CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cmp_M_Tepezza_20250521.Medicaid 1

Policy governs coverage of Tepezza (teprotumumab) under the Medicaid pharmacy benefit (medication only on Pharmacy Benefit). It specifies dosing limits, authorization length (6 months / max 8 infusions), initial and renewal criteria, administration instructions, and billing codes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_M_Tepezza_20250521.Medicaid 1

Policy CodePolicy N/A

Change TypeClarified scope; revised references

Effective DateAug 1, 2020

Next Review Date

Key ActionPrescriber must be or consult with a specialist and initial approval requires meeting all listed clinical criteria with documentation of thyroid status and prior steroid response/contraindication if applicable.

SourceLink

POLICY UPDATE CHANGES

Policy scope indicates medication only available on the Pharmacy Benefit effective 12/1/2023.

Updated references to Tepezza package insert (February 2025) and added 05/21/2025 last review date.

8Maximum infusions

6 moAuthorization length

>=18Minimum age (years)

J3241Primary HCPCS code

Coverage Summary

Scope: This policy governs coverage of Tepezza (teprotumumab) under the Medicaid Pharmacy Benefit (medication only on the Pharmacy Benefit). Effective date and scope note: Effective 12/1/2023 (Pharmacy Scope: Medicaid, Pharmacy Benefit ONLY).

Coverage stance: Tepezza is covered with criteria under the Medicaid pharmacy benefit. Authorization is provided for 6 months (maximum total of 8 infusions), and coverage may not be renewed (retreatment is not permitted).

Policy administrative dates: Effective 8/1/2020 (original effective date) and Last reviewed 05/21/2025.

Surface thresholds summary

Maximum infusions8 total infusions (over 6 months)

Initial dosing limit10 mg/kg IV initial

Maintenance dosing limit20 mg/kg IV every 3 weeks for 7 additional infusions

Quantity limit (NDC)3 vials initial, then 5 vials per 21 days for each of 7 additional doses (Tepezza 500 mg single-dose vial)

HCPCS units115 billable units initially, then 230 billable units every 3 weeks (1 unit = 10 mg, J3241)

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 18 years old
Prescribed by, or in consultation with, a specialist in ophthalmology, endocrinology, oculoplastic surgery, or neuro-ophthalmology
Patient is euthyroid
Mild hypo- or hyperthyroidism permitted: defined as FT4 and FT3 levels less than 50% above or below the normal limits; correct promptly if possible
Patient does not have corneal decompensation that is unresponsive to medical management

Authorization Length & Continuation

Length of Authorization

Coverage when following dosing/authorization limits:

ALL of the following

Coverage provided for 6 months (maximum total of 8 infusions)
Coverage may not be renewed

Renewal Criteria

ALL of the following

Coverage cannot be renewed

Dosing Limits & Administration

Dosing Limits

Permitted dosing and billing limits:

ALL of the following

Initial dose: 10 mg/kg IV (administered as specified elsewhere)
Subsequent dose: 20 mg/kg IV every 3 weeks for 7 additional infusions (total 8 doses)
Administration time: infuse diluted solution IV over 90 minutes for first two infusions; if well tolerated, subsequent infusions minimum 60 minutes; if not well tolerated, subsequent infusions minimum 90 minutes
Quantity limit (NDC unit): Tepezza 500 mg single-dose vial: 3 vials for initial dose followed by 5 vials per 21 days for each of 7 additional doses

Applicable Codes

Primary HCPCS billing codeHCPCSCovered

J3241

Injection, teprotumumab-trbw, 10 mg; 1 billable unit = 10 mg

Product NDC (Pharmacy dispensing)NDCCovered

75987-0130-xx

Tepezza 500 mg single-dose vial for injection

Covered Diagnosis CodesICD-10Covered

E05.00

Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm (hyperthyroidism)

