ModifiedAmeriHealth Caritas VIP CarePolicy MA08.115c

Teprotumumab (Tepezza) Coverage Criteria

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Medicare Advantage coverage and reimbursement for intravenous teprotumumab-trbw (Tepezza) in adults with thyroid eye disease associated with confirmed Graves' disease, subject to medical necessity, clinical findings, prescribing, dosing, and frequency requirements.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeprotumumab (Tepezza) Coverage Criteria

Policy CodePolicy MA08.115c

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionObtain a new approval when the member's dose, frequency, or regimen changes.

SourceLink

POLICY UPDATE CHANGES

The policy was revised to clarify teprotumumab coverage criteria for thyroid eye disease, including symptomatic active and inactive moderate-to-severe disease.

The policy added ICD-10-CM diagnosis codes for additional thyrotoxicosis conditions and other disorders of the orbit.

The policy added thyroid orbitopathy laterality codes for the right, left, and bilateral orbit.

The policy was reissued as part of the Company's annual review process.

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.115c

Teprotumumab (Tepezza) Coverage Criteria

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeprotumumab (Tepezza) Coverage Criteria

Policy CodePolicy MA08.115c

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionObtain a new approval when the member's dose, frequency, or regimen changes.

SourceLink

POLICY UPDATE CHANGES

The policy was revised to clarify teprotumumab coverage criteria for thyroid eye disease, including symptomatic active and inactive moderate-to-severe disease.

The policy added ICD-10-CM diagnosis codes for additional thyrotoxicosis conditions and other disorders of the orbit.

The policy added thyroid orbitopathy laterality codes for the right, left, and bilateral orbit.

The policy was reissued as part of the Company's annual review process.

8 dosesMaximum covered doses in one treatment cycle

10 then 20 mg/kgInitial and subsequent infusion doses

Every 3 weeksFrequency after the first infusion

Adults 18+Population described in the drug indication

Approved 2020FDA approval status for thyroid eye disease

1HCPCS drug billing code

Coverage Criteria

Medically necessary treatment

Covered when all of the following criteria are met:

Medical necessity requirements

Diagnosis and severity
- Moderate-to-severe TED findings
  - At least one qualifying finding: Lid retraction ≥2 mm; moderate or severe soft-tissue involvement; proptosis ≥3 mm above normal values, as determined by the professional provider; or periodic or constant diplopia.
Symptomatic TED: At least one symptom is documented: dry eye; exposure keratitis; inflammation, pain, or redness of the eye or eyelids; lagophthalmos (incomplete or defective closure of the eyelids) with excessive lacrimation; or strabismus.
Thyroid status and treatment conditions: The individual is euthyroid or has mild hypothyroidism or hyperthyroidism, defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits; does not have planned surgical ophthalmological intervention for proptosis repair; and treatment is prescribed by an ophthalmologist or by an endocrinologist in consultation with an ophthalmologist.FT4 and FT3 levels less than 50% above or below normal limits
Dosing and frequency: The first infusion is 10 mg/kg, followed by 20 mg/kg every 3 weeks for seven additional infusions.Maximum of eight doses or one cycle

Subsequent treatment or retreatment beyond a total of eight doses is considered experimental or investigational and is not covered unless the indication is supported as an accepted off-label use under the applicable policy for off-label coverage of prescription drugs and biologics.

Treatment that does not meet the policy's medical necessity criteria and is requested solely to improve an individual's appearance is considered cosmetic and is not eligible for reimbursement.

Cosmetic services intended to improve physical appearance without a significant expected improvement in physiologic function are excluded. Emotional or psychological improvement alone does not constitute improvement in physiologic function.

Initial Therapy

Initial therapy

Initial treatment is covered when all of the following medical necessity criteria are met:

Initial teprotumumab therapy: The individual is an adult with confirmed Graves' disease and active or inactive thyroid eye disease (TED); has moderate-to-severe TED with at least one qualifying sign (lid retraction ≥2 mm, moderate or severe soft-tissue involvement, proptosis ≥3 mm above normal values as determined by the professional provider, or periodic or constant diplopia); has symptomatic TED with at least one qualifying symptom (dry eye, exposure keratitis, inflammation, pain, or redness of the eye or eyelids, lagophthalmos with excessive lacrimation, or strabismus); is euthyroid or has mild hypothyroidism or hyperthyroidism, defined as FT4 and FT3 levels less than 50% above or below normal limits; has no planned surgical ophthalmological intervention for proptosis repair; is prescribed treatment by an ophthalmologist or by an endocrinologist in consultation with an ophthalmologist; and receives 10 mg/kg for the first infusion followed by 20 mg/kg every 3 weeks for seven additional infusions.Maximum of eight doses or one cycle

The dosing regimen applies to the initial course of therapy.

