Posted by Michael Wonder on 11 Apr 2019
The role of regulators in establishing added benefit of novel therapies
11 April 2019 - 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.
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 health care decision-makers.
