Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plaque Psoriasis.
Treatment: Skyrizi Pen 150mg/mL PEN INJCTR 150 for 30 Days, Pre-service.
The insurer denied the Skyrizi Pen 150mg/mL PEN INJCTR 150 for 30 Days, Pre-service.
The denial is upheld.

This patient is a female with medical history of plaque psoriasis. The patient has tried and failed Humira, methotrexate, and Tremfya. The provider is appealing the denial stating that the patient has been stable on Skyrizi for approximately a year.

No, the use of Skyrizi is not medically necessary for this patient.
According to the documentation provided for review and insurance policy guidelines, the patient has not tried and demonstrated an inadequate treatment response or intolerance to a three month trial of acitretin, cyclosporine, or methotrexate, which are supported as standard, first-line therapy options. The clinical chart notes mention methotrexate but there is insufficient evidence endorsing a 90 day trial. Additionally, there are no clinical chart notes including evidence of a negative tuberculosis (TB) screen. Given that biologic medications can reactivate latent TB (tuberculosis), this is a prerequisite for therapy with a medication like Skyrizi. Current clinical guidelines support the use of a systemic medication before trialing a biologic. Therefore, this request for Skyrizi is not medically necessary at this time.

According to the American Academy of Dermatology (AAD) on oral systemic drugs:
Many systemic agents are used in the treatment of psoriasis. They provide good control of psoriasis in the majority of patients and have improved their life quality indices. Frequently, combination therapy is utilized to synergize the efficacy of these medications. Many dermatologists are hesitant in prescribing systemic agents because of their adverse effects. However, such potential toxicities arising from these medications can largely be avoided if proper patient selection and close monitoring are performed.

Methotrexate has proven efficacy, per West et al.:
"In terms of efficacy, the present meta-analysis finds that approximately 40% of patients achieve a PASI75 (psoriasis area and severity index of 75) by 12 weeks of treatment... Nonetheless, it means that many psoriasis patients requiring systemic therapy are likely to benefit from methotrexate, even more so, as flexible dose adjustment and adaptation of route of dosing are applied under real-world conditions which would be expected to increase efficacy and reduce limiting adverse events."

Strober, B. E. states:
"Methotrexate and cyclosporines monotherapy or in combination with biologics or other drugs still have an important place in the roster of therapeutic options for patients with psoriasis. These medications are safe and effective in carefully selected patients and with careful monitoring."

Lee et al.:
"Acitretin is an oral retinoid that is approved for the treatment of psoriasis. It is unique compared to other systemic therapies for psoriasis such as methotrexate and cyclosporine in that it is not immunosuppressive. It is, therefore, safe for use in psoriasis patients with a history of chronic infection such as HIV (human immunodeficiency virus), hepatitis B, hepatitis C or malignancy who have a contraindication to systemic immunosuppressive therapy and require systemic therapy because topical therapy is inadequate and they are unable to commit to phototherapy. Acitretin is one of the treatments of choice for pustular psoriasis. Even though acitretin is less effective as a monotherapy for chronic plaque psoriasis, combination therapy with other agents, especially UVB (ultraviolet rays) or psoralen plus UVA (ultraviolet rays) phototherapy, can enhance efficacy.  Acitretin is an effective systemic therapy for psoriasis and is generally well tolerated at low doses for long-term use. If monotherapy with acitretin is inadequate, it can be used in combination with other treatments, particularly UVB (ultraviolet rays) phototherapy, to increase efficacy."

Lastly, according to Kumar, R., et al. (2016):
"Topical liposomal formulation of cyclosporine, 2.0% w/w, is effective in treatment of limited chronic plaque psoriasis with a satisfactory safety profile."