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Repository corticotropin injection is a preparation of the natural form of adrenocorticotropic hormone (ACTH). It is intended to be used as an alternative to corticosteroids in steroid-responsive conditions.
ACTH gel (repository corticotropin injection) (H.P. Acthar® gel, Questcor Pharmaceuticals/Mallinckrodt Pharmaceuticals, St. Louis, MO) is a purified, sterile preparation of the natural form of adrenocorticotropic hormone (ACTH) in gelatin to provide a prolonged release after intramuscular or subcutaneous injection. ACTH is produced and secreted by the pituitary gland; H.P. Acthar gel uses ACTH obtained from porcine pituitaries. ACTH works by stimulating the adrenal cortex to produce cortisol, corticosterone, and a number of other hormones.
H.P. Acthar gel was approved by FDA in 1952, before there was a requirement that companies provide clinical evidence of efficacy. The product label states that Acthar gel is indicated for a number of conditions, as follow:
According to the prescribing information (i.e. product label), repository corticotropin injection may be used in the treatment of the following conditions:
Among the above indications, repository cotricotropin injection is best known for the treatment of infantile spasms. This is a rare epileptic disorder of early infancy (90% of cases are diagnosed in the first year of life). When infantile spasms are accompanied by neurodevelopmental regression and electroencephalogram (EEG) findings of hypsarrhythmia, the condition is known as West syndrome. Vigabatrin oral solution is another available treatment for infantile spasms.
A synthethic derivative of ACTH is commercially available outside of the United States (under the trade names Cortosyn and Synacthen) but it is not approved by the FDA for any of the conditions currently included in the H.P. Acthar gel FDA-approved label. In addition, a depot formulation of ACTH (Synacthen Depot) is available through a compassionate-use program through the specialty pharmacy Caligor Rx in New York. In June 2013, Questcor Pharmaceuticals announced that they acquired the rights to market Synacthen in the United States, once FDA approval is obtained.
Diagnostic testing of adrenocortical function, known as the ACTH test, is typically done with synthetic ACTH. Synthetic ACTH products have been approved by the FDA for this purpose. Unlike previous versions of the H.P. Acthar product label, an updated label issued in 2010, did not mention the use of repository corticotropin injection for diagnostic testing of adrenocortical function.
Repository corticotropin injection has potential adverse effects similar to those that occur with other steroid medications such as elevated blood pressure, decrease in bone density, new infections or activation of previous infection, and overproduction of cortisol, which can cause symptoms of Cushing syndrome.
H.P. Acthar gel (Questcor Pharmaceuticals) was approved by FDA in 1952. The product label states that Acthar gel is indicated for 19 conditions, including infantile spasms. 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, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Unlike previous versions of the product label, an updated label issued in 2010, did not include the use of repository corticotropin injection for diagnostic testing of adrenocortical function.
POLICYRepository corticotropin injection may be considered medically necessary for treatment of infantile spasms (West syndrome).
Repository corticotropin injection is considered investigational for use in diagnostic testing of adrenocortical function.
Use of repository corticotropin injection is considered investigational 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.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
There may be some patients who have medical contraindications or intolerance to corticosteroids that are not expected to occur with use of repository corticotropin injection, and who therefore may benefit from repository corticotropin injections. This situation is not expected to occur commonly.
The product information material makes the following comments about dosage of H.P. Acthar gel for treatment of infantile spasms:
Acthar gel should never be used intravenously.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY2/21/2008: Policy added
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.
09/16/2014: Policy reviewed; description updated. Policy statement unchanged.
01/30/2015: Policy description updated. Policy statement unchanged. Policy guidelines updated to add product information regarding the dosage of H.P. Acthar gel for treatment of infantile spasms.
08/14/2015: Medical policy revised to add ICD-10 codes.
02/11/2016: Policy description updated. Not medically necessary policy statements changed to investigational. Policy guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 5.01.17
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.