HTA Quarterly | Fall 2016

As the gatekeeper for regulatory approval in the US, the Food and Drug Administration (FDA) has remarkable power to incentivize drug development in key areas by providing a speedier pathway for approval, either via a shortened review time or by modifying the evidence required for approval. Similarly, early access to medicines granted by the National Health Service (NHS) in the UK and the Haute Autorite de Sante (HAS) in France via specialized programs hopes to encourage development of innovative medicines addressing key unmet needs. While not all products are eligible, these programs aim to provide early access to new technologies that can help patients who are afflicted by serious diseases with a high unmet need.

The psoriasis and psoriatic arthritis (PsA) treatment paradigm has changed dramatically over the past decade, largely due to the availability of novel biologics that better control the signs and symptoms of these diseases. Ever since the Food and Drug Administration (FDA) granted marketing authorization for Enbrel® (etanercept) for the treatment of PsA in 2002, the market has become increasingly competitive as more biologics for both psoriasis and PsA come to market. The case is the same in Europe, with the European Medicines Agency (EMA) generally following the United States (US) approval sequence, with a few months difference.

Singapore has one of the most highly advanced and efficient healthcare systems in the world. With over 5.54 million people and a GDP of $402 billion in 2015, Singapore is a small country with economic influence. Singapore’s high per-capita earnings have allowed the country to make significant investments in healthcare. The government has committed $3.2 billion to improving healthcare delivery and fostering research and development in medicine. In this article, we will explore the current healthcare environment in Singapore and the implications on manufacturers who wish to achieve access and reimbursement for their products in this market.