AMNOG UPDATE – 17th of November 2017: G-BA publishes the resolutions of etelcalcetid, pembrolizumab and rolapitant

Fri, 2017 / 11 / 17

All three substances could not prove an additional benefit based on the evidence. In the case of Amgen’s drug etelcalcetid (Parsabiv®) for the treatment of secondary hyperparathyroidism, a metabolic disorder, the G-BA did not grant an additional benefit versus the appropriate comparative therapy cinacalecet. The duration of the study was too short, to express claims regarding long-term effects, and results on endpoint levels did not show any statistical significant advantages or disadvantages.

With the extension of the indication (a monotherapy for treatment of classical Hodgkin lymphoma, after failure of treatments with brentuximab vedotin and an autologous stem cell transplant (ASCT) or after brentuximab vedotin has failed and a transplant is not possible) for MSD Sharp & Dohme’s pembrolizumab (Keytruda®) the drug had to be re-assessed within the early benefit assessment in terms of the new indication. With the KEYNOTE 087 a single-arm multicenter study was presented. Furthermore, the single-arm nivolumab study Checkmate 205 was taken into account for evaluation of the additional benefit. In the resolution, the G-BA stated that both studies were not appropriate to demonstrate an additional benefit compared to the appropriate comparative therapy.

In addition, the resolution of rolapitant (Varuby®) from Tesaro was published. Rolapitant is authorized for the prevention of delayed nausea and vomiting associated with high and moderate emetogenic cancer chemotherapy in adults. Two subpopulations were determined by the G-BA. In the case of the subpopulation of patients with a high emetogenic antineoplastic chemotherapy no data was available for comparison with the appropriate comparative therapy. In the case of the subpopulation of patients with a moderate emetogenic antineoplastic chemotherapy the results of the study TS-P04834 were considered. Reasons for discontinuation of the therapy after the first cycle of chemotherapy were not recorded in the study. For this reason, valid data is only available for the first cycle. However, as the chemotherapy usually lasts for numerous cycles, it is relevant for the assessment of the additional benefit whether an anti-emetogenic effect is existent for more than one cycle. A sole consideration of the first cycle is not sufficient, therefore the relevance of the significant benefit of rolapitant in the endpoint “no emesis” in the overall phase of the first cycle is questionable.