Achieving access: Addressing the needs of payors and health technology assessment agencies

In the current economic climate, payors are demanding more evidence of real-lif effectiveness before funding drugs. Standards of evidence needed to satisfy payor may exceed regulatory standards, which in turn may vary between markets. Th resulting divergence between payors, regulatory bodies, and the healthcare industr can cause uncertainty around the launch of new technologies and reduce th availability of potentially life-saving medicines. Randomized controlled trials (RCTs remain the gold standard when investigating the safety and efficacy of a ne intervention. However, real-life data are increasingly required by payors an regulatory agencies facing both straitened budgets and an abundance of new therapie competing for the same space in the market. This particularly applies to non-vitamin antagonist oral anticoagulants-namely, the direct factor Xa inhibitors apixaban an rivaroxaban, and the direct oral thrombin inhibitor dabigatran. Despite the array o data available from RCTs, there are some areas of uncertainty around real-life use o these agents. The extent to which these drugs will be funded by payors or approve for use by regulatory agencies may therefore be centred on real-life data. This articl will discuss ways in which the healthcare industry, regulatory approval bodies, payors and patients must collaborate to find adequate solutions for generating robus evidence for the use of new interventions. We will also consider the challenges an possible solutions that may allow the healthcare industry to ensure divergent needs ostakeholders are met, to achieve a balance of clinical effectiveness and value for all.