Prior authorization requirements are associated with treatment delays and prior authorization denials are associated with greater glucocorticoid exposure, say researchers writing in Arthritis Care & Research last month.
While infused medications, including biologics, have transformed the health of patients with diseases such as rheumatoid arthritis, osteoporosis, systemic lupus erythematosus, vasculitis, and inflammatory bowel disease, they are among the most expensive drugs. Infused medications, which often have neither generic substitutes nor oral or subcutaneous formulations and require advanced planning to administer, typically require prior authorization. While prior authorization is commonly used by both public and private health payers to contain costs associated with drug coverage benefits, the requirement may increase healthcare use during delays as well as non-reimbursed provider time and administrative expenses, which can cost the United States healthcare system over $30 billion annually.
For patients with rheumatic diseases, prior authorization requirements may introduce additional treatment delays for patients who already experience diagnostic delays and poor outcomes when treatment is postponed. Meanwhile, prior authorization denials for patients with certain rheumatologic diseases and the resulting delays in access to effective, glucocorticoid-sparing medications may place patients at higher risk of glucocorticoid-related toxicity, including infection, cardiovascular disease, and diabetes.
“Little is known about the effect of prior authorization requirements, especially for infused medications, on patient-oriented outcomes such as time to treatment,” wrote the authors, led by Zachary Wallace, M.D., of Massachusetts General Hospital in Boston.
To address this knowledge gap, researchers leveraged the variability in prior authorization requirements to assess the impact of prior authorization requirements and denials. An electronic medical record system was used to identify 225 patients for whom an infusible medication was prescribed for a rheumatologic condition at the Massachusetts General Hospital between July 2016 and June 2018.
Of the 225 patients, 160 (71 percent) required a prior authorization. Results showed that prior authorizations were associated with a greater median number of days to infusion compared to cases in which no authorization was required (31 days versus 27 days, p=0.045), especially among the 33 (21 percent) patients whose prior authorization was denied initially (50 days versus 27 days, p<0.001).
Prior authorization denials were associated with greater median prednisone-equivalent glucocorticoid exposure in the three months following the request than when a prior authorization was not required (605mg versus 160mg, p=0.01). Twenty-seven (82 percent) of the 33 prior authorization requests initially denied were eventually approved. Hence, 96 percent of all prior authorizations were ultimately approved.
“If 96 percent of prior authorization request are ultimately approved, the value of such gatekeeping should be reconsidered,” the authors wrote. “If prior authorizations are required, then the turn-around time for requests, appeals, and peer-to-peer discussions must be shortened and a standardized, streamlined process for conducting such appeals should be provided. These adjustments would require commitments from both insurers as well as providers.”
In 78 percent of denials, the condition being treated had no FDA-approved medication, and nearly half of the denied patients had already tried an oral disease-modifying antirheumatic drug, which is often less expensive than an infused medication, before their prior authorization was denied.
“These findings demonstrate that the downstream detrimental effects of prior authorization denials are often imposed on patients with rare diseases and other conditions for which the treatment options are limited,” the authors wrote.
More than 25 million people in the U.S. have rare or uncommon diseases such as lupus nephritis, vasculitis, and IgG4-related disease, which are associated with diagnostic delays, can be organ- or life-threatening, and often have no FDA-approved therapies. While off-label medication use was the most common reason for prior authorization denial in this study, the FDA has acknowledged the need for off-label use in certain instances.
The median delay in the institution of treatment was 29 days, regardless of prior authorization requirements.
“One of the findings that was somewhat surprising to us was the amount of time it takes to get treatment even when you don't need a prior authorization. There's already a bottleneck. Add prior authorization denials and it's even longer,” said Dr. Wallace, @zach_wallace_md, commenting at #RheumJC Twitter chat held on Oct. 23.
The authors suggested that improving the operational efficiency of infusion centers may help them accommodate additional infusions each day, which could shorten the treatment delay.
Meanwhile, Kanika Monga, M.D., @DrKanikaMonga, commenting at #RheumJC Twitter chat held on Oct. 23, recommended “improving transparency, timeliness, and use of guidelines,” and “reduce the use of prior authorization in cases with high approval rate.”
Zachary S. Wallace, Tyler Harkness, Xiaoqing Fu, et al. “Treatment Delays Associated with Prior Authorization for Infusible Medications: A Cohort Study.” Arthritis Care Res (Hoboken). September 10, 2019. doi: 10.1002/acr.2406.