Adoption of the Financial Stabilization Act

Bill is rubber-stamped largely unchanged

Thu, 2022 / 10 / 27
On Thursday, October 20th, 2022, the members of the German Bundestag passed the Act to Stabilize the Finances of Statutory Health Insurance (Gesetz zur Stabilisierung der Finanzen der gesetzlichen Krankenversicherung, GKV-FinStG).

The bill was discussed by the Bundestag during three readings, slightly adjusted and now adopted in the amended version. Of the numerous points of criticism listed by the Bundesrat in its statement, only two aspects found their way into the draft law.

These are the most relevant adjustments for pharmaceutical companies:

Topic Proposed change Change since 2nd draft
Orphan drug privileges The maximum annual sales threshold for the loss of the orphan drug privileges within the AMNOG process will be reduced from 50 million EUR to 30 million EUR (drugs currently at 30 - 50 million EUR require a new dossier submission, albeit the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) grants an undefined transition period, for example for consultations and dossier preparation). Lowering the threshold to EUR 30 million instead of EUR 20 million
Free pricing period The free pricing period for innovative drugs which are assessed within the AMNOG process is reduced to 6 months. The negotiated §130b SGB V rebate will be valid from the first date of the 7th month – this also applies for renegotiations.
All previous agreements (and arbitrations) shall initially remain unaffected as long as a new reimbursement amount is not agreed.
No change.
Combination products For newly launched, innovative pharmaceuticals a price reduction of 20% will be introduced for combination products. "Old" G-BA resolutions must be adapted within 6 months with regard to the use of combinations. Exception of products with at least considerable added benefit from the discount.
Waste More than 20% waste due to uneconomical package sizes will be reflected in the negotiated price in form of a rebate. No change.
Price moratorium The price moratorium will be prolonged until December 31st, 2026. No change.
Mandatory pharmacy discount The mandatory pharmacy discount ("Apothekenabschlag") will be increased to 2 EUR for a period of two years. No change.
Volume-related aspects Volume-related aspects, such as volume-based staggers or maximum annual volumes, and budget impact need to be part of §130b SGB V price negotiation contracts. No change.
No added benefit No added benefit: annual therapy costs need to be at least 10% below the most economical comparator ("Muss-Regelung"), except in case of comparator without patent protection, for which the annual therapy costs should be below the most economical comparator ("Soll-Regelung").  No change.
Minor or non-quantifiable added benefit Minor ("gering") or non-quantifiable ("nicht-quantifizierbar") added benefit: in case of a comparator with patent protection, the annual therapy costs must not be higher than the most economical comparator ("Muss-Regelung"). No change.
Registry requirements In case registry requirements ("Anwendungsbegleitende Datenerhebung") are not fulfilled, the annual therapy costs must be below the originally negotiated price. Deleted.
Patent-protected comparator or vAM In case the comparator or a comparable therapy (vergleichbare Arzneimittel, vAM) did not undergo the AMNOG process, but is still patent-protected, the annual therapy costs of the active substance must be reduced by 15%. No change.
Period of notice The standard period of notice for all reimbursement amount agreements will be 3 months. No change.
Mandatory manufacturer rebate The mandatory manufacturer rebate ("Herstellerabschlag") will be increased to 12% (previous 7%). 5% is paid if the rebate was "abgelöst" in the negotiation agreements. No change.

On October, 28th, 2022, the draft law will be given to the Bundesrat for formal yet not mandatory approval. The date of coming into force is currently unknown, but a fast validation (November 2022 to January 2023 according to SKC estimates) is expected.

The numerous legal changes, which were pushed through despite considerable criticism from, among others, the pharmaceutical industry, professional societies, pharmacists' associations and ultimately the Bundesrat will have far-reaching effects on the pharmaceutical industry. For example, many drugs are not granted an added benefit by the G-BA or receive only a minor or non-quantifiable added benefit, both of which will lead to a substantial increase in price pressure in the direction of the comparator's costs. Especially in the case of rare diseases, there are hardly any specific therapies available - the comparators are generic and purely symptomatic, therefore comparatively cheap, or possibly not available at all (i.e., watchful waiting). Therefore, an early strategic positioning in the market access process will become more and more important in the future. Optimally, pharmaceutical companies start to anticipate the situation in the German AMNOG process as part of their R&D strategy and optimize their portfolio accordingly. As further possible strategic implications in response to the GKV-FinStG, we recommend, for example:

  • Niching and pricing strategies to ensure staying below the 30 million Euro annual sales threshold
  • Early discussion with regulatory affairs on package sizes and label definition
  • Exploration of bundling options and evaluation of launch sequence
  • Define a label that ensures there is an active comparator (ideally a more expensive generic) to circumvent best-supportive-care or watchful-waiting as a price anchor
  • Selection of endpoints to show maximum effects and improved validation of surrogate endpoints according to IQWiG methodology to improve the outcome of the benefit assessment

As Market Access Special Forces, we at SKC gladly support our clients regarding the strategic implications in their individual situation.


Sources (only in German language):

About the author

Ihre Ansprechpartnerin Dr. rer. nat. Laura  Könenkamp
Dr. rer. nat. Laura Könenkamp
M. Sc. Animal Biology and Biomedical Sciences
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

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