Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Plaque psoriasis. 

Treatment: Cosentyx to treat plaque psoriasis. 

The insurer denied coverage for Cosentyx to treat plaque psoriasis. 

The denial is upheld. 

This is a male patient with a history of psoriasis involving the face and scalp. The patient has failed phototherapy, methotrexate, acitretin, cyclosporine, and Taltz. The patient also has a history of frontal fibrosing alopecia (FFA). The request is for Cosentyx (secukinumab). The insurer has denied coverage due to the patient not having tried all of the preferred products with an inadequate response or intolerable adverse event. The preferred products include Humira, Otezla, Skyrizi, Stelara, and Tremfya. 

As reported by Al-Salama et al. (2018), "Guselkumab (Tremfya) is a human immunoglobulin G1  (IgG1) monoclonal antibody (mAb) that blocks the interleukin-23 (IL-23)-mediated signaling pathway in the VOYAGE trials, guselkumab was superior to placebo and to adalimumab at week 16 in terms of the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and 90% improvement from baseline in Psoriasis Area and Severity index score (PASI 90 response), with benefits of guselkumab over adalimumab maintained at week 24. To date, the beneficial effects of guselkumab treatment in these trials were maintained for up to 2 years. Inadequate responders to ustekinumab who were then randomized to guselkumab in NAVIGATE showed better responses than those randomized to ustekinumab between weeks 28-40, with a significantly greater mean number of visits at which patients had IGA 0/1 and 2-grade improvement in IGA score, as well as higher proportions of patients achieving PASI 90 and PASI 100 at week 52." 

As reported by Semble, et al. (2014), "[Tumor necrosis factor (TNF)-a] inhibitors exhibit both efficacy and tolerability in patients with moderate-to-severe plaque psoriasis. Adverse effects associated with these medications are not common and can be minimized with routine clinical monitoring and patient education...TNF-a inhibitors have a good efficacy/safety ratio for use in patients with moderate-to-severe psoriasis. Serious adverse effects are not common, and common injection-site reactions are usually manageable. The benefits of TNF-a inhibitors outweigh the risks for moderate-to-severe psoriasis." 
 
As reported by Burness et al. (2015), "Adalimumab was generally well tolerated, compared with placebo or methotrexate, during clinical trials in paediatric and adult patients with chronic plaque psoriasis. Thus, adalimumab remains an important treatment strategy in adults with moderate-to-severe chronic plaque psoriasis..." 

Based on the review of the medical record and literature, Cosentyx (secukinumab) to treat this patient's plaque psoriasis is not considered medically necessary at this time. There are no treatment algorithms to recommend the use of Cosentyx over the available options of Humira, Otezla, Skyrizi, Stelara or Tremfya. Humira, Otezla, Skyrizi, Stelara, and Tremfya are all Food and Drug Administration (FDA)-approved for the treatment of plaque psoriasis. The patient does not have any contraindication to the available treatment options. The patient has no documented trial and failure to any of the preferred options. Therefore, there would be no exception for Cosentyx for this patient. 

The health plan acted reasonably and with sound medical judgment and the best interest of the patient. Humira, Otezla, Skyrizi, Stelara, and Tremfya are all Food and Drug Administration (FDA) approved for plaque psoriasis. 

The medical necessity for Cosentyx to treat plaque psoriasis is not substantiated. The insurer's denial should be upheld.