CurrentCentenePolicy CP.PHAR.95

Thyrotropin Alfa (Thyrogen) coverage criteria

Defines medical necessity criteria, prior authorization/documentation expectations, dosing limits, continuation criteria, and coverage exclusions for Thyrotropin alfa (Thyrogen) for Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyThyrotropin Alfa (Thyrogen) coverage criteria

Policy CodePolicy CP.PHAR.95

Change TypeNo material changes

Effective Date03.12

Next Review Date

Key ActionSubmit clinical documentation (office notes, lab results, imaging, prior surgery documentation) showing the member meets all approval criteria for diagnosis, thyroidectomy status, absence of distant metastases when used for ablation, or prior thyroidectomy for diagnostic use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0.9 mg x 2Maximum routinely authorized regimen (IM injections)

6 monthsApproval duration for initial and continued therapy

18+Minimum age for coverage

Commercial/HIM/MedicaidLine of business

Medical Necessity Criteria

Initial Approval Criteria — Thyroid Cancer

Thyrogen is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of well-differentiated thyroid cancer
Age ≥ 18 years>= 18 years
Thyrogen will be used for one of the following
- Adjunctive treatment for radioiodine ablation
  - Adjunctive treatment for radioiodine ablation of thyroid tissue remnants
  - Member has undergone a near-total or total thyroidectomy
  - No evidence of distant metastatic thyroid cancer
- Adjunctive diagnostic tool for serum thyroglobulin (Tg) testing in members who have previously undergone thyroidectomy
Dose does not exceed an initial 0.9 mg IM injection followed by a second 0.9 mg IM injection 24 hours later
Maximum authorized regimen is two 0.9 mg IM injections 24 hours apart

Provider must submit documentation (e.g., office chart notes, lab results, imaging, prior surgery documentation) showing the member meets all approval criteria (diagnosis, thyroidectomy status, absence of distant metastases when used for ablation, or prior thyroidectomy for diagnostic use).

Initial Approval Criteria — Other diagnoses/indications

If the request is for other diagnoses/indications:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the appropriate formulary or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255; or HIM.PA.103, CP.PMN.16).
References provided to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If requested use is not listed in section III and no recent label change applies, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).
References CP.CPA.09, HIM.PA.154, CP.PMN.53

Provider should reference HCPCS code J3240 (Injection, thyrotropin alpha, 0.9 mg) when submitting documentation.

Continued Therapy — Thyroid Cancer

Continued therapy is authorized when ALL of the following are met:

ALL of the following

ANY of the following
- Member currently receiving medication via Centene benefit
- Member previously met initial approval criteria
- Member is currently receiving medication and enrolled in a state and product with continuity of care regulations
  Refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B
Member is responding positively to therapy
Clinical documentation of response required

Diagnoses/Indications Not Authorized

Coverage is not authorized for:

ALL of the following

Non-FDA approved indications not addressed in this policy, unless sufficient documentation supports efficacy and safety per the off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid).

Requests for non‑FDA indications risk denial unless sufficient evidence is provided per the referenced off-label policies or evidence of coverage documents.

Relevant Billing Codes

HCPCS - product codeHCPCSCovered

J3240

Injection, thyrotropin alpha, 0.9 mg, provided in 1.1 mg vial

What Providers Must Do

Prior Authorization

Prior authorization requirement

Prior authorization is implied; requests for Thyrotropin alfa (J3240) will be reviewed against the clinical criteria and require supporting documentation. Approval duration is 6 months and covers the maximum authorized regimen (two injections).

HCPCS: J3240

Documentation Required

Submit supporting documentation

Submit clinical documentation demonstrating the member meets all approval criteria — examples include office chart notes, laboratory results, imaging, and prior surgery documentation (e.g., thyroidectomy). Include relevant billing code(s) when submitting the request.

Required code: J3240

Documentation Required

Dose limit enforcement

Dose requests that exceed the authorized regimen will not meet criteria. The maximum routinely authorized regimen is an initial 0.9 mg IM injection followed by a second 0.9 mg IM injection 24 hours later (two 0.9 mg IM injections). For requests impacted by recent label changes or formulary status, refer to the appropriate formulary/non‑formulary policy.

Dose code: J3240

Denial Risk

Off-label or non-FDA use

Requests for non‑FDA approved indications not addressed in this policy risk denial unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies.

Relevant code: J3240

Clinical Background

Thyrotropin alfa (Thyrogen) is a recombinant human thyroid stimulating hormone (TSH) indicated for two primary uses in the management of well-differentiated thyroid cancer. As a diagnostic adjunct, Thyrogen is used to assist serum thyroglobulin (Tg) testing, with or without radioiodine imaging, in the follow-up of patients who have previously undergone thyroidectomy. As an ablation adjunct, Thyrogen is indicated to assist radioiodine ablation of remnant thyroid tissue in patients who have had a near-total or total thyroidectomy for well-differentiated thyroid cancer and who have no evidence of distant metastatic disease.

Numeric & Dosing Thresholds

Thresholds — Thyrotropin alfa (Thyrogen)

Minimum age for coverage>= 18 years

Authorized dosing regimen0.9 mg IM x 1, followed by 0.9 mg IM 24 hours later (total two injections)

Defined Terms

Abbreviations / Definitions

IMintramuscular

Tgthyroglobulin

TSHthyroid stimulating hormone

Policy Dates

Policy Number: CP.PHAR.95. Status: CURRENT. Effective Date: 03.12; Last Review Date: 08.25; Next Review Date: (none listed).

Policy Summary

PayerCentene

PolicyThyrotropin Alfa (Thyrogen) coverage criteria

Policy CodePolicy CP.PHAR.95

Change TypeNo material changes

Effective Date03.12

Next Review Date

SourceLink

On This Page

Thyrogen will be used as an adjunctive diagnostic tool for serum Tg testing

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

Dose increase limit: maximum authorized regimen is two 0.9 mg IM injections 24 hours apart

Prior authorization is implied — requests will be reviewed against criteria and require documentation; approval duration is 6 months (covers two injections).

Thyrotropin Alfa (Thyrogen) coverage criteria

Medical Necessity Criteria

Relevant Billing Codes

What Providers Must Do

Clinical Background

Numeric & Dosing Thresholds

Defined Terms

Read With / Cross-References

Policy Dates