Editor’s note: In the Aetna Expert Series, we ask clinical and health experts at Aetna to answer one compelling question. In this installment, we hear from Aetna’s vice president for pharmaceutical policy and strategy, Ed Pezalla, M.D., MPH.
How does Aetna decide whether to cover a new drug after the Food and Drug Administration (FDA) approves it?
The FDA and Aetna have a shared goal: to ensure people receive the best treatments for their medical conditions, with the best health outcomes. But we each play a different role.
The role of the FDA: The FDA brings a new drug to market by approving it, allowing the manufacturer to market it and make it available to doctors and patients.
Aetna’s role: Aetna decides how and if we will cover those medications and make them available to our members.
The decision-making process starts when the FDA allows a new pharmaceutical to come to the marketplace. Those new pharmaceuticals have been proven in clinical trials to have some efficacy and meet reasonable safety standards. But the FDA is not responsible for making sure that those medications are really a good idea in every circumstance, and they have no responsibility for the cost of medications.
How do we make decisions about a new drug?
We start by looking at how the medicine will be used. Is it used for something that we cover as insurance? We cover medications that treat diseases and disease processes. So the first determination is: Is it a coverable benefit?
Then the next determination is: Is this medication really an improvement over those medicines that have gone before and the treatments that patients receive now?
And the third consideration is: how expensive is it? Are there processes we should implement to limit inappropriate use?
How does the approval process work on Aetna’s end?
When the FDA approves a medication and it comes to the marketplace, there are a number of people at Aetna who are assessing that medication and how we will cover it. It starts in the pharmacy department, with a review by pharmacists and other researchers who understand pharmaceuticals. They read through relevant material, including technical issues that have been addressed by the FDA, as well as the peer-reviewed journal articles that support use of that medication.
The FDA approves medications based on safety and efficacy — not on economics or whether they are cost-effective.
At the same time a department of clinical policy and clinical policy researchers examines the medication. Together, they decide if it would be appropriate to cover the medication under a medical (health) or pharmacy benefit. From there, we determine whether coverage will be available and if so, at what level.
The FDA’s actions matter to Aetna because they bring those medications to our members and help us provide access. At the same time, we have to recognize that the FDA approves medications based on safety and efficacy—not on economics or whether they’re cost-effective. So we need to watch for what happens at the FDA and which medications are approved—to be ready for those expenses for our members, but also to be ready to manage those expenses on our customers’ behalf.
Just the beginning
Once Aetna begins covering a medication, our true work with the FDA begins. Through the Sentinel Initiative, Aetna and other insurers work with the FDA to report on safety concerns.