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

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Dear AMNOG Monitor readers,

For our 100th issue of the monthly AMNOG Monitor, we present innovations to support your daily work in preparing and compiling benefit dossiers. For this purpose, we have also updated the step-by-step instructions.

  • Automatic data export to Excel: In the interactive evaluation, you can now export your created tables to Microsoft Excel at the push of a button in order to continue working there.
    • Excel links to the original resolutions: The cells "Active substance" and "Trade name" are each implemented as hyperlinks, so that you can access further data and the associated G-BA documents directly from Excel
    • Ease of use in Excel: The data export is programmed in such a way that dates, currencies, etc. are automatically converted into appropriate Excel formats so that they can be used for calculations immediatly.
  • Save/load "bookmarks" for interactive analyses: In the interactive analysis, you can now save the table configurations you have created, to forward them to colleagues or to reload them at a later time.
    • Updated automatically: When you reload a configuration, or "bookmark", your analysis updates itself with current data. In this way you can easily repeat analyses at later points in time, always with the newest data.
  • Restructuring of the monthly summary: Therapy area overviews are now grouped according to indication areas instead of just chronologically. In this way you can now quickly bring together all procedures e.g. for melanoma, for multiple myeloma or diabetes. Related indications are grouped (e.g. Dravet or West syndrome are assigned to epilepsy), so that comparable procedures are clearly grouped. In addition, the monthly summary provides numerous other evaluations such as reassessments ordered by reason (e.g. time limitation, §13 requests, §14 applications).
  • G-BA procedure ID: As an additional identifier, the procedure ID (case number) under which the respective procedure was managed at the G-BA is shown in all detailed analyses and in the interactive analysis.
  • EPAR and SmPC: In addition, all detailed analyses now also contain download links for the EMA assessment reports and the current SmPC, where applicable. These are available retroactively for all 610 G-BA resolutions as well as for all ongoing procedures.

We are already planning new improvements for the coming year. We look forward to your suggestions for the further development of the AMNOG Monitor.

In July 2021, a further 17 G-BA resolutions were published, the results of which are summarised in the following table. A total of 610 procedures have now been completed. In 2021, the G-BA will decide on a total of 135 early benefit assessments, 40% more than in 2020 or 2019, which itself had seen the hitherto highest numbers of resolutions

Blinatumomab (5) Blincyto® Acute lymphoblastic leukemia (ALL), refractory or relapse 100% Hint for non-quantifiable additional benefit
Pertuzumab / Trastuzumab (3) Phesgo® Mamma carinoma, HER2+, metastatic or local recurring (inoperable), combinatiion with Docetaxel 100% no additional benefit
Pertuzumab / Trastuzumab (2) Phesgo® Mamma carcinoma (MM), HER2+, locally advanced or inflammatory or early relapse risk, neoadjuvant therapy 100% no additional benefit
Pertuzumab / Trastuzumab Phesgo® Mamma carcinoma (MM) HER2+, early high relapse risk, adjuvant therapy 100% Hint for minor additional benefit
Levofloxacin / Dexamethason Ducressa® Infection and inflammation in context of cataract operations 100% no additional benefit
Dolutegravir (3) Tivicay® HIV-Infection, children ≥ 4 weeks < 6 years 100% no additional benefit
Niraparib (4, reassessment) Zejula® Ovarian carcinoma, tube or peritoneal carcinoma 100% no additional benefit
Fenfluramin Fintepla® Dravet syndrome, ≥ 2 years 100% Hint for considerable additional benefit
Inclisiran Leqvio® Primary hypercholesteremia, Dyslipidemia 100% no additional benefit
Upadacitinib (3) Rinvoq® Psoriasis arthritis (PA) 69% Hint for considerable additional benefit
Upadacitinib (2) Rinvoq® Ankylosing spondylitis (AS) 100% no additional benefit
Carfilzomib (4) Kyprolis® Multiple myeloma (MM), pretreated, combination with Daratumumab and Dexamethason 100% no additional benefit
Nivolumab (14) Opdivo® Squamous cell carcinoma of esophagus, pretreated patients 36% Hint for minor additional benefit
Afamelanotid (2, reassessment) Scenesse® Erythropoietic protoporphyria (EPP) 100% Hint for non-quantifiable additional benefit
Dupilumab (5) Dupixent® Atopic Dermatitis, 6 - 11 years 100% Hint for non-quantifiable additional benefit
Lenvatinib (5, reassessment, Kisplyx®) Kisplyx® Renal cell carcinoma (RCC) 100% no additional benefit
Lumasiran Oxlumo® Hyperoxaluria 100% Hint for non-quantifiable additional benefit

Changes in reimbursement prices of AMNOG products were observed in July 2021 following the price negotiations for: Apremilast (Otezla®), Ozanimod (Zeposia®) and Secukinumab (Cosentyx®).

The "Hauptstadtkongress" in Berlin took place from 15-17 June as a hybrid event. It was dominated by the topics pandemic and digitalisation. Prof Karl Max Einhäupl pleaded for using the opportunities of digitalisation to optimise workflows and treatment paths. New therapeutic approaches such as CAR T-cell therapies, CRISPR/Cas, checkpoint inhibitors, etc. will pose enormous challenges for doctors, patients, companies and the healthcare system, which require a constant exchange between the players.

The early benefit assessment of medicinal products is to be gradually transferred to the European level. With the planned EU HTA Regulation, initially oncology drugs, including for orphan diseases, and advanced therapies (ATMPs) are to be evaluated by the HTA coordination group. Three years later, the remaining orphan drugs are to be added, and another two years later all other medicinal products and medical devices. The trialogue compromise provides that the decisions on the additional benefit as well as the pricing will remain national tasks of the member states. In Germany these tasks are the responsibilities of the Gemeinsamer Bundesausschuss (G-BA) and the GKV-Spitzenverband (GKV-SV).

We look forward to further intensive exchange with you over the coming months, and we thank you for your trust.

Kind regards,
Dr Johannes Hankowitz, Christian Rieke