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 April 2026

Dear readers of the AMNOG Monitor,

Following our report last month on the 66 recommendations made by the Health Finance Committee to stabilise the statutory health insurance (GKV) system, the government's draft version on the austerity package – the so-called Statutory Health Insurance Contribution Stabilisation Act (GKV-BSG) – is now available.

The measures presented are based on two key principles: a) increases in expenditure will be limited to the growth in real revenue; b) only those services with a demonstrable medical benefit will be reimbursed. The proposed measures are expected to generate savings of just under €20 billion per year. Patients, hospitals, health insurance funds and the pharmaceutical industry must expect significant losses in order to achieve this savings potential. The planned changes are set out in detail in the 157-page draft bill (see link). The pharmaceutical industry is expected to make a substantial contribution to this:

Measure change in Mio. € per year
2027 2028 2029 2030
Dynamic manufacturer rebate
7% + annual adjustment for 2027 + 3.5%
-1,230 -2,110 -3,885 -6,115
Price-volume agreement
according to Dapagliflozin arbitration court
- -67 -167 -500
Selective contracts for 5 medical groups* - -200 -400 -600
Orphan Drug Privilege
(30 Mio. € turnover limit unchanged)
- - - -
Price moratorium from 2010 prolonged until 2030 - - - -
Abolition of combination rebate (-20%) +60 +160 +185 +200
Abolition of rebate guard rails +167 +333 +500 +667

*Estimated savings or additional costs resulting from planned changes in accordance with the draft bill; selective contracts until 2030 for five AM groups: CGRP antagonists, as well as JAK-, PARP-, PCSK9- and PD-L1/PD-1 inhibitors

RefE_BStabG_2026.pdf

In April, there were 7 new decisions on early benefit assessment (Fig. A), and 8 new procedures were initiated (Fig. B). Price changes are shown in Fig. C, and the current EU HTA procedures are listed via the link below.

Two new procedures have been opened: taletrectinib for the treatment of ROS1-positive patients with advanced NSCLC, and zamtocabtagene autoleucel for large B-cell lymphoma (LBCL), bringing the total number of ongoing EU HTA procedures to 15.

AMNOG Monitor

We will be updating the layout of the AMNOG Monitor to make it more modern and user-friendly, and will be introducing a range of new features, which we would be delighted to demonstrate to you in a free training session.

Please arrange a training session – feel free to suggest a specific date and time.

We look forward to seeing you.
With best regards

Dr. Johannes Hankowitz
Munich, 20th April 2026