Dosing and Quantity Limits

Teprotumumab-trbw (Tepezza) dosing

First infusion10 mg/kg

Subsequent infusions20 mg/kg for seven additional infusions

FrequencyEvery 3 weeks after the first infusion

Coding and Clinical Thresholds

CPT Procedure CodesCPT

N/A

ICD-10 Procedure CodesICD-10

N/A

Covered ICD-10 Diagnosis CodesICD-10Covered

E05.00	Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm
E05.10	Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm
E05.20	Thyrotoxicosis with toxic multinodular goiter without thyrotoxic crisis or storm
E05.30	Thyrotoxicosis from ectopic thyroid tissue without thyrotoxic crisis or storm
E05.80	Other thyrotoxicosis without thyrotoxic crisis or storm
E05.90	Thyrotoxicosis, unspecified without thyrotoxic crisis or storm
H05.831	Thyroid orbitopathy, right orbit
H05.832	Thyroid orbitopathy, left orbit
H05.833	Thyroid orbitopathy, bilateral
H05.89	Other disorders of orbit

Covered HCPCS Level II CodesHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Revenue CodesRevenue

N/A

Lid retraction

Clinical findingLid retraction

Required thresholdAt least 2 mm

DocumentationDocumented as a qualifying finding of moderate-to-severe thyroid eye disease

Proptosis or exophthalmos

Clinical findingProptosis or exophthalmos

Required thresholdAt least 3 mm above normal values

Provider Requirements and Denial Risks

Prior Authorization

New Approval Required for Regimen Changes

If the member's dose, frequency, or regimen changes—including changes related to member weight or incomplete therapeutic response—the provider must submit the changes to the Company for a new approval through the utilization management process.

Documentation Required

Medical Necessity Records Required

The individual's medical record must reflect the medical necessity for the care provided. Records may include documentation from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports, and must be made available to the Company upon request.

The Company may review and audit services regardless of the provider's participation status.
Failure to produce requested medical records may result in denial of the drug.

Clinical Background

Thyroid eye disease (TED) is an autoimmune condition associated with Graves' disease. Inflammation of the tissues behind the eyes may cause proptosis, pain, diplopia, and difficulty closing the eyes. Teprotumumab-trbw is a fully human antibody that targets the insulin-like growth factor-1 receptor (IGF1R). The policy provides coverage for adults with active or inactive TED when the applicable clinical and dosing criteria are met.

Clinical Definitions

Moderate-to-severe Graves' orbitopathy

Lid retractionAt least 2 mm

Soft-tissue involvementModerate or severe soft-tissue involvement

ExophthalmosAt least 3 mm above normal values, as determined by the professional provider

DiplopiaInconstant or constant diplopia

Sight-threatening disease

Qualifying conditionAt least one sight-threatening finding is required

Optic nerve findingDysthyroid optic neuropathy (DON)

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyTeprotumumab (Tepezza) Coverage Criteria

Policy CodePolicy MA08.115c

Change TypeModified

Effective DateDec 15, 2025

Next Review DateN/A

Key ActionObtain a new approval when the member's dose, frequency, or regimen changes.

SourceLink

On This Page

AssessmentDetermined by the professional provider

Thyroid hormone status

Thyroid statusEuthyroid or mild hypo- or hyperthyroidism

FT4 requirementFree thyroxine (FT4) less than 50% above or below normal limits

FT3 requirementFree triiodothyronine (FT3) less than 50% above or below normal limits

Treatment duration

Maximum courseEight doses or one cycle

Total dose limitTreatment is limited to a maximum of eight doses

Cycle limitOne treatment cycle

Documentation Required

Support Nonstandard Dosing or Regimens

Coverage requested outside the policy's dosing and frequency requirements requires supporting documentation from the prescribing professional provider, including published peer-reviewed literature supporting the requested amount, dose, frequency, or regimen.

The Company may modify dosing and frequency requirements based on current FDA recommendations, Company-recognized authoritative pharmacology compendia, or published peer-reviewed clinical research.
For a list of recognized pharmacology compendia, refer to the policy on off-label coverage for prescription drugs and biologics.

Denial Risk

Denial Risk for Nonqualifying or Excess Treatment

Teprotumumab-trbw (Tepezza) is not covered when medical necessity criteria are not met or when treatment exceeds the policy limit of eight doses or one cycle, unless the indication is supported as an accepted off-label use under the applicable policy.

Subsequent treatment or retreatment beyond a total of eight doses is considered experimental/investigational and is not eligible for coverage or reimbursement unless the accepted off-label coverage requirements are met.

Denial Risk

Cosmetic Use Is Excluded

Requests that do not meet the policy's medical necessity criteria and are made solely to improve an individual's appearance are considered cosmetic services. Cosmetic services are a benefit contract exclusion and are not eligible for reimbursement consideration.

This rule applies to cosmetic requests under the Company's products, subject to the applicable Evidence of Coverage.

Denial Risk

Insufficient Documentation May Result in Denial

All documentation requested by the Company must be provided to support the medical necessity and coverage of teprotumumab-trbw (Tepezza). Failure to submit requested medical records or the required peer-reviewed literature for treatment outside the policy's dosing and frequency requirements may result in denial.

Medical records must support the care provided and may be requested during review or postpayment audit.
Published peer-reviewed literature must support any requested dose, frequency, or regimen outside the policy requirements.

Denial Risk

Appearance-Only Use Is Cosmetic

Cosmetic services are services provided to improve an individual's physical appearance when no significant improvement in physiologic function can be expected. Emotional or psychological improvement alone does not constitute improvement in physiologic function.

Appearance-only requests without expected significant physiologic improvement are cosmetic and excluded from coverage.

Corneal findingCorneal breakdown

Mild Graves' orbitopathy

Lid retractionMinor lid retraction less than 2 mm

Soft-tissue involvementMild soft-tissue involvement

ExophthalmosLess than 3 mm above normal values, as determined by the professional provider

Diplopia or corneal exposureNo or intermittent diplopia, or corneal exposure responsive to lubricants

Cosmetic services

PurposeServices provided to improve an individual's physical appearance

Physiologic functionNo significant improvement in physiologic function can be expected

Emotional or psychological improvementEmotional and/or psychological improvement alone does not constitute improvement in physiologic function