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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Thyrogen is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.
2. Thyrogen is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid
tissue remnants in patients who have undergone a near-total or total thyroidectomy for
well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
B. Compendial Uses
1. Adjunct treatment for multinodular goiter
2. Adjunct treatment for thyroid cancer
3. Adjunct treatment for brain metastases
II. CRITERIA FOR INITIAL APPROVAL
A. Adjunctive diagnostic tool for well-differentiated thyroid cancer
Authorization of 1 month may be granted for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing when ALL of the following criteria are met:
1. Member is receiving follow-up for well-differentiated thyroid cancer
2. Member has previously undergone a thyroidectomy
B. Adjunct treatment for thyroid remnant ablation
Authorization of 1 month may be granted as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants when ALL of the following criteria are met:
1. Member has received a near-total or total thyroidectomy for well-differentiated thyroid cancer
2. Member does not show evidence of distant metastatic thyroid cancer
C. Adjunct treatment for multinodular goiter
Authorization of 1 month may be granted when used for adjunct treatment prior to radioiodine treatment of large multinodular goiters.
D. Adjunct treatment for thyroid cancer
Authorization of 1 month may be granted when used as adjunct treatment for the stimulation of radioiodine uptake in the treatment of patients with differentiated thyroid carcinoma.
E. Adjunct treatment for brain metastases
Authorization of 1 month may be granted when used as adjunct treatment for the stimulation of radioiodine uptake for the treatment of brain metastases from thyroid cancer.
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.
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).
REFERENCES
1. Thyrogen [package insert]. Cambridge, MA: Genzyme Corporation; March 2020.
2. IBM Micromedex® DRUGDEX ® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at https://www.micromedexsolutions.com. (Accessed: July 25, 2023)
3. Silva MNC, Rubio IGS, Romao R, et al: Administration of a single dose of recombinant human thyrotropin enhances the efficacy of radioiodine treatment of large compressive multinodular goiter. Clin Endocrinol 2004; 60:300-308.
4. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Thyroid Carcinoma. Version 3.2023. Accessed August 3, 2023. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf
5. Rudavsky AZ & Freeman LM: Treatment of scan-negative, thyroglobulin-positive metastatic thyroid cancer using radioiodine 131-I and recombinant human thyroid stimulation hormone. J Clin Endocrinol Metabolism 1997; 82:11-14.
6. Chiu AC, Delpassand ES, & Sherman SI: Prognosis and treatment of brain metastases in thyroid carcinoma. J Clin Endocrinol Metab 1997; 82(11):3637-3642.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
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.
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