Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriasis Vulgaris
Treatment: Taltz
The insurer denied the Taltz.
The denial is upheld.

The patient is a man. He has psoriasis affecting 20% BSA (body surface area). Taltz has been requested to treat the patient's condition. He has tried and failed topical steroids.

No, the treatment with Taltz is not medically necessary.
Per the health plan, the patient should satisfy the following before Taltz (ixekizumab) would be considered to be medically necessary:

History of failure of a three month trial of methotrexate at maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced, and history of failure, contraindication, or intolerance to two of the following preferred biologic products: Humira (adalimumab), Stelara (ustekinumab), Tremfya (guselkumab), Cimzia (certolizumab), Skyrizi (risankizumab), one of the following: history of 6 month trial of Cosentyx (secukinumab) with moderate clinical response yet residual disease activity, or both of the following: history of intolerance or adverse event to Cosentyx, physician attests that in their clinical opinion, the same intolerance or adverse event would not be expected to occur with Taltz.

There is no documentation that the patient satisfies the above. There is no documentation of contraindications or intolerance of methotrexate or the biologic therapies covered by the plan. However, in the era of biologic therapies for psoriasis, use of methotrexate is not the most appropriate first-line treatment, because its long term safety and efficacy are inferior to biologic therapies.

Biologics show superior results to conventional systemic therapies (70% improvement versus 40% improvement) for the treatment of patients with moderate to severe psoriasis, as measured by decrease in simple-measure for assessing psoriasis activity (S-MAPA) (physician global assessment [PGA] multiplied by body surface area) at week 24. These results were observed despite the fact that patients on biologics had a greater baseline severity and had a greater number of previous treatments.

A retrospective observational study was carried out, in which a group of the first 59 patients treated with secukinumab after its commercialization, was compared with another group of the first 29 patients treated with ixekizumab. The PASI (Psoriasis Area and Severity Index) 75, 90, and 100 response obtained at 52 weeks was 64.4%, 49.2%, and 41.4% for secukinumab and 75.9%, 62.1%, and 41.4% for ixekizumab, respectively, with no statistically significant differences. Regarding previous biological treatment, both treatments showed a decrease in efficacy as the number of prior biologics increases. No differences were found between secukinumab and ixekizumab in bio-naive or bio-experienced patients, with the exception of a higher PASI (Psoriasis Area and Severity Index) 75 response at week 52 for ixekizumab in those patients with two or more previous biologics Secukinumab and ixekizumab have demonstrated high efficacy and safety, with no statistically significant differences.

Therefore, given the above, the treatment with Taltz is not medically necessary.
The plan offers formulary medications that are on par with the efficacy and safety of Taltz for moderate to severe psoriasis, such as Cosentyx, and there is no documentation of side effects, intolerance, or contraindication to the use of the available formulary medication, which is approved for use in this indication and has the same mechanism of action as Taltz (IL17 [interleukin-17] inhibitor).

The current treatment guidelines, which 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, cyclosporine) and biologics.