Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis.
Treatment: Ilumya.

The insurer denied the Ilumya. The denial is overturned. 

This is a woman with severe psoriasis for whom Ilumya is requested. She has a documented history of anxiety and depression. She has tried and failed multiple topical therapies, Otezla, Humira and Cosentyx.

Yes, the proposed Ilumya is medically necessary.

The current treatment guidelines that are in accordance with nationally accepted standards of medical practice for moderate to severe plaque psoriasis recommend typical first line treatments such as topical corticosteroids and calcipotriene followed by typical second line treatments such as ultraviolet phototherapy, oral systemic treatments (methotrexate, acitretin, cyclosporine) or biologics. The patient has tried and failed topical treatments, Otezla, Humira and Cosentyx. 

ILUMYA is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.  The patient has involvement of sensitive areas which categorize her disease as moderate to severe and warrant systemic therapy. Tildrakizumab (tildrakizumab-asmn in the USA) [Ilumetri; Ilumya] is a humanized monoclonal antibody (mAb) that selectively targets the subunit of interleukin (IL)-23, thereby inhibiting the (interleukin) IL-23/IL-17 axis, the signaling pathway primarily implicated in the immunopathogenesis of psoriasis. Administered subcutaneously, it is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy (e.g. in the European Union [EU] and Australia) and those who are candidates for systemic therapy or phototherapy (in the USA). 

In the pivotal phase III reSURFACE 1 and 2 trials, tildrakizumab was superior to placebo and efficacious compared with etanercept, in terms of the proportion of patients achieving a response [greater than or equal to [>=]75% improvement from baseline in Psoriasis Area and Severity index score (PASI 75) and a Physician's Global Assessment score of 0/1] at week 12. Response rates peaked at week 22 and the vast majority of patients achieving PASI (Psoriasis Area and Severity) 75 at week 28 maintained this response after a total of three years of treatment in the reSURFACE trials and their ongoing open-label extension studies. In addition, patients with a partial or no response to etanercept at week 28 benefitted from switching to the highest approved dose of tildrakizumab in the reSURFACE 2 trial and its ongoing extension. Treatment with tildrakizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. Tildrakizumab thus expands the range of useful therapeutic options for patients with moderate-to-severe plaque psoriasis, particularly those with an inadequate response to phototherapy and conventional systemic agents. 

In two phase III trials, tildrakizumab 200 milligrams (mg) and 100 milligrams (mg) were efficacious compared with placebo and etanercept and were well tolerated in the treatment of patients with moderate-to-severe chronic plaque psoriasis.

Since the patient has already trialed and failed two biologic medications, including a tumor necrosis factor (TNF) alpha inhibitor (which makes it unlikely that Enbrel would be efficacious), Ilumya is medically appropriate and necessary.