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Resolutions April 2021

Dear readers of the AMNOG Monitor,

The G-BA has postponed six benefit assessments originally  planned for March until the beginning of April, so that there was only one benefit assessment: For the orphan drug Belantamab-Mafodotin the G-BA saw an indication for a non-quantifiable additional benefit in patients with multiple myleoma and at least four prior therapies, whose disease is refractory and progressive. In addition, there were two new arbitration decisions: Cannabidiol (Epidyolex®) and Betibeglogene autotemcel (Zynteglo®).

Changes in manufacturer's prices (APU) were reported for Brolucizumab (Beovu®), Daratumumab (Darzalex®), Insulin glargin / Lixisenatid (Suliqua®), Ribociclib (Kisqali®), Rurioctocog alfa pegol (Adynovi®), Tezacaftor / Ivacaftor (Symkevi®) as well as Upadacitinib (Rinvoq®). And Ombitasvir / Paritaprevir / Ritonavir (Viekirax®) has been discontinued by the last remaining supplier in Germany.

The pandemic situation of the covid-19 virus in Germany changed significantly and worsened in March: After months of lockdown and falling infections, the incidence is now rising steadily. One must now speak of a "3rd wave". With decisions of 3 March, the government changed its strategy: Despite rising infection figures, openings are set in five steps for individual areas, which are automatically withdrawn again if certain incidences (100/100,000 in 7 days) are exceeded ("emergency brake"). The latter was already the case in more than 100 districts in mid-March - however, many districts do not adhere to these stipulations. In addition, test concepts are to be developed to prevent a further increase in infections. At the same time, vaccination is to be promoted, which continues to make slow progress in Germany. A third lockdown in Germany is expected to be announced on 22 March.

On 11 March, the EMA approved Johnson & Johnson's adenovirus vaccine. The Russian adenovirus vaccine Sputnik V has been in rolling review since the beginning of March. However, there have been no orders for this vaccine from the EU Commission or Germany so far.
On 15 March, the Paul Ehrlich Institute (PEI) announced that vaccination with the AstraZeneca vaccine would be suspended for the time being due to very rare side effects (cerebral venous thrombosis). Previously, on 4 March, the STIKO had changed its recommendation of 29 January 2021, which deviated from the EMA approval, and now recommended vaccinating patients over 65 years of age with the AstraZeneca preparation, due to experiences in England and Scotland. For the 2nd vaccination, the interval between the two vaccinations should be 12 weeks if possible. This period is also covered by the marketing authorisation. On 18 March, the EMA confirmed a benefit of the AstraZeneca vaccine with no increase in thromboembolic events. However, the vaccine may be associated with very rare cases of clots in
cerebral veins (Cerebral Venous Sinus Thrombosis; CVST).

We have used the past month to change our monthly analysis (PDF) as well as the accompanying Powerpoint presentatio (PPTX) to include the G-BA classification of the procedures in 14 therapeutic areas. In addition, we do continue to report the results for orphan drugs.

Stay healthy!
Dr Johannes Hankowitz

Belantamab-Mafodotin Blenrep® Multiples Myeloma, at least 4 prior reatments, monotherapy 100% Hint for non-quantifiable additional benefit