Germany Shifts from Next Generation Sequencing Panels to Whole Genome Sequencing Coverage

Pilot Program for the Integration of Genomic Medicine into German Healthcare

Today in Germany, patients are reimbursed for the cost of NGS analysis which uses gene panels to identify diseases. Starting on the first of January, whole genome sequencing (WGS) will be reimbursed for patients at selected reference center hospitals across Germany as part of a pilot program described within SGB V §64e. This pilot program, focused specifically on oncology and rare diseases, is scheduled to last for five years, and, if successful, will then be expanded nationwide. Success will be measured by the number of fully sequenced genomes completed and a significant increase in the number of patients included in personalized medicine clinical trials, among other key performance indicators. SGB V §64e is part of genomDE, Germany’s national strategy for personalized medicine.

This shift from NGS panels to WGS is driven by the limitations of the former and the possibilities of the latter. Expanding to the whole genome rather than focusing narrowly on a panel enables researchers to examine the patient’s entire DNA to find disease drivers, including new mutations. Whole genome sequencing also allows the discovery of druggable variants. Healthcare providers can determine and deliver the most appropriate treatment corresponding to the biomarkers identified by the sequencing. In addition, studying the whole genome of patients with particular diseases will contribute to improved predictability of the evolution of a disease.

The SGB V §64e pilot program covers:

• Diagnostic and personalized therapy identification via genome sequencing
• Review of the indication for genome sequencing, guided as far as possible by evidence-based guidelines and consideration of other diagnostic or therapeutic options in multidisciplinary case conferences where all medical specialties relevant to the particular case are represented
• Standardized phenotyping
• Sequencing, with parallel studies of all coding segments
• Bioinformatic analysis
• Clinical interpretation, the reporting of findings after sequencing has been performed
• Implementation of uniform re-evaluation cycles
• Potential genome sequencing of one or both of the insured’s biological parents with consent

Impact of the SGB V §64e Pilot Program

For patients, the SGB V §64e pilot program means enhanced coverage for genomic medicine and the chance to receive treatment that is precisely designed for them.

The participating reference center hospitals will collect, secure, and anonymize patient data. Authorized users can access the data for improved care through personalized therapies and oncogenomic diagnostics, for quality assurance, and for scientific research.

This presents a great opportunity for IVD manufacturers seeking Real-World Data (RWD) to secure the efficacy of their devices, RWE solution providers needing new data sources, and companies that run oncology and rare disease trials. IVD manufacturers also have more visibility for their products, greater reimbursement opportunities, and increased commercial opportunities.

The SGB V §64e pilot program has the potential to transform healthcare in Germany by making personalized medicine a reality for everyone.

Our deep understanding of coverage pathways, and of this new pilot program in Germany, will boost your personalized medicine market access strategy. Contact us today for support.