CurrentMass General Brigham Health PlanPolicy N/A

Tepezza (teprotumumab) coverage for Thyroid Eye Disease

Defines prior authorization, eligibility, and dosing limits for teprotumumab (Tepezza) for members with Thyroid Eye Disease under Mass General Brigham Health Plan pharmacy and medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTepezza (teprotumumab) coverage for Thyroid Eye Disease

Policy CodePolicy N/A

Change TypeCriteria clarifications and removals

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, at least one qualifying clinical sign, prescriber specialty, age ≥18, and thyroid status (attestation or labs).

SourceLink

POLICY UPDATE CHANGES

Removed clinical activity score requirement.

Removed requirement that Tepezza will not be used with other immunomodulators.

Euthyroid/mild hypo- or hyperthyroidism criteria changed from requiring documentation to allowing attestation with defined lab thresholds.

8 dosesmaximum lifetime doses authorized per course

18+minimum member age (years)

3 mmminimum proptosis for eligibility

2 mm

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minimum lid retraction for eligibility

Coverage and Medical Necessity Criteria

Initial and continuation coverage criteria

Covered when ALL of the following are met for initial therapy OR continuation conditions apply.

Entry pathways: Authorization may be granted if the member is currently receiving Tepezza and has not received more than 8 doses (excluding samples or manufacturer's patient assistance program product).

Continuation pathway

Initial therapy criteria: Authorization may be granted when ALL of the following are met:

Initial therapy pathway

Initial therapy details

Diagnosis and clinical findings
- Qualifying clinical signs (one of): a. Lid retraction of at least 2 mm; b. Moderate or severe soft-tissue involvement; c. Proptosis at least 3 mm above normal values for race and gender; d. Periodic or constant diplopia; e. Mild corneal exposure.
Prescriber: Medication is prescribed by or in consultation with an ophthalmologist or an endocrinologist.
Documentation of prescriber specialty or consultation required
Age: Member is at least 18 years of age.>= 18 years
Age must be documented
Thyroid status: Member is euthyroid OR has mild hypothyroidism or hyperthyroidism defined as free T4 and free T3 levels less than 50% above or below normal limits.
Documentation or attestation of thyroid status acceptable

Approvals for teprotumumab (Tepezza) are limited to a maximum of 8 doses for one course of therapy per member lifetime. Requests that would exceed this quantity will be denied.

Coding, Key Clinical Thresholds, and Metrics

Product referenceNDC

NDC/Horizon Tepezza

Tepezza (teprotumumab) product — pharmacy specialty benefit (document references pharmacy benefit and specialty medications).

inv-04: Proptosis threshold

Proptosis threshold>= 3 mm above normal values for race and gender

ContextQualifying sign for initial authorization when documented with diagnosis of Thyroid Eye Disease

Measurement referencePolicy specifies comparison to normal values for race and gender

inv-05: Lid retraction threshold

Lid retraction threshold>= 2 mm

Role in criteriaOne of the qualifying clinical signs required for initial authorization

Documentation

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Tepezza (teprotumumab). Members currently receiving treatment may continue to receive coverage provided they have not exceeded 8 doses (lifetime limit) when doses obtained as samples or via manufacturer's patient assistance programs are excluded.

Prior authorization required for Tepezza (teprotumumab).
Members already receiving treatment may continue if total doses ≤ 8 (does not count samples or manufacturer patient assistance program supplies).

Step Therapy

Step therapy: No step therapy requirement. There is no requirement to fail glucocorticoids or any other therapy prior to authorization of Tepezza.

Background and Clinical Context

Teprotumumab (Tepezza) is an insulin-like growth factor-1 receptor antagonist indicated for the treatment of Thyroid Eye Disease (TED) regardless of disease activity or duration. Clinical evidence supporting its use includes randomized trials and the product prescribing information and the policy allows coverage when documented clinical criteria are met or when a member is already receiving treatment and has not exceeded the lifetime dose limit.

For initial authorization, the policy requires a diagnosis of TED and documentation of at least one qualifying clinical sign (examples include lid retraction ≥2 mm, proptosis ≥3 mm above normal for race/gender, moderate/severe soft-tissue involvement, periodic or constant diplopia, or mild corneal exposure). The prescriber should be an ophthalmologist or endocrinologist (or consultation with one should be documented), and the member must be at least 18 years old. Thyroid status must be documented or attested as euthyroid or as mild hypo-/hyperthyroidism defined by free T4 and free T3 levels within ±50% of normal limits.

Prior authorization is required for Tepezza; approvals may also be granted for members currently receiving treatment who have not received more than 8 doses (excluding samples or manufacturer patient assistance program product). The policy does not specify any step therapy requirement to fail glucocorticoids prior to Tepezza.

Definitions and Clinical Terms

inv-15: Thyroid Eye Disease (TED)

DefinitionThyroid Eye Disease (TED) is an autoimmune inflammatory disorder affecting orbital tissues

FDA indicationTepezza (teprotumumab) is indicated for the treatment of Thyroid Eye Disease regardless of activity or duration

Role in policyDiagnosis of TED is required with documentation of at least one qualifying clinical sign for authorization

inv-16: Mild hypothyroidism or hyperthyroidism

Definition of mild hypo-/hyperthyroidismFree thyroxine (free T4) and free triiodothyronine (free T3) levels <50% above or below normal limits

Acceptable thyroid status for authorizationMember may be euthyroid or meet the mild hypo-/hyperthyroidism definition

Policy Summary

PayerMass General Brigham Health Plan

PolicyTepezza (teprotumumab) coverage for Thyroid Eye Disease

Policy CodePolicy N/A

Change TypeCriteria clarifications and removals

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, at least one qualifying clinical sign, prescriber specialty, age ≥18, and thyroid status (attestation or labs).

SourceLink

On This Page

Must be submitted with diagnosis of Thyroid Eye Disease

inv-06: Age threshold

Age threshold>= 18 years

ApplicabilityMember must be at least 18 years old for initial authorization

DocumentationAge must be documented as part of prior authorization request

Documentation Required

Required Clinical Findings

Required clinical findings: Authorization requires a documented diagnosis of Thyroid Eye Disease (TED) and documentation of at least ONE qualifying clinical sign.

Lid retraction of at least 2 mm.
Moderate or severe soft-tissue involvement.
Proptosis at least 3 mm above normal values for race and gender.
Periodic or constant diplopia.
Mild corneal exposure.

Documentation Required

Prescriber Specialty and Age

Prescriber and age requirements: Medication must be prescribed by an ophthalmologist or endocrinologist, or there must be documented consultation with one. Member must be at least 18 years of age.

Prescriber: ophthalmologist or endocrinologist, or documented consultation with one.
Age: member ≥ 18 years.

Denial Risk

Thyroid Function and Quantity Limit

Thyroid function and quantity limits: Member must be either euthyroid or have only mild hypo-/hyperthyroidism (defined as free T4 and free T3 levels <50% above or below normal limits). Quantity limit: approvals granted for a maximum of 8 doses per lifetime; requests exceeding 8 doses will be denied.

Thyroid function: euthyroid OR mild hypothyroidism/hyperthyroidism (free T4 and free T3 <50% above or below normal limits).
Quantity limit: maximum 8 doses per lifetime (excludes samples and manufacturer assistance program supplies).

Documentation optionPolicy allows documentation or attestation of thyroid status using these lab thresholds