Repository Corticotropin Intramuscular Injection

Policy ID: I-9121-004

Section: Injections

Effective Date: January 04, 2021

Revised Date: September 11, 2023

Revision Effective Date: October 01, 2023

Last Reviewed: September 12, 2023

Applies To: Commercial Only

Description

Repository c orticotropin (Acthar Gel ^® , Purified Cortrophin ^™ Gel ) is an adrenocorticotropic hormone (ACTH) analogue indicated as monotherapy for the treatment of infantile spasms (West Syndrome) in infants and children less than two (2) years of age.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Repository corticotropin injection (Acthar Gel, Purified Cortrophin Gel) may be considered medically necessary for use in individuals who meet the following criteria:

The individual has a diagnosis of infantile spasms; and
The individual is less than 24 months of age; and
If the request is for Purified Cortrophin Gel, then ONE of the following:
- The individual has tried and had an inadequate response to Acthar Gel that is not expected to occur with Purified Cortrophin Gel; or
- The individual has an intolerance or hypersensitivity to Acthar Gel that is not expected to occur with Purified Cortrophin Gel; or
- The individual has and FDA labeled contraindication to Acthar Gel that is not expected to occur with Purified Cortrophin Gel; and
The individual does NOT have any FDA labeled contraindications to repository corticotropin injection.

The use of repository corticotropin injection (Acthar Gel, Purified Cortrophin Gel) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J0801

J0802

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

G40.821

G40.822

G40.823

G40.824

Professional Statements and Societal Positions Guidelines

Acthar Gel FDA Labeled Contraindication(s)

• Intravenous administration
• Individuals with 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, or sensitivity to proteins of porcine origin
• Administration of live or live attenuated vaccines is contraindicated in individuals receiving immunosuppressive doses of Acthar Gel
• In individuals under two (2) years of age with suspected congenital infections

Purified Cortrophin Gel FDA Labeled Contraindication(s)

Intravenous administration
Individuals with 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 derived from porcine sources
Individuals with primary adrenocortical insufficiency or adrenocortical hyperfunction

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopted medical policy, a pharmacy policy is currently available

Internal Medical Policy Committee 11-23-2021 Annual review, contraindications added to policy

Internal Medical Policy Committee 3-23-2022 Added Purified Cortrophin Gel to the policy

Internal Medical Policy Committee 3-23-2023 - Effective May 01, 2023

Removed 'The requested quantity (dose) is within FDA labeled dosing for the requested indication' criteria
Updated experimental/investigational statement

Internal Medical Policy Committee 9-12-2023 Effective October 01, 2023

Added new codes, J0801 and J0802, to the policy
Removed code, J0800, from the policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-9121-003