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

Nature of Statutory Criteria/Case Summary: The patient was diagnosed with psoriasis. The provider noted extensive plaque psoriasis to the patients scalp, trunk, groin, and extremities which was noted to be chronic and worsening with a body surface area of 20%. The Health Plan Prescription Drug Prior Authorization or Step Therapy Exception Request Form noted the patient had trialed and failed treatment with Stelara and topical steroids. The provider has recommended Cosentyx for the patient. The health plan has denied this request indicating that the requested medication Cosentyx is not medically necessary for the treatment of this patient. The submitted documentation does not support that the requested medication is medically necessary. Armstrong and colleagues report that systemic treatment of psoriasis is indicated when topical treatments fail or do not achieve sufficient control of disease. There are several FDA approved systemic options for moderate-severe psoriasis: non-biologics including methotrexate, cyclosporine, acitretin, cyclosporine, and apremilast (Otezla), and biologics including TNF-alpha inhibitors, IL-17 pathway inhibitors, IL-12/23 inhibitors (Stelara), and IL-23 inhibitors (such as Skyrizi and Tremfya). The non-biologics have poorer efficacy than the biologics. The IL-23 inhibitors and IL-17 inhibitors have the best efficacy of all the biologics, as noted in a recently published meta-analysis of 60 clinical trials. The meta-analysis concluded that brodalumab (IL-17), guselkumab (IL-23), ixekizumab/Taltz (IL-17), and risankizumab (IL-23) were associated with the highest Psoriasis Area and Severity Index (PASI) response rates in both short-term and long-term therapy (Armstrong, A., et al.). There is no particular indication that one of these IL-17 or IL-23 agents is significantly better than another. Lockshin and colleagues state that ixekizumab has the greatest prolonged drug survival (that is, longest use by patients presuming both efficacy and tolerability) of TNF inhibitors or IL-17 inhibitors from the Corrona Psoriasis registry. An IL-17 or IL-23 biologic is indicated for patients with resistance/non-responsiveness to Stelara. In this case, the submitted records indicate that the patient has trialed and failed treatment with Stelara and topical steroids. However, the provider has not given any rationale for why Cosentyx is necessary compared to other medications such as Skyrizi, Tremfya, or Taltz. As noted above, recent meta-analysis has concluded that these medications were associated with the highest Psoriasis Area and Severity Index (PASI) response rates in both short-term and long-term therapy. Under these circumstances, the requested medication Cosentyx 150 mg/ml Sensoready (300 mg by subcutaneous injection at weeks 0, 1, 2, 3 and 4 followed by 300 mg every four weeks) is not medically necessary to treat this patients medical condition.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 dermatology 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.