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Reimbursement Considerations for Early Stage Companies

June 24, 2014
Panelists at Tuesday’s breakout session – Reimbursement Considerations for Early Stage Companies – overwhelmingly agreed that emerging biotech companies must consider reimbursement at the earliest stages of development.

Christopher de Wolff, MSFS, Consultant, Numerof & Associates, Inc. moderated the panel and kicked it off by pointing out that many drugs achieve regulatory approval yet fail when they reach the market because of a lack of data and evidence directed at reimbursement. He asserted that the ‘bar is getting higher as providers, insurers, and investors are demanding more data earlier in the pipeline.

“The days of ‘build it and they will come’ are over, early stage companies must now have a clear reimbursement story to share with potential investors,” said Niall O’Donnell, PhD, Managing Director, RiverVest. He added that ‘this has been a big sea change in the last 6-7 years.’

Chris Seaton, Senior Vice President of Negotiations at Bayer AG urged early stage companies to collect their own data to share with potential partners since it shows credibility. Stephen Butts, MBA, President, COO and Co-Founder of Aerial BioPharma LLC added that collecting data can help companies evaluate the research conducted by potential partners and challenge if necessary.

When asked if there are ever exceptions, such as with rare diseases or breakthrough cures, panelists agreed that it is still critical to show value through data.

“It used to be that novel was a good word, now my questions are mainly focused on does it work, is it protected, and what is the value proposition,” said Seaton.

Pricing is a key consideration in the value discussion, Seaton pointed out that the reality is that ‘most drugs fail, most drugs that make it to market don’t make money based on the investment.’

Panelists also emphasized the importance of considering markets in other countries in early stages of R&D, and reaching out to regulators in other countries since they will influence FDA and vice versa. O’Donnell advised talking to FDA since the agency can be a critical partner throughout drug development.

This session is part of the Market Access and Commercialization track, sponsored by Genzyme, which will address emerging health policy issues and key developments impacting the market and reimbursement landscape for innovative biopharmaceutical companies.