Law to stabilize the financial situation of the statutory health insurances in Germany
Update 2nd reference draft
The German Federal Ministry of Health has presented its second draft for the law to stabilize the financial situation of the statutory health insurances ("GKV-Finanzstabilisierungsgesetz"). Unfortunately, the draft has not taken a positive turn for the pharmaceutical industry.
These are the most relevant aspects for pharmaceutical companies:
| Topic | Proposed change | Change since first 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 20 million EUR (it is unclear whether already marketed products won't be affected). | Confirmed, no change. |
| Free pricing period | The free pricing period for innovative drugs which are assessed within the AMNOG process is reduced to six months. The negotiated § 130b SGB V rebate will be valid from the first date of the 7th month – this also applies for renegotiations. | Confirmed, no change. |
| Combination products | For newly launched, innovative pharmaceuticals a price reduction of 20% will be introduced for combination products. The German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) mentions the respective products in the resolution. The specific modalities still need to be determined. | Confirmed, no change. |
| Waste | More than 20% waste due to uneconomical package sizes will be reflected in the negotiated price in form of a rebate. | Confirmed, more precise threshold. |
| Price moratorium | The price moratorium will be prolonged until December 31, 2026. | Confirmed, no change. |
| Mandatory pharmacy discount | The mandatory pharmacy discount ("Apothekenabschlag") will be increased to 2 EUR for a period of two years. | Confirmed, no change. |
| Volume-related aspects | Volume-related aspects, such as volume-based staggers or maximum annual volumes, need to be part of § 130b SGB V price negotiation contracts. | Confirmed, no change. |
| No added benefit | No added benefit: annual therapy costs should be at least 10% below the most economical comparator ("Soll-Regelung"). | Newly added. |
| No added benefit without evidence | No added benefit due to limited evidence or incomplete dossier leads to lower annual therapy costs to a reasonable extent compared to the most economical comparator ("Muss-Regelung"). | Newly added. |
| Minor or non-quantifiable added benefit | Minor ("gering") or non-quantifiable ("nicht-quantifizierbar") added benefit: annual therapy costs should not be higher than the most economical comparator ("Soll-Regelung"). | Newly added. |
| Comparator | If the most economical appropriate comparative therapy / comparator ("zVT/zweckmäßige Vergleichstherapie") is generic, the cost-thresholds (see above) do not apply. | Newly added. |
| Registry requirements | In case registry requirements ("Anwendungsbegleitende Datenerhebung") are not fulfilled, the annual therapy costs must be below the originally negotiated price. | Newly added. |
| Patent-protected comparator or vAM | In case the comparator or a comparable therapy ("vAM/vergleichbare Arzneimittel") did not undergo the AMNOG process, but is still patent-protected, the annual therapy costs of the active substance must be reduced by 15%. | Newly added. |
| Period of notice | The standard period of notice for all reimbursement amount agreements will be 3 months. | Newly added. |
| Solidarity payment | A solidarity payment in the amount of 1 billion Euro per year will be paid by the pharmaceutical industry in 2023 and 2024 – split according to spending volume related to all patent-protected and orphan drug products of the statutory health insurances in the previous calendar year. | Newly added. |
| Mandatory manufacturer rebate | The mandatory manufacturer rebate ("Herstellerabschlag"), especially for patent protected pharmaceuticals in line with § 130a Abs. 1 S. 1 ("allgemeiner Herstellerabschlag"), will be limited and staggered and determined by the law for pharmaceutical rebates. | Deleted. |
| Value added tax | The value added tax for pharmaceuticals will be reduced to 7% from 2023 onwards (part of a separate law). | Deleted. |
As mentioned in our blog about the first reference draft for the law to stabilize the financial situation of statutory health insurances in Germany, we expect that the lobbying power of the pharmaceutical companies and their associations will soften the proposed law over the summer period. Nevertheless, we recommend to stay ahead of the changes and carefully assess the strategic impact of each measure on your portfolio with a scenario modelling approach.
Next to the general assessment of the attractiveness of the German market and the anticipation of market access scenarios for our client's products, several factors need to be analysed and discussed in order to improve the market access situation of currently marketed products and ensure a successful launch of pipeline products such as (not exhaustive):
- Niching and pricing strategies to ensure that one stays below the 20 Mio. Euro annual sales threshold
- Early discussion with regulatory affairs related to pack sizes and label definition
- Exploration of bundling options and evaluation of launch sequence
- Definition of a label that ensures that there is an active comparator (best case: higher priced generic) to bypass best-supportive-care or watchful-waiting as price anchor
- Choice 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, SKC supports the analysis of the impact the potential changes might have on our client's portfolio.
