Evaluation of the GKV-FinStG insubstantial at this time?

The BMG now requested a statement from various societies and associations on the effects of the GKV-FinStG. In particular, the lowering of the turnover threshold for orphan drugs, the combination discount, the increase in the manufacturer's discount, the price-quantity regulation, the guard rails for the reimbursement amount negotiation as well as the retroactive validity of the reimbursement amount were to be assessed here.

The German Pharmaceutical Industry Association (BPI), the German Association of Research-Based Pharmaceutical Companies (vfa) and the Alliance of Chronic Rare Diseases (ACHSE), among others, are critical of the short evaluation period of about 6 months. Since the GKV-FinStG came into force, not a single newly introduced drug has gone through the AMNOG procedure completely. Thus, only very limited data are available for a well-founded impact assessment of the measures and there is a risk of underestimating the scope of the legislative interventions.

Nevertheless, it is already becoming apparent that drug launches in Germany or the EU will be delayed or not be sought at all. A vfa member survey showed, for example, that 30 medicines are at risk of not being supplied in Germany in the next two years, 13 medicines will be significantly delayed or not available at all in Germany and that five EU approvals will be delayed or not even sought due to the legal changes brought about by the GKV-FinStG. Public case studies include the market withdrawals of Spesolimab and Amivantamab as well as the non-introduction of the combination of Nivolumab and Relatlimab or the capsid inhibitor Lenacapavir.

The BPI and vfa explicitly criticise the far-reaching interventions by the GKV-FinStG in the previously established assessment and pricing system of the AMNOG and the departure from the basic principle of appropriate remuneration of additional therapeutic benefits. The law is characterised by unilateralism, breach of contract by interfering with negotiated agreements and ongoing procedures, arbitrariness and unnecessary bureaucracy that benefits neither the system nor patients. The introduction of the guard rails, for example, leads to a continuous "basement effect" and a negative price spiral. Also, the cumulative effect of the price reduction instruments from rigid guard rails, price-quantity discounts, combination discounts or the increase of the manufacturer's discount is not considered at any point in the law. Especially for manufacturers of orphan drugs, the system sets false incentives, criticises ACHSE, and it is feared that this will have a detrimental effect on the care of patients with rare diseases.

The associations call for the statutory evaluation mandate to be extended in order to be able to meaningfully evaluate the already clearly undesirable trends and predicted negative effects. It is unclear whether the statutory evaluation mandate on the effects of the GKV-FinStG will lead to an adjustment of the legislation due to the criticism of the associations. We at SKC continue to monitor the developments surrounding the GKV-FinStG closely and will keep you informed of all new developments. Please feel free to contact us if you have any questions about the strategic implications of the GKV-FinStG. We are the market access special forces.

Sources:

• BPI-Stellungnahme zur Evaluierung des GKV-Finanzstabilisierungsgesetzes
• Vfa. Stellungnahme: Evaluation der Auswirkungen des GKV-FinStG auf die Versorgung und den Wirtschaftsstandort
• Stellungnahme ACHSE zur Evaluation des FinStG