2017 brings many new expectations for the healthcare market place, including the ongoing transformation of our nation’s healthcare system from volume to value. As stakeholders continue pivoting to achieve success in an increasingly value-driven environment, renewed focus on data, outcomes, and transparency will ultimately enable better, more cost effective care for every patient.
Health Economics and Outcomes Research teams within pharma/biotech manufacturers are already generating powerful post-market data/studies that reinforce the value of their life-altering therapies in the real world, and for patients benefiting from these treatments. Historically, manufacturers have been able to share this rich, quality information through unsolicited request by their customers—but the new year and transparency horizon shows promise in transforming this practice.
Enabling better care and population level decisions based on value, demands reliance on robust economic and outcomes data—and payers and health systems can only make the necessary, value-based decision when they have transparent and reliable economic and outcomes data at their disposal.
The recent draft guidance from the FDA regarding manufacturers sharing healthcare economic information (HCEI) with payer formulary decision makers or other similar entities is refreshing. The guidance aligns not only with the shift from volume to value, but also in large part with consensus recommendations made by the Academy of Managed Care Pharmacy (AMCP) regarding information exchange between manufacturers and payers/health systems to enable better, patient-centric decisions.
With the ever-shrinking healthcare dollar and growing pressures of population health management, payer organizations need the ability to appropriately forecast and structure benefit designs. The ability to exchange information during the pre-approval period allows manufacturers to partner early to provide information and insights that their payer customers can incorporate into decision-making and longer term planning.
Manufacturers should consider incorporating the pre-approval information exchange clause as a critical pre-launch communication opportunity that may provide their account management teams with the ability to share appropriate information early, so post-approval they might be able to condense customer discussions and ultimately enable a more streamlined formulary review process and timeline.
Outcomes data and evidence generation is a critical component in todays healthcare marketplace, and pharma/biotech manufacturers need to take a step back to rethink their marketing and communications approach and how to fully integrate the use of appropriate HCEI into proactive, promotional customer engagements. From redefining pre-launch data generation and communications to on-going, post-market evidence generation and dissemination to bolster and refine the value story through their brands lifecycle—Klick Market Access is here to help.
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