuvision) of a stimulation technology (Okustim), the Federal Joint Committee (G-BA) decided on a trial guideline for a co-funded study defining the key points of the planned study, including type and time period of the study, target population and control intervention. Results from the trial will be evaluated and may lead to reimbursement of the method in both, the inpatient and outpatient sectors.

Too little evidence was available to evaluate the efficacy and safety of liposuction for the treatment of lipedema in the inpatient sector in Germany. However, the Federal Joint Committee (G-BA) regards the method as a potential treatment alternative. It, therefore, plans a co-funded trial in cooperation with the manufacturer to create missing evidence with a start in 2018.

On August 15th, the German Institute of Medical Documentation and Information (DIMDI) published the preliminary version of the new procedure catalogue for the inpatient sector in Germany. The final version of the catalogue will come into effect with the start of the year 2018. MTRC will report about new procedures and other changes included in the catalogue after the release of the official version in the beginning of 2018.

On 6th of September, the Joint Federal Committee (G-BA) released announcement for manufacturers of OCT equipment to notify about their devices till 4th of October before G-BA makes the final decision about coverage of the procedure in out-patient settings within statutory health insurance. 

In 2016, Joint Federal Committee (G-BA) commissioned Institute for Quality and Efficiency in Health Care (IQWIG) for benefit assessment of telemonitoring systems in patients with implantable cardioverter defibrillators (ICD). In July 2017, IQWIG published a preliminary report. Due to lack of evidence, no benefit statement was made.

G-BA started review process for number of procedures for treatment of benign prostate enlargement in 2009. After publication of the results of rapid health technology assessment by the Institute for Quality and Efficiency in Health Care (IQWiG), G-BA was able to come to the conclusion in June 2017 about efficacy and safety of the thulium laser resection of prostate are well documented and procedure can be covered within statutory health insurance in Germany.

Article “Cost-utility analysis of bariatric surgery compared with conventional medical management in Germany: a decision analytic modeling” was published in the BMC Surgery. Surgery was found cost-effective at 10-year time horizon and cost saving over life time of operated cohort. Delay in provision of surgery led to reduction of gained health benefits.

Reinhard Busse et al. published article “Statutory health insurance in Germany: a health system shaped by 135 years of solidarity, self-governance, and competition” in the Lancet. Article provides valuable insights into history and current state of statutory health insurance system in Germany.

New version 5.0 of the guidance “Allgemeine Methoden” provides basis for the scientific work of the Institute and its external experts. Multiple changes were made to existing sections, several new sections were added as well. Guidance provides brief overview of assessments performed in connection to benefit assessment for high class risk medical technologies, submitted for the innovation funding (NUB) for the first time.