After the implementation of the BStabG with far-reaching consequences, a reform of the AMNOG process itself (AMNOG 2.0) is now being discussed. Beyond that the Finance Committee on Health recently proposed expanding the role of cost-benefit assessments for reimbursement price negotiations, effective…
With the German Health Insurance Contribution Rate Stability Act (BStabG) now in force, statutory health insurances can establish cross-molecule rebate contracts for clusters of innovative, patent-protected medicines under §130e SGB For manufacturers, the implications are significant: Intensi…
The draft bill for the health care reform in Germany not only extends the price moratorium until 2030 but also cuts free pricing for nex Gx products. In the future, Gx prices for new products will depend on the existing market prices. The decisive factor will be whether a drug with the same active i…
The dynamic manufacturer rebate is a regulatory misstep The planned introduction of a dynamic manufacturer rebate for patent-protected medicines (§ 130a para. 1b SGB V) as part of the BStabG (statutory health insurance contribution rate stabilization bill) raises significant regulatory questions — p…
The price-volume regulation shall no longer be subject to arbitration. The default mechanism kicks in if no agreement between the pharmaceutical company and the statutory health insurances is reached and adjusts the reimbursement amount annually (starting in the third calendar year after launch) usi…
The current draft bill on statutory health insurance contribution rate stabilization (BStabG) sets out the health policy objective of tighter expenditure control — with direct implications for pricing, market access, and reimbursement in the German market. An overview of the key changes for innovati…
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
Products with initial market entry after January 1st, 2025 are now benefiting from less strict pricing guidelines if the studies used for AMNOG benefit assessment included ≥ 5 % German patients. The benefit will last for 3 years and can be maintained even afterwards for companies with active R&D…
Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to § 130b SGB V following AMNOG benefit assess…
Confidential reimbursement amounts are finally available in Germany. However, the medicinal product and the pharmaceutical company must meet several requirements. Above all, the confidential reimbursement amount will only be available for new medicinal products with initial market entry in Germany a…
With the SHI Financial Stabilisation Act (GKV-FinStG), the framework conditions for price negotiations for medicinal products in Germany have been made more complex and have been systematically tightened by the legislator to the disadvantage of the pharmaceutical industry. On the one hand the extend…
Overview of our services in the field of non-randomised studies and indirect comparisons Strategic consulting Systematic research Study design consulting Statistical consulting Non-randomised studies and non-adjusted indirect comparisons in benefit assessments Benefit assessments, at EU level as wel…
We are pleased to inform you that our analysis of confidential reimbursement prices in Germany has been published in the journal “Market Access & Health Policy”: Schnorpfeil W, Kiehlmeier S. Einführung vertraulicher Erstattungsbeträge setzt falsche Anreize. Market Access & Health Policy. 202…
Regulation (EU) 2021/2282 Article 7 (1) of Regulation (EU) 2021/2282 specifies when a health technology must undergo a Joint Clinical Assessment (JCA). Paragraph 1a stipulates that the time of initial market authorization application (MAA) is decisive. A JCA of the new health technology only needs t…
SAVE THE DATE: 16.01.2024 From 10:00 am to 11:30 am Speakers: Dr. Willi Schnorpfeil, Dr. Angela Lammert We are offering a webinar on the topic of “Price negotiations with the SHI under consideration of the legal changes”. The webinar is aimed at managing directors and employees of pharmaceutical com…
