Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid arthritis (RA)
Treatment: Orencia ClickJet 125 milligrams/milliliter (mg/ml) subcutaneous (SC) solution auto injector (SOAJ)
The insurer denied coverage for Orencia ClickJet 125 mg/ml SC SOAJ.
The denial is overturned.

The patient has the medical diagnosis of moderate to severe active rheumatoid arthritis (RA). The patient has been seen and treated with a past medical history (PMH) of RA. The patient has tried and failed methotrexate (MTX) and Rinvoq. The treating provider prescribed Orencia ClickJet and it was denied. The denial is being appealed for Orencia ClickJet, which is the topic of this review. The treating provider prescribed therapy with Orencia ClickJet 125 milligrams/milliliter (mg/ml) subcutaneous (SC) solution auto injector (SOAJ). The treating provider is requesting plan approval for treatment with Orencia ClickJet 125 mg/ml SC SOAJ.

Orencia ClickJet 125 mg/ml SC SOAJ is considered medically necessary for this patient.

The treating provider is requesting plan approval for treatment with Orencia ClickJet 125 mg/ml SC SOAJ. The patient has congestive heart failure (CHF). The patient cannot use TNF (tumor necrosis factor) inhibitors. The patient had recurrent infections on previous trials with Rinvoq. Thus, the formulary alternative (FA) Xeljanz is not an appropriate choice for this patient. The patient has diverticulitis and Kevzara is contraindicated. Therefore, the request is approved and medically necessary for this patient. 

"The abatacept autoinjector demonstrated usability without patterns of preventable use errors, and with high acceptability ratings across all key attributes assessed. Preference over competitor autoinjectors was due to device ergonomics, visualization of dose progression, confidence of dose delivery, and overall ease of use." (Schiff, et al, 2016). 

"The biological DMARD (disease-modifying antirheumatic drugs) (bDMARD) (biologic disease-modifying anti-rheumatic drugs) abatacept (Orencia), a recombinant fusion protein, selectively modulates a co-stimulatory signal necessary for T-cell (lymphocyte) activation. In the EU (European Union), abatacept is approved for use in patients with highly active and progressive rheumatoid arthritis (RA) not previously treated with methotrexate. Abatacept is also approved for the treatment of moderate to severe active RA in patients with an inadequate response to previous therapy with at least one conventional DMARD (cDMARD) (conventional disease-modifying antirheumatic drugs), including methotrexate or a TNF inhibitor. In phase III trials, beneficial effects on RA signs and symptoms, disease activity, structural damage progression and physical function were seen with intravenous (IV) or subcutaneous (SC) abatacept regimens, including abatacept plus methotrexate in methotrexate-naive patients with early RA and poor prognostic factors, and abatacept plus methotrexate or other cDMARDs in patients with inadequate response to methotrexate or TNF inhibitors. Benefits were generally maintained during longer-term follow-up. Absolute drug-free remission rates following withdrawal of all RA treatments were significantly higher with abatacept plus methotrexate than with methotrexate alone. Both IV and SC abatacept were generally well tolerated, with low rates of immunogenicity. Current evidence therefore suggests that abatacept is a useful treatment option for patients with RA." (Blair, et al, 2017). 

The insurer's denial of coverage for Orencia ClickJet 125 mg/ml SC SOAJ is overturned. Medical necessity is substantiated.