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According to the 2010 product information (product labeling), repository corticotropin injection may be used in the treatment of the following conditions:

• Infantile spasms: Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.
• Multiple Sclerosis: Treatment of acute exacerbations of multiple sclerosis in adults.
• Rheumatic Disorders: Indicated as 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.
• Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).
• Dermatologic Diseases: Indicated for treatment of severe erythema multiforme, Stevens-Johnson syndrome.
• Allergic States: Serum sickness.
• Ophthalmic Diseases: 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.
• Respiratory Diseases: Symptomatic sarcoidosis
• Edematous State: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Contraindications for use of this agent include scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, hypertension, or sensitivity to proteins of porcine origin. 

West Syndrome/Infantile Spasms
West syndrome is a rare epileptic disorder of early infancy (90% of cases are diagnosed the first year of life) consisting of three main characteristics; infantile spasm, mental retardation and hypsarrhythmia, a specific abnormal pattern on EEG. Often the term infantile spasms is used synonymously with West syndrome. Infantile spasms are characterized by an initial contraction phase followed by a more sustained tonic phase.

In December 2008, Questcor resubmitted a supplemental new drug application (sNDA) for H.P. Acthar gel (repository corticotrophin) injection to the FDA for treating infantile spasms. Approval was granted in October 2010.

Alternative Treatments for Infantile Spasms

Synthetic ACTH
Cosyntropin (Cortosyn®, Amphastar), a synthetic form of ACTH, is created by isolating the first 24 amino acids from ACTH peptide. The only FDA-labeled indication is in the diagnostic testing of adrenal function. Unlike the natural form of ACTH, which is given intramuscularly or subcutaneously, Cortrosyn should only be given intravenously. A depot formulation of cosyntropin (Synacthen Depot) is not approved by the FDA.

Vigabatrin
In August 2009, vigabatrin (Sabril®, Lundbeck, Inc.) oral solution was approved by the FDA. Sabril is indicated as monotherapy for pediatric patients.

Repository corticotropin injection is considered not medically necessary for use in diagnostic testing of adrenocortical function.

Use of repository corticotropin injection is considered not medically necessary as treatment of corticosteroid-responsive conditions, unless there are medical contraindications or intolerance to corticosteroids that are not also expected to occur with use of repository corticotropin injection.

Except as noted above, use of repository corticotropin injection is considered investigational for conditions that are not responsive to corticosteroid therapy including, but not limited to, use in tobacco cessation, acute gout, and childhood epilepsy.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

3/27/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)

06/22/2010:  Policy title changed from “ACTH gel” to “ACTH Gel (Repository Corticotropin Injection).  Terminology updated throughout policy. Policy statement regarding repository corticotropin injection use in diagnostic testing of adrenocortical function changed from medically necessary to not medically necessary. Deleted the following ICD-9 codes from the Covered Codes table due to the policy statement change: 255.0, 255.10, 255.11, 255.12, 255.13, 255.14, 255.2, 255.3, 255.41, 255.42, 255.5, 255.6, 255.8, 255.9. Policy statement updated regarding corticosteroid-responsive conditions and to add acute gout and childhood epilepsy as investigational conditions. Policy guidelines updated with supporting explanations. FEP verbiage added to the Policy Exceptions section. Added CPT code 96372.  

08/11/2011: Policy description and guidelines updated. Policy statement unchanged.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

Covered Codes