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

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Resolutions August 2022

Start Resolution Procedure (no.) Brand name Indication Additional benefit (best subpopulation)
Ivacaftor / Tezacaftor / Elexacaftor (10) Kaftrio® Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (9) Kaftrio® Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (8) Kaftrio® Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor) 100% no additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (7) Kaftrio® Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit
Ivacaftor / Tezacaftor / Elexacaftor (6) Kaftrio® Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation) 100% Indication of considerable additional benefit
Ivacaftor (26) Kalydeco® Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit
Ivacaftor (25) Kalydeco® Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor 100% no additional benefit
Ivacaftor (24) Kalydeco® Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor). 100% no additional benefit
Ivacaftor (23) Kalydeco® Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation) 100% Hint for non-quantifiable additional benefit
Ivacaftor (22) Kalydeco® Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutation) 100% Indication of considerable additional benefit
Avacopan Tavneos® Granulomatosis with polyangiitis or microscopic polyangiitis, combination with rituximab or cyclophosphamide 100% Hint for minor additional benefit
Sotorasib Lumykras® Non-small cell lung cancer (NSCLC), KRAS G12C mutation, ≥ 1 therapies 100% no additional benefit
Sofosbuvir / Velpatasvir (3) Epclusa® Chronic hepatitis C, ≥ 3 to < 6 years of age 100% no additional benefit

Dear AMNOG Monitor readers,

In July, the Federal Ministry of Health published the draft of a law to financially stabilise the statutory health insurance system (GKV-FinStG). The subject of the draft are amendments in particular to sections 35a and 130b of the German Social Code, Book V, which include the early benefit assessment of new active substances and the subsequent price negotiations with the statutory health insurance. In addition, two new sections 130e and 130f are to be added.

The most important points are summarised below:

  • Negotiated reimbursement price to take effect from the 7th month instead of the 13th month.
  • New threshold for orphan drugs privilege at €20 million instead of €50 million annual turnover
  • Price reduction if >20% of the drug has to be discarded due to uneconomical pack sizes.
  • Extension of the price moratorium for 4 more years until 31 Dec 2026.
  • 20% additional discount if the new entity is used in combination with other AMNOG products.
  • Additional 15% discount on annual therapy costs if the patent-protected ZVT is not subject to AMNOG.
  • Further restrictions in price negotiations: If ZVT is patent or data protected and no additional benefit is granted, the reimbursement price should be reasonably lower than ZVT. If minor or non-quantifiable additional benefit is granted, the reimbursement price should be at the level of ZVT. Only in the case of considerable or major additional benefit can an additional price be negotiated.

There were two further G-BA resolutions on the collection of routine practice data (AbD) in Jul 2022: for Risdiplam in spinal muscular atrophy and for Autologous anti-CD19-transduced CD3-positive cells in relapsed or refractory mantle cell lymphoma (MCL).

In total, there were 13 G-BA resolutions on the early benefit assessment in July (see Fig. B). For Duvelisib in chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL; Duvelisib(2)) after at least 2 prior therapies, the product was withdrawn from the market in Germany in May 2022.

Lusutrombopag with the indication thrombocytopenia in chronic liver disease is leaving the German market per option-out.

In the arbitration on the three Selpercatinib resolutions, the Arbitration Board for the first time commented on the discretionary provision of the AM-VSG. The G-BA had not granted any additional benefit for Selpercatinib in all three indications, but had assessed the product as "a relevant therapy option in individual cases". The Arbitration Board did not make use of the provision for the reimbursement price, but made it clear that it would decide on a case-by-case basis in each case.

Recent changes in reimbursement prices of AMNOG products 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

Start Resolution Procedure (no.) Brand name Indication Additional benefit (best subpopulation)
Calcifediol Rayaldee® Secondary hyperparathyroidism in chronic renal failure 100% no additional benefit
Isofluran Sedaconda® Sedation of mechanically ventilated patients during intensive care therapy (ICT) 100% no additional benefit
Burosumab (5, reassessment >€50m) Crysvita® X-linked hypophosphatemia, ≥ 18 years of age 100% no additional benefit
Burosumab (4, reassessment >€50m) Crysvita® X-linked hypophosphatemia, ≥ 1 to < 18 years of age 100% Hint for non-quantifiable additional benefit
Duvelisib (2) Copiktra® Follicular lymphoma (FL), after ≥ 2 prior therapies 100% no additional benefit
Duvelisib Copiktra® Chronic lymphocytic leukemia (CLL), after ≥ 2 prior therapies 100% no additional benefit
Abrocitinib Cibinqo® Atopic Dermatitis (AD) 100% Hint for considerable additional benefit
Amivantamab Rybrevant® Lung cancer, non-small cell (NSCLC), EGFR exon 20 insertion mutation, after platinum-based therapy 100% no additional benefit
Remdesivir (2) Veklury® COVID-19, no need for supplementary oxygen, increased risk of severe progression 100% Hint for minor additional benefit
Lenvatinib (7, Kisplyx®) Kisplyx® Advanced renal cell carcinoma (RCC), first-line, combination with pembrolizumab 100% no additional benefit
Lenvatinib (6) Lenvima® Endometrial carcinoma (EC), after platinum-based therapy, combination with pembrolizumab 100% Indication of considerable additional benefit
Pembrolizumab (20) Keytruda® Endometrial carcinoma (EC) , after platinum-based therapy, combination with lenvatinib 100% Indication of considerable additional benefit
Pembrolizumab (19) Keytruda® Advanced renal cell carcinoma (RCC), first-line, combination with lenvatinib 100% no additional benefit