Cost-Benefit Ratio – EMA to harmonise HTA processes
London – While looking for a successor to EMA Executive Director Thomas Lönngren, the agency has opened a debate on a hot topic for biopharmaceutical companies and health technology assessors – defining the rules for what kinds of evidence must be provided to determine a drug candidate’s risk-benefit balance and its economic value. Although the EMA says it is not aiming to establish a Euro-NICE, more harmonisation could lower hurdles for drug developers in reaching EU markets. It could also bring down R&D costs for candidate drugs in early development.
AstraZeneca, GlaxoSmithKline and Johnson & Johnson are now funding a four-month pilot discussion looking at diabetes treatment that will include clinicians, health technology assessors, patient groups, payers, regulators and drug developers from France, Germany, Italy, the Netherlands, Sweden and the UK. Participants believe the experiment could help shape subsequent pilots, and broaden initiatives for early consultation. However, recommendations from the October meeting and two further discussions will be non-binding.
Advice for the developers of novel medicines is urgently needed in markets where pressure to control healthcare costs is on the rise. The EMA has been working closely with HTA bodies since 2008 to determine how clinical trials must be designed to provide data that allow evaluation of the risk-benefit ratio of a compound, as well as the comparison of a drug’s relative effectiveness and benefit-cost ratio.