Aug. 19, 2023

Obtaining prior authorizations (PAs) for medication coverage has become a standard step required by payers seeking to manage healthcare costs and avoid improper medication use. For many clinicians, however, the PA process can be challenging and time-consuming.

In a letter to the editor published in Inflammatory Bowel Diseases in 2023, co-authors Francis A. Farraye, M.D., M.S., and Lauren P. Loeb, M.D., discuss several ways in which the PA process affects clinicians and their patients with inflammatory bowel disease (IBD). Dr. Farraye is a gastroenterologist and clinical investigator at Mayo Clinic in Florida, and Dr. Loeb is a resident in internal medicine at Mayo Clinic in Florida.

Dr. Farraye has been studying this issue for several years. In an article published in Inflammatory Bowel Diseases in 2019, Dr. Farraye and co-authors note that PA requests can have multiple impacts for gastroenterologists and patients with IBD. Although step therapy was previously regarded as an acceptable standard of care for patients with IBD who are prescribed expensive medications, more-recent research data have shown that patients with moderate to severe disease benefit from the use of high-cost specialty medications, including biologic agents and small-molecule drugs, early in the course of disease.

"In this high-risk patient population, step therapy requirements and the failure of payers to recognize updated IBD treatment pathways can cause treatment delays or denial of care," explains Dr. Farraye." And treatment delays and denial can lead to a recurrence of symptoms, disease progression and increased costs. Patients with disease progression may require bridging or prolonged courses of steroids, hospitalization for intravenous steroid administration, or even surgical management."

In their 2023 article, Drs. Farraye and Loeb share new study data that illustrate these challenges. The researchers collected and analyzed data related to the PA process in 42 patients with IBD seen at Mayo Clinic in Florida, comparing PA approval times for biologics associated with both commercial and noncommercial (Medicare and Medicaid) insurers. Their analysis includes the following findings:

• The mean length of time from prescription to PA approval was 5.8 days (range, 1 to 34 days). However, 26% of patients waited longer than two business weeks for PA approval.
• Among the 26% of patients whose PA approval time took longer than two weeks, three patients required steroids and one patient required hospitalization due to complications of poorly controlled IBD.
• Average wait times for PA approval from commercial insurers were six days, versus 22 days for noncommercial insurers. The disparity between PA approval times for commercial insurers versus noncommercial insurers means that sociodemographic inequalities can be exacerbated by the PA process.

"Unfortunately, the findings of our study are very common," says Dr. Farraye. "Delays in care related to prior authorization have been a problem from the inception of this policy. In the 1960s, utilization reviews to evaluate the need for inpatient treatment were assessed by physicians. Today, reviews are performed via pre-populated questionnaires fed through an algorithm, without consideration for the clinical rationale of the request. Equally worrisome is the evidence that factors unrelated to medicine — including payer type, pharmacy type or the presence of a pharmacy benefits manager — are often major contributors to denial. Although the goal of prior authorizations is to control healthcare spending in a climate of rapidly escalating healthcare costs, the evidence-based management of the patient must be prioritized."

Drs. Farraye and Loeb suggest that healthcare professionals and clinical pharmacy teams should continue to seek out educational resources to help them navigate the PA process.

"We know that identifying top payers, obtaining payer formularies and establishing a reliable point of contact can increase the likelihood of prior authorization approval," explains Dr. Farraye. "Clinicians also need to emphasize the consequences of ineffective management, the high cost of hospitalization that can be required if IBD progresses and any evidence-based contraindications for a payer's alternative therapy. If we can reform the prior authorization process so that it uses an evidence-based approach that is cognizant of cost control, we can make a positive impact on patient outcomes."

"Our study and multiple others have demonstrated the need for prior authorization reform," says Dr. Loeb. "With an abundance of evidence supporting the need for this reform, the next steps should focus on optimizing prior authorization policy design. Artificial intelligence (AI) has been the focus of many recent studies and may serve as a tool to help streamline prior authorization. Automation of prior authorization by AI tools could help provide standardized information to payers while reducing delays in approval and ameliorating health professional burnout."

For more information

Loeb L, et al. Prior authorization of biologics in the management of inflammatory bowel disease. Inflammatory Bowel Diseases. In press.

Bhat S, et al. Advocating for patients with inflammatory bowel disease: How to navigate the prior authorization process. Inflammatory Bowel Diseases. 2019;25:1621.

Refer a patient to Mayo Clinic.