Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Seropositive rheumatoid arthritis.
Treatment: Orencia SQ (subcutaneous).

The insurer denied: Orencia SQ (subcutaneous). The denial is upheld.

The patient is an adult female with seropositive rheumatoid arthritis (RA) diagnosed in earlier this year. She also has a history of non-alcoholic steatohepatitis (NASH) and breast cancer. She has been treated with NSAIDs (nonsteroidal anti-inflammatory drugs) and Medrol 12 mg (milligrams) daily. The patient's provider now wishes to prescribe subcutaneous Orencia 125 mg (milligrams) weekly in combination with Plaquenil 200 mg (milligrams) twice daily. At her most recent office visit, this patient had a modest response to three sample doses of subcutaneous Orencia.

Coverage for subcutaneous Orencia was denied for this patient by the health plan, because she has not tried or failed all of the Plan-preferred alternatives (i.e., Enbrel, Humira, Actemra IV [intravenous], Inflectra, Renflexis, Orencia IV [intravenous] and Xeljanz). The provider asserts that this patient is not a candidate for methotrexate, sulfasalazine, leflunomide or IL (interleukin)-6 inhibition due to risk of hepatic injury with NASH (non-alcoholic steatohepatitis). The provider prefers to avoid TNF (tumor necrosis factor) inhibitors and JAK (janus kinase) inhibitors, due to this patient's history of breast cancer. The provider does not wish to use IV (intravenous) Orencia because the patient travels often. The appeal is for subcutaneous Orencia 125 mg (milligrams) weekly for the treatment of RA (rheumatoid arthritis).

The requested subcutaneous Orencia is not medically necessary for this specific patient.
The provider wishes to prescribe Orencia 125 mg (milligrams) SC (subcutaneous) weekly for this patient with recently diagnosed RA (rheumatoid arthritis) on Medrol 12 mg (milligrams) daily. Coverage for subcutaneous Orencia was denied for this patient by the health plan, because she has not tried or failed all of the Plan-preferred alternatives (i.e., Enbrel, Humira, Actemra IV [intravenous], Inflectra, Renflexis, Orencia IV [intravenous] and Xeljanz). The patient's provider asserts that this patient is not a candidate for methotrexate, sulfasalazine, leflunomide or IL (interleukin)-6 inhibition due to risk of hepatic injury with NASH (nonalcoholic steatohepatitis). The provider prefers to avoid TNF (tumor necrosis factor) inhibitors and JAK (janus kinase) inhibitors, due to this patient's history of breast cancer in 2018. The provider does not wish to use IV (intravenous) Orencia because the patient travels often.

Orencia is FDA (United States Food and Drug Administration)-approved for the treatment of RA (rheumatoid arthritis), and its use for this patient would be clinically appropriate and in accordance with standard of care in the rheumatology community. Intravenous Orencia dosed monthly is a plan preferred alternative for this patient, but the provider wishes to prescribe subcutaneous Orencia for patient convenience, citing that this patient travels often. Subcutaneous Orencia and IV (intravenous) Orencia would be expected to have comparable efficacy and safety profiles, per a published phase 3b non-inferiority study. Thus, the requested subcutaneous Orencia is not medically necessary for this patient, as it is being prescribed solely for patient convenience in lieu of Plan preferred IV (intravenous) Orencia.