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- AMNOG-Monitor Analysis · Pricing · Prediction (325 KB)
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.
Dear readers of the AMNOG Monitor,
The German parliamentary elections seem to signal a new era: The federal government will probably consist of a three-party alliance with the Greens and the Liberals. The SPD now has the best chance of leading the government in a so-called "traffic light coalition", having replaced the CDU as the strongest party. The Ministry of Health, which has been led by the CDU, will be reassigned. However, it is too early to speculate on the impact on healthcare and early benefit assessments.
The G-BA is increasingly using the instrument of collection of routine practice data (Anwendungsbegleitende Datenerhebung; AbDE) and commissioning IQWiG to prepare the respective concepts. Corresponding procedures were initiated in October 2021 for Tecartus® in mantle cell carcinoma (MCL), as well as for Risdiplam (Evrysdi®) in spinal muscular atrophia (SMA) and for Fedratinib (Inrebic®) in myelofibrosis (MF). For Inclisiran (Leqvio®) there is a partial exclusion from prescription according to Annex III AM-RL, except for patients with primary hypercholesterolaemia or dyslipidemia who require LDL apheresis.
Adjustments to reimbursement prices of AMNOG products were seen in October for Emicizumab (Hemlibra®), Glycopyrroniumbromid (Sialanar®), Lonoctocog alfa (Afstyla®), Nintedanib (Ofev®) and Melatonin Slenyto®. Baloxavir marboxil (Xofluza®) was withdrawn from the German market.
We thank you for your trust and we promise to continue to expand the AMNOG Monitor in 2022. Please feel free to contact us for an appointment if you require AMNOG-Monitor training.
Changes to reimbursement prices of AMNOG products were seen in September 2021 for Abemaciclib (Verzenios®), Andexanet alfa (Ondexxya®), Damoctocog alfa pegol (Jivi®), Dulaglutid (Trulicity®), Elosulfase alfa (Vimizim®), Ixekizumab (Taltz®), Luspatercept (Reblozyl®), Riociguat (Adempas®), Ropeginterferon alfa-2b (Besremi®) and for Talazoparib (Talzenna®).
Dr Johannes Hankowitz and Christian Rieke
Resolutions October 2021
|Cabotegravir||Vocabria®||HIV-1 infection, pre-treated, combination with rilpivirin||100% no additional benefit|
|Erenumab (2, reassessment)||Aimovig®||Migraine prophylaxis||100% Hint for considerable additional benefit|
|Risdiplam||Evrysdi®||5q-associated spinal muscular atrophy (SMA)||42% Hint for non-quantifiable additional benefit|
|Cabozanitinib (6, Cabometyx®)||Cabometyx®||Renal cell carcinoma (RCC), first-line, combination with nivolumab||100% no additional benefit|
|Nivolumab (16)||Opdivo®||Renal cell carcinoma (RCC), first-line, combination with cabozantinib||100% no additional benefit|
|Rilpivirin (3, Rekambys®)||Rekambys®||HIV-1 infection, pre-treated, combination with cabotegravir||100% no additional benefit|
|Pemigatinib||Pemazyre®||Cholangiocarcinoma with FGFR2 fusion or FGFR2 rearrangement, at least 1 prior therapy||100% Hint for non-quantifiable additional benefit|