Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Psoriasis

Treatment: Sotyktu 6 milligram (mg) OR TABS

The insurer denied coverage for Sotyktu 6 milligram (mg) OR TABS

The denial is upheld.
 

According to the medical records, the patient is an adult with a history of psoriasis, affecting more than 15% (percent) of his body surface area (BSA). The patient has tried and failed topical steroids. The treating provider is requesting approval for Sotyktu.

The formulary drugs are not likely to cause the patient an adverse reaction.

The patient's insurance requires prior treatment with Humira, Stelara, Tremfya, Skyrizi, Taltz, and Otezla. These medications would be an appropriate next step treatment option for this patient who has not failed any biologics in the past. Tremfya, Skyrizi, and Taltz have demonstrated significant efficacy, achieving psoriasis Area Severity Index (PASI)75 scores of 80-89%, and Humira and Stelara achieved a PASI 75 score of about 67% in clinical studies. 

Otezla is Food and Drug Administration (FDA)-approved for the treatment of psoriasis. Thirty milligrams (mg) twice daily reduced the severity of moderate to severe plaque psoriasis in the phase 3 ESTEEM trials, as well as improving difficult-to-treat nail, scalp and palmoplantar psoriasis. Most patient-reported outcomes, including pruritus and the total Dermatology Life Quality Index, also improved to a significantly greater extent with Otezla than with placebo, with significant improvements in pruritus and skin discomfort/pain visual analogue scale scores seen as early as week 2 with Otezla.

Therefore, it is appropriate based on the patient's insurance policy, to use these medications prior to Sotyktu.      

The formulary drug(s) have not been tried and failed, therefore, have not been ineffective based on the patient's clinical history.

The non- formulary drug is not expected to be more effective than the formulary alternatives

There is no supporting documentation that the patient has any contraindications to these biologics. Namely, the patient does not have a history of severe active infections, untreated active, latent tuberculosis, moderate to severe congestive heart failure, or multiple sclerosis.

"As immune-related pathways involved in the pathogenesis of psoriasis are elucidated, new biologic treatments targeting these steps of the psoriatic immune cascade are developed. In this article, we review the literature on Interleukin (IL)-23 and IL-17 inhibitors in the pipeline for use in moderate to severe psoriasis. Numerous pipeline biologic therapies, including risankizumab, guselkumab, tildrakizumab, ixekizumab, and brodalumab, are being investigated in phase 2 and 3 studies to establish the efficacy and safety of these new agents. Of these newest biologics being studied for psoriasis, ixekizumab has been approved and brodalumab is pending approval by the US Food and Drug Administration." (Dong, J. et al. 2017).

"The use of biologics has revolutionized the treatment of psoriasis but choosing the right agent could be challenging. Currently, there are multiple biologic options, each with advantages and disadvantages." (Dave, R. et al. 2021).

"Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess the durability of their efficacy and safety profiles over time." (Papp, K. A. et al. 2018).

The carrier's denial of a request for a Formulary Exception for Sotyktu 6 milligram (mg) OR TABS to treat psoriasis is upheld.