From “a breach of trust” to “fear of market withdrawals”

The cabinet draft of the GKV-FinStG has been published

Fri, 2022 / 07 / 29
After the highly disputed 1st and 2nd draft of the law to stabilize the financial situation of the statutory health insurances in Germany ("GKV-Finanzstabilisierungsgesetz") had been published, it was expected that the lobbying power of the pharmaceutical companies and their associations will soften the proposed law over the summer period. Now, the respective ministries published the final cabinet draft of the GKV-FinStG – with a tremendous negative echo from all major players in the German health care system.

"The KBV board considers the draft of the GKV-FinStG passed by the Cabinet as a breach of trust on the part of politics." Kassenärztliche Bundesvereinigung (KBV)

"Federal government turns the tap on innovation", "BAH fears market withdrawals", "As the only sector of the economy, we have no possibility to pass on cost increases. [...] The passed draft of the GKV-FinStG threatens a secure supply of medicines, especially in times of crisis."Pharma associations

"Associations demand: Parliament must now pull the emergency plug on the GKV-FinStG." Payer associations

"Today's cabinet decision on the GKV-FinStG is still only aimed at short-term relief effects." GKV-Spitzenverband (GKV-SV)

In summary, Federal Health Minister Lauterbach apparently prevailed against Federal Minister of Finance Lindner, the cabinet draft looks almost exactly like the recently presented reference draft.

 

Topic Proposed change Change since second 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 (drugs currently at 20-50 million EUR require a new dossier submission, albeit the G-BA grants an undefined transition period, for example for consultations and dossier preparation). Confirmed, further specified.
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.
All previous agreements (and arbitrations) shall initially remain unaffected as long as a new reimbursement amount is not agreed to.		 Confirmed, further specified.
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. Confirmed, further specified.
Waste More than 20% waste due to uneconomical package sizes will be reflected in the negotiated price in form of a rebate. Confirmed, no change.
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, and budget impact need to be part of § 130b SGB V price negotiation contracts. Confirmed, 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"). Confirmed, further specified.
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"). Confirmed, further specified.
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"). Confirmed, further specified.
Comparator If the most economical appropriate comparative therapy / comparator ("zVT/zweckmäßige Vergleichstherapie") is generic, the cost-thresholds (see above) do not apply. Deleted.
Registry requirements In case registry requirements ("Anwendungsbegleitende Datenerhebung") are not fulfilled, the annual therapy costs must be below the originally negotiated price. Confirmed, no change.
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%. Confirmed, no change.
Period of notice The standard period of notice for all reimbursement amount agreements will be 3 months. Confirmed, 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. Newly added, replaced solidarity payment.
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 of the statutory health insurances in the previous calendar year related to all patent-protected and orphan drug products. Deleted.
 
The GKV-FinStG aims to substantially cut the costs for the system with as stated substantial criticism coming from all sides. However, the FDP made already clear that they want to change the law in the upcoming parliamentary procedure. The cabinet draft usually passes through three consultations in the "Bundestag" - the so-called "readings", which include public plenary sessions, intensive discussions in expert committees and a final vote on the (potentially adapted) future law.
 
As mentioned above, it is likely that the cabinet's draft will be adapted during the upcoming parliamentary procedure. Nevertheless, we as SKC recommend staying ahead of the changes and carefully assess the strategic impact of each measure on your individual situation. As usual, all political streams and potential changes are continuously monitored and directly implemented in our daily consulting business.
 
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About the author

Ihr Ansprechpartner Dr. rer. nat. Ingo Hantke
Dr. rer. nat. Ingo Hantke
Director Market Access
M.Sc. Life Science
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
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