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BIO 2015 Dispatches: Payer considerations, engagement key to biopharma success

by Donna Young

Too often, biopharmaceutical firms put their investment and attention mostly on research and development and gaining regulatory approval and fail to provide equal support to the commercial market access side of their businesses – which can ultimately result in a successfully approved drug being a flop in the marketplace, three expert consultants said during a 16 June session at the annual Biotechnology Industry Organization (BIO) International Conference in Philadelphia.

Indeed, it's not all about just getting a drug on the market, they said. To be successful, firms must ensure those products are paid for by insurers and government reimbursement agencies – a fact some companies have learned too late and to their detriment.

Companies make mistakes by designing their programs for regulatory approval but not market access success, said Dr Laurie Smaldone, president and chief scientific officer at PharmApprove, a regulatory and scientific communications consultancy firm, which helps drug makers prepare for regulatory and payer negotiation meetings.

Drug manufacturers must not only engage with regulators, like the FDA and the European Medicines Agency, but also with health technology assessment (HTA) bodies, such as National Institute for Health and Care Excellence and Agenzia Italiana del Farmaco in Europe, US government payers, like Medicare and Medicaid, along with private insurers, she said.

Dr Smaldone noted, however, those interactions with government reimbursement bodies currently occur more in Europe than in the US.

But, Dr Steffen Thirstrup, director of the NDA Regulatory Advisory Board at the NDA Group, a regulatory and HTA consultancy, told Scrip....

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From The Pink Sheet. “The Pink Sheet” provides expert, in-depth analysis of biopharma regulatory, legislative, legal and business developments. Find out more at www.ThePinkSheet.com.

From Scrip. SCRIP delivers indispensable news and strategic analysis to the global pharma industry. Find out more at www.scripintelligence.com.

[newmediaandmarketing]

Before biopharma companies can better compete in an era of changing healthcare it has to look inward at the organization first and foremost. To many big biopharma organizations have way too many layers (matrix organization) to compete today. They have to not only attract game changing talent they also need people who can ask “why are we doing it this way ?”