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Methodological issues in the choice among different drugs approved for the same
therapeutic indication: a position paper by the Italian Association of Medical
Oncology (AIOM)
#MMPMID28255452
Di Maio M
; Bruzzi P
; Perrone F
; Torri V
; Montemurro F
; Tiseo M
; Vasile E
ESMO Open
2016[]; 1
(6
): e000109
PMID28255452
show ga
In oncology, as in other clinical fields, different treatments are often approved
for the same therapeutic indication. In many cases, no direct comparisons are
available to inform the choice in clinical practice. In 2015, the Italian
Association of Medical Oncology (AIOM) instructed a working group, including both
clinicians and methodologists, to discuss the issue of the best choice among
different treatments available for the same indication. The working group
discussed 3 different scenarios: (1) biosimilar drugs; (2) different drugs with
same mechanism of action; (3) different drugs with different mechanism of action.
For each scenario, methodological issues were discussed, along with the priority
for investment of resources in the conduct of clinical trials testing direct
comparison. As for biosimilar drugs, the panel recommended that, following
comparability exercise and approval by regulatory agencies, they should be widely
used, considered that their use allows financial savings. As for different drugs
(with either the same or a different mechanism of action), the panel agreed that
indirect comparisons and network meta-analyses are associated with relevant risk
of bias and imprecision, and direct comparisons should be encouraged. The
priority of these direct comparisons should be higher when the potential
differences in efficacy and/or toxicity are clinically relevant. The choice of
the study design (superiority vs non-inferiority) depends on the toxicity
profiles and also on the presumed difference in efficacy. Scientific societies
should put pressure on public bodies to identify all the administrative and
financial mechanisms useful to facilitate the conduct of trials testing direct
comparisons, when needed. Decision about therapeutic equivalence can have
important consequences on innovation: the availability of drugs characterised by
the same effectiveness, but at a lower cost, could enable non-negligible savings
of economic resources that could be used to guarantee access to innovative,
high-cost drugs.
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