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 December 2021

Dear readers of the AMNOG Monitor,

During the weeks since the federal election and in view of low vaccination rates, politicians have failed to prepare the population for the consequences of the 4th wave of the Corona pandemic. The traffic light coalition is now about to conclude coalition negotiations. The Health and Care working group (AG Gesundheit und Pflege) has already presented its draft statement on 18 Nov 2021. In addition to vague formulations such as further developing the AMNOG, reforming of the G-BA and ensuring the supply of innovative medicines and vaccines, the paper specifies:

  • An increase of the manufacturer's rebate for patent-protected medicinal products to 16% (up from 7%)
  • Continuation of the price moratorium
  • Reimbursement prices valid from the 7th month after market launch (previously 13th month).
  • Reduction of VAT for medicinal products from 19% to 7%

The European Council has adopted the Regulation on Health Technology Assessments (EU-HTA) on 9 November 2021. The legislative process, which had been initiated by the Commission in 2018, is nearing completion. Adoption by the European Parliament is expected in December 2021.

In November, 19 new early benefit assessment resolutions were adopted (cf. table). At the same time, the G-BA adopted a new framework guideline for minimum quality-assurance requirements for gene and cell therapies (ATMP). https://www.g-ba.de/presse/pressemitteilungen-meldungen/994/
 
The evaluation of Onasemnogen-​Abeparvovec (Zolgensma®) for the treatment of spinal muscular atrophy (SMA) was eagerly awaited. In this assessment, the €50 million threshold was reached before the initial benefit assessment was completed, so that the manufacturer was required to provide a full dossier with a comparison to an appropriate comparative therapy which the G-BA has specified as Spinraza®. The G-BA did see no additional benefit for Onasemnogen-​Abeparvovec in any of the patient groups. New data based on the first collection of routine practice data (AbD) are expected to be available in summer 2027. Professor Hecken, the chairman of the G-BA, expressly emphasized that this does not mean a restriction of application. The costs for a single patient exceeds 2 million euros.

Recent changes in reimbursement prices of AMNOG products in November 2021 can be seen here.
A list of current EMA Positive Opinions for new drugs is available here.

Kind regards,
Dr Johannes Hankowitz and Christian Rieke

Ivacaftor / Tezacaftor / Elexacaftor (5) Kaftrio® Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation). 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (4) Kaftrio® Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (3) Kaftrio® Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)). 100% no additional benefit
Ivacaftor (21) Kalydeco® Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation) 100% no additional benefit
Ivacaftor (20) Kalydeco® Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation) 100% no additional benefit
Bosutinib (4, reassessment) Bosulif® Chronic myeloid leukaemia (CML), Ph+, first-line 100% no additional benefit
Enzalutamid (5) Xtandi® Prostate carcinoma (PC), metastatic, hormone-sensitive, combination with androgen deprivation therapy 100% no additional benefit
Cenobamat Ontozry® Epilepsy, focal seizures, after at least 2 previous therapies 100% no additional benefit
Atezolizumab (9) Tecentriq® Non-small cell lung carcinoma (NSCLC), PD-L1 expression ≥50 % on TC or ≥10 % on IC, EGFR/ALK negative, first-line 100% no additional benefit
Ivacaftor (19) Kalydeco® Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and gating mutation (incl. R117H)) 100% no additional benefit
Isatuximab (2) Sarclisa® Multiple myeloma (MM), after at least 2 previous therapies, combination with pomalidomide and dexamethasone 100% Hint for minor additional benefit
Isatuximab Sarclisa® Multiple myeloma (MM), after at least 1 prior therapy, combination with carfilzomib and dexamethasone 100% no additional benefit
Lanadelumab (2, reassessment >€50m) Takhzyro® Hereditary angioedema (HAE), prophylaxis, ≥ 12 years 100% no additional benefit
Onasemnogen-​Abeparvovec Zolgensma® 5q-associated spinal muscular atrophy (SMA) 100% no additional benefit
Obinutuzumab (6, reassessment >€50m) Gazyvaro® Follicular lymphoma (FL), first-line 100% no additional benefit
Obinutuzumab (5, reassessment >€50m) Gazyvaro® Chronic lymphocytic leukemia (CLL) 100% no additional benefit
Obinutuzumab (4, reassessment >€50m) Gazyvaro® Follicular lymphoma (FL) 100% no additional benefit
Cannabidiol (5) Epidyolex® Seizures in Tuberous Sclerosis, ≥ 2 years 100% Hint for non-quantifiable additional benefit
Atidarsagen autotemcel OTL-200 Libmeldy® Metachromatic leukodystrophy with biallelic mutation in the ARSA gene 50% Hint for major additional benefit