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

A 45-year-old female enrollee has requested authorization and coverage for the medication Taltz. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis. A review of the record indicates that the enrollee has been diagnosed with plaque psoriasis. The records reflect that the enrollee has a history of joint pain. The records indicate that the enrollee has tried and failed various treatments including methotrexate, clobetasol, Kenalog, and Nizoral shampoo. The enrollee has also tried Humira, and Stelara. The submitted records reflect that the enrollee has started treatment with Taltz. Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. In recent years, the use of anti- tumor necrosis factor (TNF) biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus. Despite several difficulties with documenting risks, some systemic treatments for psoriasis have been linked with an increased risk of selected cancers. The best-documented association is nonmelanoma skin cancer with psoralen plus ultraviolet A therapy and cyclosporin. In addition, patients treated with anti- TNF drugs may develop adverse events such as infections, acute infusion and injection reactions, autoimmunity and cardiovascular effects. Anti-TNF biologic therapies of psoriasis patients increase the risk for malignancy and infection, mandating prior testing for tuberculosis.The requested medication, Taltz (ixekizumab), was approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of moderate-to-severe plaque psoriasis. Ixekizumab is a monoclonal antibody that targets interleukin 17A. This cytokine is involved in the activation and proliferation of keratinocytes, so blocking its action aims to reduce the severity of psoriasis. This drug has been investigated in three main trials  UNCOVER-1, -2 and -3. The primary outcome of the trials was at least a 75% reduction in patients Psoriasis Area and Severity Index (PASI75) score and a score of 0 (clear) or 1 (minimal psoriasis) on the six-point static Physician Global Assessment (sPGA) after 12 weeks of treatment. Ixekizumab is well tolerated by patients, with the most common adverse events being injection site reaction and infections such as nasopharyngitis and upper respiratory tract infections. Thus, ixekizumab represents a very promising therapy, providing an alternative mechanism of action with high efficacy and safety profiles, sustained total skin clearance, and rapid onset of effect for psoriasis patients who previously failed or experienced an inadequate response to systemic therapies.In this case, the patient has a diagnosis of moderate to severe chronic plaque psoriasis that is affecting greater than 50% of her body surface area (BSA). She has tried and failed methotrexate, clobetasol, Kenalog, and Nizoral shampoo, and she has had adverse reactions to Humira and Stelara. Given that the patient has previously failed or experienced an inadequate response to these systemic therapies, and she has started treatment with Taltz with no adverse events noted, Taltz is a promising therapy for this patient. Under these circumstances, the medication Taltz is medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the requested medication 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 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.