BlueCross BlueShield of Tennessee Medical Policy Manual

Thyrotropin Alfa

NDC CODE(S)

58468-0030-XX Thyrogen 1.1 MG SOLR (GENZYME)

DESCRIPTION

Thyrotropin alfa is a recombinant human thyroid stimulating hormone (rhTSH) preparation which a heterodimeric glycoprotein comprised of two non-covalently linked subunits of amino acid residues.  The amino acid sequences of these two subunits together are identical to that of human pituitary TSH.  The activity of thyrotropin alfa is determined relative to a reference standard calibrated against the World Health Organization (WHO) TSH reference standard.

Thyrotropin (rhTSH) stimulates the thyroid gland to produce thyroid hormone. Binding of thyrotropin alfa to TSH receptors on normal thyroid epithelial cells or on well-differentiated thyroid cancer tissue stimulates iodine uptake and synthesis and secretion of thyroglobulin (Tg), triiodothyronine (T3) and thyroxine (T4).

The effect of rhTSH activation of thyroid cells is to increase uptake of radioiodine to allow detection or radioiodine killing of thyroid cells. TSH activation also leads to the release of Tg by thyroid cells. Tg functions as a tumor marker which is detected in blood specimens.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Thyroid Cancer

Two-injection regimen: 0.9 mg administered intramuscularly followed by a second 0.9 mg intramuscular injection 24 hours later.

LENGTH OF AUTHORIZATION

Coverage will be for two doses and may not be renewed.

Click here to view DOSAGE LIMITS

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 validates the use of thyrotropin alfa for the treatment of other conditions or diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Thyrotropin. Retrieved February 2, 2018 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Treatment Guidelines®. Thyroid Carcinoma. Retrieved February 05, 2018 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Thyrogen® (thyrotropin alfa for injection), for intramuscular injection. Retrieved February 02, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020898s054lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  4/10/2018

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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

Thyroid Cancer

1 billable unit = 0.9 mg  

1 billable unit daily for 2 doses