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

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Dear readers of the AMNOG Monitor,

Despite, or perhaps because of, the pandemic, there is an enormous innovation push in the development of new medicines: In the first half of the year, 72 G-BA resolutions on early benefit assessment are planned; more than ever before. In February 2021 alone, there were 17 new G-BA resolutions, the results of which are listed in the table below.

We once again expanded the AMNOG Monitor, too. Additional options are now available in the Interactive Analysis including the result of the IQWiG benefit assessments "IQWiG additional benefit (best subgroup)". By request, premium customers of the AMNOG Monitor can now access the negotiated annual therapy costs, the associated relative rebates and the markups on the appropriate comparator therapy resulting from these negotiations in the Interactive Analysis. In the detail views of all 553 G-BA, premium customers will find the negotiation results, where available, clearly presented in sections "7. price trend (PZN)" and "8. annual therapy costs (G-BA)".

Changes in ex-factory prices / reimbursement prices were seen in February 2021 for Andexanet alfa (Ondexxya®), Belimumab (Benlysta®), Doravirin (Pifeltro®), Dupilumab (Dupixent®), Fidaxomicin (Dificlir®), Fremanezumab (Ajovy®) as well as Trastuzumab Emtansin (Kadcyla®).

The G-BA decided on a mandatory ABDE (anwendungsbegleitende Datenerhebung)  for the active substance Zolgensma for the first time: It is planned that, with the help of indication registers (SMrtCARE register), as many as possible 500 children with pre-symptomatic SMA and with SMA type 1 and 2 who are older than 6 months and 6 weeks, respectively, are to be included in the data collection and the manufacturer is to submit a study protocol in accordance with the PICO scheme vis-à-vis nusinersen by August 2021. At the same time, the reimbursability of Zolgensma will be limited to those physicians/clinics participating in the ABDE.
https://www.g-ba.de/beschluesse/4702/ and https://www.g-ba.de/beschluesse/4703/

The SARS Cov-2 virus pandemic continues to keep the world on tenterhooks. The pharmaceutical industry has impressively demonstrated its capabilities: One year after the outbreak of the pandemic, there are already 3 different vaccine approved in Europe, with more expected soon. Unfortunately, this positive news was partly marred by false expectations and communication errors. In Germany, € 188.3 million vaccine doses are expected to be available in the I quarter, € 77.1 million in the II quarter, € 126.6 million in the III quarter and € 100 million in the IV quarter, so that an offer can be made to everyone willing to be vaccinated by the autumn.

In January 2021, the results of Johnson & Johnson's vaccine candidate were published, and the EMA received the US company's marketing authorisation application in February. The vaccine candidate, Ad26.COV2.S, which requires only a single injection and can be stored at normal refrigerator temperatures, achieved a 72% protective efficacy against COVID-19 in a phase 3 study. The vaccine consists of a recombinant serotype 26 (Ad26) adenovirus that is incapable of replication. It was loaded with a copy of the complete spike protein of SARS-CoV-2.
Sadoff J et al.:  Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. N Engl J Med (2021); https://doi.org/10.1056/NEJMoa2034201

On 2 February, the results of the Russian vaccine Sputnik V were published in the Lancet. According to the results, the adenovirus-based recombinant vaccine showed a relative efficacy of 91.6%. 21 days after vaccination, 0.1% in the vaccine group (16/14,964) and 1.3% in the placebo group (62/4,902) showed a positive covid-19 test.
Logunov DY et al.: Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost covid-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021; https://doi.org/10.1016/S0140-6736(21)00234-8

For 19 March 2021, the G-BA invites to an online event "10 Jahre AMNOG" with top-class speakers. Registration until 01.03.2021 is free of charge.
www.g-ba.de/downloads/17-98-5075/G-BA_Programmflyer_AMNOG-bf.pdf