Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rheumatoid Arthritis

Treatment: Acthar Gel

The insurer denied Acthar Gel.

The denial was upheld.

This is a female patient with a history of RA (Rheumatoid Arthritis).  She is on anti-viral therapy for immunedeficiency.  She has been on Acthar Gel for several months for active RA.  She is also on Sulfasalazine, Plaquenil and diclofenac gel.  When seen she had stiffness, pain and multiple tender joints.  An increase in medications is considered. 
	
Documentation stated that the patient has severe pain and swelling in the hands, knees, ankles, and elbows, as well as daily morning stiffness.  Her symptoms are debilitating.  She has tried and failed Enbrel, Humira, Hydroxychloroquine, Sulfasalazine and Diclofenac gel.  The patient has been using Acthar gel successfully since February to relieve her symptoms.  Acthar gel is Food and Drug Administration (FDA) approved and indicated for short-term administration for rheumatoid arthritis.  Dr. Disla cites clinical studies and requests approval for continuation of treatment.


The patient has RA that is active despite therapy with sulfasalazine, Plaquenil and Acthar.  She has apparently failed anti-TNF agents in the past.  This is with anti-viral therapy for immune deficiency in the background.  There is no mention in the available documentation about prior use of other biologics, prednisone, methotrexate or leflunomide. 

The FDA approval for Acthar includes the following [underlining by reviewer]

Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis.

No definition of selected cases is given.

While Acthar may have mechanisms of action besides stimulation of corticosteroids, the latter still happens and needs to be taken into account.  The labelling has a spectrum of side-effects typical of prednisone and other corticosteroids. 

A search of www.uptodate.com finds no reference to the use of Acthar in the treatment of RA.

The Gillis study noted by Dr. Disla is a 12-week open-label study of 8 patients with no controls or comparator therapies. 

The Gaylis study is a 10-patient 24-week open label study of Acthar with a fixed dose of MTX at 15 mg/wk.  The study was not designed to look at long-term X-ray benefit.  There is no control or comparator in the study. 

The Fleischmann paper is an abstract. This reviewer did not find an article published. 

The patient has already received 3-4 months of Acthar and still has active RA.  There is no dose titration schedule with Acthar, and it has the same long-term toxicities as conventional steroids. There is no evidence it works any better as a Disease-Modifying Anti-Rheumatic Drug (DMARD) than conventional steroids.  There doesn't appear to be an advantage to maintaining Acthar over using conventional corticosteroids and other long-acting agents. 

The health plan acted reasonably with sound medical judgment in the best interest of the patient. 

The carrier's denial of coverage for Acthar Gel IS SGM is upheld.  The medical necessity is not substantiated.