Repository Corticotropin Injection
Medical Policy: 05.01.22
Original Effective Date: January 2009
Reviewed: May 2012
Revised: June 2010
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Repository corticotropin injection (H.P. Acthar® Gel, Questcor, Union City, CA) is a purified sterile preparation of adrenocorticotropic hormone (ACTH) in gelatin to provide a prolonged release after intramuscular or subcutaneous injection. ACTH works by stimulating the adrenal cortex to produce cortisol, corticosterone, and a number of other hormones.
According to the 2011 product information (product labeling), repository corticotrophin injection may be used in the treatment of the following conditions:
- Infantile spasms in infants and children under 2 years of age
- Acute exacerbations of Multiple Sclerosis in adults
- Rheumatic disorders:
- Adjunctive therapy for short-term administration in psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), and ankylosing spondylitis
- Collagen diseases::
- During an exacerbation or as maintenance therapy in systemic lupus erythematosus or systemic dermatomyositis (polymyositis)
- Dermatologic diseases such as:
- Severe erythema multiforme
- Steven-Johnson syndrome
- Allergic states such as:
- Ophthalmic disease such as:
- Keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Respiratory diseases such as:
- Edematous states such as:
Contraindications for the 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, uncontrolled hypertension, or sensitivity to proteins of porcine origin.
West syndrome is considered a triad of infantile spasms, an EEG pattern named hypsarrhythmia, and mental retardation, although not all 3 components are required. Often the term infantile spasm is used synonymously with West syndrome. Infantile spasms are characterized by an initial contraction phase followed by a more sustained tonic phase. Repository corticotropin injection has been considered the first-line treatment for infantile spasms. Data for its use was summarized in a practice parameter for the American Academy of Neurology. While this review concluded that repository corticotropin injection is “probably an effective agent in the short-term treatment of infantile spasms” evidence for it was stronger than for any other pharmacologic agent. The report also indicates that there is insufficient evidence to determine whether oral corticosteroids are effective and that vigabatrin was possibly effective but that there are concerns about retinal toxicity. This report also notes that the impact of treatment of seizures/spasms on long-term patient outcomes is unknown.
Other than in infantile spasms, there is minimal published literature concerning use of repository corticotropin injection for conditions not considered steroid-responsive. For potential use in tobacco cessation, one article described an uncontrolled study of its use in 15 patients. A 2007 Cochrane review on childhood epilepsy included a single randomized controlled trial that recruited 5 patients. There is also a paucity of literature on the potential use of repository corticotrophin injection in acute gout. Thus, except for use in infantile spasm, use of repository corticotropin injection in conditions that are not responsive to corticosteroids is considered investigational.
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Prior Approval:
Not applicable
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Policy:
Repository corticotropin injection may be considered medically necessary for treatment of infantile spasms (West Syndrome).
Repository corticotropin injection is considered not medically necessary for use in diagnostic testing of adrenocortical function.
Repository corticotropin injection is considered not medically necessary as a treatment of steroid-response conditions, unless there are medical contraindications or intolerance to corticosteroids that are not also expected to occur with the use of ACTH gel.
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, childhood epilepsy, and acute gout.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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96372 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular.
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J0800 Injection, corticotropin, up to 40 units
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Selected References:
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Mackay MT, Weiss SK, Adams-Webber T et al. Practice Parameter: Medical treatment of Infantile Spasms: Report of the American Academy of neurology and the Child Neurology Society. Neurology 2004; 62(10):1668-81.
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Thompson Healthcare. Corticotropin (systemic) monograph. USP DI, Volume 1 Drug Information for the Health Care Professional. Greenwood Village CO: Thompson Micromedex; 2007:964-6.
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Riikonen R. The latest on infantile spasms. Curr Opin Neurol 2005; 18(2):91-5.
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Kwon YS, Jun YH, Hong YJ et al. Topiramate monotherapy in infantile spasm. Yonsie Med J 2006; 47(4):498-504.
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McElhaney JL. Repository corticotrophin injection as an adjunct to smoking cessation during the initial nicotine withdrawal period: results from a family practice clinic. Clin Ther 1989; 11(6):846-53.
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Questcor Pharmaceuticals, Inc. H.P. Acthar® Gel (repository corticotrophin injection). Prescribing Information. Union City, CA: Questcor Pharmaceuticals; issued June 2011. Available at: . http://www.acthar.com/files/Acthar-PI.pdf. Accessed May 2012.
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Policy History:
Date Reason Action
June 2011 Annual review Policy renewed
May 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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