Appeal type: Medical Necessity
Decision: 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 enrollees rheumatologist requested prior authorization for Orencia, but in the interim, changed the enrollees medication to Enbrel. At a follow-up visit, improvement in foot pain was noted, but no significant change in her hand/finger symptoms. She complained of injection site reactions, which were worsening. The rheumatologist started the enrollee on Cimzia, to begin seven days after her last Enbrel injection. Review of the record indicates the enrollee complained of injection-site reactions, and redness from a previous injection, which was administered over a week prior to presentation. Her rheumatoid arthritis was not suppressed to remission on Enbrel/methotrexate.  The subjective impression was supported by an increased C-reactive protein.  The provider indicated he would ideally change the enrollees medication to Orencia.  The medical literature indicates guidelines for standard of care recommend the use of a biologic disease modifying antirheumatic drug (DMARD) for rheumatoid arthritis patients who have not achieved a response with conventional DMARDs, or who are intolerant of traditional agents. Disease modifying treatment is usually initiated in rheumatoid arthritis (RA) patients at an early stage of the disease. Early intervention could reduce joint damage and inhibit disease progression. Biologic therapy, including drugs such as Orencia, is a newer line of treatment, typically following treatment with disease modifying anti-rheumatic drugs (DMARDs). Biologic agents block certain chemicals in the blood from activating the immune system. A joint treatment regimen of both biologic and DMARD therapy is the standard of care. This enrollee failed methotrexate and at least two Tumor Necrosis Factor (TNF) inhibitors. Thus, it is medically appropriate to change to a medication with a different mechanism of action, such as Orencia, in this case. Orencia is approved by the Food and Drug Administration (FDA), and is recommended for patients with moderately to severely active rheumatoid arthritis. Orencia has shown to provide significant reductions in disease activity and improvements in physical function that were maintained over the course of 12 months in patients with rheumatoid arthritis that had remained active despite methotrexate (MTX) treatment.  Orencia was found to be well tolerated and safe over the course of one year.  Although Orencia demonstrated similar efficacy to other medications, Orencia has a relatively more acceptable safety and tolerability profile with fewer serious adverse events, fewer serious infections, fewer acute infusional events and fewer discontinuations due to adverse events.                                                        Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in rheumatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or similar medical condition.