CurrentEmblemHealthPolicy MG.MM.PH.213

Tepezza (teprotumumab-trbw)

Defines medical necessity, authorization limits, dosing, prescribing specialties, eligibility criteria, exclusions, coding (J3241), and NDC for Tepezza (teprotumumab-trbw) for treatment of thyroid eye disease for EmblemHealth/ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicyTepezza (teprotumumab-trbw)

Policy CodePolicy MG.MM.PH.213

Change TypeRevisions & additions (2024–2025)

Effective DateMay 18, 2020

Next Review Date

Key ActionTreating physician or primary care provider must submit clinical evidence that the member meets criteria for treatment; without documentation EmblemHealth will not review the request.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that active disease be 'of at least moderate severity based on signs and symptoms' and added multiple new criteria (BCVA no decrease due to optic neuropathy in prior 6 months; euthyroid definition; corneal decompensation exclusion; uncontrolled diabetes exclusion; hearing assessment; single agent therapy).

Added requirement that patient had an inadequate response or intolerance/contraindication to high-dose IV glucocorticoids.

Updated length of authorization and dosage limits.

Added J-code J3241 (Injection, teprotumumab-trbw, 10 mg) effective 10/01/2020.

Removed C-code C9061 (deleted 9/30/20).

8Maximum Infusions per member lifetime

6 monthsAuthorization Duration

J3241

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Primary Billing Code

Thyroid Eye Disease (TED)Approved Indication

Coverage Summary

coverage_stance: covered_with_criteria; scope_summary: Defines medical necessity, authorization limits, dosing, prescribing specialties, eligibility criteria, exclusions, coding (J3241), and NDC for Tepezza (teprotumumab-trbw) for treatment of thyroid eye disease for EmblemHealth/ConnectiCare members.; approved_indication: Thyroid Eye Disease (aka Graves' ophthalmopathy/orbitopathy); authorization_duration: 6 months; stats: Approved Indication (Thyroid Eye Disease): 1; Primary Billing Code: J3241; thresholds: Coverage provided for 6 months (max total of 8 infusions); may NOT be renewed; HCPCS billable units per dose: 115 units initial dose followed by 230 units every 3 weeks for total of 8 doses; BCVA change exclusion window: No decrease in BCVA due to optic neuropathy within previous 6 months (decrease of 2 lines on Snellen chart, new visual field defect, or color defect); Euthyroid definition: FT4 and FT3 levels less than 50% above or below normal limits.

Authorization durationCoverage provided for 6 months (max total of 8 infusions); may NOT be renewed.

Maximum infusions (lifetime)Maximum total of 8 infusions

HCPCS billable units per dose115 billable units initially followed by 230 billable units every 3 weeks for a total of 8 doses

BCVA change exclusion windowNo decrease in BCVA due to optic neuropathy within the previous 6 months (decrease of 2 lines on Snellen chart, new visual field defect, or color defect).

Euthyroid definition (per policy)FT4 and FT3 levels less than 50% above or below normal limits (mild hypo- or hyperthyroidism permitted and should be corrected promptly).

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Thyroid Eye Disease (aka Graves' ophthalmopathy, Graves' orbitopathy, thyroid-associated ophthalmopathy, and thyroid orbitopathy).
Patient is > 18 years of age;
ONE of
- According to the prescriber, the patient has been assessed as having active disease; AND patient had an inadequate response, or there is a contraindication or intolerance, to high-dose intravenous glucocorticoids.
- Patient has inactive disease;

Continuation / Maintenance Criteria

EmblemHealth requires that coverage is not renewed beyond a maximum of 8 infusions (coverage provided for 6 months and may not be renewed). Continued use beyond 8 infusions in the patient's lifetime is considered not medically necessary and will be denied. Authorization duration is 6 months and dosing limits are 115 billable units for the initial infusion then 230 billable units every 3 weeks for a total of 8 doses.

Exclusions and Precautions

Exclusions / Precautions

The following exclusions/precautions from the Initial Approval Criteria must be met (absence of these excludes coverage):

No decrease in best corrected visual acuity (BCVA) due to optic neuropathy within the previous six months (defined as decrease of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement).
No corneal decompensation that is unresponsive to medical management.
No uncontrolled diabetes.
Patient hearing will be assessed before, during, and after treatment (assessment required).

Applicable Codes

Applicable HCPCS / J-codeHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg. J-Code effective date: 10/01/2020

Applicable NDCsNDCCovered

75987-130-15

Tepezza (teprotumumab) 500mg single-dose vial

Applicable ICD-10 Diagnoses (thyrotoxicosis related codes listed in policy)ICD-10

E05.00	Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm.
E05.01	Thyrotoxicosis with diffuse goiter with thyrotoxic crisis or storm
E05.10	Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm.
E05.11	Thyrotoxicosis with toxic single thyroid nodule with thyrotoxic crisis or storm.
E05.20	Thyrotoxicosis with toxic multinodular goiter without thyrotoxic crisis or storm.
E05.21	Thyrotoxicosis with toxic multinodular goiter with thyrotoxic crisis or storm.
E05.30	Thyrotoxicosis from ectopic thyroid tissue without thyrotoxic crisis or storm.
E05.31	Thyrotoxicosis from ectopic thyroid tissue with thyrotoxic crisis or storm.
E05.40	Thyrotoxicosis factitia without thyrotoxic crisis or storm.
E05.41	Thyrotoxicosis factitia with thyrotoxic crisis or storm.

