BlueCross BlueShield of Tennessee Medical Policy Manual

Pegademase Bovine

NDC CODE(S)

57665-0001-XX Adagen 250 UNIT/ML SOLN (LEADIANT BIOSCIENCES)

DESCRIPTION

Pegademase bovine is an enzyme derived from bovine intestine modified for human enzyme replacement therapy for the treatment of severe combined immune deficiency disease (SCID) associated with a deficiency of adenosine deaminase (ADA).  SCID associated with ADA deficiency is a rare, inherited and often fatal disease.  Without the ADA enzyme, purine substrates accumulate and cause metabolic abnormalities that are directly toxic to lymphocytes.

While this immune deficiency can be cured by bone marrow transplantation, if a suitable marrow donor is not available or if the transplantation fails, prior to the development of an enzyme replacement, periodic transfusions of irradiated red blood cells have provided some relief, but with serious risks of iron overload and viral transmission. Direct replacement of the deficient enzyme eliminates toxic metabolites of the deficiency and improved immune function.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Adenosine deaminase deficiency

Adagen is administered every 7 days by IM (intramuscular) injection.

Initiation:

First dose: 10 units/kg

Second dose: 15 units/kg

Third dose: 20 units/kg

Maintenance:

20 units/kg/week

The weekly dose may be increased by increments of 5 units/kg/week based on laboratory monitoring up to a maximum of 30 units/kg/week.

LENGTH OF AUTHORIZATION

Coverage will be provided per 12 months 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.

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).

SOURCES

Hirschfield, M. (2006, October, Updated 2017, March). Adenosine Deaminase Deficiency. In: Adam, M. P., Ardinger, H. H., Pagon, R. A., et al., eds., GeneReviews®. Seattle (WA): University of Washington, Seattle; 1993-2018. Retrieved October 31, 2018 from https://www.ncbi.nlm.nih.gov/books/NBK1483/.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, August). Pegademase bovine. Retrieved October 31, 2018 from MICROMEDEX Healthcare Series.

National Heart, Lung and Blood Institute Health Topics. (2018) Thrombocytopenia. National Institutes of Health; U.S. Department of Health and Human Services. Retrieved October 31, 2018 from https://www.nhlbi.nih.gov/health-topics/thrombocytopenia.

U.S. Food and Drug Administration. (2014, June). Center for Drug Evaluation and Research. Adagen® (pegademase bovine) injection. Retrieved October 31, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  3/2/2019

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.

This document has been classified as public information.

 


DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

Adenosine deaminase deficiency

25 IU = 1 billable unit

150 billable units per 7 days