CurrentCountyCarePolicy 5063.CC

Tepezza (teprotumumab-trbw) Prior Authorization for Thyroid Eye Disease

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This guideline governs prior authorization for Tepezza under the Health Plan medical benefit for Medicaid members and establishes initial authorization criteria, dosing, documentation, and infusion limits.

Policy Summary

PayerCountyCare

PolicyTepezza (teprotumumab-trbw) Prior Authorization for Thyroid Eye Disease

Policy CodePolicy 5063.CC

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation supporting the diagnosis, qualifying thyroid eye disease findings, recent testing, prior glucocorticoid therapy, dosing, and required safety attestations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

12 weeksGlucocorticoid history

6 monthsInitial authorization

8Maximum infusions

J3241

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CurrentCountyCarePolicy 5063.CC

Tepezza (teprotumumab-trbw) Prior Authorization for Thyroid Eye Disease

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Policy Summary

PayerCountyCare

PolicyTepezza (teprotumumab-trbw) Prior Authorization for Thyroid Eye Disease

Policy CodePolicy 5063.CC

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum member age

12 weeksGlucocorticoid history

6 monthsInitial authorization

8Maximum infusions

J3241

MedicaidLine of business

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met.

Initial Tepezza therapy

Eligibility and diagnosis
- The member is age 18 years or older.>= 18 years
- Tepezza is prescribed by, or in consultation with, an ophthalmologist or endocrinologist.
- Chart-note documentation supports both Graves' disease and moderate to severe thyroid eye disease (TED), also known as Graves' ophthalmopathy, Graves' orbitopathy, or thyroid-associated ophthalmopathy.
ONE qualifying TED manifestation
- Lid retraction is at least 2 mm.>= 2 mm
- Moderate or severe soft tissue involvement is present.Moderate or severe
- Proptosis is at least 3 mm above normal for race and gender.>= 3 mm above normal for race and gender
- Inconstant or constant diplopia is present.
Recent laboratory or imaging requirements
- Laboratory screening/results or imaging documentation was collected within the last 3 months.Within the last 3 months
- For diabetic members, HbA1c is below 9.0%.< 9.0%
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels are less than 50% above or below the normal limit.< 50% above or below normal limit
- For women of child-bearing age, the pregnancy test is negative.
There is documentation of intolerance, contraindication to, or trial and failure of glucocorticoid therapy for at least 12 weeks.At least 12 weeks
The prescribed dose is within the manufacturer's dosing guidelines in the FDA-approved labeling, based on diagnosis, weight, and other applicable factors.FDA-label dosing
Safety and monitoring attestations
- The member does not have optic neuropathy or corneal decompensation unresponsive to medical management.
- Hearing was assessed before therapy with Tepezza and will continue to be assessed during and after treatment.
- If the member is of child-bearing age, appropriate contraception counseling was provided before initiation, during treatment, and for at least 6 months following the last dose of Tepezza.

Continuation Therapy

Reauthorization is not available beyond the total infusion limit.

Continuation therapy

The member has not exceeded 8 total Tepezza infusions.Maximum 8 total infusions
Tepezza is not eligible for reauthorization beyond 8 total infusions.

Reauthorization is excluded beyond 8 total Tepezza infusions.

Coding and Clinical Thresholds

Applicable Tepezza CodeHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg

Member age

Minimum age18 years or older

Authorization phaseInitial review criteria

Related eligibility requirementThe member must also have Graves' disease and moderate to severe thyroid eye disease

Lid retraction

Qualifying measurementLid retraction of at least 2 mm

Clinical requirementAt least one qualifying thyroid eye disease manifestation must be present

Other qualifying findings

Provider Requirements and Review Outcomes

Prior Authorization

Prior Authorization Required

Tepezza (teprotumumab-trbw) requires prior authorization under the Health Plan's medical benefit. Requests are reviewed against FDA criteria for medical necessity; requests that do not meet established criteria may be referred to a Medical Director when required by the plan and request level.

Applies to all practitioners involved in providing the requested drug.
The guideline defines the prior authorization process for Tepezza.

Step Therapy

Glucocorticoid Prerequisite

Document intolerance, contraindication to, or trial and failure of glucocorticoid therapy for at least 12 weeks before requesting Tepezza.

The prerequisite applies to the initial request.
Submit supporting clinical documentation in the member's chart.

Policy Background

Tepezza (teprotumumab-trbw) is authorized under this guideline for adults with Graves' disease and moderate to severe thyroid eye disease.

Definitions

Initial Therapy Criteria

Initial Therapy

Initial therapy requires ALL of the following criteria.

Initial Tepezza authorization

Adult age, specialist involvement, and diagnosis
- The member is age 18 years or older.>= 18 years
- Tepezza is prescribed by, or in consultation with, an ophthalmologist or endocrinologist.
- Chart-note documentation supports both Graves' disease and moderate to severe thyroid eye disease (TED), also known as Graves' ophthalmopathy, Graves' orbitopathy, or thyroid-associated ophthalmopathy.
ONE qualifying thyroid eye disease manifestation

Continuation Criteria

Maximum Total Infusions

Continuation therapy is subject to the total infusion limit.

Maximum total infusions

The member has not exceeded 8 total Tepezza infusions.Maximum 8 total infusions
Tepezza is not eligible for reauthorization beyond 8 total infusions.

