Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Juvenile idiopathic arthritis. 
Treatment: Humira 40 milligram every 10 days. 
The insurer denied: Humira 40 milligram every 10 days. 
The denial is overturned. 

This patient is a teenage female with history of juvenile idiopathic arthritis with bilateral sacroiliitis. The patient was started on Humira two years ago initially at every other week dosing however then began to experience wearing off of the medication and a magnetic resonance image (MRI) seven months ago continued to show inflammation. Humira was initially denied due to the policy not allowing coverage of the requested drug if the prescribed dosing frequency for the requested drug is more frequent than the Food and Drug Administration's (FDA's) recommended dosing frequency for the patient's diagnosis. The reason the provider is appealing the determination is because the patient has responded well to Humira however it is starting to wear off and the provider feels that increasing the frequency will improve the patient's symptoms. 

The health plan should cover the proposed treatment. 

The patient has a history of juvenile idiopathic arthritis with bilateral sacroiliitis. The patient's symptoms have been longstanding. The patient was started on Humira 2 years ago, but the medication was wearing off prior to the next dose so the provider is trying to increase the Humira frequency. There have been many studies indicating that weekly Humira is safe without an increased risk of side effects. The Food and Drug Administration (FDA) has approved weekly Humira dosing escalation in those with incomplete response to every other week dosing in rheumatoid arthritis. While weekly dosing has not yet been approved by the Food and Drug Administration for the treatment of juvenile idiopathic arthritis, there have been many studies in which they have shown that patients can have improvement in symptoms when the dose is increased to weekly Humira. While many of these studies do not analyze for statistically significant differences between every other week and every week dosing of Humira, they do find that both treatment options are a viable treatment option. In a study done by Correll et al evaluating the efficacy and safety of high-dose biologics in juvenile idiopathic arthritis, they showed "Disease activity scores including clinical juvenile arthritis disease activity score (cJADAS), physician- and parent/patient global assessments, and active joint counts improved in both groups. Patient reported outcomes including pain intensity and functional mobility also improved in both groups. Although not statistically significant, there was a relatively large difference in the change in patient-reported outcomes measurement information system (PROMIS) physical function-upper extremity t-score between the high dose and switch biologic groups (4.86 versus 0.22, adjusted p = 0.447) respectively). Given these clinical studies and what is done as standard of care by many practicing clinicians, the health plan should cover the proposed treatment. The requested health service or treatment is more beneficial that any standard treatment for the patient's disease. The patient has history of juvenile idiopathic arthritis with sacroiliitis. There are minimal medications that are approved for this disorder. The patient has been started on Humira and overall has had good clinical response to therapy and is in the patient's best interest to maximize this therapy prior to advancement to any other medication in which the patient may not respond as well.