Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rheumatoid Arthritis
Treatment: Rasuvo 25MG/0.5ML SC SOAJ, pre-service
The insurer denied the Rasuvo 25MG/0.5ML SC SOAJ, pre-service
The denial is upheld

The patient is a female with seropositive rheumatoid arthritis (RA). She has been treated
with oral methotrexate for approximately four years. Her dose was progressively escalated to 25 mg (milligrams) weekly and folic acid daily. As part of a clinical trial, she was also treated with methotrexate and Humira. She was lost to follow up, and had a flare of her arthritis.

At her most recent office visit, the patient reported GI (gastrointestinal) upset on
methotrexate 25 mg (milligrams) weekly, and wished to pursue an alternative treatment. She had widespread pain without synovitis, full range of motion of all joints on exam, and a normal inflammatory marker (ESR [erythrocyte sedimentation rate] =14). The patient's provider prescribed Rasuvo 25 mg (milligrams) SC (subcutaneous) weekly, as a subcutaneous methotrexate alternative.

Rasuvo was denied coverage by the health plan for this patient because she has not tried or failed other Plan-preferred alternatives, such as leflunomide, Plaquenil or sulfasalazine. The appeal is for Rasuvo for the treatment of RA (rheumatoid arthritis).

No, the requested Rasuvo for the treatment of RA (rheumatoid arthritis) is not medically necessary.

This patient with seropositive RA (rheumatoid arthritis) has been treated with oral methotrexate up to 25 mg (milligrams) weekly with folic acid, in addition to Humira as part of a clinical trial. At her most recent office visit she reported GI (gastrointestinal) upset with oral methotrexate 25 mg (milligrams) weekly, and wished to pursue an alternative treatment. She had widespread pain without synovitis, full range of motion of all joints on exam, and a normal inflammatory marker (ESR [erythrocyte sedimentation rate]=14). Coverage for Rasuvo was denied by the health plan for this patient because she has not tried or failed other Plan-preferred alternatives, such as leflunomide, Plaquenil or sulfasalazine.

Per attached documentation, there is no contraindication to a trial of any of these alternate Plan preferred DMARDs (disease-modifying anti-rheumatic drugs). In addition, there are other options for adjusting oral methotrexate in the setting of GI (gastrointestinal) intolerance, such as split-day methotrexate dosing and/or increasing folic acid dosing. Furthermore, generic liquid methotrexate is available for subcutaneous administration (as opposed to brand Rasuvo auto injector), and with this
patient's normal joint exam, there is no obvious contraindication to self-administration of generic subcutaneous methotrexate. All of these options would be clinically appropriate, and in accordance with standard of care in the rheumatology community. Therefore, the proposed Rasuvo for the treatment of RA (rheumatoid arthritis) is not medically necessary for this specific patient, as there are other treatment options, including Plan-preferred options, that would be equally efficacious as brand Rasuvo.

Yes, the health plan acted reasonably, with sound medical judgment and in the best interest of the patient.