BERLIN, Dec 19 (APM) - Bristol-Myers Squibb (BMS) criticised how the highest health technology assessment (HTA) body G-BA changed comparators during the assessment of their immuno-oncology combination Opdivo (nivolumab)+Yervoy (ipilimumab) in advanced melanoma.
In a Friday statement, Han Steutel, managing director of BMS Germany said: "[T]he decision is absolutely incomprehensible for us, I am shocked".
BMS noted that "surprisingly", the G-BA differs from its original choice of the appropriate comparative therapy in the course of the assessment procedure,
When G-BA commissioned the lowest HTA body IQWiG for the assessment of Opdivo+Yervoy, Yervoy was designated by G-BA as the comparative therapy for treatment-naïve patients with a BRAF-V600 wildtype tumour.
In its recommendation, IQWiG saw an indication of considerable added benefit in men, and a suggestion of unquantifiable added benefit in women in this sub-group. In two other sub-groups, IQWiG saw no proof of an added benefit (APMMA 49605).
But the appropriate comparative therapy was modified by the G-BA after the consultation phase, which took place after IQWiG gave its recommendation, BMS said. G-BA chose as comparator a monotherapy with Opdivo or Merck & Co's Keytruda (pembrolizumab).
In its ruling, G-BA said that it was "justified in the specific case to establish nivolumab and pembrolizumab as equally useful comparative therapies" for the sub-group of treatment-naïve patients with a BRAF-V600 wildtype tumour.
But, Opdivo+Yervoy was rated as having no added benefit since Bristol-Myers Squibb had submitted only the results for nivolumab plus ipilimumab versus ipilimumab in the dossier and no data comparing the combination to Opdivo or Keytruda.
According to BMS, this process may put in question the relevance of G-BA's early consultations, made with manufacturers to determine the relevant comparators and data for the assessment.
Steutel said: "We are wondering about the importance of early consultations with the G-BA if the comparative therapy can be changed before the decision is taken and without informing us."
"This may have far-reaching implications for the entire industry," added Steutel who is also chairman of the German association of research-based pharma companies vfa.
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