Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Iridocyclitis
Treatment: Corticotropin (H.P. Acthar gel)
The insurer denied the Corticotropin (H.P. Acthar gel)
The denial is overturned

The patient is a female with rheumatoid arthritis and recurrent iridocyclitis of the left eye for whom coverage of Acthar gel is the subject of review. Reportedly, the patient is currently taking oral prednisone and hydroxychloroquine after having tried and failed or had intolerance to Humira (adalimumab), Orencia (abatacept), and methotrexate. Ocular history is also notable for superficial keratitis and dry eye syndrome.

An exam documents vision as 20/20 OD (right eye) and 20/25 OS (left eye). The left eye demonstrated 1+ flare and a 1+ nuclear sclerotic cataract. Risk benefits and alternatives to systemic immunosuppressive therapy were discussed and the provider recommended considering Acthar. Upon appeal, the patient is identified as being a steroid responder with intraocular pressure increased as high as 34 mmHg (millimeters of mercury).

Yes, the requested Acthar is established as medically necessary.
According to the package insert, H.P. Acthar Gel may be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous state. Ophthalmic diseases include severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis; iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis; anterior segment inflammation.

In this case, Acthar is proposed for the treatment of recurrent uveitis/ iridocyclitis of the left eye associated with rheumatoid arthritis.  Several case reports are identified in the peer reviewed medical literature which support the safety and efficacy of Acthar in the treatment of such non-infectious uveitis.

Agarwal et al recently published a case report describing the potential role of subcutaneously administered ACTH (adrenocorticotropic hormone) gel in the management of a patient with non-infectious panuveitis with significant retinal vasculitis, macular edema, and optic nerve inflammation. Therapy with ACTH (adrenocorticotropic hormone) gel resulted in rapid and adequate control or retinal vascular leakage, macular edema and optic nerve inflammation. At the end of 6 weeks, there were no safety concerns and no systemic or local adverse events were recorded. The authors encouraged future clinical trials employing repository corticotropin injection in the management of uveitis.

In a second case report by Ahmad et al, a 16-year-old female with recurrent uveitis associated with poorly controlled juvenile idiopathic arthritis reported remission of uveitis symptoms after receiving RCI (repository corticotropin injection) (80 units administered intramuscularly 2 times per week) as additive therapy. Notably, before RCI (repository corticotropin injection) therapy, she reported 1 to 2 uveitis flares per month despite ongoing systemic therapy, including steroids, methotrexate, and infliximab. Remission of ocular symptoms was achieved within 2 weeks of initiating RCI (repository corticotropin injection) and continued for at least 6 months.

Sharon et al. reported the clinical course of three patients with bilateral, non-infectious anterior and intermediate uveitis, treated with ACTH (adrenocorticotropic hormone) gel for 12 months. All three patients had chronic and steroid-dependent ocular inflammation with subsequent development of ocular complications. Twice-weekly treatment with subcutaneous 80 units/day ACTH (adrenocorticotropic hormone) gel was administered, and clinical outcome measures were observed. After a mean period of 14 months, all patients demonstrated significant improvement in disease activity, stable visual acuity, and an absence of side effects. Systemic steroids dosage was successfully reduced from a mean dose of 16 milligrams/day upon the initiation of ACTH (adrenocorticotropic hormone) gel treatment to 2 milligrams/day at last follow up. They concluded that subcutaneous ACTH (adrenocorticotropic hormone) gel has shown to be a safe and effective therapy in the management of non-infectious uveitis. Specifically, ACTH (adrenocorticotropic hormone) gel plays a role in refractory and steroid-dependent cases and in those who do not respond to or are unable to tolerate other immunomodulatory therapies.

Most recently, Nelson et al performed a retrospective medical records review of patients who had a diagnosis of uveitis, received Repository corticotropin injection (RCI) in the past 12 months and had completed or were receiving RCI (repository corticotropin injection) treatment at the time of data collection. Their study included 91 patients (mean age 41 years, 62% female, and mean time since diagnosis 3.98 years). Most patients had moderate (n [number] = 48, 53%) to severe (n [number] = 21, 23%) visual impairment, and none was blind before RCI (repository corticotropin injection) therapy. Patients used an average of 2.5 medications before RCI (repository corticotropin injection). Initial RCI (repository corticotropin injection) dosing regimens, dose adjustments, and treatment durations were different for each patient. Concomitant medication use and dosages were reduced during RCI (repository corticotropin injection); 76 patients (84%) improved, 15 patients (16%) stayed the same, and none worsened; 86% of patients had improvements in vision. The author concluded that physicians individualized RCI (repository corticotropin injection) therapy among patients who suffered uveitis for several years and when previous therapies were inadequate. Most patients improved after initiating RCI (repository corticotropin injection), most commonly in vision. The findings support use of RCI (repository corticotropin injection) for uveitis.

Uveitis is usually treated with a step-wise approach using corticosteroids, immunosuppressive therapy, and biologics. This patient has tried and failed or been intolerant to such therapies including prednisolone/prednisone, methotrexate, and the biologics Humira and Orencia. There is support for the requested use in the peer reviewed medical literature. Therefore, the medical necessity of the requested Acthar is established in this case.

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