Step Therapy

Step	Required glucocorticoid history	Timing
1	Document intolerance, contraindication to, or a trial and failure of glucocorticoid therapy.	At least 12 weeks before Tepezza authorization

Quantity Limits

Quantity limit

MedicationTepezza (teprotumumab-trbw)

Maximum quantity8 total infusions maximum

Reauthorization limitNo reauthorization beyond 8 total infusions

Policy Summary

PayerCountyCare

PolicyTepezza (teprotumumab-trbw) Prior Authorization for Thyroid Eye Disease

Policy CodePolicy 5063.CC

Change TypeNo material change

Effective DateMar 1, 2026

Next Review DateN/A

SourceLink

On This Page

Moderate or severe soft tissue involvement, qualifying proptosis, or inconstant or constant diplopia

Proptosis

Qualifying measurementAt least 3 mm above normal for race and gender

Clinical requirementProptosis is one of the qualifying thyroid eye disease manifestations

Alternative qualifying findingsLid retraction, moderate or severe soft tissue involvement, or inconstant or constant diplopia

HbA1c for diabetic members

Required HbA1cBelow 9.0%

Applies toDiabetic members

Documentation timingLaboratory screening or results must be collected within the last 3 months

FT4 and FT3 levels

Required rangeFT4 and FT3 levels must be less than 50% above or below the normal limit

Tests requiredFree thyroxine (FT4) and free triiodothyronine (FT3)

Documentation timingLaboratory screening or results must be collected within the last 3 months

Glucocorticoid therapy

Minimum durationAt least 12 weeks

Acceptable historyDocumented intolerance, contraindication, or trial and failure of glucocorticoid therapy

Authorization timingThe required history must be documented before Tepezza authorization

Recent testing

Required recencyCollected within the last 3 months

Documentation typeLaboratory screening/results or imaging documentation

Required resultsAs applicable, HbA1c below 9.0%, FT4 and FT3 within the specified range, and a negative pregnancy test for women of child-bearing age

Total Tepezza infusions

Maximum total8 total Tepezza infusions

ReauthorizationNot available beyond 8 total infusions

Coverage consequenceReauthorization beyond 8 total Tepezza infusions is excluded

Documentation Required

Diagnosis Documentation

Submit chart-note documentation confirming both Graves' disease and moderate to severe thyroid eye disease (TED), also known as Graves' ophthalmopathy, Graves' orbitopathy, or thyroid-associated ophthalmopathy. The member must be at least 18 years old, and Tepezza must be prescribed by or in consultation with an ophthalmologist or endocrinologist.

Document the qualifying diagnoses in the medical record.
Include the prescribing or consulting specialist's information.

Documentation Required

Clinical Severity Finding

Document at least one qualifying thyroid eye disease manifestation.

Lid retraction ≥ 2 mm
Moderate or severe soft tissue involvement
Proptosis ≥ 3 mm above normal for race and gender
Inconstant or constant diplopia

Documentation Required

Recent Laboratory or Imaging Documentation

Submit laboratory screening, laboratory results, or imaging documentation for all applicable requirements, collected within the last 3 months.

For diabetic members: HbA1C < 9.0%.
Free thyroxine (FT4) and free triiodothyronine (FT3) levels must be less than 50% above or below the normal limit.
For women of child-bearing age: negative pregnancy test.

Step Therapy

Prior Glucocorticoid Therapy

Provide documentation establishing the required prior glucocorticoid history before Tepezza initiation.

Document intolerance to glucocorticoid therapy, a contraindication to therapy, or trial and failure of therapy.
The trial-and-failure or treatment history must cover at least 12 weeks.

Billing Rule

Label-Concordant Dosing

Prescribe Tepezza at a dose within the manufacturer's dosing guidelines based on the diagnosis, weight, and other factors specified in the FDA-approved labeling.

Document that the requested dose and regimen are label-concordant.

Documentation Required

Safety Attestations and Monitoring

Submit documentation or a prescriber attestation addressing required safety exclusions and monitoring.

The member does not have optic neuropathy or corneal decompensation unresponsive to medical management.
Hearing was assessed before Tepezza therapy and will continue to be assessed during and after treatment.
For a member of child-bearing age, document counseling on appropriate contraception before initiation, during treatment, and for at least 6 months after the last Tepezza dose.

Denial Risk

Failure to Meet Initial Criteria

If the initial criteria are not met, the request may be denied or referred to a Medical Director for review when required by the plan and level of request.

Ensure all required clinical documentation is submitted with the request.
Medical Director review does not replace the need to address the applicable criteria.

Denial Risk

Maximum of 8 Total Infusions

Tepezza is not eligible for reauthorization beyond 8 total infusions.

Track the member's cumulative number of infusions when submitting a reauthorization request.

Lid retraction is at least 2 mm.>= 2 mm

Moderate or severe soft tissue involvement is present.Moderate or severe

Proptosis is at least 3 mm above normal for race and gender.>= 3 mm above normal for race and gender

Inconstant or constant diplopia is present.

Laboratory or imaging documentation

Laboratory screening/results or imaging documentation was collected within the last 3 months.Within the last 3 months
For diabetic members, HbA1c is below 9.0%.< 9.0%
FT4 and FT3 levels are less than 50% above or below the normal limit.< 50% above or below normal limit
For women of child-bearing age, the pregnancy test is negative.

Prior therapy

There is documentation of intolerance, contraindication to, or trial and failure of glucocorticoid therapy for at least 12 weeks.At least 12 weeks

Dosing

The prescribed dose is within the manufacturer's dosing guidelines in the FDA-approved labeling, based on diagnosis, weight, and other applicable factors.FDA-label dosing

Safety and monitoring

The member does not have optic neuropathy or corneal decompensation unresponsive to medical management.
Hearing was assessed before therapy with Tepezza and will continue to be assessed during and after treatment.
If the member is of child-bearing age, appropriate contraception counseling was provided before initiation, during treatment, and for at least 6 months following the last dose of Tepezza.