Updated on 18 March 2013
In October 2012, the company received full approval from the US Food and Drug Administration to commence a pivotal clinical trial. In January this year, the company initiated the trial with 500 people living with uncontrolled type 2 diabetes and obesity in 25 sites in the US.
The price of the therapy varies in different markets. In addition to private or self-paying patients, GI Dynamics is utilizing a mixture of reimbursement mechanisms across markets, including pursuing national reimbursement, regional insurances, local institutional-level funding and more for its pricing model. "To expand our patient population and increase sales, our goal is to obtain reimbursement for our product from local and national health authorities in our target markets," explains Mr Randle.
"We are currently gathering the necessary clinical and economic data that will support our application for reimbursement in key countries. Our reimbursement strategy will involve applying for reimbursement codes, lobbying obesity and diabetes societies and establishing pricing and cost models. Several of these reimbursement activities are underway in the UK, Netherlands, Austria and Germany at the local or national level."
GI Dynamics has a committed global development program for EndoBarrier Therapy. "Our strategy in 2013 is to focus on maximizing the success and market penetration of our existing centers, while also commencing sales in a select number of new markets," says Mr Randle The company is currently focused on the transition from its successful clinical trial experience to broader commercialization.