Biologics for JIA? Not So Fast, Say Insurers Save

It's not a simple matter to prescribe tumor necrosis factor (TNF) inhibitors for patients with juvenile idiopathic arthritis (JIA), at least those with insurance, a single-center study found.

Among 54 patients seen at Boston Children's Hospital for newly diagnosed JIA in 2018-2019, their insurers required prior authorization for all but one, according to researchers there led by Jordan E. Roberts, MD.

And for 14 of those, the initial requests were denied, the group reported in JAMA Network Open. Four of the patients ended up taking another type of medication because of the denials, although TNF inhibitors were eventually approved for all 54.

That latter finding indicates that insurers' policies "present barriers to care despite appropriate specialty medication requests," Roberts and colleagues argued -- a situation also faced by adults with rheumatoid arthritis and similar conditions for which TNF inhibitors are a standard of care.

In many cases, insurers insisted on particular forms of "step therapy" with either (or both) nonsteroidal anti-inflammatory drugs (NSAIDs) or nonbiologic disease-modifying anti-rheumatic drugs (DMARDs) before they would authorize TNF inhibitors.

For some patients, insurers demanded that patients receive a different TNF inhibitor from that prescribed by clinicians. Four such patients, for example, were required to take adalimumab (Humira) instead of etanercept (Enbrel) or infliximab (Remicade). "Infliximab's intravenous formulation allows for more precise weight-based dosing than subcutaneously administered [TNF inhibitors]," Roberts and colleagues pointed out.

In other cases the insurer simply decreed that TNF inhibitors were not a "medical necessity," even though clinicians judged that their patients were not responding adequately to nonbiologic therapy. TNF inhibitors are "strongly recommended" in the most recently published guidelines, and were already central to treatment as far back as 2011.

In fact, 91% of the patients in the Boston Children's study had previously received conventional DMARDs and 61% had taken NSAIDs. Mean patient age was 10 and just over half were girls; no particular JIA subtype was predominant.

Median active joint count was 2 (interquartile range 1-4) when TNF inhibitors were first recommended, and medians for patient/parent and clinician global assessments stood at 3 on a 10-point scale, with 10 representing the most burdensome disease. Both figures suggest that most patients were experiencing some degree of difficulty that TNF inhibitor therapy could help relieve.

Public insurance (n=10) was no better than private in terms of the barriers erected, the admittedly limited data indicated. Denials of initial requests ensued in 30% of these cases, compared with 25% of patients covered by private insurance, and median times to approve prior authorization and to start TNF inhibitor treatment after the requests were made were similar (2.5 vs 3 days and 20 vs 24 days, respectively).

While a 3-week wait to begin recommended therapy may not seem long, Roberts and colleagues observed that early aggressive treatment has been tied to improved outcomes.

Limitations to the study were the small number of patients and its location in Massachusetts, where Medicaid is "relatively comprehensive"; formularies differ considerably among state Medicaid programs as well as among private insurers.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791440