Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Recurrent Pericarditis
Treatment: Ilaris 150 milligrams (mg) / milliliter (ml) subcutaneous (SC) solution (SOLN)
The insurer denied coverage for Ilaris 150 milligrams (mg) / milliliter (ml) subcutaneous (SC) solution (SOLN)
The denial is upheld

The patient has a history of recurrent pericarditis. He has failed nonsteroidal anti-inflammatory drugs (NSAIDs), prednisone and colchicine. The treating provider is requesting plan approval for treatment with Ilaris (canakinumab).

According to Klein, A. L., et al. 2020 regarding Arcalyst (rilonacept): "Objective: Recurrent pericarditis (RP) incurs significant morbidity. Rilonacept inhibits both interleukin-1 alpha (IL-1) and IL-1; these cytokines are thought to play a major role in RP. This phase II study evaluated rilonacept efficacy and safety in RP.  Methods: This multicentre, open-label study enrolled adult patients with idiopathic or post pericardiotomy RP, symptomatic (2 pericarditis recurrences) or corticosteroid (CS) dependent (2 recurrences prior). Patients received rilonacept 320 mg (milligrams) SC load/160 mg SC weekly maintenance in a 6-week base treatment period (TP) followed by an optional 18-week on-treatment extension period (EP) (option to wean background therapy).  Results: Outcomes: pericarditis pain (numeric rating scale (NRS)) and inflammation (C reactive protein (CRP)) for symptomatic patients; disease activity after CS taper for CS-dependent patients.  Secondary outcomes: health-related quality of life (HRQOL), pericarditis manifestations and additional medications. 25 unique patients enrolled, while 23 completed the EP (seven colchicine failures and five CS failures). In symptomatic patients, NRS and CRP decreased; response was observed after first rilonacept dose. NRS decreased from 4.5 at baseline to 0.7, and CRP decreased from 4.62 mg/dL (milligrams per deciliter) at baseline to 0.38 mg/dL at end of TP. Median time to CRP normalization: 9 days. Pericarditis manifestations resolved. 13 patients on CS at baseline completed the EP; 11 (84.6%) discontinued CS, and 2 tapered; CRP and NRS remained low without recurrence. Mean HRQOL scores improved in symptomatic patients. One serious adverse event (SAE) resulted in discontinuation of rilonacept.  Conclusions: Rilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL. CSs were successfully tapered or discontinued; safety was consistent with known rilonacept safety profile"  

In consideration of the clinical standards of the plan, the information provided concerning the patient, the attending physician's recommendation, and applicable generally accepted practice guidelines developed by the federal government, national or professional medical societies, boards and associations, the health care plan did act reasonably, with sound medical judgment and in the best interest of the patient. The patient has recurrent pericarditis and has failed basic treatment. Although the patient would benefit from an interleukin one inhibitor, the preferred drug for the patient's condition is Arcalyst (rilonacept). There is no evidence that patient has any contraindication to Arcalyst.      

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Ilaris 150 milligrams (mg) / milliliter (ml) subcutaneous (SC) solution (SOLN) services is not substantiated.