The local press reports that Health Minister Prof. Karl Lauterbach has put forward a number of proposed cost-containment measures impacting the pharmaceutical sector. The proposals are set out in the draft Statutory Health Insurance Financial Stabilisation Bill (GKV Finanzstabilisierungsgesetz) which aims to address the deficit of the statutory health insurance system.
Key proposals in relation to the pharmaceutical system, as reported by the local press, are:
- Limit the current period of free pricing to six months. Currently, there is 12 months free pricing with the price negotiated between the manufacturer and the GKV-Spitzenverband only applying as of the 13th month following launch in Germany.
- Increase mandatory manufacturer rebates. A tiered system would be introduced which would set the rebate at 19% (up from 7%) in 2023, before lowering it in three steps to 10% in 2026. Savings are estimated at €1.8 billion in 2023 alone.
- Lower from €50 million to €20 million the sales threshold at which orphan drugs become subject to the standard AMNOG assessment. Savings of €100-200 million are anticipated.
- Extend the current price freeze on medicines (not included in the reference price system) by four years until the end of 2026 (the existing price freeze had been due to expire on 31 December 2022).
- Include in rebate negotiations what the press refers to as “quantity-related aspects” eg annual prescription volume caps.
- Introduce a 15% discount on the reimbursement price for combination products with new active ingredients.
- Increase the pharmacy rebate from €1.77 to €2.00 for a period of two years, saving €170 million.
- Reduce VAT on medicines from 19% to 7% from 2023.
Notably, the proposals have not yet received government approval.
Hans Georg Feldmeier, Chairman of the Federal Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie, BPI), labelled the proposals “irresponsible”, noting that “pharmaceuticals only make up around 11% of statutory health insurance expenditure, so they are not the decisive cost factor in the system”. He went on to state, “New drugs must continue to be available quickly in Germany. The current corona [virus] crisis shows how important a system that is open to innovation is. Instead of making cuts at this critical point in particular, the minister should first make a proposal as to how we can secure our supply of medicines, especially against the background of unstable supply chains worldwide and also the sharply rising costs for research, development and production. We will only meet the challenges in supply and secure supply chains if there are reliable framework conditions and reasonable prices for all drug therapies.”
Dr Carola Reiman, Chairman of the Board of the AOK Federal Association of health insurers meanwhile welcomed “the fact that the price and spending spiral in the pharmaceuticals sector is to be turned back somewhat and that meaningful savings are planned”.
- www.bpi.de, “GKV-Finanzierungsgesetz: Maßnahmen gefährden kritische Infrastruktur! Versorgungsrisiken drohen akut!”, 15th March 2022
- www.handelsblatt.com, “Lauterbach legt Plan gegen Milliardendefizit der Krankenkassen vor – die warnen weiter vor höheren Beiträgen”, 15th March 2022
- www.aerzteblatt.de, “Bundeszuschuss zur gesetzlichen Krankenversicherung soll um fünf Milliarden steigen”, 16th March 2022
- www.deutsche-apotheker-zeitung.de, “BMG will Kassenabschlag von 1,77 auf 2 Euro erhöhen”, 15th March 2022
- www.eucope.org, “German draft bill on the “Financial Stabilisation of the Statutory Health Insurance System”, 16th March 2022