The Medication Assurance Program is a new initiative of Univera Healthcare aimed at reducing self-funded employer group overall spend. This program is designed to reduce spend on medications by holding manufacturers accountable for drugs that were approved through the Food and Drug Administration’s (FDA) Accelerated Approval Program. Unlike traditional FDA-approved drugs, accelerated approval drugs have unconfirmed clinical benefit at the time of the approval.
While we support the FDA’s Accelerated Approval Program for some drugs, we are concerned about drugs that have not completed clinical benefit trials in the timely manner mandated by the FDA. Most accelerated approval drugs are “specialty drugs,” which are high-cost medications used to treat rare and complex conditions and as utilization continues to rise, this has created challenges nationally for health plans, including Univera Healthcare. Our new Medication Assurance Program drives affordability by reducing spend on drugs that have no, or questionable clinical benefit.
Beginning in October 2023, manufacturers of accelerated approval drugs that agree to participate in our Medication Assurance Program will have their accelerated approval FDA progress monitored. If program requirements are not met, the manufacturer will pay a financial guarantee back to the health plan. A drug manufacturer who declines to participate in the program will not have their accelerated approval drug covered.
Learn more about our Medication Assurance Program.
Get the Medication Assurance Program Flyer →