Thyrotropin alfa (Thyrogen) coverage
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Defines medical necessity, prior authorization, dosing, and continuity criteria for Thyrogen (thyrotropin alfa) for members under Peach State Health Plan lines of business including Commercial, HIM/ICHRA, and Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met:
Approval duration: 6 months (2 injections)
inv-02: Other Indications
For uses not specified in main indications (other diagnoses/indications):
See referenced policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53
inv-03: Continuation Therapy
Continued therapy covered when ALL of the following are met:
Approval duration: 6 months (2 injections)
Requests for uses of Thyrotropin alfa (Thyrogen) that are non‑FDA approved and are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), or CP.PMN.53 (Medicaid) for the required evidence or to any applicable evidence of coverage documents.
Examples of uses that are likely to be considered not medically necessary include requests for non‑FDA‑approved indications when the provider does not supply supporting clinical documentation consistent with the referenced off‑label use policies. In addition, certain diagnostic limitations may affect medical necessity determinations: Thyrogen‑stimulated thyroglobulin (Tg) levels are generally lower than Tg after thyroid hormone withdrawal, Thyrogen‑stimulated testing (even when combined with radioiodine imaging) may miss disease or underestimate extent of disease, and the presence of anti‑Tg antibodies can confound Tg assays and render results uninterpretable — all of which may make the test/therapy inappropriate for the requested purpose.
Initial Therapy
inv-14: Initial Therapy
Initial approval criteria for thyroid cancer:
Approval duration: 6 months (2 injections)
Continuation Criteria
inv-15: Continued Therapy
Continued therapy criteria for members with thyroid cancer:
Approval duration: 6 months (2 injections)
Coding
| J3240 | Injection, thyrotropin alpha, 0.9 mg, provided in 1.1 mg vial |
Provider Actions
Prior authorization required; approval when criteria met (6‑month duration)
Prior authorization is required for Thyrogen (J3240). Approval will be granted only when the listed initial or continued therapy criteria are met. Approval duration is 6 months and covers two 0.9 mg IM injections (initial 0.9 mg IM, second 0.9 mg IM 24 hours later).
- Covered dose limit: initial 0.9 mg IM followed by a second 0.9 mg IM 24 hours later (two injections).
- Approval duration: 6 months (covers the two-injection course).
Refer to formulary/off‑label policies for label changes or unlisted uses
If the drug’s FDA label has changed within the last 6 months and the policy is not yet updated, or the requested use is not listed in this policy, refer the request to the applicable formulary/no‑coverage, non‑formulary, or off‑label use policy for the member’s line of business rather than relying solely on this policy.
- For recent label changes (within 6 months): follow the no coverage or non‑formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable).
- For unlisted uses not addressed in section III: refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).
Submit clinical documentation to support all approval criteria
Provider must submit supporting documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating the member meets all approval criteria.
- Include documentation of diagnosis (well‑differentiated thyroid cancer when applicable), age, prior thyroidectomy status, evidence of no distant metastases when required, indication for use (adjunctive ablation or Tg testing), and dosing administered.
- Provide records showing response to therapy for continuation requests or prior approval history if applicable.
Non‑FDA indications may be denied without off‑label documentation
Requests for non‑FDA‑approved indications that are not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policy.
- If requesting a non‑FDA indication, supply evidence per off‑label policies CP.CPA.09 (commercial), HIM.PA.154 (ICHRA), or CP.PMN.53 (Medicaid) as applicable.
- If adequate documentation is not provided, coverage for the non‑FDA use is likely to be denied.
Step Therapy
| Step | Requirement / guidance |
|---|---|
| No explicit step-therapy steps defined in this policy | Refer to formulary, non‑formulary, or off‑label use policies when a requested indication or recent label change is not addressed in this policy (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53) |
| Policy does not impose a required prior agent or failure step within this document | If drug label changed within last 6 months and policy not updated, follow the referenced no‑coverage or non‑formulary policies based on formulary status; otherwise refer to the appropriate off‑label use policy for requests not listed as excluded |
Site of Care
Intramuscular (buttock) administration per dosing regimen
Administer intramuscularly to the buttock per the dosing regimen; the policy specifies IM (buttock) administration and does not impose additional site‑of‑care restrictions.
- Dosing regimen: 0.9 mg IM to the buttock followed by a second 0.9 mg IM to the buttock 24 hours later.
Background
Thyrotropin alfa (Thyrogen) is a recombinant human thyroid‑stimulating hormone used in the management of well‑differentiated thyroid cancer as an adjunct for diagnostic serum thyroglobulin (Tg) testing and as an adjunct to radioiodine ablation of thyroid tissue remnants after near‑total or total thyroidectomy when no distant metastases are present. Clinicians should be aware of limitations: Thyrogen‑stimulated Tg levels are generally lower than Tg after hormone withdrawal, anti‑Tg antibodies may confound assay results, and the long‑term effect on recurrence beyond five years post‑ablation has not been fully evaluated.
Definitions
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