|58468-0030-XX Thyrogen 1.1 MG SOLR (GENZYME)|
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.
Thyrotropin alfa for the treatment/diagnosis of well-differentiated thyroid carcinoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Thyrotropin alfa for the treatment of other conditions/diseases is considered investigational.
Thyrotropin alfa is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of well-differentiated thyroid carcinoma for ANY ONE of the following:
Used as adjunctive diagnostic testing with prior thyroidectomy
Used as adjunctive treatment for radioiodine ablation of thyroid tissue remnants in individual who has undergone a near-total or total thyroidectomy without distant metastatic thyroid cancer.
Thyrotropin alfa is NOT considered medically appropriate for renewal/maintenance therapy.
DOSAGE & ADMINISTRATION
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.
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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, August). Thyrotropin. Retrieved March 11, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Treatment Guidelines®. Thyroid Carcinoma. Retrieved March 11, 2019 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 March 11, 2019 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020898s054lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 4/9/2019
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