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AMNOG monitor
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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