Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriatic Arthritis

Treatment: HUMIRA 40/0.4 milliliters (ML) injection (INJ)

The insurer denied coverage for HUMIRA 40/0.4 milliliters (ML) injection (INJ)

The denial is overturned

The patient is seeking coverage for Humira 40 milligrams (mg) / 0.4 milliliters (mL) injection weekly.

The patient presented for an evaluation.  The patient had psoriatic arthritis, uveitis, psoriasis, and psoriatic nail disease with severe onycholysis.  The patient has been treated with Humira.  The patient was previously on methotrexate, but this was stopped due to severe nausea.  The patient had been treated with corticosteroids for several years.  The patient was tolerating Humira.  The patient's neck pain was improved with low-dose naltrexone.  However, the patient had very vivid dreams and was waking up with tension.  The patient had headache and nonrestorative sleep.  The patient still had over an hour of stiffness in the hands and sacroiliac/coccyx joint.  The patient had persistent painful nail disease.  The assessment was psoriatic arthritis not optimally controlled.  There was a plan to increase Humira dose to 40 mg once a week.

The Food and Drug Administration states that Humira is indicated for psoriatic arthritis and uveitis.  Psoriatic arthritis treatment is recommended at 40 mg every other week.  For uveitis, treatment is recommended at 80 mg for the initial dose followed by 40 mg every other week.  Per the cited references, some studies have found that weekly Humira treatment after failing every other week dosing for ocular inflammation have promoted remission. Ryan et. al. notes that patients with psoriasis, the safety of Humira every week dosing and every other week dosing was comparable and consistent with expected adverse effect profile of the medication.  The safety of Humira dosing in patients with dermatological conditions was supported by data comparing every week and every other week dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis.  In this case, the patient was being treated with Humira 40 mg every 2 weeks.  While the patient had some improvement with Humira, the results were inadequate to sufficiently control symptoms.  The patient was being treated for severe psoriatic nail disease, arthritis, and uveitis.  The patient continued to experience persistent and debilitating symptoms of both psoriatic arthritis and uveitis.  The patient's condition had significantly affected their quality of life.  The provider requested an increase in frequency in the medication.  The request does not meet Food and Drug Administration approved frequency for the patient's diagnoses.  However, the cited literature notes that dose escalation has been found to be safe and effective for patients with uveitis that has been inadequately controlled at standard 2-week dosing.  Current literature also supports increased frequency of dosage for patients with inflammatory dermatological conditions who have had inadequate response to initial standard dosing.  The dose escalation is needed to prevent deterioration of the patient's health which could result in hospitalization.  The treatment has been found safe and effective based on recent literature.  Switching to alternative treatments when Humira has not been exhausted could result in antibody formation and inability to utilize Humira in the future.  Thus, the dose escalation is reasonable in this case.  As such, the denial of Humira 40 mg / 0.4 mL injection weekly is overturned as 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 HUMIRA 40/0.4ML INJ is substantiated.