Taltz denials in California external review

What the reviewers wrote

Where the denial was overturned

A 45-year-old female enrollee has requested authorization and coverage for the medication Taltz. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee’s plaque psoriasis. A review of the record indicates that the enrollee has been diagnosed with plaque psoriasis. The records reflect that the enrollee has a history of joint pain. The records indicate that the enrollee has tried and failed various treatments including methotrexate, clobetasol, Kenalog, and Nizoral shampoo. The enrollee has also tried Humira, and Stelara. The submitted records reflect that the enrollee has started treatment with Taltz. Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient with a diagnosis of optic neuritis and human leukocyte antigen (HLA)-B27 positive ankylosing spondylitis (AS) has requested authorization and coverage for Taltz auto-injector. In this case, the patient has been diagnosed with positive antiphospholipid antibodies as well as a demyelinating condition, optic neuritis. The patient has also been referred to neurology to undergo an evaluation for multiple sclerosis, which is another demyelinating disorder. The records indicate that the patient tried and failed to respond to treatment with Cosentyx. Both Enbrel and Humira are tumor necrosis factor inhibitors (TNFi) and are not recommended for patients with demyelinating conditions, as they are associated with new onset or exacerbation of demyelinating disorders.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Taltz. Systemic treatment of psoriasis is indicated when topical treatments fail or do not achieve sufficient control of disease. For patients with psoriasis in the scalp or hands or other difficult to treat areas with topical medications, or with any joint involvement, systemic medication may also be indicated. The U.S. Food and Drug Administration (FDA) has approved systemic options for psoriasis including non-biologics such as methotrexate, cyclosporine, acitretin, cyclosporine, and Otezla, and biologics including tumor necrosis-factor (TNF)-alpha inhibitors, interleukin 17 (IL-17) pathway inhibitors, IL-12/23 inhibitors, and IL-23 inhibitors. The biologics have been found to have greater efficacy than the non-biologics.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Taltz injections. Taltz injections are not a standard treatment in this patient’s case. The standard treatment of rheumatoid arthritis includes both nonpharmacologic treatment and pharmacologic therapy. Medications for rheumatoid arthritis include nonsteroidal anti-inflammatory drugs, glucocorticoids and disease-modifying antirheumatic drugs (DMARDs). DMARDs encompass a heterogeneous group of antirheumatic medications, including interleukin-6 receptor antagonist antirheumatic medications. Taltz is an anti-interleukin 17A monoclonal antibody. Taltz has been approved by the U.S. Food and Drug Administration for the treatment of plaque psoriasis and has shown efficacy for psoriatic arthritis. The records do not document that the patient has psoriasis or psoriatic arthritis.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Taltz, then check the rights and deadlines that apply to your plan.