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Identify decision-paths and trends in early benefit assessment. The AMNOG monitor is indispensable for managers and decision-makers in market access, pricing and reimbursement.

Dear AMNOG Monitor readers,

After the Pharmaceutical Associations and the National Association of Health Insurance Funds (GKV-Spitzenverband) were unable to agree on the details of the implementation of the so-called combination discount almost two years after the entry into force of the GKV-FinStG, the Ministry of Health has now set the regulations by means of an implementation regulation. Combination discounts will be limited to medicinal products dispensed on medical prescription. The GKV-Spitzenverband had demanded that the use of medicinal products in hospitals or outpatient facilities should also be included, while the industry only wanted to see medicinal products covered that were dispensed in public pharmacies. The criteria for distinguishing between a free combination and a therapy change were also disputed. Now, only the accounting data of the health insurance funds will be used as the data basis for the discount. The AMNOG monitor offers a comprehensive search function for combination discounts according to Appendix XIIa AM-RL (Festsetzungsbescheid des BMG (PDF); Lesefassung Regelung Kombiabschlag §130e_SGB_V (PDF)).

A new Hospital Care Improvement Act (Krankenhausversorgungsverbesserungsgesetz ; KHVVG) is intended to improve the quality of treatment in hospitals and ensure comprehensive medical care for patients, including in rural areas. The Bundestag passed this on October 17. It is unclear whether the law can come into force as planned on 1 January 2025, however, or whether the Bundestag will request a mediation (www.bundesgesundheitsministerium.de/presse/pressemitteilungen/bundestag-beschliesst-krankenhausreform-pm-17-10-2024.html).

Preparations for the launch of the EU HTA are in full swing at the European level: the EU Commission published the new guidelines for the evaluation of clinical studies for the Joint Clinical Assessment (JCA) and the draft of the Implementation Act for scientific advice.

In September, there were 10 G-BA resolutions for early benefit assessment (see table below). 14 new procedures were started. For Efanesoctocog alfa (Altuvoct®) for the prophylaxis and therapy of hemophilia A, no additional benefit was granted for the first time for an orphan drug. The product was assigned directly to a reference price group by the G-BA. The manufacturer had not submitted a dossier. In the interactive analysis, the dimension “Price: availability” now reflects the status “option out - reintroduced”, which applies not only to Amivantamab but also to three old procedures.

New reimbursement prices of AMNOG products are available here.
EMA Positive Opinions for new drugs are shown here.

Kind regards,
Dr Johannes Hankowitz and Christian Rieke