How Prior Authorization, Step Therapy Result in Medication Discontinuation and Worse Outcomes

Utilization management tools, such as step therapy and prior authorization (PA), are not only time consuming for patients, but they are a burden on providers and their practices due to the time and effort spent on the process, explained Jessica Farrell, PharmD, and Madelaine Feldman, MD, FACR, during their session at the 2019 ACR/ARP Annual Meeting, held November 8-13 in Atlanta, Georgia.

These tools, both speakers explained, are often used because the insurers claim they save money and help keep prescribers in check around high-cost medications.

Both speakers referenced a recent paper from Wallace et al published in Arthritis Care & Research, which outlined the full impact PA can have on treatment delays and poor outcomes.¹ The research showed that even when PAs were approved initially, patients who needed an infusible medicine still saw a delay to the start of treatment compared with situations where no PA was needed (31 days vs 27 days). When a PA is denied initially, even if it is ultimately approved, the delay is even longer (50 days).

Physicians also have to deal with an extra burden, Farrell said. When it comes to PA, the American Medical Association has found that 64% of providers have waited at least 1 business day for a PA from their health plan and 30% have waited at least 3 business days. In addition, 86% said the burden of PA has increased over the last 5 years.

Practices have to spend a lot of time and money with staff spending hours, if not the full day, just going through PAs. She recommended spending the time to educate staff on the disease state being treated and the medications, as well as training staff on International Classification of Diseases, Tenth Revision, codes and what happens if the wrong code is used. Staff should also be able to identify non—FDA-approved indications before sending in the PA, she recommended.

PA is 1 of 4 utilization management tools that Feldman, a practicing rheumatologist in New Orleans, Louisiana, and president of the Coalition of State Rheumatology, outlined. Quantity limits is one tool that Feldman views as “mostly fine”—it encompasses things like 7-day limits on pain medications that have been implemented since the beginning of the opioid crisis.

Nonmedical switching is one tool that usually results because the payer is no longer covering a medication—perhaps because of a change in formulary tiers, of the medication moving off formulary, or the insurer is no longer accepting co-pay cards—and a patient has to switch to another one despite being stable. This sort of tool “ignores the patient’s well-being,” Feldman said, and results in more visits to the physician, more emergency department visits or hospitalizations, and greater utilization of things like laboratory tests. Ultimately, what was supposed to be a less costly alternative can become more expensive for patients and insurers, she said.

Maine passed a state law in 2018 that required insurers to report changes to the formulary that result in higher cost sharing, and in one quarter there were 300 changes reported. The changes had resulted in 80% of the patients affected facing increased out-of-pocket costs. Patients could file an appeal, but half of those appeals were denied.

“This data is important when trying to bring legislation, both state and federally, to show how many people are really affected by this, and what actually happens,” she said.

Finally, there is step therapy, known commonly as “fail first.” The challenge rheumatologists face is that they sometimes have to try 3 drugs with the same mechanism of action before they can move onto a new mechanism of action, and during this time, Feldman said, patients will often see a worsening of their disease.

“Because our patients are heterogenous, having a specific set of step therapy for every single patient, it really shows that it’s not based on clinical data,” she said.

There is also a lot of variability among step therapies, which means that in some cases patients can take 3 months to get through the therapies they need to and in other cases patients might take 6 months to get through all the steps.

Research from Xcenda based on interviews, surveys, and claims data has helped to highlight the impact of step-therapy policies on patients. The patients involved had psoriasis, rheumatoid arthritis, ulcerative colitis, and Crohn disease. There were 632 patients and the mean time to diagnosis was 7 to 16 years, so they were fairly far along in the disease. These were chronically ill patients with high out-of-pocket costs and the more obstacles put between them and their treatment, the higher their out-of-pocket costs were.

According to the findings, it was not uncommon for patients on step therapy to stop taking their medications. A total of 40% stopped taking medicines they were forced to step through because the medicines did not help. In addition, 29% said they stopped taking medicines due to cost and 27% stopped taking medicines because the insurance company did not pay for them.

“So, there was a lot of discontinuation of medications because of step therapy based on this survey data with patients,” she said.

On average, the claims data showed that it took about 30 days to get the medication for patients who were approved, but the most patients stop trying to get their medications at 17 to 23 days.

In the survey, 35% of patients said step therapy negatively impacted the one main thing in their life that brought them the most satisfaction, 52% said it negatively affected their emotional health, 20% said their overall health declined, and 36% said their quality of life declined.

Xcenda also surveyed physicians, pharmacists, and payers. Physicians and pharmacists both thought step therapy prevented patients from receiving innovative therapiess (89% of physicians and 78% of pharmacists).

In comparison, payers thought step therapy had little to no impact on the ability of clinicians to provide the best guidance and care for their patients.

“Only 1 in 5 payers agree that efficacy and safety are more important than cost. So that means 4 out of 5 think the other way,” Feldman said. “I think it kind of gets to the point of why we have these utilization management tools.”

Reference

Wallace ZS, Harkness T, Fu X, Stone JH, Choi HK, Walensky RP. Treatment delays associated with prior authorization for infusible medications: a cohort study [published online September 10, 2019]. Arthritis Care Res (Hoboken). doi: 10.1002/acr.24062.