John E. Harris, M.D., Ph.D., of the UMass Chan Medical School in Worcester, Massachusetts, and director of a vitiligo clinic and research center there, discusses some of the insurance issues regarding Opzelura (ruxolitinib) cream.
After the FDA approved Opzelura (ruxolitinib) cream as treatment for vitiligo in July 2022, the vitiligo clinic and research center that he directs was flooded with phone calls from patients who wanted the drug, says John E. Harris, M.D., Ph.D., an associated professor at the UMass Chan Medical School in Worcester, Massachusetts.
But the news hadn’t apparently reached some of the people minding the approval processes at health insurers.
“Some of the responses we were getting very early on was this was not approved for vitiligo. We’re like, ‘It is, it is,’” Harris said in an interview with Managed Healthcare Executive.
Harris says insurance coverage still varies, state-by-state, but that now two-thirds of patients have insurance coverage of Opzelura for vitiligo. He noted that MassHealth, the Massachusetts Medicaid program, has put it on it formulary.
But Harris noted that Opzelura has advantages over prior treatment strategies, which included use of class-one topica steroids, which because of their side effects, have to be use in an alternating pattern with tacrolimus ointment.
Harris also noted that the FDA approval is limited only to people age 12 and older, so that he sees parents and children at his clinic who wish Opzelura was approved for children. The FDA approval is also limited to people who have 10% or less of body surface area affecged by vitiligo.
“There are multiple interpretation of that,” Harris. “If somebody has 20% body surface area vitiligo, is it Ok for them to choose 10% and use the cream on 10%. Some payers are saying no, if they have more than 10%, if they have 11% body surface area, we won’t give them the cream at all. But’s very reasonable for patients to say, ‘Look, I’ve got 20% but I want to put it on my face and my hands. That is what really what I care about.’ So. we’re learning on how to talk to payers.”
The limits of the FDA and insurance company scutiny put a premium on careful documentation, said Harris. "Explaining in your note what type of vitiligo is it, is it segmental or nonsegmental, what's the body surface area — those are important parameters."