Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Psoriasis. 
Treatment:  Formulary Exception for Taltz Autoinjector 80 mg/ml.

The insurer denied coverage for Formulary Exception for Taltz Autoinjector 80 mg/ml.  The denial is upheld. 

This is a male patient with psoriasis affecting 40% body surface area (BSA).  The patient has been on Taltz samples.  The request is for Taltz. 

The records do not indicate that the patient has failed any topical agents, which would be considered first-line therapies.  The patient does not have a demyelinating disorder, congestive heart failure (CHF), lupus like syndrome or active infection.  The patient is not immunosuppressed or immunocompromised and does not have major depressive disorder.  The records do not indicate that the patient has failed topical agents or any of the Federal Drug Administration (FDA) approved options of Humira, Otezla, Stelara, Skyrizi, Cosentyx, Enbrel and Tremfya.  While the patient has had efficacy with Taltz, there is no indication that the patient cannot have efficacy with preferred therapy or experience adverse effects with a change in therapy.  There would be no exception for Taltz. 

Per Fala, L., "the therapeutic goals for psoriasis include (1) slowing the speed of skin growth to reduce inflammation and plaque formation, and (2) smoothing the skin.  Topical treatments for psoriasis include topical corticosteroids, vitamin D analogues, anthralin, topical retinoids, calcineurin inhibitors, salicylic acid, and coal tar.  Phototherapy with artificial ultraviolet A or ultraviolet B light is sometimes used alone or in combination with other medications.  Oral or injectable therapies include methotrexate, retinoids, cyclosporine, and the biologic immunomodulator agents, including several tumor necrosis factor-alpha inhibitors (e.g., adalimumab, etanercept, infliximab) and the interleukin-12/interleukin-23 inhibitor (i.e., ustekinumab)." 

According to the American College of Rheumatology and National Psoriasis Foundation guidelines Phototherapy and oral agents for psoriasis (i.e., acitretin, cyclosporine, and methotrexate) may be used first-line in various clinical situations.  For example, acitretin is a first-line systemic drug for palmoplantar or pustular psoriasis and is especially useful in those with severely sun damaged skin, in which it may suppress actinic keratoses and even invasive malignant neoplasms.  Cyclosporine may be effective long-term but is normally reserved for intermittent use (up to 12 weeks) to control a flare, so the patient can transition to another drug for long-term maintenance.  When used intermittently, a course of cyclosporine can induce an average decrease of greater than 75% in psoriasis severity.  Methotrexate is considered a first-line systemic agent for plaque psoriasis that may be used continuously for many years or decades with durable benefits.  The same guidelines advocate for the use of Humira and Enbrel as appropriate first-line biologics for treatment of psoriasis.  Enbrel and Humira have amassed the longest published safety data of any drug Food and Drug Administration (FDA) approved for the treatment of plaque psoriasis, respectively. 

Per Bartos, S. et al., "long-term response rates of systemic treatment of psoriasis are high.  Effect may be influenced by many factors and can be analyzed in different ways, making comparisons across different trials difficult."                                                    

The carrier's denial of request for Formulary Exception for Taltz Autoinjector 80 mg/ml [milligrams per milliliter] is upheld.