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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Dear AMNOG monitor readers,

Despite major successes in containing the coronavirus pandemic in Europe, the economic consequences are as yet difficult to assess. It is questionable whether the billions in debt-based aid programmes will lead to sustainable growth. Germany took over the presidency of the Council of the EU in July 2020. Due to the coronavirus pandemic, however, the original agenda has completely changed. The controversial harmonisation of European health technology assessments (EU-HTA) that was meant to be advanced under German leadership has been postponed, and vaccine development will now have top priority.

A new information system for physicians (Arztinformationssystem, AIS) has also been available since July 2020, currently still limited to ten recent resolutions. Further resolutions will be added over the next six months, the relevant parts of which we will be implementing in the AMNOG Monitor for you. Highly anticipated are the G-BA’s new procedural rules for the collection of routine practice data (ABDE). Prof Josef Hecken has announced they will be used for the medicinal product Onasemnogen-Abeparvovec (Zolgensma®), which is currently undergoing an early benefit assessment. The G-BA resolution is expected in December.

July also saw the first two arbitration decisions of the new arbitration board under the direction of Prof. Huster regarding Regadenoson (Rapiscan®) and Turoctocog alfa pegol (Esperoct®).

The Digital Supply Act (Digitale-Versorgungs-Gesetz; DVG) is intended to promote the creation and updating of medical guidelines through active support from the G-BA’s Innovation Fund. The German Federal Ministry of Health can also commission the Institute for Quality and Efficiency in Health Care (IQWiG) to conduct evidence research on specific questions in guidelines.

In addition, there were also three new G-BA resolutions:

  • A hint for minor additional benefit was demonstrated for the a new indication of Trastuzumab Emtansin (2) as an adjuvant treatment of women with early stage HER2+ breast cancer..
  • The new active ingredient Upadacitinib was shown to have additional benefits in adults with moderately severe to severe active rheumatoid arthritis in two subpopulations. There is a hint for considerable additional benefit in patients for whom initial therapy with bDMARDs or tsDMARDs is advisable, and a hint for a minor additional benefit in a combination therapy with Methotrexat in patients with a high disease activity who did not respond adequately to or did not tolerate previous treatment with one or more bDMARDs and/or tsDMARDs. In other subpopulations no additional benefit was proven.
  • The reassessment of Dulaglutid (2, reassessment) demonstrated an indication for minor additional benefit only for the combination therapy in adults for whom diet, exercise and treatment with a short-acting insulin (with or without another blood glucose-lowering medicinal product) do not adequately control blood glucose.

Changes in the effective manufacturer's price (APU minus mandatory §130a rebates) were seen in July for Evolocumab (Repatha®), Glycopyrroniumbromid (Sialanar®), Inotuzumab Ozogamicin (Besponsa®), Lorlatinib (Lorviqua®), Nusinersen (Spinraza®), Pegvaliase (Palynziq®), Ravulizumab (Ultomiris®) as well as Vigabatrin (Kigabeq®). Due to a temporary VAT reduction in Germany in the second half of 2020, the pharmacy sales prices (AVP) of all medicinal products subject to the Pharmaceutical Price Ordinance (AMPreisV) have been adjusted with effect from 1 July 2020, which in turn has an effect on the nominal annual therapy costs after deduction of legally prescribed discounts.

As you can see, a summer break or lockdown effect is nowhere to be found, and all parties are attempting to continue and even accelerate normal business operations under these new conditions.

On that note, stay healthy.
Dr Johannes Hankowitz