Featured Viewpoint on Maximizing Product Value in the Era of Comparative Effectiveness Research
In today’s cost-conscious healthcare arena, public and private insurers are increasingly demanding that novel products demonstrate an ability to reduce treatment costs, improve medical outcomes, or provide some other tangible benefit over existing therapies if they are to be placed on formularies, approved for reimbursement, and added to the therapeutic guidelines used by healthcare professionals.
Industry Perspective:
Understanding the Impact of Comparative Effectiveness Research
The fact that public and private payers are now looking to engage in CER will significantly impact the biopharmaceutical industry. The main goal of CER is to analyze “real world” data on therapies to determine which ones are best for patients. This focus on results from patients in realistic treatment settings is critical, because it requires an analysis of the therapies outside the confines of randomized, controlled clinical trials.
Best Practices: Demonstrating Product Value
With the continuing growth of evidence-based medicine across the healthcare environment, receiving regulatory approval is just one of the many hurdles that a biopharmaceutical company must overcome to achieve commercial success for a new drug or medical device. A sponsor must also ensure that the new product is readily available to physicians and patients, that public and private insurance plans will cover its use for the approved indication, and that reimbursement rates will be adequate.
