After the FDA approved Opzelura cream (ruxolitinib) as a treatment for vitiligo in July 2022, the vitiligo clinic and research center he leads has been flooded with phone calls from patients wanting the drug, says John E. Harris, MD, Ph.D. , an associate professor at the UMass Chan School of Medicine in Worcester, Massachusetts.
However, this news apparently has not reached some of the people who take care of the approval process at the health insurance company.
“Some of the feedback we got early on was that this is not approved for vitiligo. We were like, ‘Yeah, right,’” Harris said in an interview with Managed Healthcare Executive.
Harris says insurance coverage still varies, state to state, but now two-thirds of patients have Opzelura insurance coverage for vitiligo. He noted that MassHealth, Massachusetts’ Medicaid program, had included it in its formulary.
But Harris noted that Opzelura had advantages over previous treatment strategies, including the use of a first-class topical steroid, which, because of side effects, had to be used in an alternating pattern with tacrolimus ointment.
Harris also noted that FDA approval is limited to people 12 and over, so he’s seen parents and children at his clinic who want Opzelura approved for children. FDA approval is also limited to people who have 10% or less of the body surface area affected by vitiligo.
“There are many interpretations of that,” Harris. “If someone has 20% body surface area vitiligo, is it okay for them to choose 10% and use a cream at 10%. Some payers say no, if they have more than 10%, if they have 11% body surface area, we won’t give them any cream at all. But it makes a lot of sense for patients to say, ‘Look, I have 20% but I want to put it on my face and hands. That’s what I really care about.’ So. we learned about how to talk to payers.
Limited oversight by the FDA and insurers puts a premium on careful documentation, Harris said. “Describing in your notes what type of vitiligo it is, whether it’s segmental or nonsegmental, what’s the body surface area — those are important parameters.”