Regulators
have a role to play in ensuring that there is a solid evidence base to support
the assessment of added therapeutic benefit of novel treatments compared with
existing and potentially cheaper therapies, according to the European Medicines
Agency.
To
help health technology assessment bodies, payers, clinicians and patients to
separate merely new from truly better medicines, the regulators, firstly, should
provide explicit reasoning on a medicine’s added benefit compared to other
treatments at the time of approval. And secondly, they should insist on
‘evidence by design’. This means they must make companies aware of the need to
plan the development programmes of medicines upfront, so that they are suitable
to address the evidence needs of all relevant healthcare decisions-makers.
In
this article, the authors analyse the benefits and risks of different proposals
regarding the role of regulatory agencies in establishing the added therapeutic
benefit of novel treatments in light of the ongoing debate about medicines
pricing. Health-care payers emphasise that ‘innovation’ is not always
synonymous with ‘added therapeutic benefit’ and increasingly resist paying high
prices for new medicines with no or only minor added benefit.
To
read more, see EMA - https://www.ema.europa.eu/en/news/role-regulators-establishing-added-benefit-novel-therapies
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
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