Appeal type: Medical Necessity
Decision: Upheld

 The enrollee is requesting authorization and coverage for the medication, Siliq 210 mg/1.5 ml. The enrollee has a 35-year history of psoriasis and of Hepatitis B-positive serology. He is being followed by a hepatologist and takes lamivudine, 150mg, as prophylaxis while on biologic therapy. The psoriasis is present on fifteen percent of his body surface area (BSA). He has large erythematous patches with silvery scales on his lower extremities. His fingernails show irregular pitting. He was treated with Humira for twenty months, but the provider documents a failed response to this treatment. The record indicates the enrollee has also failed treatment with topical steroids, phototherapy, Chinese medicine, acitretin and cyclosporine. Given the lack of positive response to previous medications, treatment choice has been taken into careful consideration by the provider. The provider believes the enrollee should not be treated with any additional tumor necrosis factor (TNF) inhibitor therapy as he has failed previous treatment with Humira, which has the same mechanism of action as Enbrel (etanercept). When compared to Siliq (brodalumab), Cosentyx (secukinumab) has many gastrointestinal adverse effects, such as diarrhea and exacerbation of inflammatory bowel disease. The provider cites the enrollees many co-morbidities and does not want him to experience new conditions along with his existing ones. The provider believes Siliq will improve the enrollees clinical condition and eliminate the risk of infection and possible hospitalization. Based on the enrollees minimal improvement response to tumor necrosis factor (TNF) inhibitor therapy (Humira), an IL-17 inhibitor medication, Siliq (brodalumab) 210mg subcutaneously at weeks 0, 1, and 2; then 210 mg subcutaneously every other week was prescribed. The provider preferred treatment with Siliq (brodalumab) over Cosentyx (secukinumab) due to the gastrointestinal adverse effects associated with Cosentyx. However, while the provider describes the enrollee as having many co-morbidities and indicates the enrollee does not want to experience new conditions along with his existing ones, the record lists comorbidities of hypertension and pre-diabetes. It does not include inflammatory bowel disease or gastrointestinal (GI) risks. According to the medical literature, evaluation of brodalumab (Siliq) for the treatment of moderate to severe plaque psoriasis, a network meta-analysis comparing brodalumab with other therapies indicated brodalumabs probability of response was similar to secukinumab (Cosentyx). A systematic review on the risk of new-onset inflammatory bowel disease (IBD) with the use of anti-interleukin-17 agents notes neither Siliq nor Cosentyx use was associated with an increased risk of developing new-onset IBD or having diarrhea when compared to placebo. The physician reviewer found that  moderate quality of evidence that IBD risk is not increased with these agents, the incidence of new-onset IBD was, overall, very rare for patients with autoimmune disease, including psoriasis. Another study reviewed the safety and adverse effects of brodalumab across several clinical trials and found that suicidal ideation and behavior events have been reported with brodalumab treatment and are of significant concern. The record provides insufficient evidence of the enrollees having an increased risk for developing new-onset IBD with Cosentyx. He has no prior history or family history of GI issues. Neither Cosentyx nor Siliq increases the risk for new onset IBD or diarrhea compared to placebo. The evaluation supports that Siliq and Cosentyx are equally effective in treating patients with moderate to severe plaque psoriasis. Based on the medical literature and review of the record, Siliq is not considered medically more effective or more likely to result in adverse effects than the alternative medication, Cosentyx, to treat this enrollees medical condition.                                                           Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition.