ACTH Gel (Repository Corticotropin Injection)

POLICY NUMBER

A.5.01.17

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Repository corticotropin injection is a preparation of the natural form of adrenocorticotropic hormone (ACTH). The injection is used to treat corticosteroid-responsive conditions and as a diagnostic tool to test adrenal function.

Repository Corticotropin Injection

Repository corticotropin injection (H.P. Acthar Gel) 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.

Indications

H.P. Acthar Gel was approved by the U.S. Food and Drug Administration (FDA) before the requirement that companies provide evidence of clinical efficacy. The table below summarizes the current prescribing indications and usage for Acthar Gel. In 2006, a review of an efficacy supplement for the infantile spasms indication was initiated. The sponsor was requested to provide a dossier of safety and efficacy data from preexisting clinical trials and archival literature. In 2010, the FDA finalized this review and determined there was sufficient scientific and clinical evidence to support its use for the infantile spasms indication.

Indications for Repository Corticotropin Injection

^aControlled trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.^bKeratitis; iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis; anterior segment inflammation.^cWithout uremia of the idiopathic type or due to lupus erythematosus.

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.

Adverse Events

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, primary adrenocortical insufficiency, adrenocortical hyperfunction, suspected congenital infection in infants, concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel, or sensitivity to proteins of porcine origin.

Repository corticotropin injection has potential adverse events similar to those that occur with other steroid medications such as elevated blood pressure, a decrease in bone density, new infections (or activation of previous infection), and overproduction of cortisol, which can cause symptoms of Cushing syndrome.

In 1952, H.P. Acthar Gel (Questcor Pharmaceuticals/Mallinckrodt Pharmaceuticals) was approved by the FDA. The original product label included at least 19 separate conditions, including infantile spasms. A 1979 efficacy supplement added the treatment of acute exacerbation of multiple sclerosis. At one time, this product was indicated as an injection for diagnostic testing of adrenocortical function. In 2010, this indication was removed with an update to the product label.

POLICY

Repository corticotropin injection may be considered medically necessary for the 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 a 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 EXCEPTIONS

State Health Plan (State and School Employees) Participants

Federal 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.

POLICY GUIDELINES

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

Some individuals may 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 common.

Product information provides the following on dosage of H.P. Acthar® Gel for treatment of infantile spasms:

• In the treatment of infantile spasms, the recommended dose is 150 U/m² divided into twice daily intramuscular injections of 75 U/m². After 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 2-week period.

• In the treatment of other disorders and diseases, dosing will need to be individualized, depending on the disease under treatment and the medical condition of the individual. It may be necessary to taper the dose.

H.P. Acthar gel is used for intramuscular or subcutaneous injection and 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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

2/21/2008: 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.

05/26/2016: Policy number A.5.01.17 added.

11/29/2016: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding the use of Acthar gel.

10/31/2017: Policy description updated regarding indications for repository corticotropin injection. Policy statements unchanged.

11/05/2018: Policy description updated regarding products. Policy statements unchanged.

11/19/2019: Policy reviewed; no changes.

11/23/2020: Policy description updated regarding indications and contraindications. Policy statements unchanged.

01/17/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/13/2022: Policy reviewed. Policy statements unchanged. Policy Guidelines updated with minor wording changes.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

09/25/2023: Code Reference section updated to make note of deleted HCPCS code.

03/04/2024: Policy description updated regarding adverse events. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals."

12/16/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy statements unchanged. Code Reference section updated to remove deleted HCPCS code J0800.

01/10/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 5.01.17

CODE REFERENCE

This 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.

Covered Codes

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