Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for the medication Otezla. The enrollee has psoriasis over 30-40% of his body surface area (BSA). He has had psoriasis all over his body for many years. Prior treatments of various lotions have not demonstrated significant improvement. He was planning to start Otezla last year, but he had an elevated white blood cell (WBC) count and required further workup. After recent lab work, the PCP approved treatment with Otezla. The dermatology nurse practitioner (NP) reviewed the labs and noted the enrollee had elevated WBCs, neutrophils and eosinophils; which have been elevated for the last three years. An Otezla titration package was given to the enrollee.  The NP notes the enrollee has tried and failed various treatments; including Enstilar and various other topicals. The prescribing information for Enbrel, Humira, and Cosentyx notes side effects include an increased risk of serious infections, leading to hospitalization or death; including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Additionally, lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers. The enrollee is not a candidate for these biological therapies due to the serious side effects and his multiple comorbidities. The patient has an unidentified blood dyscrasia and latent syphilis.  The presence of latent syphilis is an infection. There is a contraindication for the prescribing of Enbrel, Humira, and Cosentyx when there is a potential infection.  In addition, these medications are contraindicated in the presence of potential blood dyscrasias.  For all these reasons, the request for Otezla should be approved. Literature describes how biologic agents such as antitumor necrosis factor (anti-TNF) have emerged as treatment for chronic inflammatory diseases, especially in cases refractory to conventional treatment modalities. However, opportunistic infections have become a major safety concern in patients on anti-TNF therapy. Physicians who utilize these agents must understand the increased risks of infection. Awareness of the therapeutic potential and associated adverse events is necessary to maximize therapeutic benefits while minimizing adverse effects. When serious infections occur, withdrawal of the anti-TNF therapy may be necessary until the infection has been identified and treated. According to the Humira prescribing information, the medication should not be initiated during an active infection. If an infection develops, monitor carefully, and stop HUMIRA if the infection becomes serious. Enbrel prescribing information also discusses active infection as a contraindication, with the same follow-up instructions as Humira.Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in dermatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.