Thyrogen (thyrotropin alfa for injection)
Indications for Prior Authorization
Thyrogen (thyrotropin alfa for injection)
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For diagnosis of Adjunctive Diagnostic Tool for Serum Thyroglobulin Testing in Well Differentiated Thyroid Cancer
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.Limitations of Use: Thyrogen-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal. Even when Thyrogen-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease. Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable.
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For diagnosis of Adjunct for Thyroid Remnant Ablation in Well Differentiated Thyroid Cancer
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.Limitations of Use: The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated.
Criteria
Thyrogen
Prior Authorization
Length of Approval: 1 Time Approval
- One of the following: [A]
- Thyrogen is being used as a diagnostic tool for serum thyroglobulin testing in well differentiated thyroid cancer OR
- All of the following:
- Thyrogen is being used as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants AND
- Patient has undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer AND
- Patient does not have evidence of distant metastatic thyroid cancer
P & T Revisions
2026-03-04, 2025-02-17, 2024-04-04, 2022-03-28, 2021-09-28, 2021-09-27, 2021-05-25, 2020-03-12
References
- Thyrogen Prescribing Information. Genzyme Corporation. Cambridge, MA. February 2023.
- Ringel MD, Sosa JA, Baloch Z, et al. 2025 American Thyroid Association management guidelines for adult patients with differentiated thyroid cancer. Thyroid. 2025 Aug; 35(8): 841-985.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Thyroid Carcinoma. v1.2025. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed March 3, 2026.
End Notes
- For patients with differentiated thyroid cancer requiring radioactive iodine remnant ablation or adjuvant therapy, the use of exogenous recombinant human thyroid stimulating hormone (rhTSH) (i.e., Thyrogen) is preferred over thyroid hormone withdrawal as rhTSH is associated with lower risk of symptomatic hypothyroidism, better tolerability, and comparable efficacy to thyroid hormone withdrawal. [2, 3]
Revision History
- 2026-03-04: Annual Review 2026 - Removed requirement for T/F/CI to thyroid hormone withdrawal in line with 2025 ATA & NCCN recommendations. Updated approval length to 1 time approval. Removed EHB formulary. Background updates.
- 2025-02-17: 2025 Annual Review. No criteria changes.
- 2024-04-04: 2024 Annual Review: No criteria changes
- 2022-03-28: 2022 Annual Review - No changes to criteria, updated background information
- 2021-09-28: Updated GPI
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-25: Addition of EHB formulary to guideline, no changes to
- 2020-03-12: Annual Review - No Changes
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