THYROGEN, Thyrotropin Alfa Form

Thyrotropin alfa (Thyrogen®) is a recombinant human thyroid stimulating hormone (TSH). FDA Approved Indication(s) Thyrogen is indicated for: • Diagnostic: 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. • Ablation: 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. Limitation(s) of use:
• Diagnostic: o Thyrogen-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal. o 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. o Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable.
• Ablation: The effect of Thyrogen on thyroid cancer recurrence greater than 5 years post- remnant ablation has not been evaluated. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Thyrogen is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Thyroid Cancer (must meet all):

1. Diagnosis of well-differentiated thyroid cancer;

   2. Age ≥ 18 years;
   3. Thyrogen will be used for one of the following (a or b): a. Adjunctive treatment for radioiodine ablation of thyroid tissue remnants and both of the following are met (i and ii): Page 1 of 5

   CLINICAL POLICY
   Thyrotropin Alfa i. Member has undergone a near-total or total thyroidectomy; ii. There is no evidence of distant metastatic thyroid cancer; b. Adjunctive diagnostic tool for serum Tg testing in members who have previously undergone thyroidectomy;

2. Dose does not exceed an initial 0.9 mg IM injection followed by a second 0.9 mg IM injection 24 hours later. Approval duration: 6 months (2 injections) B. Other diagnoses/indications (must meet 1 or 2):
3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Thyroid Cancer (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. Thyrogen will be used as an adjunctive diagnostic tool for serum Tg testing;
   4. If request is for a dose increase, new dose does not exceed an initial 0.9 mg IM injection followed by a second 0.9 mg IM injection 24 hours later. Approval duration: 6 months (2 injections) B. Other diagnoses/indications (1 or 2):

6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 5

   CLINICAL POLICY
   Thyrotropin Alfa CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration
   IM: intramuscular Appendix B: Therapeutic Alternatives Not applicable Tg: thyroglobulin TSH: thyroid stimulating hormone Appendix C: Contraindications/Boxed Warnings • Contraindication(s): If Thyrogen is administered with radioiodine, the contraindications to radioiodine also apply to this combination regimen. • Boxed warning(s): none reported.
   V. Dosage and Administration Indication Adjunctive diagnostic tool for serum thyroglobulin testing in well differentiated thyroid cancer Adjunct to treatment for ablation in well differentiated thyroid cancer Dosing Regimen 0.9 mg IM injection to the buttock followed by a second 0.9 mg IM injection to the buttock 24 hours later Maximum Dose See regimen VI. Product Availability
   Lyophilized powder for reconstitution: 0.9 mg VII.