Tremfya denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that: Nature of Statutory Criteria/Case Summary:The patient has requested authorization and coverage for Tremfya injection for the stated condition of psoriasis vulgaris. Current medical literature indicates that systemic treatment of psoriasis is indicated when, as in this case, topical treatments or do not achieve sufficient control of the disease. There are several FDA approved systemic options for moderate-severe psoriasis such as non-biologics including methotrexate, cyclosporine, acitretin, and apremilast (Otezla), and biologics including TNF-alpha inhibitors, IL-17 pathway inhibitors, IL-12/23 inhibitors (Stelara), and IL-23 inhibitors. A review of differing approaches indicate that non-biologics have a poorer efficacy than biologics in the treatment of psoriasis.

Findings: The physician reviewer found that a patient has requested authorization and coverage for Tremfya used in combination with already approved Rinvoq. Current medical literature supports the request for Tremfya (to be used with Rinvoq) for the treatment of Crohn's disease. The patient’s disease is severe and anatomically extensive, with need for multiple surgeries, and the patient has failed multiple medications recommended by guidelines for the treatment of Crohn's disease. Several studies have assessed the use of multiple therapies concurrently, including biologic therapy (such as Tremfya) with small molecule therapy (such as Rinvoq). In aggregate, no significant safety issues have been attributed to combination therapy, and the therapy has been shown to be broadly successful in improving response in patients who have failed biologic therapy. Rinvoq and Tremfya are U.S.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Tremfya 100mg/ml injections. According to the medical record, the enrollee was initially seen by a dermatologist complaining of a rash on his body that was not responding to Benadryl or cortisone cream. He was diagnosed with psoriasis vulgaris with 50% of body surface area involvement including his arms, legs, feet, back, and buttocks. He was not a good candidate for Methotrexate or Soriatane due to their effects on the liver. In addition, the enrollee is unable to go to the office for ultraviolet therapy. A Quantiferon TB gold test was negative. He was given a sample injection of Tremfya with plans for his next injection in four weeks. He also used topical steroids. At follow-up, his psoriasis has improved to one percent body surface area involvement.

Nature of Statutory Criteria/Case Summary: The patient is requesting Tremfya injections. Findings: The physician reviewer found that there is no documented contraindication to the use of formulary alternatives such as Humira, Enbrel or Cosentyx. Therefore, Tremfya100 injections are not medically necessary for the patient. The Health Plan has denied the requested medication as the Health Plan has approved formulary alternatives, Humira, Enbrel and Cosentyx. At issue in this case is whether Tremfya injections are medically necessary for treatment of the patient’s medical condition. According to the American Academy of Dermatology and the National Psoriasis Foundation, formulary alternative medications such as Humira, Enbrel and Cosentyx, are safe and effective for the treatment of psoriasis (Menter, et al.).

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 Tremfya, then check the rights and deadlines that apply to your plan.