Prior Authorizations Delay Care in Rheumatology Save

Physicians who believe their patients' health is negatively affected by insurers' demands for prior authorization, and the delays that often result, will find that opinion vindicated by a new study of rheumatology care: when permission had to be sought from insurers to provide intravenous drugs, average time to begin treatment was longer and patients had twice the corticosteroid exposure, a single-center analysis found.

Among patients who were first denied authorization for infusible medications such as rituximab (Rituxan) and infliximab (Remicade), the time to receiving the infusion was 50 days compared with 27 days for patients were not required to obtain prior authorization (P0.001), according to Zachary S. Wallace, MD, and colleagues from Massachusetts General Hospital in Boston.

And those whose authorization was initially denied had cumulative prednisone exposures of 605 mg during the subsequent 3 months compared with 160 mg for those who had no prior authorization requirement (P=0.01), the researchers reported online in Arthritis Care & Research.

"Infused medications are among the most expensive drugs. They are frequently used to treat rare conditions that can be organ- or life-threatening and for which few or no medications have received regulatory approval because of their relative scarcity," Wallace and colleagues wrote.

Many insurance payers require prior authorization for the use of these drugs, with the goal of holding down drug costs, but such requirements may have unintended consequences such as delays in treatment and greater healthcare utilization during these delays. In addition, for patients with rheumatologic diseases, delays can increase exposure to corticosteroids, with the attendant risks of infection, diabetes, and cardiovascular disease.

These challenges have been an increased focus of attention recently, with 370 healthcare groups having signed a letter to Congress urging reform of prior authorization in Medicare Advantage plans. One of the signatories was the American College of Rheumatology, which urged passage of the Improving Seniors' Timely Access to Care Act of 2019.

The college's president, Paula Marchetta, MD, said in a statement, "While intended to control costs, the unregulated use of prior authorization has devolved into a time-consuming and obstructive process that often stalls or outright revokes patient access to medically necessary therapies."

"Many healthcare plans now use prior authorization indiscriminately, ensnaring the treatment delivery process in webs of red tape and creating gratuitous hurdles for patients and providers," she continued.

In an effort to quantify some of these difficulties faced by rheumatology patients, Wallace's group reviewed the electronic health records of 225 patients seen in their hospital's rheumatology unit from 2016 to 2018 who were given a prescription for an infusible treatment.

Two-thirds of the patients were women, most were white, and mean age was 53. The diagnoses were inflammatory arthritis in 32%, vasculitis in 23%, IgG4-related disease in 17%, connective tissue disorder in 10%, myositis/interstitial lung disease in 9%, and "other" such as psoriasis and sarcoidosis in 9%. Medications included rituximab, which was the most common, requested for 70%, with smaller numbers for infliximab, tocilizumab (Actemra), zoledronic acid, and intravenous immunoglobulin. In 40%, the condition had no FDA-approved medication, and 53% were for diseases designated as rare.

No prior authorization was required for 29%, and among the 71% requiring authorization, approval was given for 56% and the request was denied in 15%.

Compared with cases not requiring authorization, those with the requirement had a greater number of days before response from the insurance company (5 days vs 0 days, P0.001), approval from the insurance company (6 days vs 0 days, P0.001), and receipt of the infusion (31 days vs 27 days, P=0.045). The mean cumulative prednisone exposure in the ensuing 3 months was 364 mg compared with 160 mg.

The most common conditions associated with denial were IgG4-related disease (33%), connective tissue disease (27%), and inflammatory arthritis (15%), and most of the denials were for rituximab (70%). In almost half of the initial denials, the patient had previously tried an oral disease-modifying drug such as methotrexate.

In 82%, the reason for denial was because of off-label use, but in 78% of the denials, there was no FDA-approved medication for the condition. Among patients who were initially denied, there was significantly greater prednisone exposure (740 mg vs 0 mg, P=0.006) in the subsequent 3 months.

After appeal, most were eventually approved, and ultimately, 96% were given approval, usually after peer-to-peer discussions.

"Our findings highlight opportunities to improve access to treatment for patients who might benefit from infusible medications. First, if 96% of prior authorization requests are ultimately approved, the value of such gatekeeping should be reconsidered. Second, if prior authorizations are required, then the turnaround time for requests, appeals, and peer-to-peer discussions must be shortened and a standardized, streamlined process for conducting such appeals should be provided," Wallace and colleagues argued.

Similar proposals were included in the letter sent by the 370 healthcare groups to Congress on Sept. 9, which called for an electronic prior authorization program, a requirement for plans to report to the Centers for Medicare and Medicaid Services on the extent of their prior authorization requirements, and adherence to evidence-based medical guidelines. Doctors across various specialties also requested input in how prior authorization processes should work in a hearing this week before a House subcommittee.

Limitations of the study, the authors noted, included its single-center design and a lack of information on potential confounders such as socioeconomic status.

The authors received funding from the NIH's National Institute of Arthritis and Musculoskeletal and Skin Diseases, from a Rheumatology Research Foundation Scientist Development Award, and from the Steven and Deborah Gorlin MGH Research Scholar Award.

They reported no financial conflicts.