Launching new drugs in the Outcome Era; report

The pharmaceutical industry is facing the Outcome Era. Launching a novel drug today obliges companies to convince on its value. They have to prove the best possible health outcomes and additional benefit to achieve adequate price and reimbursement, according to a new report from Camelot Management Consultants.

A pioneer of enforcing evidence-based proof of the cost-effectiveness of treatments is the NHS (National Health Service) in UK. Since its creation, its recommendations have become global benchmark for pricing information. However, the latest commotion in the market access environment was certainly caused by the German AMNOG (Act on the Reform of the Market for Medicinal Products). AMNOG now draws a direct connection between additional benefit and reimbursed price. This new legislation set off a domino effect beyond Germany as lower prices are adopted via international reference pricing.

With the UK introducing a value based pricing (VBP) approach in 2014, the mutual influence of market access mechanisms between mature markets becomes obvious. Similarly, in the USA the biggest concern when launching a novel drug is not clearing the Food and Drug Administration approval hurdle anymore. It is to gain market access with good pricing and reimbursement and to this end to realize solid evidence and outcome proof beyond randomized controlled trials (RCT).