The role of regulators in establishing added benefit of novel therapies

April 11, 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 … (leggi tutto)