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H.P. Acthar® (repository corticotropin injection) *

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 05.01.22 
Original Effective Date: January 2009 
Reviewed: June 2015 
Revised: June 2014 


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: 

The intent of the H.P. Acthar® drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. 

 

H.P. Acthar® has been approved by the FDA for the following indications:

  • Treatment of infantile spasms in children under 2 years of age
  • Treatment of exacerbation of multiple sclerosis

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Prior Approval: 

 

Prior approval is required. Submit a prior approval/treatment request now 


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Policy: 

I. H.P. Acthar® may be considered medically necessary for the treatment of infantile spasms when all of the following criteria are met:

 

•Patient must be less than 2 years of age
•Prescriber must be a neurologist
•Patient must have diagnosis of infantile spasms supported by documented symptom presentation and EEG features


Approval will be for 1 month.

 

II. H.P. Acthar® may be considered medically necessary for the treatment of acute exacerbations of multiple sclerosis when all of the following criteria are met:

 

•Prescriber must be a neurologist
•Patient must have tried and failed appropriate therapeutic doses of corticosteroids OR have a contraindication to corticosteroid use
•Patient must have tried and failed plasma exchange


Approval will be for 1 month.

 

III. H.P. Acthar® may be considered medically necessary for the treatment of nephrotic syndrome when all of the following criteria are met:

 

•Prescriber must be a nephrologist
•Patient must have a diagnosis of nephrotic syndrome
•Patient must have tried and failed appropriate therapeutic doses of corticosteroids OR have a contraindication to corticosteroid use
•Patient must have tried and failed at least two immunosuppressive agents

 
Approval will be for 6 months.

 

IV. H.P. Acthar® is considered medically necessary for corticosteroid-responsive conditions for which there are medical contraindications or intolerances to corticosteroids that are also not expected to occur with use of repository corticotropin injection.

 

Approval will be for 1 month.

 

V. H.P. Acthar® is considered not medically necessary for use in diagnostic testing of adrenocortical function.

 

CLINICAL RATIONALE

 

Repository corticotropin was approved in 2010 by the FDA as monotherapy in the treatment of infantile spasms. Prior to its approval, repository corticotropin was used off-label for this purpose for many years. Infantile spasms are a rare form of epilepsy characterized by myoclonic seizures and EEG findings of hypsarrhythmia.

 

The 2004 AAN Practice Parameter for the Medical Treatment of Infantile Spasms concluded repository corticotropin was probably effective in the treatment of infantile spasms and vigabitrin was considered possibly effective; however vigabitrin was associated with retinal toxicity.  An update to this guideline was conducted in 2012 and indicated that both repository corticotropin and vigabitrin were useful for short-term treatment of infantile spasm with repository corticotropin considered preferred over vigabitrin. Additionally, repository corticotropin may be considered over vigabitrin for use in cryptogenic infantile spasms. A 2008 Cochrane review compared the effects of single drugs in the treatment of infantile spasm and found no single treatment to be more efficacious than any of the others with the exception of one underpowered study of vigabitrin in the treatment of infantile spasms associated with tuberous sclerosis. However the authors did conclude that the strongest evidence suggests that hormonal treatment (prednisone, synthetic ACTH, and corticotropin) lead to resolutions of spasms faster and in more infants than vigabitrin.

 

Peer reviewed literature regarding use of repository corticotropin injection for use in treatment of acute exacerbations of MS is extremely limited. To date, there have been no studies showing corticotropin to be more effective than corticosteroids. Studies comparing corticotropin to corticosteroids have found corticosteroids to be equally or more effective than corticotropin in acute MS exacerbations. Per AAN guidelines, plasmapheresis should be considered as second-line treatment in steroid-resistant exacerbations of relapsing forms of MS.

 

Studies for other uses of corticotropin are limited. A retrospective case series was conducted on the use of corticotropin in nephrotic syndrome. The sample size was small and the majority of the subjects who were enrolled had trialed at least two immunosuppressive agents prior to using corticotropin.

 

The product label also states repository corticotropin may be used for the treatment of rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases and respiratory diseases. The published evidence in support of these conditions is sparse; however, repository corticotropin injection may potentially be a treatment option for an individual with one of these corticosteroid-responsive conditions who has contraindications or intolerance to corticosteroids.





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Procedure Codes and Billing Guidelines: 

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
  • J0800 Injection, corticotropin, up to 40 units

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Selected References: 

• H.P. Acthar [package insert]. Union City, CA. Questcor Pharmaceuticals, Inc; October 2010.

• Pellock JM, Hrachvoy R, Shinner S, et al. Infantile spasms: a U.S. consensus report. Epilepsia 2010;51(10):2175.

• Baram TZ, Mitchell WG, Tournay A, et al. High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996; 97(3):375-379.
• 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.
• Go CY, Mackay MT, Weiss SK, et al; Child Neurology Society; American Academy of Neurology. Evidence-based guideline update: medical treatment of infantile spasms. Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012; 78(24):1974-1980.
• Thompson AJ, Kennard C, Swash M, et al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse in MS. Neurology. 1989; 39(7):969-971.
• Abbruzzese G, Gandolfo C, Loeb C. "Bolus" methylprednisolone versus ACTH in the treatment of multiple sclerosis. Ital J Neurol Sci. 1983; 4(2):169-172.
• Cortese I, Chaudhry V, So Y, Cantor F, Cornblath D, Rae-Grant A. Evidence-based guideline update: Plasmapheresis in neurologic disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2011:76(3):294.
• Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011; 5:147-153.
• Filippini G, Brusaferri F, Sibley WA, et al. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database Syst Rev. 2000
• Milanese C, La Mantia L, Salmaggi A, et al. Double-blind randomized trial of ACTH versus
dexamethasone versus methylprednisolone in multiple sclerosis bouts. Clinical, cerebrospinal fluid and neurophysiological results. Eur Neurol 1989;29(1):10-4.


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Policy History: 

 

Date                                        Reason                              Action

June 2011                              Annual review                    Policy renewed

May 2012                              Annual review                    Policy renewed

June 2013                              Annual review                    Policy revised

June 2014                              Annual review                    Policy revised

June 2015                              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 assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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