Skin Disorders
Pharmacy/Prescription Drugs

Diagnosis: Plaque Psoriasis
Treatment: Sotyktu
The insurer denied the request for Sotyktu.
The health plan's determination is upheld.

The patient is a female with moderate to severe plaque psoriasis affecting up to 20 percent (%) of her body surface area including involvement of the hands and feet. She has previously failed therapy with topical corticosteroids, ultraviolet (UV) phototherapy, and Otezla.

The formulary drugs Stelara, Skyrizi, Tremfya, Enbrel, Cimzia, and Cosentyx have not been ineffective, would not have adverse effects, and would be as effective as the non-formulary drug Sotyktu. The patient has not had trial of other formulary drugs among Humira, Skyrizi, Stelara, Cosentyx, Cimzia, Enbrel, and Tremfya, nor has a contraindication to these other preferred plan alternative formulary drugs. These formulary drugs are Food and Drug Administration (FDA) approved for moderate to severe plaque psoriasis and have shown good efficacy with acceptable safety profiles when used to treat plaque psoriasis.
Review of phase III clinical trial data shows Sotyktu achieving a psoriasis area and severity index (PASI) of 75 in psoriasis patients of 58.4% after 16 weeks of therapy. This is inferior to the PASI 75 rates seen in phase III clinical trials with Humira, Cimzia, Stelara, Cosentyx, Tremfya, and Skyrizi, which show PASI 75 rates between 67% and 91% at their primary endpoints. The patient does not have a clinical reason to not use Humira, Cimzia, Stelara, Cosentyx, Tremfya, or Skyrizi as well. Therefore, Sotyktu has inferior efficacy compared to multiple formulary treatments that are available for the patient to use instead. For the above reasons, the use of Sotyktu is not considered medically appropriate or necessary at this time.

The health plan's determination is upheld in whole.