Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Acthar Gel.Findings:  The physician reviewer found that American College of Rheumatology guideline on the treatment of psoriatic arthritis notes, In treatment-naive patients with active psoriatic arthritis (PsA), a tumor necrosis factor inhibitor (TNFi) biologic agent is recommended over an oral small molecule (OSM) as a first-line option. OSMs may be used instead of a TNFi biologic in patients without severe PsA and without severe psoriasis, those who prefer an oral drug instead of parenteral therapy, or those with contraindications to TNFi treatment, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease. For treatment-naive patients with active PsA, the use of a TNFi biologic or OSM is recommended over an interleukin-17 inhibitor (IL-17i) or IL-12/23i biologic. An IL-17i or IL-12/23i biologic may be used instead of TNFi biologics in patients with severe psoriasis or contraindications to TNFi biologics and may be used instead of OSMs in patients with severe psoriasis or severe PsA. Methotrexate is recommended over nonsteroidal anti-inflammatory drugs (NSAIDs) in treatment-naive patients with active PsA. NSAIDs may be used instead of methotrexate after consideration of possible contraindications and side effect profile in patients without evidence of severe PsA or severe psoriasis and in those at risk for liver toxicity. An IL-17i biologic is recommended over an IL-12/23i biologic. IL-12/23i biologics may be used in patients who have concomitant inflammatory bowel disease or who desire less frequent drug administration. Nelson and colleagues report that repository corticotropin injections (RCI) have anti-inflammatory and immune-modulatory effects and are approved for multiple indications, including several rheumatologic conditions. However, the authors noted that study limitations included potentially incomplete data in the medical records and a relatively short duration of three months for capturing medical resource use changes. Brown reports that in a case series of nine patients with psoriatic arthritis who were treated with repository corticotropin injection, all patients experienced at least transient improvements in their active skin and joint disease. However, this study was limited by a small sample size. In this case, the patient has evidence of active psoriatic arthritis and has recently started on Stelara plus sulfasalazine. The records did not document an adequate trial of this combination. While the records note trials of  adalimumab, secukinumab, and etanercept, the submitted documentation did not include dosage, dates of trials, results of trials or side effects of these medication. The records note a variable response to corticosteroids without a contraindication. Given that the records fail to demonstrate adequate trials of TNFi therapy and other medications including oral small molecules, the requested medication is not medically indicated. Therefore, Acthar Gel is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certifications in rheumatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.