Provider Actions & Requirements

Prior Authorization

Prior authorization required with specialist involvement

Prescriber must be or consult with a specialist in ophthalmology, endocrinology, oculoplastic surgery, or neuro-ophthalmology; initial approval requires meeting all listed clinical criteria and documentation of thyroid status and prior steroid response/contraindication if applicable

J3241
75987-0130-xx

Documentation Required

Document thyroid function and prior steroid therapy

Document euthyroid status (mild hypo- or hyperthyroidism permitted defined as FT4 and FT3 within ±50% of normal limits) and record prior inadequate response, intolerance, or contraindication to high‑dose IV glucocorticoids when applicable.

Clinical Evidence

Key randomized controlled trial: Teprotumumab for Thyroid-Associated Ophthalmopathy, N Engl J Med 2017;376:1748-1761.

Package insert: Tepezza [package insert], Horizon Therapeutics Ireland, DAC, February 2025.

Background & Definitions

Background: Teprotumumab (Tepezza) is FDA-approved for Thyroid Eye Disease related to Graves' disease. The policy focuses on Medicaid pharmacy benefit coverage and specifies eligibility criteria including minimum age, specialist prescriber requirement, thyroid function parameters (euthyroid with mild imbalance permitted), exclusions for corneal decompensation and poorly controlled diabetes, requirement that therapy be single-agent and not used for retreatment, and dosing limits.

Definitions

Euthyroid (policy-defined)FT4 and FT3 levels less than 50% above or below the normal limits; efforts should be made to correct mild hypo- or hyperthyroidism promptly

Revision History

12/1/2023scope clarification

Policy scope: Medication only available on the Medicaid Pharmacy Benefit (Pharmacy Benefit ONLY) effective 12/1/2023.

02/2025updated references/package insert

Updated references to Tepezza package insert (Tepezza [package insert], Horizon Therapeutics Ireland, DAC, February 2025).

05/21/2025last reviewLatest

Last review date recorded: 05/21/2025 (policy review/update).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_M_Tepezza_20250521.Medicaid 1

Policy CodePolicy N/A

Change TypeClarified scope; revised references

Effective DateAug 1, 2020

Next Review Date

SourceLink

On This Page

Patient does not have poorly controlled diabetes

Must be used as single agent therapy and Tepezza cannot be used for retreatment

Patient's dose does not exceed 10 mg/kg IV initially, then 20 mg/kg IV every three weeks

Thyroid Eye Disease (TED) specific

Patient has a clinical diagnosis of TED related to Graves' disease (Graves' orbitopathy)
Patient has active disease
ONE of
- Patient had an inadequate response to high-dose intravenous glucocorticoids
- There is a contraindication or intolerance to high-dose intravenous glucocorticoids
- Patient has inactive disease

Max units (HCPCS unit): 115 billable units initially followed by 230 billable units every 3 weeks thereafter for total of 8 doses

1 billable unit = 10 mg (HCPCS J3241)

Billing Rule

Dose billing / unit conversion

Bill HCPCS code J3241 using 1 unit = 10 mg. Expect initial billing equivalent to 115 units and subsequent doses billed as 230 units every 3 weeks per dosing/quantity limits.

J3241

Documentation Required

Administration time documentation

Record infusion durations: 90 minutes for the first two infusions; subsequent infusions minimum 60 minutes if well tolerated or minimum 90 minutes if not well tolerated.

Record 90 minutes first two; subsequent 60 minutes if tolerated or 90 minutes if not.

Denial Risk

Nonrenewal and retreatment restriction

Claims for continuation beyond 8 total infusions/6 months or for retreatment with Tepezza will be denied; coverage may not be renewed and Tepezza cannot be used for retreatment.

Billing Rule

Dose billing / unit conversion

Bill HCPCS code J3241 using 1 unit = 10 mg. Expected billing: initial dose equivalent to 115 units and subsequent doses 230 units every 3 weeks per dosing and quantity limits.

J3241