Background On 21 December 2015, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to conduct supplementary assessments for Commission A15-33 (Pembrolizumab – Benefit Assessment According to §35a Social Code Book (SGB)).
In its written comments, the pharmaceutical company (hereinafter referred to as “the company”) submitted supplementary information, which went beyond the information provided in the dossier, to prove the added benefit. This information concerned analyses on immune-related adverse events (AEs) of the KEYNOTE 006 study on the comparison of pembrolizumab and ipilimumab for research questions 1 and 2 in dossier assessment A15-33. Research question1 comprises pretreated patients, research question2 treatment-naive patients with BRAF V600 wild type (wt) tumour (BRAF: serine/threonine-protein kinase B- Raf [rapidly accelerated fibrosarcoma – isoform B]). In the dossier, the analyses were only available for the total population of the KEYNOTE 006 study, which in its totality was not relevant for the dossier assessment. The G-BA commissioned IQWiG with the assessment of the additional analyses on AEs (research questions 1 and 2) presented by the company in its written comments. Moreover, the G-BA commissioned IQWiG with the assessment of the data of the KEYNOTE 006 study for treatment-naive patients with BRAF V600 mutated tumour (research question 3) available in the dossier.
The responsibility for the present assessment and the results of the assessment lies exclusively with IQWiG. The assessment is forwarded to the G-BA. The G-BA decides on the added benefit.
Keywords: Pembrolizumab; Melanoma; Benefit Assessment.
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