BlueCross BlueShield of Tennessee Medical Policy Manual

Thyrotropin Alfa

NDC CODE(S)

58468-1849-xx Thyrogen 1.1mg SOLR (Genzyme)

 

58468-0030-xx Thyrogen 1.1mg powder (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications Dose is 0.9 mg IM daily for 2 doses

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 thyrotropin alfa for the treatment of other conditions or diseases.

SOURCES

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Thyrotropin. Retrieved August 23, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Treatment Guidelines®. Thyroid Carcinoma. Retrieved August 24, 3016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2014, March). Center for Drug Evaluation and Research. Thyrogen® (thyrotropin alfa for injection), for intramuscular injection. Retrieved August 23, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020898s054lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

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

Thyrotropin Alfa (Thyrogen®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #4

  1. Does the individual have a diagnosis of well-differentiated thyroid carcinoma for ANY ONE of the following?

If yes, go to question #3

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

  1. Is the request for 1 billable unit (0.9 mg) daily for up to 2 doses or 0.9 mg IM daily?

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 approval criteria in questions 2 & 3?

If yes, go to question #3

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

  1. Is there absence of unacceptable of toxicity from the agent, e.g., urticaria, rash, pruritus, flushing and respiratory signs and symptoms?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

This document has been classified as public information.