Early benefit assessment: Detailed analysis of all G-BA resolutions

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Resolutions January 2021

Dear readers of the AMNOG Monitor,

In December, the approval studies for SARS Cov-2 vaccines from AstraZeneca were published in Lancet and from BioNTech/Pfizer in New Engl J Med. Both studies show high efficacy: with the BioNTech/Pfizer vaccine, there were covid-19 infections in the vaccine group in 0.36% of the study participants (8/2214), and in 7.29% in the placebo group (162/2222). This corresponds to a relative risk reduction of 95%. The corresponding figures for AstraZeneca's adenovirus vaccine are 0.22% (3/1367) and 2.18% (30/1374), with a relative risk reduction of 94%. The EMA is expected to decide on  21 December 2020 on a positive opinion for BioNTech/Pfizer's mRNA vaccine. The EU Commission can then issue a marketing authorisation within 1-2 days, so that Corona vaccination might start before Christmas. Two vaccinations are required at intervals of 21 days. Germany has developed a national pandemic vaccination plan for this purpose. In the meantime, the US FDA also authorised the Moderna mRNA-1273 vaccine for emergency use.

• Polak et al. (2020): Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine; N Engl J Med; DOI: 10.1056/NEJMoa2034577; https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
• Voysey et al. (2020): Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK; Lancet; DOI: 10.1016/S0140-6736(20)32661-1; https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
• FDA Briefing Document - Pfizer-BioNTech COVID-19 Vaccine; https://www.fda.gov/media/144245/download
• FDA Briefing Document – Moderna COVID-19 Vaccine; https://www.fda.gov/media/144434/download
• Federal Ministry of Health: National Vaccination Strategy COVID-19; https://www.bundesgesundheitsministerium.de/fileadmin/Dateien/3_Downloads/C/Coronavirus/Impfstoff/Nationale_Impfstrategie.pdf

In December 2020, there were eight new G-BA decisions, the results of which are listed in the table below.

On 03. Dec 2020 the G-BA decided to suspend the orphan drug assessment of Onasemnogen-Abeparvovec (Zolgensma®) because the sales threshold of €50 million was already exceeded. In accordance with the legal requirements the manufacturer now has to submit a full dossier to prove an additional benefit. Until then, the product can be prescribed in compliance with the quality-assurance standards that the G-BA has established. Because the result of the new AMNOG procedure will not be known until probably November 2021, the new reimbursement price will come into force retroactively, applicable from 01.07.2021 onwards, as Prof. Hecken explained in a statement.

A change in effective reimbursement prices on the "APU minus §130a" level was seen for Atezolizumab (Tecentriq®), Cemiplimab (Libtayo®), Gilteritinib (Xospata®), Larotrectinib (Vitrakvi®) and Neratinib (Nerlynx®) – in each case following G-BA decisions – as well as for Cladribin (Mavenclad®).

On 16 December 2020, the G-BA adopted procedural rules regarding the implementation of routine data collection (Anwendungsbegleitende Datenerhebung; AbD) taht take BMG comments into account.