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Navigatingthe Rules of Drug Pricing

Learn how to stay compliant with the current and future regulatory and industry changes.

The debate over drug pricing and reimbursement, which has grown louder and more incessant on both sides of the Atlantic in recent years, reached a new high as the payer backlash against costly new products intensified. In this charged environment, even developers of truly innovative, life-changing drugs can struggle to win what they believe is a fair price. The only chance of success is to enter payer negotiations with a data-laden value proposition—and this means rethinking R&D.

Until recently, drug developers viewed regulatory approval of their products as the last major hurdle between them and the chance to start recouping a return on their hefty investments in R&D. Innovative new products almost unquestionably commanded premium prices. The main challenge was to demonstrate to physicians why they should prescribe a particular treatment. Gradually, this model, which pharma companies understood and were designed to serve, has given way to a new normal. Now, budget holders, not regulators, are the main gatekeepers to market access.


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