Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Psoriatic Arthritis
Treatment: Taltz
The insurer denied the Taltz.
The denial is upheld. 

The patient is a man with moderate to severe psoriasis involving the face and scalp and psoriatic arthritis, for whom Taltz is requested. He has tried and failed methotrexate, meloxicam, naprosyn, and Humira. He is allergic to TNF (tumor necrosis factor) alpha inhibitors, so Cimzia, Enbrel and Simponi are not appropriate treatments for him.

No, the treatment with Taltz is not medically necessary.

Cosentyx (secukinumab) for injection and Taltz (ixekizumab) injection are human monoclonal antibodies to interleukin-17A used to treat moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Side effects of Cosentyx and Taltz that are similar include sore throat and nose, upper respiratory tract infection, sinus infection (sinusitis), stuffy or runny nose, and fungal infections (ringworm, athlete's foot and jock itch). Side effects of Cosentyx that are different from Taltz include diarrhea, oral herpes, hives, tonsillitis, oral thrush, impetigo, inflammatory bowel disease, ear infection, eye infection or inflammation (conjunctivitis), increased liver transaminases, and low white blood cell count (neutropenia). Side effects of Taltz that are different from Cosentyx include injection site reactions (redness, pain) and nausea. Both Cosentyx and Taltz may interact with warfarin, cyclosporine, and "live" vaccines.

The latest indication for Taltz follows two randomized, double-blind, placebo-controlled phase 3 studies including 657 adults with active AS (ankylosing spondylitis). COAST-V (A Study of Ixekizumab in bDMARD [biologic disease-modifying antirheumatic drug]-Naive Participants With Radiographic Axial Spondyloarthritis) evaluated patients without a history of bDMARDs, while COAST-W (A Study of Ixekizumab in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis) analyzed patients with a previous inadequate response or intolerance to TNF inhibitors.

Each study had the same primary efficacy endpoint: the proportion of patients achieving 16-week Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo. In COAST-V, among patients receiving Taltz 80 mg (milligrams) every four weeks, 48% of Taltz patients achieved 16-week ASAS40, versus 18% of placebo patients, and in COAST-W, it was achieved by 25% and 13% of patients, respectively. The secondary endpoint was the proportion of patients who achieved ASAS20 (Assessment of Spondyloarthritis International Society 20) after 16 weeks. In COAST-V, 64% of Taltz patients and 40% of placebo patients met this endpoint, and in COAST-W, 48% and 30% did, respectively.

Cosentyx was tested in AS patients in two randomized trials: MEASURE 1 (16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis) and MEASURE 2 (16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis). In these studies, the primary endpoint was the proportion of patients who achieved ASAS20 after 16 weeks. Among patients receiving 75 mg Cosentyx in MEASURE 1, 60% of patients achieved ASAS20, compared to 29% of placebo patients; in MEASURE 2, the outcomes were 41% and 28%, respectively.

Based on the above, Cosentyx and Taltz have very similar efficacy in psoriasis and psoriatic arthritis. Since Cosentyx is a preferred medication for the patient's formulary, Taltz is not considered medically necessary.