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