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

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Cosentyx injectables 150 mg, two times subcutaneous on week 0, 1, 2, 3, and 4. The Health Plan has denied this request indicating that the requested medication regimen is not medically necessary for treatment of the patients psoriatic arthritis and psoriasis. The submitted documentation supports the medical necessity of the requested medication regimen. The American College of Rheumatology does not currently have any national guidelines for the U.S. regarding the recommendations for the treatment of psoriatic arthritis (PsA). However, the European League Against Rheumatism national guidelines recommend five overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The current guidelines recommend the first bDMARD, which would be a tumour necrosis factor (TNFi) inhibitor, as the first line therapy for the treatment of PsA. Medications such as bDMARDs targeting interleukin (IL) 12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom a TNFi would be inappropriate and a tsDMARD, such as a phosphodiesterase 4-inhibitor (apremilast), if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. These are the current international guidelines recommendation for treatment of PsA. Anti-TNF agents have been proven very effective for PsA and are disease modifying agents. They prevent progression of disease, erosions and disability and are thus the preferred agent for PsA. The European League Against Rheumatism and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis treatment recommendations for peripheral arthritis include non-steroidal anti-inflammatory drugs (NSAIDs), intra-articular glucocorticoid injections, DMARDs, and TNFi. According to the American Academy of Dermatology, a minimum body surface area of 10 percent has been traditionally used as a prerequisite to starting a systemic therapy for psoriasis, a subset of patients with limited disease have debilitating symptoms. For example, although severe psoriasis of the palms and soles or severe scalp psoriasis affects less than five percent of the body surface area, the significant negative affect on the quality of life of the patient makes a systemic approach to treatment appropriate. In recent years, biologics have changed the treatment of psoriasis, giving the medical community additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to have an important role in the treatment of psoriasis with an oral route of administration, as compared with biologics, making them an important treatment option for the appropriate patient. A comparative study by researchers found patients may have a response to biologic agents. However, recent meta-analyses have shown that patients, who responded to biologic agents, may have an increased response rate infliximab in the treatment of severe psoriasis. Specifically for the treatment of pustular psoriasis, the 2012 National Psoriasis Foundation states that treatment with Acitretin, cyclosporine, methotrexate, and infliximab are considered to be first-line therapies for those with generalized pustular psoriasis. Studies show other therapies would be considered second line therapies. In this patients case, the provider states in an appeal letter that the patient had plaque psoriasis of 63 percent of the body surface area and arthritis. The records submitted for review document the severity on skin examination to be greater than five percent due to disease on the patients face, scalp, elbows, and legs. The patient has failed Enbrel, methotrexate and ultraviolet light therapy. Although there is a lack of evidence of PsA by means of history, physical, or imaging records, it is noted that the patient has failed at least one TNFi. Given the severity of this patients skin disease and failure of one TNFi, a trial of another TNFi or IL-17A would be reasonable. As such, Cosentyx injectables 150 mg, two times subcutaneous on week 0, 1, 2, 3, and 4 is medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification 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.