Advantages to using surrogate vs clinical end points in drug approvals include earlier access, but there can be concerns about the efficacy and end result of the drug, said Yuqian Liu, PharmD, senior director of specialty clinical solutions at Magellan Rx Management.
At AMCP 2023, Yuqian Liu, PharmD, senior director of specialty clinical solutions at Magellan Rx Management, explains how using surrogate vs clinical outcomes data can influence a drug's time to market, and how drugs approved through the accelerated pathway affect formulary management differently based on the line of business.
How do surrogate end points differ from clinical end points, and what are some pros and cons of using them in the accelerated drug approval process?
A surrogate end point is a predictor of clinical outcome, whereas an actual clinical end point is the outcome itself. So it's a metric of outcome, and that's the main difference between a surrogate end point and a clinical end point. From a patient perspective, now the use of a surrogate end point does allow you to bring the drug to market a lot sooner. So the predictor doesn't require the full scope and the spectrum of time to be able to achieve that end result, what the end result does. So from a patient perspective, they'll be able to see the accelerated approvals come to market a lot quicker through use of a surrogate end point.
However, from a payer perspective, it is very good that we're supporting the patient, but at the same time we are concerned about whether or not the surrogate end points can truly predict the end result. Because, like I said before, it’s not a true metric. From a payer perspective, we’re also very concerned about the safety and ultimately whether or not the drug works for the patient. So there are some pros and cons to both—earlier access to the drug, but at the same time, you have to worry about the efficacy and the end result of the product.
How do drugs approved through the accelerated approval pathway affect formulary management?
It's different based on the line of business. So Medicare obviously have their own regulations regarding how to provide coverage for the accelerated approval products. They have an NCD [national coverage determination] that will only cover the accelerated approvals when it's used in an approved trial. Now, Medicaid are state regulated, so the individual states have their way to regulate accelerated approvals. And then, for the commercial population, usually that's a decision on a health plan basis, so then the individual health plan gets to assess, based on the clinical efficacy data available at the time, whether or not a drug should be covered on their formulary or not.