The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have finalised “a joint work plan outlining key areas of collaboration for the next three years”. The main areas of collaboration are information exchange at market entry, data generation post approval and early dialogue. These areas are expected to also provide support in orphan drug assessment. The plan emphasized the aim to increase the understanding of differences between the significant benefit of orphan medicines versus their added therapeutic value. The EMA-EUnetHTA collaboration began in 2010 to increase efficiency and quality of processes within each organisation whilst encouraging a “…mutual understanding and dialogue on evidence needs”. (November 13, 2017)
Implications
- Large disparities between the reimbursement pathways set out by individual countries in EUnetHTA make this collaboration with EMA significant. The EMA has a centralised procedure which will likely positively influence the streamlining of potential reimbursement decision making criteria. This will potentially result in more efficient, faster HTA decisions
- This partnership will influence the framework of guidelines or final recommendations from EUnetHTA
- Through this collaboration, the EMA and EUnetHTA will be able to aid pharmaceutical companies improve the quality of clinical research being submitted. Companies that adhere to the advice will be more likely to receive a positive decision from EMA-EUnetHTA
The plan will likely benefit rare disease companies who are looking for some clarity in orphan drug assessment
