Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis vulgaris
Treatment is Ilumya 100 milligrams/milliliter subcutaneous SOSY
The insurer denied coverage for Ilumya 100 milligrams/milliliter subcutaneous SOSY
The denial is upheld.

The patient is a male who has a diagnosis of psoriasis vulgaris affecting the hands, extremities and trunk. The patient has failed therapy with topical steroids and phototherapy. Also noted are prior trials of Cosentyx and Skyrizi which he failed. However, the only note mentioning the latter 2 biologics lists both agents as active with no clinical data to clarify their usage. The requested medication is Ilumya.  Laboratory tests reveal normal liver function tests, a normal CBC (complete blood count), and a negative hepatitis surface antigen. The provided note is not clear regarding whether the patient has failed any other systemic psoriasis therapies. The provided Assessment/Plan states only "procedure: apply Ilumya" with no further documentation.

Based on the provided documentation, Ilumya is not medically necessary.  The documentation does not provide sufficient details regarding the patient's clinical response to tried and failed therapies, specifically systemic therapeutic options. The documentation does not provide a documentation of severity, body surface area, or other relevant factors important in determining the severity of the patient's psoriasis.  

There is no comparative, controlled head-to-head studies showing that Ilumya has a superior efficacy or safety profile to formulary alternatives such as Humira. According to the American Academy of Dermatology Psoriasis Guidelines and dermatology literature alternative effective treatments for the management of psoriasis are available and appropriate for this patient (1-4).

Up to Date note that "Biologic agents include the most effective therapies for moderate to severe psoriasis. Network meta-analyses support their efficacy and demonstrate varying degrees of efficacy among the individual biologic treatments [88-94]. In a network meta-analysis of Psoriasis Area and Severity Index (PASI) response data from randomized trials assessing the efficacy of biologic treatments (etanercept, adalimumab, certolizumab pegol, infliximab, ustekinumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, guselkumab, and risankizumab) or oral nonbiologic treatments (apremilast, dimethyl fumarate, acitretin, cyclosporine, fumaric acid esters, and methotrexate) for psoriasis, risankizumab, brodalumab, ixekizumab, and guselkumab had the highest PASI 75, 90, and 100 response rates (ie, achieved at least 75, 90, or 100 percent improvement in PASI) after 10 to 16 weeks [89]. There were no statistically significant differences in efficacy among these four treatments. PASI 90 rates ranged from 67 to 72 percent. These four treatments had the highest PASI 75, 90, and 100 rates in a traditional meta-analysis that assessed long-term responses (after 44 to 60 weeks) [89]." Thus, the data do not support the need for Ilumya (Tildrakizumab) which as noted in the Up to Date quote is not necessarily the optimal choice with multiple other agents available.

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for the medication Ilumya 100 milligrams/milliliter subcutaneous SOSY services is not substantiated.