Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid arthritis (RA)
Treatment: Orencia Clickject 125 mg/ml (milligram/milliliter) injection
The insurer denied coverage for Orencia Clickject 125 mg/ml injection.
The denial is overturned. 

The patient is an adult female with a history of seronegative rheumatoid arthritis. The patient has failed Plaquenil and methotrexate. The provider prescribed Orencia which is the topic of this review. Per the visit note, the patient was seen for follow up for seronegative inflammatory arthritis. The patient has a history of polyarticular joint pain. The patient has pain to back, knees, shoulders, left elbow, Achilles, and right wrist, and has plantar fasciitis. The patient has been trying massage therapy, which does provide some relief but not complete relief. Methotrexate was increased. Magnetic resonance imaging (MRI) and x-rays were done, showing mild bilateral sacroiliac joint arthrosis, mild subacromial spurring and mild subacromial/subdeltoid bursitis to left shoulder. Left knee shows tricompartmental osteoarthritis with moderate to severe chondromalacia of medial tibiofemoral and patellofemoral compartments. Plan to consider biologic, Plaquenil ineffective, methotrexate nine tablets per week now.

"In the end, a recommendation was made in favor of a bDMARD (biologic disease-modifying antirheumatic drug) or tsDMARD (targeted synthetic disease modifying anti-rheumatic drugs) because of the more rapid onset of benefit and concerns related to the poor tolerability and durability of triple therapy in real- world practice (13,14). In particular, the patient panel highlighted the importance of a rapid onset of benefit after already having had an inadequate response to methotrexate" (Fraenkel, et al., 2021).

"Abatacept (CTLA-4Ig (protein)) represents a soluble, recombinant, fully humanized fusion protein, comprising the extracellular domain of CTLA-4 and the Fc (fragment crystallizable) portion of Ig (immunoglobulin) G1. Abatacept binds to the costimulatory molecules CD (cluster of differentiation) 80 and CD86 on antigen-presenting cells (APC), thereby blocking interaction with CD28 on T cells (lymphocyte). In humans, Abatacept treatment was shown to be effective in patients with various autoinflammatory diseases including rheumatoid arthritis" (Bonelli, et al., 2018).

"These 5-year data establish that SC (subcutaneous) ABA (Abatacept) 125 mg (milligrams)/wk (week) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX (methotrexate)" (Genovese, et al., 2018).

The patient has failed two non-biological disease-modifying antirheumatic drugs (DMARDs) (Plaquenil, and methotrexate). The patient's MRI shows inflammatory arthritis. The patient's stiffness and pain has not improved with use of Plaquenil or methotrexate. Treatment with a biologic would be an appropriate next step. Per the ACR (American College of Radiology) and EULAR (European Alliance of Associations for Rheumatology) recommendations, this patient would qualify for a biological. ACR guidelines do not recommend any biologic over another. Further, there are no studies showing the superiority of the preferred drugs over Orencia. Therefore, Orencia is considered medically necessary.

The health plan did not act reasonably, with sound medical judgment, or in the best interest of the patient.

The insurer's denial of coverage for Orencia Clickject 125 mg/ml (milligram/milliliter) injection is overturned. Medical necessity is substantiated.