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Provider Actions & Billing Rules

Prior Authorization

Preauthorization and clinical documentation required

Treating physician or primary care provider must submit clinical evidence that the member meets the medical necessity criteria for Tepezza prior to review. Without this documentation EmblemHealth will not review the request.

Applicable code: J3241

Documentation Required

Hearing assessment requirement

Patient hearing must be assessed and documented before starting treatment, monitored during treatment, and reassessed after completion of treatment.

Clinical Evidence & References

Evidence sources: Tepezza injection prescribing information, Horizon Therapeutics; January 2020. EmblemHealth-derived criteria are based on review of the literature, regulatory status, and evidence-based guidelines, and coverage determinations depend on meeting the policy's medical necessity criteria and the member's benefit program.

Background

Mechanism: Tepezza is a human IgG1 monoclonal antibody that binds to IGF-1R, which is overexpressed in orbital connective tissues of patients with thyroid eye disease. Indication: Thyroid eye disease. EmblemHealth-derived criteria were developed based on review of peer-reviewed literature, regulatory status of the therapy, and evidence-based guidelines; coverage is subject to meeting the policy's medical necessity criteria and the member's specific benefit program.

Policy numberMG.MM.PH.213

Effective date2020-05-18

Last review date2025-02-11

StatusCURRENT

PayerEmblemHealth

Revision History

02/11/2025revisedLatest

Revision replaced previous severity requirement with additional specific criteria and expanded prescriber list to include oculoplastic surgery; added BCVA exclusion, euthyroid definition, corneal decompensation exclusion, uncontrolled diabetes exclusion, hearing assessment requirement, and single-agent therapy requirement.

01/22/2024added

Added requirement that patient had an inadequate response or intolerance/contraindication to high-dose IV glucocorticoids (added to Initial Criteria).

01/22/2024

Policy Summary

PayerEmblemHealth

PolicyTepezza (teprotumumab-trbw)

Policy CodePolicy MG.MM.PH.213

Change TypeRevisions & additions (2024–2025)

Effective DateMay 18, 2020

Next Review Date

Key ActionTreating physician or primary care provider must submit clinical evidence that the member meets criteria for treatment; without documentation EmblemHealth will not review the request.

SourceLink

On This Page

Patient has not had a decrease in best corrected visual acuity (BCVA) due to optic neuropathy within the previous six months (i.e., decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement);

Patient is euthyroid. Note: mild hypo- or hyperthyroidism is permitted which is defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits (every effort should be made to correct the mild hypo- or hyperthyroidism promptly).

Patient does not have corneal decompensation that is unresponsive to medical management;

Patient does not have uncontrolled diabetes;

Patient hearing will be assessed before, during, and after treatment;

Used as single agent therapy;

Tepezza is prescribed by, or in consultation with, an ophthalmologist, endocrinologist, oculoplastic surgery or neuro-ophthalmology, or physician who specializes in thyroid eye disease.

Patient is euthyroid per policy definition (FT4 and FT3 levels less than 50% above or below normal limits; mild hypo- or hyperthyroidism permitted but should be corrected promptly).

Euthyroid (policy definition): FT4 and FT3 levels less than 50% above or below the normal limits; mild hypo- or hyperthyroidism is permitted and should be corrected promptly.

BCVA decrease exclusion (policy definition): Decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within previous 6 months.

Billing Rule

Dose billing units

Bill 115 HCPCS units for the initial infusion and 230 HCPCS units for subsequent infusions every 3 weeks. Maximum total of 8 doses per member lifetime. Map billing to J3241 (Injection, teprotumumab-trbw, 10 mg).

Initial infusion: 115 units
Subsequent infusions: 230 units every 3 weeks
Maximum: total of 8 doses
HCPCS/J-code: J3241

Denial Risk

Duration / lifetime limit

Continued use of Tepezza beyond 8 infusions in the patient's lifetime is not considered medically necessary and will be denied.

Documentation Required

Prescriber specialty requirement

Tepezza must be prescribed by, or in consultation with, one of the following specialties and this should be documented: ophthalmologist, endocrinologist, oculoplastic surgery, neuro-ophthalmology, or a physician who specializes in thyroid eye disease.

Ophthalmologist
Endocrinologist
Oculoplastic surgery
Neuro-ophthalmology
Physician specializing in thyroid eye disease

Updated length of authorization and dosage limits.

09/11/2020added

Added J-code J3241 (Injection, teprotumumab-trbw, 10 mg) effective 10/01/2020.

01/13/2023removed

Transferred to new template and removed C-code C9061 (deleted 9/30/20).