AMNOG update – 15th of November 2017: Federal Joint Committee published five initial benefit assessments by the IQWiG

Thu, 2017 / 11 / 16

The active ingredient Sarilumab, produced and distributed by Sanfoi-Aventis under the name Kevzara®, is approved for the treatment of adult patients with moderate to serious active rheumatic arthritis. The drug is applied in combination with Methotrexat – in the case of an intolerance to Methotrexat, Sarilumab can be prescribed as a monotherapy. In three out of five subpopulations, the IQWiG didn’t grant an additional benefit. An additional benefit was solely determined in the patient group of bDMARD-naïve patients with MTX-intolerance. The treatment of patients with a therapeutic objective of remission was assessed with an indication for a non-quantifiable benefit, for those patients where a remission as a therapeutic objective is unsuitable, the IQWiG granted an indication for a considerable additional benefit.

In the therapeutic area of chronical hepatitis C, two active substances produced by Gilead Sciences were assessed by the IQWiG. The triple-substance Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®) was evaluated by the IQWiG according to different CHC-Genotypes and according to the existence of cirrhosis in 13 subpopulations. If the CHC-Genotype 3 existed in combination with a compensated cirrhosis the IQWiG granted an indication for a minor benefit – the remaining 12 subpopulations did not receive any additional benefit. The second CHC-Substance, a combination of Ledipasvir and Sofosbuvir (Harvoni®), was assessed once again within an extended indication (adolescent patients between 12 and 17 years). Pre-treated as well as non-treated patients with a CHC-Genotype 1 received indications for non-quantifiable benefits. The remaining genotypes did not show any additional benefit, according to the IQWiG.

Furthermore, two orphan-drugs for the treatment of myelomatosis have been assessed after exceeding the 50-million-euro sales limit. Daratumumab (Darzalex®) was evaluated as monotherapy and in combination with Bortezomib/Dexamethason as well as in combination with Lanalidomid/Dexamethason (LenDex). The combined therapy with LenDex by Janssen-Cilag was the only treatment which was granted an additional benefit by the IQWiG, differentiated by sex. While the female subgroup received a hint for a considerable additional benefit, the male subgroup did not gain any benefit from the substance. The second orphan drug, which had to undergo a full assessment, is named Kyprolis® and contains the active substance Carfilzomib, produced by Amgen. The IQWiG differentiated the subgroups, also treated in combination with LenDex, according to age (< 65, ≥ 65). Only the treatment of patients under 65 years received an indication for a non-quantifiable additional benefit. The remaining subgroups, patients over 65 years plus patients treated with Dexamethason, did not get any additional benefit at all.

For more information (in German) please click on the following links:

https://www.g-ba.de/informationen/nutzenbewertung/305/

https://www.g-ba.de/informationen/nutzenbewertung/306/

https://www.g-ba.de/informationen/nutzenbewertung/307/

https://www.g-ba.de/informationen/nutzenbewertung/308/

https://www.g-ba.de/informationen/nutzenbewertung/309/