Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cardiac/Circulatory Problems. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied: Humira. 
The denial is overturned in whole. 

The patient is a male with systemic sarcoidosis including cardiac involvement for whom coverage of adalimumab (Humira) was requested. The initial request was denied by the health plan because coverage criteria were not met. The denial was upheld on appeal. The prescribing rheumatologist appealed the denial in a letter and also submitted a Telehealth office note.

The health plan's determination is overturned in whole. 

Humira is medically necessary for this patient. Typically, treatment of sarcoidosis, regardless of specific manifestations, initially involves treatment with corticosteroids. If corticosteroids fail to control the sarcoid disease activity, common practice over the past several decades has employed the use of "standard" immunosuppressives such as Methotrexate, Azathioprine, Leflunomide or Mycophenolate to treat refractory pulmonary Sarcoidosis (Cremers, et. al.; Korsten, et. al.; Vorselaars, et. al.). There is a relative paucity of data in the peer-reviewed literature regarding the most appropriate treatment for specific organ systems or for multiorgan system involvement. Much of the literature to guide clinicians is based upon small case series, case reports, and review articles authored by experts in this condition. While conventional immunosuppressive drugs are often utilized as first-line steroid-sparing agents in the treatment of sarcoidosis refractory to corticosteroids, there are no large-scale, prospective, randomized studies demonstrating their efficacy in this condition. There is extensive literature suggesting specific TNF (tumor necrosis factor) antagonists as effective treatments for refractory sarcoidosis, particularly Infliximab and Adalimumab (Adler, et. al.; James, et. al.). The evidence is based upon case series, case reports, retrospective studies, open label prospective studies, and several small, randomized, controlled studies.
Sweiss, et. al. performed an open-label 52-week prospective study (number [n]=11) of Humira in the treatment of refractory pulmonary sarcoidosis and found that it was effective and well-tolerated. Pariser, et. al. performed a double-blinded randomized prospective study of Humira versus Placebo for 12 weeks (n=16) followed by a 12-week open-label extension and 8 weeks of no treatment in patients with refractory cutaneous sarcoidosis. Humira was found to be effective in reducing the size of the lesions and was well-tolerated. In a small, prospective, observational 24- week study, Humira reduced disease activity in 9/10 refractory sarcoidosis patients as assessed by FDG-PET (fluorodeoxyglucose - positron emission tomography) Rosenthal, et. al. (cited by the provider) described positive outcomes in over 80% of patients (improvement in FDG uptake) or resolution of FDG uptake in over 60% of patients receiving Adalimumab in combination with Methotrexate. In this case, the patient had severe cardiac sarcoidosis which inadequately responded to treatment with corticosteroids and methotrexate alone. There is as much evidence in the peer-reviewed medical literature to support the use of Humira in steroid refractory Sarcoidosis as with any alternative immunosuppressive medications. As such, Humira is medically necessary as supported by current medical literature, and there are no alternative medications anticipated to be more health beneficial in this scenario.