Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Immunologic disorders. 
Treatment:  Pharmacy/Prescription Drug (Humira). 
The insurer denied the Pharmacy/Prescription Drug (Humira).  The denial is upheld in whole.

The patient is a male with a diagnosis of systemic sarcoidosis, which is mostly characterized by hypercalcemia, splenic lesion, skull lesion and generalized lymphadenopathy.  He has skin lesions, some of which are likely related to sarcoidosis and some which appear to be psoriatic.  Initially the provider documented two equivocal QuantiFERON gold tests, but later documentation states that the patient ruled out for latent tuberculosis.  The patient tested negative for Hepatitis B and C, despite history of increased transaminase.  Although he has had pleural and pericardial effusions, echocardiogram did not confirm a diagnosis of cardiac involvement with sarcoidosis.  He has been treated with steroids, but as of late only 20 milligrams (mg) by mouth (PO), daily (QD), which has been incompletely effective.  Due to increased transaminase studies, methotrexate was not a treatment option.  The provider is seeking authorization to treat with Humira, which is the subject of this review.

The health plan's determination is upheld in whole.

No, Humira is not medically necessary for this patient.  Humira is not a Food and Drug Administration (FDA) approved treatment option for Sarcoidosis and is not considered the standard of care for this diagnosis.  Although the patient may have psoriasis, it is mild and can be treated with topical agents.  Although the patient has a diagnosis of systemic sarcoidosis, the progress notes suggest that when patient is treated with high dose steroids there is a reasonable response.  The provider elected to taper steroids, and the most recent dose appears to be only 20 mg PO QD.

A review by Soto-Gomez, et al. suggested "An international consensus statement recommended prednisone (or its equivalent) at a starting dosage of 20 to 40 mg per day for four to six weeks (1).  If the patient's condition is stable or improved, the dosage should be tapered slowly to approximately 5 to 10 mg per day.  If there is no clinical response after three months of steroid therapy, a response to longer courses is unlikely.  Treatment should be continued for a minimum of 12 months before tapering off."  The patient may not have received high enough doses for a reasonable amount of time.  Per the same author, "Second- and third-line therapies for pulmonary sarcoidosis, including methotrexate, azathioprine (Imuran), leflunomide (Arava) biologic agents, and corticotropin (H.P. Acthar) gel are reserved for patients with corticosteroid-refractory disease, intolerable adverse effects, or toxicity from corticosteroids, as well as patients who choose not to take corticosteroids."  The patient's most recent transaminase studies were normal, which means methotrexate is not contraindicated.  There is also literature to suggest that anti-tumor necrosis factor (TNF) agents can cause or exacerbate sarcoidosis. (Mengi, et. al.)

Sweiss et al. used Humira successfully in some patients with sarcoidosis, who were refractory, but since this patient has not tried disease modifying anti-rheumatic drug (DMARD) therapy and is also not receiving higher dose steroids, he cannot be considered refractory.

In summary, Humira is not the standard of care for this diagnosis and is not medically necessary.  The patient has not tried all other reasonable therapies per the standard of care.