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

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Dear AMNOG Monitor readers,

With a total of 21 decisions on the early benefit assessment, including 8 additional benefit resolutions, the G-BA again had an extensive program to complete in June: Several controversial decisions regarding quality assurance measures (ATMP-QS-RL) were noticeable: quality assurance measures were rejected for Voretigen Neparvovec, but approved for valoctocogene roxaparvovec and etranacogene dezaparvovec as gene therapies for haemophilia A and B, respectively, as well as for tabelecleucel for the treatment of Epstein-Barr virus-positive post-transplantation lymphoma (EBV+ PTLD) (all three without benefit assessment procedures according to §35a). The plenary also rejected the application for the collection of routine practice data (AbD) for the active substance Tafasitamab for the treatment of r/r diffuse large B-cell lymphoma (DLBCL).

In addition, existing time limits were lifted for Dabrafenib (4) and Trametinib (3) for the adjuvant treatment of adults after complete resection of BRAF V600-mutated stage III melanoma and for Pembrolizumab (8) for the adjuvant treatment of adults with stage III melanoma with lymph node involvement after complete resection. The time limits for Olaparib (5) in ovarian cancer and belantamab mafodotin for the advanced treatment of multiple myeloma were extended until the new trial data are available.

Two procedures were suspended until the ECJ conclusively clarifies questions regarding the protection of documents: Diroximelfumarat and Dimethylfumarat (13-17 years), both for multiple sclerosis.

In addition, 8 G-BA decisions on the early benefit assessment were made, which are shown in the following table. With Ripretinib, an orphan drug in oncology for the treatment of adults with advanced gastrointestinal stromal tumours (GIST) received an indication for major additional benefit. In the procedure on Zanubrutinib for the treatment of patients with Waldenström's disease, the G-BA decided that the submitted dossier was incomplete, so that no additional benefit could be given.

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