Orencia denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the requested medication, Orencia injections. The enrollee has rheumatoid arthritis, seropositive and centromere antibody positive. She started Humira and at a follow-up visit reported continued pain and loss of motion in a right finger. She also reported resolution of right wrist pain and knee pain. Her prior treatments include prednisone, which was tapered; methotrexate, for which higher doses were believed to be associated with hair loss; Humira, which she is no longer taking, and Enbrel. The enrollee’s rheumatologist requested prior authorization for Orencia, but in the interim, changed the enrollee’s medication to Enbrel. At a follow-up visit, improvement in foot pain was noted, but no significant change in her hand/finger symptoms.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orencia (1,000 mg intravenous (IV) loading dose following in one week by self-administered 125 mg weekly subcutaneous maintenance doses). The available records document that this patient developed psoriasis as a result of treatment with tumor necrosis factor inhibitor (TNFi) therapy with Humira. The patient’s provider indicated that alternate TNFi therapy such as Enbrel or infliximab should be avoided. In a retrospective study of patients who developed TNFi-induced psoriasis over a 10-year period, the authors reported that switching to an alternate form of TNFi therapy resulted in persistent or recurrent psoriasis in approximately 50% of patients (Mazloom, et al.). These findings are consistent with additional studies in the peer-reviewed medical literature. In addition, the U.S.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orencia 125 mg/mL syringe. On review of the available medical records, this patient presents with the history of seropositive rheumatoid arthritis. The provider noted that the patient continues to report symptoms of active rheumatoid arthritis despite treatment with methotrexate 17.5 mg once a week. The patient has not been able to tolerate higher doses of methotrexate, due to elevated liver tests and a history of fatty liver. The patient has also been treated with Orencia 125 mg once a week, for two doses, with documented improvement in pain and joint swelling.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orencia infusions. The records provided for review document that this patient presents with history of rheumatoid arthritis and cerebral infarction in the right occipital region. The patient has been treated with Plaquenil with reported worsening of symptoms. The patient is noted to have a history of germ cell cancer and renal cell carcinoma. Given the patient’ history of malignancy, the provider states that treatment with that TNF blocker is not recommended. The patient’s provider has recommended treatment with Orencia infusions. Per the U.S. Food and Drug Administration (FDA), Xeljanz and Rinvoq have been associated with an increased risk of major cardiovascular events, such as heart attack and cerebral vascular accidents.

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