Does not apply to Medicare Advantage.
63004-8710-XX - Acthar H.P Gel 80 units/ml injection (Mallinckrodt Pharmaceuticals)
Corticotropin is a highly purified sterile preparation of adrenocorticotropic hormone (ACTH). It is currently only commercially available in gelatin to provide a prolonged release in tissues after subcutaneous or intramuscular injection. ACTH stimulates the adrenal cortex to produce multiple hormones, including cortisol, corticosterone and aldosterone.
Corticotropin therapy for the treatment of infantile spasms (West syndrome) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Corticotropin therapy for diagnostic testing of adrenocortical function is considered not medically necessary.
Corticotropin therapy for the treatment of other conditions/diseases is considered investigational.
Corticotropin therapy is considered medically appropriate if ALL of the following are met:
Diagnosis of infantile spasms (West syndrome) is clinically documented
Individual is 2 years of age or younger
Documentation that individual is free from suspected congenital infection
Treatment must be as monotherapy
Corticotropin therapy is considered medically appropriate for renewal for one month if ALL of the following criteria are met:
All original criteria for approval are met
Disease response is indicated by improvement or resolution of symptoms and/or normalization of laboratory tests
Absence of unacceptable toxicity from the e.g., GI bleeding; gastric ulcer; hypertension; hypokalemia; severe depression; frank psychotic manifestations; posterior subcapsular cataracts; glaucoma; new onset seizures; pancreatitis
DOSAGE & ADMINISTRATION
75 units/m² intramuscularly given twice daily for 2 weeks, then taper the dose over a 2 week period (e.g., 30 units/m2 in the morning for 3 days; 15 units/m2 in the morning for 3 days; 10 units/m2 in the morning for 3 days; and 10 units/m2 every other morning for 6 days)
LENGTH OF AUTHORIZATION
Coverage will be provided for 1 month and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). Repository corticotropin injection (5.01.17). Retrieved January 4, 2019 from BlueWeb.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, November). Corticotropin. Retrieved January 4, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, April). Center for Drug Evaluation and Research. H. P. Acthar gel (repository corticotropin) injection, gel for intramuscular / subcutaneous use. Retrieved January 4, 2019 from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008372s057lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/14/2008
MOST RECENT REVIEW DATE: 7/9/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; up to 40 units = 1 billable unit