Patients with retinal diseases often waited days or even weeks for insurers to respond to prior authorization requests to approve anti-vascular endothelial growth factor (VEGF) intravitreal injections, though most requests were ultimately granted, a prospective multicenter study showed.
Of 2,225 prior authorization requests for anti-VEGF drugs made at nine U.S. retinal clinics, 96.2% were approved, but 59.6% were not resolved within 24 hours, resulting in delayed care, reported Sabin Dang, MD, of the Retina Institute in Brentwood, Missouri, and colleagues in .
In a granular analysis of 725 delayed approvals, 3.9% were approved within 1 day, 15.9% were approved within 2 to 3 days, 21.5% were approved within 4 to 7 days, 26.3% were approved within 8 to 31 days, and 12.4% were approved within more than 31 days.
Of note, staff members needed to spend a median of 100 minutes to get just one prior authorization.
The results were consistent across geographic regions and among insurers other than traditional Medicare, which doesn't require prior authorization, Dang told .
The high prior authorization approval rate suggests that "no one's asking for things that people don't need," he said. "What a waste of everybody's time."
Insurers are spending money on a process that's "not stopping any abuse," he added, and potentially causing delays that can harm patients.
Dang and team conducted the study after noticing that prior authorization requests for anti-VEGF drugs were typically granted. "Anecdotally, a lot of my peers and I have found that no one's ever telling us no," Dang said.
At the same time, approvals are often delayed, forcing patients to make return visits when they could have had same-day treatment for conditions such as wet age-related macular degeneration, he added.
These delays can be especially difficult for seniors, he noted. "They feel so guilty about asking their family to bring them into their doctor's visits, and then they have to ask again." Delays lead to multiple visits even though "they're willing to get the treatment that day."
Delays in treatment due to prior authorization requests also have the potential to harm patients, Dang said. While same-day treatment isn't crucial, "patients can lose their driving vision in a matter of weeks to months" while they wait for approvals.
"Luckily, we have means to treat them through samples from the generosity of the pharmaceutical industry, or we're able to get them free medication through other means. But time is critical in these patients," he stressed.
As for the rare prior authorization rejections, Dang said insurers often refuse to cover the injections on an off-label basis for rare diseases. Or, in some cases, requests are rejected because insurers insist on preferred drugs.
The cost of anti-VEGF drugs varies widely, from $50 to $3,000 per injection. Patients often need several injections a year, sometimes as often as monthly.
Dang advised colleagues to advocate for lawmakers to impose restrictions on prior authorization. He supports a "gold card" approach that would grant freedom from prior authorization requirements to clinicians who have shown that they're trustworthy in regard to requests.
Zachary Kroeger, MD, of Oregon Health & Science University in Portland, told that the findings reveal how "increased administrative costs due to prior authorizations are directly increasing healthcare costs, not reducing them."
Kroeger added that delayed approvals are costly in more ways than staff time. "In any practice, the standard model is for the physician or group to purchase the pharmaceutical from a wholesale middleman and maintain an in-office stock for patient use," he explained. "The group is then reimbursed by the insurance provider once the drug is used. That is, the upfront cost burden is on the group, and a delay in reimbursement -- such as a prior authorization process -- places a prolonged and significant financial strain on the practice."
While single doses "may not break the bank," he said, "many practices are caring for hundreds of patients per day, a majority of whom are receiving injections, resulting in a deficit of hundreds of thousands of dollars per day."
He added that "anti-VEGF drugs are the only treatment for exudative macular degeneration and first-line therapy for several etiologies of macular edema and proliferative disease -- diabetic macular edema, vein occlusions, neovascularization, etc. There is no step-wise therapy to consider for these diagnoses. While treatment may be considered high cost, it is certainly not low value."
For this study, Dang and colleagues tracked prior authorization requests for three commonly used anti-VEGF medications -- aflibercept (Eylea), ranibizumab (Lucentis), and bevacizumab (Avastin) -- at retinal clinics in six states from January to June 2022. The most common reason for requesting prior authorization (64%) was reauthorization for a previously used medication.
Approval rates were 99% for bevacizumab, 95% for aflibercept, and 96% for ranibizumab. Denials were most common among patients starting treatment (15%).
In 0.54% of cases, staff needed to spend more than 20 hours to get prior authorization approval.
"A disproportionate share of denials may end up targeting the most vulnerable patients, those without prior treatment and those where the medication was deemed ineffective, necessitating a switch," the study authors wrote.
They suggested that insurers no longer require prior authorization for bevacizumab -- a less expensive anti-VEGF drug -- and reconsider the need for reauthorization, since both bevacizumab and reauthorization requests have such high approval levels.
Disclosures
Dang reported receiving personal fees from Genentech and Regeneron.
Co-authors reported multiple relationships with industry.
Kroeger has no disclosures.
Primary Source
JAMA Ophthalmology
Dang S, et al "Anti-VEGF pharmaceutical prior authorization in retina practices" JAMA Ophthalmol 2024; DOI: 10.1001/jamaophthalmol.2024.2217.