BlueCross BlueShield of Tennessee Medical Policy Manual

Corticotropin Therapy

Does not apply to Medicare Advantage.

NDC CODE(S)

63004-8710-XX - Acthar H.P Gel 80 units/ml injection (Mallinckrodt Pharmaceuticals)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE

Infantile spasms

75 units/m²/dose given twice daily for 2 weeks, then taper the over a 2 week period

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

No controlled studies were found in the published literature that validate the use of corticotropin therapy for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2015). Repository corticotropin injection (5.01.17). Retrieved February 19, 2016 from BlueWeb.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, August). Corticotropin. Retrieved August 26, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2010, October). Center for Drug Evaluation and Research. H. P. Acthar gel (repository corticotropin) injection, gel for intramuscular / subcutaneous use. Retrieved February 19, 2016 from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  9/14/2008

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Corticotropin Therapy (H.P. Acthar® Gel)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Does the individual have a diagnosis of infantile spasms (West syndrome) in an individual 2 years of age or younger who is free from suspected congenital infection (documented)?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is treatment as monotherapy?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 63 billable units every 28 days with dosage of 75 units/m²/dose given twice daily for 2 weeks, then tapered the over a 2 week period for one month with possible renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 4?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there disease response with treatment as indicated by resolution of symptoms and/or normalization of laboratory tests?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, e.g., GI bleeding, gastric ulcer, hypertension, hypokalemia, severe depression, frank psychotic manifestations, posterior subcapsular cataracts, glaucoma?

If yes, this satisfies medical necessity and medical appropriateness criteria for one month

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.