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

Dear AMNOG monitor readers,

On 20 March 2020, the G-BA amended its rules of procedure to allow written votes in the event of special circumstances and decided that such special circumstances are in effect. Detailed, up-to-date information can be found on the G-BA website. Due to the current pandemic phase of Covid-19 disease, the GKV-Spitzenverband announced that reimbursement amount negotiations pursuant to §130b SGB V will be conducted via telephone conference up to and including 17 April 2020. In Germany, the Robert Koch Institute provides daily updates on recommendations and on current cases in Germany and worldwide. The AMNOG Monitor will of course remain up-to-date and available without restriction for our customers - also for work from the home office. We are happy to take over individual analyses for you remotely.

In March 2020 there was only one new G-BA resolution: No additional benefit was proven for the active ingredient Ropeginterferon alfa-2b, which is authorised for the treatment of adult patients with polycythaemia vera without symptomatic splenomegaly.

Changes of manufacturer’s prices (APU) were seen for Bictegravir / Emtricitabin / Tenofoviralafenamid (Biktarvy®), Brentuximab Vedotin (Adcetris®), Elvitegravir / Cobicistat / Emtricitabin / Tenofoviralafenamid (Genvoya®), Elvitegravir / Cobicistat / Emtricitabin / Tenofovirdisoproxil (Stribild®), Emtricitabin / Rilpivirin / Tenofoviralafenamid (Odefsey®), Emtricitabin / Rilpivirin / Tenofovirdisoproxil (Eviplera®), Guselkumab  (Tremfya®), Emicizumab (Hemlibra®), Lanadelumab (Takhzyro®), Mepolizumab (Nucala®), Mexiletin (Namuscla®) and Rucaparib (Rubraca®). In addition, Cenegermin (Oxervate®) was withdrawn from the German market.

Due to legal requirements (Regulation on Fundamental Requirements and Interfaces – Grundlegende Anforderungen- und Schnittstellen-Verordnung (GASV)), various changes to early benefit assessment are planned in 2020:

• New templates for the preparation of benefit dossiers (binding as of 1 April 2020)
• Machine readable Doctors’ Information System (Arztinformationssystem – AIS) available as of 1 July 2020
• Involvement of specialist companies and the Drug Commission of the German Medical Association (DCGMA) in determining the appropriate comparative treatment (change to Rules of Procedure of the Federal Joint Committee – Verfahrensordnung des Gemeinsamen Bundesausschusses (G-BA VerfO))
• Change to G-BA VerfO concerning the collection of routine practice data, see also applicable section of the AMNOG monitor.
• New guideline regarding ATMP: cross-sector quality requirements
• Information regarding the exchangeability of biosimilars at the level of the doctor (August 2020) and pharmacist (August 2020)
• The completion of 100 early benefit assessment processes is expected in 2020.

The German Federal Constitutional Court (Bundesverfassungsgericht – BVerfG) judgement on Section 217 German Criminal Code (Strafgesetzbuch) (ban on facilitating suicide as recurring pursuit) of 26 February 2020 was awaited with anticipation. The Federal Constitutional Court determined, with surprising clarity, that Section 217 German Criminal Code violates personal freedoms (Article 2 (1)) enshrined in the Basic Law for the Federal Republic of Germany (Grundgesetz). That general right to personal freedoms guarantees an individual’s right to make their own decision to consciously and intentionally end their own life. It thereby extends beyond what is known as assisted suicide for the terminally ill, and applies to all people (facilitating suicide). The Federal Constitutional Court explained that the restriction of protections to certain causes and motives, and therefore the evaluation of the motivations of those who have decided to commit suicide, is not compatible with the concept of freedom in the Basic Law for the Federal Republic of Germany. It requires no further reasons or justification, and must be respected by the state and society. That does not affect the fact that, for example, doctors are not obliged to assist in suicides.

Stay safe! Yours faithfully
Dr Johannes Hankowitz