Early benefit assessment: Detailed analysis of all G-BA resolutions

The AMNOG monitor provides current, well-founded analyses of all early benefit assessments and an overview of the negotiated reimbursement prices in Germany. It is an indispensable tool for HTA, market access and pricing managers.
 

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Resolutions October 2024

Dear AMNOG Monitor readers,

On 27 September, the Bundesrat (Federal Council) adopted the Medical Research Act in Germany, which will, among other things, allow for confidential reimbursement prices. Time will tell whether this will achieve the goal of reducing drug prices. www.bundesgesundheitsministerium.de

In the first six months of 2024, the 95 statutory health insurance funds (SHI) recorded a deficit of € 2.2 billion. Expenditure of € 161.3 billion was offset by income of € 159.1 billion. Hospital treatment expenditure rose by 7.9% (+€3.6 billion), outpatient medical treatment by 5.3% (+€1.3 billion) and spending for pharmaceuticals by 10.0% (+€2.5 billion) and. The sharp increase in pharmaceutical expenditure is partly due to the expiry of a temporary measure of the GKVFinStG that had raised the mandatory rebate from 7% to 12% in 2023 and back to 7% at the beginning of 2024. www.bundesgesundheitsministerium.de

In September 2024, there were 4 G-BA resolutions on early benefit assessments (see table below). 13 new procedures were started.

With two landmark rulings (Soolantra® and Trimbow®) on data exclusivity (Unterlagenschutz) and the definition of “novelty”, the Federal Social Court (BSG) has invalidated two early benefit assessment procedures. The BSG found that the G-BA had exceeded its scope and that these two drugs are not subject to mandatory early benefit assessment (AMNOG), and thus upheld the pharmaceutical companies' complaints. You can find detailed information on this in the AMNOG Monitor under Arbitration results > Bundessozialgericht decisions.

The active substance Tirzepatid (Mounjaro®) in the indication weight reduction as well as Rilectinib (Litfulo®) in the indication alopecia areata will be classified as lifestyle drugs by the G-BA and will be included in Annex II of the AM-RL.

As of this month, the AMNOG Monitor is completely bilingual.
We look forward to continuing to work with you!

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