Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid Arthritis. 
Treatment: Simponi 50mg/0.5mL Pen Injector. 

The insurer denied the Simponi 50mg/0.5mL Pen Injector. 
The denial is overturned. 

The patient is a male with rheumatoid arthritis (RA). He has been treated with Simponi for over a year, which has helped for his RA (rheumatoid arthritis) symptoms, but he has residual uveitis. He was noted to have a positive quantiferon test, consistent with latent tuberculosis infection (LTBI). No symptoms consistent with active tuberculosis were reported, and a chest x-ray was normal. There is no documentation of any treatment for LTBI (latent tuberculosis infection) in this patient. 

Coverage for Simponi was denied by the health plan for this patient, because he was deemed to have increased tuberculosis risk due to laboratory evidence of LTBI (latent tuberculosis infection). The appeal is for continuation of Simponi 50 milligrams (mg)/0.5 milliliter (mL) Pen Injector for the treatment of RA (rheumatoid arthritis) in the setting of a positive quantiferon test consistent with LTBI (latent tuberculosis infection). 

Addended clinicals received include a progress note stating that this patient was treated for tuberculosis in the past and had a full course of medications. 

Yes, the requested Simponi is medically necessary. 

This patient with RA (rheumatoid arthritis) has been treated with Simponi for over a year, which has helped for his RA (rheumatoid arthritis) symptoms. The patient was noted to have a positive quantiferon test, consistent with LTBI (latent tuberculosis infection). No symptoms consistent with active tuberculosis were reported, and a chest x-ray was normal.  Addended clinicals received include a progress note stating that this patient was treated for tuberculosis in the past and had a full course of medications. 

Per a recent Up To Date review, "in accordance with the CDC [Centers for Disease Control and Prevention], we recommend treatment of LTBI [latent tuberculosis infection] for all patients planning to take a TNF [tumor necrosis factor]-alpha inhibitor who have a positive tuberculosis test and no evidence of active tuberculosis. A number of studies have suggested that no delay is necessary and that, consistent with CDC [Centers for Disease Control and Prevention] recommendations, treatment for LTBI [latent tuberculosis infection] can start any time before TNF [tumor necrosis factor]-alpha inhibitor initiation (including the same day)." 

This patient with a positive quantiferon test and was treated for tuberculosis in the past and had a full course of medications.  He has no current symptoms consistent with active tuberculosis, and a chest x-ray was normal.  His RA (rheumatoid arthritis) symptoms are improved on Simponi.  Continuation of Simponi is in accordance with standard of care in the medical community and is clinically appropriate, along with cautious ongoing monitoring for any symptoms of active tuberculosis. Therefore, the proposed continuation of Simponi for this patient with RA (rheumatoid arthritis) is medically necessary. 

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.