FDA Approves Priorauthazine, First Drug Requiring Prior Authorization for Its Own Prior Authorization

In a move regulators described as "the natural endpoint of utilization management," the U.S. Food and Drug Administration announced today the approval of Priorauthazine, the first medication that requires a prior authorization before prescribers can obtain the prior authorization form.

Under the new process, prescribers must first submit a Pre-Prior Authorization Request to the patient's pharmacy benefit manager, which will review the medical necessity of the paperwork itself. If the request is approved, the actual prior authorization form will be sent by fax within 6 to 8 business weeks. Determinations on the form will then be sent by fax in another 6 to 8 business weeks.

"For decades, prior authorizations have only been able to delay one thing at a time," said Gregory Phelan, executive director of the Coalition for Responsible Paperwork (CRP). "With Priorauthazine, we can finally delay the delay."

Priorauthazine's mechanism of action is not fully understood, although early studies suggest it binds selectively to fax machines. In the Phase III trial, no participants received a single dose. Investigators called that result "highly consistent with real-world outcomes."

Several major payers have already added the drug to their formularies with step therapy requirements. To qualify, prescribers must document failure of at least two preferred prior authorizations for a lower-cost medication.

Pharmacies are preparing for the rollout. Test claims for Priorauthazine return NCPDP reject code 75, "Prior Authorization Required," followed by a newly created supplemental message reading "Prior Authorization Required for Prior Authorization. Please Call Help Desk." The help desk directs callers to a provider portal.

"I ran the claim, called the number on the reject, got told to fax a number, and that fax told me to log into a portal that's been down since 2019," said Denise Kowalczyk, PharmD, a community pharmacist in Toledo. "Honestly, it's the most consistent the process has ever been."

Prescriber offices are struggling with the change. One medical assistant in Phoenix said she had been on hold with the PBM since the announcement and was "about four songs from a human being."

FDA officials stressed that the approval reflects the agency's commitment to "access, in theory."

At press time, the FDA confirmed its approval letter had been sent to the manufacturer by fax and should arrive in 6 to 8 business weeks.