Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Rheumatoid arthritis

Treatment: Orencia subcutaneous (SQ) 125 milligrams (mg)

The insurer denied coverage for Orencia subcutaneous (SQ) 125 milligrams (mg)

The denial is overturned
 

This case involves an adult female with a request for Orencia 125 milligrams (mg) subcutaneous injection once weekly.

The patient has a significant history of Seropositive erosive rheumatoid arthritis (RA) diagnosed many years ago, type 2 diabetes, ulcerative keratitis, hyperlipidemia. The patient has tried Prednisone, Enbrel, methotrexate 15 mg weekly, and 25 mg weekly but continues to have flareup. The patient was started with Orencia 125 mg in combination with Methotrexate 25 mg weekly. The patient had self-discontinued methotrexate for 10 months and continued Orencia monotherapy. Keratitis was discovered, restarted on methotrexate.

Recently the patient was seen for follow up of seropositive and erosive rheumatoid arthritis. The patient reports sciatica, back pain, neck pain, some hand pain/stiffness that is worse in the last weeks. The patient reported dyspnea on exertion, dry mouth. Labs: Sedimentation rate 20, C reactive protein (CRP) 1.57. The patient stated that she has been out of Methotrexate for a few months and has some mild recurrent symptoms that are related to osteoarthritis (OA). Physical examination: swan-neck deformity, Boutonniere deformity, and ulnar deviation present. Right first digit rheumatoid nodule, scattered metacarpophalangeals (MCPs), Proximal interphalangeals (PIPs), and positive for crepitus. 

The Food and Drug Administration (FDA) states Orencia (Abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Recommended dosage: Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given).

Per the Milliman Care Guidelines (MCG), Abatacept (Orencia) is indicated for subsequent course with rheumatoid arthritis when the following criteria are met: Age 18 years or older, Favorable response to prior administration of abatacept, No active infection, No concurrent treatment with Janus kinase inhibitor or other biologic drug (e.g., tumor necrosis factor inhibitor, Anakinra), No concurrent use of live vaccine during treatment or within 3 months of discontinuing treatment, and no untreated latent or active tuberculosis.

The provider is requesting coverage for continuation therapy with Orencia weekly injection. The medical records provided for review do support the service being requested. The clinical documentation indicates that the patient achieved and maintain a positive clinical response with her current medication regimen as evidence by disease activity improvement (CRP from 5.83 on  then 2.0). Therefore, it is appropriate to approve this request for this medication as it was noted that the patient has tolerated this medication well with no complications and this medication has yielded the highest degree of disease control. Discontinuation of this medication is detrimental to the patient's overall health condition and would lead to deterioration and hospitalization. Therefore, the denial for Orencia 125 mg subcutaneous injection once weekly is reversed.

The formulary drugs are not expected to cause adverse effects. 

Some formulary drugs were tried, and the patient did not have an adverse reaction or contraindication.

The formulary drugs are expected to be ineffective.

The non- formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Orencia subcutaneous (SQ) 125 milligrams (mg) to treat rheumatoid arthritis is overturned.