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12:00 AM
Aug 01, 2011
 |  BioCentury  |  Strategy

Payers in product development

Sanofi-Medco, AstraZeneca-HealthCore bring payer side into clinical development

Randomized, controlled trials are the gold standard for regulatory approval, but they do not necessarily provide what payers want to see: evidence of benefit in the real-world setting. Sanofi's global partnership with Medco Health Solutions Inc. is the latest pharma collaboration with the reimbursement side aimed at designing trials and mining data to ensure that payers get the answers they need at product launch.

The Sanofi-Medco deal, signed in June, echoes a collaboration between AstraZeneca plc and HealthCore Inc., the outcomes research subsidiary of health benefits company WellPoint Inc. Under that February deal, HealthCore will conduct real-world studies in the U.S. to determine the value of a medicine to the total healthcare system.

If these kinds of deals work, they could solve an increasingly common problem for drug companies: delays in reimbursement that can push out sales timelines by six months or more.

"It is clear that the pharma environment is changing. We have more and more difficulty getting coverage and reimbursement of our products. We need to show real added value to our patients," said Sanofi CMO Jean-Pierre Lehner.

With healthcare costs under scrutiny, the pressure is on payers to understand the value of new products, Lehner noted. "That puts pressure on us early in development. We need new evidence in parallel with clinical trials: not just safety and efficacy, but also effectiveness."

"Randomized trials are not going to be enough for payers...

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