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 May 2021

Baricitinib (2) Olumiant® Atopic dermatitis (AD) 100% no additional benefit

Dear readers of the AMNOG Monitor,

In May 2021, there were 16 G-BA resolutions. We have summarized the results in the following table. This year will see,  for the first time since the introduction of AMNOG, more than 100 resolutions on early benefit assessments. May saw price changes for the following AMNOG-assessed products: Apalutamid (Erleada®), Cabazitaxel (Jevtana®), Enzalutamid (Xtandi®), Melatonin (Slenyto®), Mexiletin (Namuscla®), Naldemedin (Rizmoic®), Opicapon (Ongentys®), Romosozumab (Evenity®), Simoctocog alfa (Nuwiq®), Solriamfetol (Sunosi®), and Tisagenlecleucel (Kymriah®). For Alpelisib (Piqray®) the pharmaceutical manufacturer chose to withdraw the product from the German market (option out). Vigabatrin (Kigabeq®) was discontinued, too.

On April 23, the new Infection Control Act (4. Bevölkerungsschutzgesetz) came into force. From an incidence of 100 new infections per 100,000 inhabitants in the past 7 days in one region, an "emergency brake" takes effect. This means that if the incidence on three consecutive days is higher than 100, additional measures specified in the law apply. If the incidence rises above 165, schools and daycare centers will close (no more face-to-face teaching), with the exception of emergency care. If the 7-day incidence falls below the values of 100 or 165 respectively for five consecutive working days, these measures will cease to apply.

In the AMNOG-Monitor, we have overhauled our monthly report and have structured it according to the 14 therapeutic areas in the same way as the G-BA. In addition, we have arranged the procedures within the therapeutic areas according to indications so that you get immediate overviews for indications such as rheumatoid arthritis, diabetes or hemophilia. These standard analyses are updated monthly.

In the past few weeks, we conducted numerous training sessions on the AMNOG monitor. We found that many of the newer options of the monitor are not yet knwon. We are pleased to be able to maintain such close contact with our customers despite the pandemic and we continue to offer free trainings via web conference. Please contact us to arrange an appointment.

Kind regards,
Dr Johannes Hankowitz

Avapritinib Ayvakyt® Gastrointestinal stromal tumor 100% Hint for non-quantifiable additional benefit
Burosumab (3) Crysvita® X-chromosomal Hypophosphatemia, ≥ 18 years 100% Hint for minor additional benefit
Bempedoinsäure / Ezetimib Nustendi® Hypercholesterolemia, Dyslipidemia 100% no additional benefit
Bempedoinsäure Nilemdo® Hypercholesterolemia, Dyslipidemia 100% no additional benefit
Semaglutid (2, reassessment) Ozempic® Diabetes mellitus Typ 2 100% no additional benefit
Cannabidiol (4, reassessment) Epidyolex® Lennox-Gastaut-Syndrome, ≥ 2 years, combination with Clobazam 100% Hint for considerable additional benefit
Cannabidiol (3, reassessment) Epidyolex® Dravet-Syndrome, ≥ 2 years, combination with Clobazam 100% Hint for considerable additional benefit
Filgotinib Jyseleca® Rheumatoid arthritis (muscle-skeleton-system) 33% Hint for minor additional benefit
Ibrutinib (7) Imbruvica® CLL, first line, combination with Rituximab 59% Hint for considerable additional benefit
Durvalumab (2) Imfinzi® NSCLC, first line, combination with Etoposid and either Carboplatin or Cisplatin 100% Hint for minor additional benefit
Sofosbuvir / Velpatasvir (2) Epclusa® Chronic hepatitis C, ≥ 6 and < 18 years 100% no additional benefit