Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid arthritis. 
Treatment: Simponi 100 milligram/milliliter (mg/ml) pen injector, Quantity 2, 28 day supply. 

The insurer denied coverage for Simponi 100mg/ml pen injector, Quantity 2, 28 day supply. 

The denial is overturned. 

This case involves a patient diagnosed with asthma, depression, and spondyloarthropathy who was recommended Simponi 100 milligram/milliliter (mg/mL) pen injector, quantity 2 for a 28-day supply.  The patient was seen for a spondyloarthropathy versus seronegative rheumatoid arthritis visit.  The received 2 doses of Simponi and claimed to feel "like a new person" 3 days after taking the medication, which lasted for 3 weeks.  The patient's symptoms returned the week before the next injection and promptly resolved after taking the injection.  At the time of the visit, the patient noticed that their pain was usually deep inside, particularly when going upstairs and is dampened while taking the medication.  The patient tapered off Medrol and had been off the medication for 2 months.  The patient discontinued methotrexate after an incident where they soiled themselves after experiencing a flareup in symptoms.  The patient previously tried Taltz for 3 months but had frequent flares.  Humira lost efficacy and The patient received no relief with the use of Xeljanz.  

On physical examination, the patient had an elevated pulse of 120 and an elevated body mass index of 35.62.  The patient's assessment was otherwise unremarkable.  The patient's active problem list consisted of spondyloarthropathy, numbness of the foot, vitamin D deficiency, and knee swelling.  The plan at that time was to adjust Simponi injections to 100 mg/mL subcutaneous every 3 weeks.  The patient received a notice of adverse determination regarding Simponi with claims that there is a limit to 1 pen injector per 28-day supply.  The request for treatment every 3 weeks was reportedly not supported as a medical necessity.  

The Food and Drug Administration states that Simponi is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis alone, or combination with methotrexate, active ankylosing spondylitis, and moderate to severe ulcerative colitis with an adequate response or intolerant to prior treatment requiring continuous steroid therapy.  Patients are recommended 50 milligram (mg) administration by subcutaneous injection once a month for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.  Current medical literature notes that a unique aspect of some biologic used to treat rheumatoid arthritis is the potential for on label dose escalation.  This might take the form of an increase either in the dose administered or in the dosing frequency, or both.  Evidence has shown that the dose escalation of golimumab versus infliximab showed that the effectiveness was more prevalent in golimumab-intravenous (IV) for treating rheumatoid arthritis patients.  The information provided for the review noted that the patient benefited from the prior use of Simponi with no adverse side effects.  However, the patient did endorse that they were having diminished efficacy 3 weeks following each dose and was therefore being recommended for biweekly administration of Simponi.  Given that this medication has been approved for dose escalation to treat patients with ulcerative colitis, it was therefore determined to be safe and effective to treat other conditions requiring biological agents to treat symptoms.  Based upon the documentation and medical literature, the prior determination is overturned as Simponi (100 MG/ML pen injector, Quantity: 2, 28-day supply) is medically necessary.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.  

The medical necessity for Simponi (100 MG/ML pen injector, Quantity: 2, 28 day supply) is substantiated.