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.

Unrivalled AMNOG Process Knowledge

Gain relevant insights from our summary analysis and our evaluation of all AMNOG resolutions. more >>

Every Resolution Reviewed in Detail

The AMNOG monitor includes detailed analyses of every sinlge benefit assessment since 2011. more >>

Reimbursement Price Trends

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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. 

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Dear AMNOG Monitor readers,

At the start of 2022, Germany’s new Health Minister Karl Lauterbach (SPD) has appointed several officials: Claudia Moll (SPD) is the new Commissioner for Nursing Care (“Pflege­bevollmächtigte”), Stefan Schwartze (SPD) is the Commissioner for Patients' Affairs (“Patienten­beauftragter”), and the new Commissioner for Drugs and Addiction (“Beauftragter für Sucht- und Drogenfragen”) is Burkhard Blinert (SPD).

On 16 December 2021, the G-BA commissioned the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen to conduct a systematic search for indication registries in order to facilitate the G-BA's decision-making process as to whether it useful to order the collection of routine practice data (Anwendungsbegleitende Datenerhebung; AbD) in certain indications for active substances with limited data.

In January 2022, three reserve antibiotics were exempted from the regular benefit assessment. According to the new regulation (§35a sec. 1c, sentence 5-6 SGB V) an additional benefit is automatically considered proven if the criteria of the Robert Koch Institute (RKI) for a reserve antibiotic are met.

According to calculations of the Arzneimittelverordnungsreport 2021, expenditures on medicines increased by +5.1% to €45.6 billion in 2020 and thus remains unchanged at 17.2% of expenditures of the statutory health insurance. The GKV-Spitzenverband calculated savings of € 3.7 billion from reimbursement price negotiations for AMNOG substances.

In 2021, the G-BA set a new maximum of 146 G-BA resolutions on early benefit assessment per year, after a total of 92 resolutions in 2020. In January 2022, there were another 10 new G-BA resolutions (see table below).

in 2022, the AMNOG Monitor will again bring several new features and additions. Available as of now, for example, are cumulative patient numbers for every AMNOG substance, which you will find under point 6 of the respective individual analysis, as well as a new chapter on reserve antibiotics. We will be happy to train you and your team on the analysis options of the Monitor. Please contact us.

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

Resolutions January 2022

Start Resolution Procedure (no.) Brand name Indication Additional benefit (best subgroup)
Ceftolozan / Tazobactam (5) Zerbaxa® Complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) Exempted from benefit assessment (reserve antbiotic)
Teriflunomid (2) Aubagio Relapsing-remitting multiple sclerosis (MS), 10 to 17 years 100% no additional benefit
Blinatumomab (6) Blincyto® B-cell acute lymphoblastic leukaemia (ALL), high-risk first relapse, Ph-, CD19+, 1 to ≤ 18 years 100% Indication of major additional benefit
Nivolumab (18) Opdivo® Colorectal carcinoma (CRC) with mismatch repair deficiency or high microsatellite instability, pre-treated patients, combination with ipilimumab 100% no additional benefit
Cemiplimab (3) Libtayo® Basal cell carcinoma (BCC), locally advanced or metastasised 97% Hint for minor additional benefit
Cemiplimab (2) Libtayo® Non-small cell lung carcinoma (NSCLC), first-line 100% no additional benefit
Daratumumab (6) Darzalex® Systemic light chain amyloidosis, first-line, combination with cyclophosphamide, bortezomib and dexamethasone 50% Hint for minor additional benefit
Ceftazidim / Avibactam Zavicefta® Complicated intra-abdominal infections, complicated urinary tract infections, nosocomial pneumonias, infections caused by aerobic gram-negative pathogens Exempted from benefit assessment (reserve antbiotic)
Imipenem / Cilastatin / Relebactam Recarbrio® Pneumonia, Bacteriemia Exempted from benefit assessment (reserve antbiotic)
Satralizumab Enspryng® Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years 100% Hint for minor additional benefit
Empagliflozin (3) Jardiance® Chronic heart failure (CHF) 100% Hint for minor additional benefit
Tralokinumab Adtralza® Atopic dermatitis (AD) 100% no additional benefit
Angiotensin-II-Acetat Giapreza® Hypotension 100% no additional benefit