CurrentCignaPolicy IP0134

Triptodur

Defines medical necessity, authorization, dosing, and coding for Triptodur (triptorelin extended-release) for central precocious puberty and for use in gender-dysphoric/gender-incongruent persons when prescribed by or in consultation with an appropriate specialist. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTriptodur coverage policy

Policy CodePolicy IP0134

Change TypeAdded dosing for gender‑dysphoria indicationtitle update

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation that criteria are met; approvals (initial and reauthorization) are for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Added dosing for diagnosis, Gender-Dysphoric/Gender-Incongruent Persons; Person Undergoing Gender Reassignment.

Updated title of coverage policy.

22.5 mgsingle injection dose (IM) every 24 weeks

up to 12 monthsapproval duration

J3316HCPCS code for triptorelin ER 3.75 mg

2 indicationscovered diagnoses

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inv-01: Initial Therapy

Triptodur is considered medically necessary when ONE of the following criteria are met:

Covered indications

Central Precocious Puberty (CPP): Individual meets ALL of the following: A. Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males; B. Diagnosis confirmed by documentation of ONE of: (i) pubertal basal LH >= 0.3 mIU/mL OR (ii) pubertal LH response to a GnRH stimulation test.>= 0.3 mIU/mL
Dosing: one injection (22.5 mg) IM once every 24 weeks.
Gender-Dysphoric/Gender-Incongruent Persons: Medication prescribed by, or in consultation with, an endocrinologist or a physician who specializes in the treatment of transgender individuals.
Dosing: one injection (22.5 mg) IM once every 24 weeks.

inv-02: Continuation Therapy / Reauthorization

Reauthorization (Continuation) criteria

Reauthorization: Continuation is medically necessary when initial medical necessity criteria are met AND there is documentation of beneficial response to therapy.

Reauthorization approval duration: up to 12 months.

Peripheral precocious puberty (GnRH‑independent) — and any other uses not expressly listed as medically necessary in this policy — are considered not medically necessary. Children with peripheral precocious puberty do not respond to GnRH agonist therapy; treatment for those conditions is directed at addressing the source of excess sex steroids (for example, tumor removal or medical therapy for adrenal steroidogenesis disorders).

Any use of Triptodur other than the covered diagnoses specified in this policy is considered not medically necessary. Specifically, peripheral (GnRH‑independent) precocious puberty is not a covered indication because these conditions do not respond to GnRH agonist therapy; therefore claims for indications outside the listed diagnoses may be denied.

Initial Therapy Dosing & Prescriber Requirements

inv-14: Initial therapy dosing

Initial dosing and prescriber requirement where applicable

CPP initial therapy: Single injection 22.5 mg IM once every 24 weeks; must meet CPP diagnostic criteria including age of onset and confirmatory LH testing.

Receipt of sample product does not satisfy coverage criteria.

Gender-dysphoria initial therapy: One injection 22.5 mg IM once every 24 weeks; medication prescribed by or in consultation with an endocrinologist or physician who specializes in transgender care.

No specific FDA dosing for off-label use; FDA-approved dosing cited for off-label uses.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Triptodur (IP0134). Initial approvals may be granted for up to 12 months. Reauthorization approvals may be granted for up to 12 months.

Prior authorization required for both initial and reauthorization requests
Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months

Step Therapy

No step therapy (failure of a specified prior agent) requirements are specified for Triptodur in this policy.

Documentation Required

Required Clinical Documentation

Documentation must confirm the diagnostic criteria for the covered indications and must be provided with initial and reauthorization requests. For Central Precocious Puberty (CPP), include documentation of ALL of the following: onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males; and confirmation by ONE of: pubertal basal LH ≥ 0.3 mIU/mL, or a pubertal LH response to a GnRH stimulation test. For gender-dysphoric/gender-incongruent persons, include documentation that the medication is prescribed by or in consultation with an endocrinologist or a clinician who specializes in transgender care. Reauthorization requests must include documentation of beneficial response to therapy. Receipt of sample product does not satisfy documentation requirements.

Initial documentation must confirm diagnostic criteria for the covered diagnosis (e.g., CPP diagnostic labs or stimulation test results)
For gender-dysphoric/gender-incongruent persons, include documentation of specialist involvement (endocrinologist or clinician specializing in transgender care)
Reauthorization requests must include documentation of beneficial response to therapy
Receipt of sample product does not satisfy documentation requirements

Denial Risk

Not Covered Indications

Use of Triptodur for any indication other than the covered diagnoses is considered not medically necessary. Examples include peripheral (GnRH‑independent) precocious puberty, which does not respond to GnRH agonist therapy and should be managed by addressing the underlying cause.

Use for indications other than listed covered diagnoses is considered not medically necessary
Peripheral (GnRH-independent) precocious puberty is not covered

Step	Requirement
1	No preference among GnRH agonists; policy does not mandate prior use of another specific GnRH agonist before Triptodur.

Background

Gonadotropin‑releasing hormone (GnRH) agonists, including triptorelin formulations such as Triptodur, are the accepted standard of care for central precocious puberty (CPP). Long‑acting GnRH analogs are commonly used to suppress premature activation of the hypothalamic–pituitary–gonadal axis, and their effects are generally reversible. These agents are also used off‑label to suppress puberty in adolescents with gender dysphoria/gender‑incongruent identities when prescribed by or in consultation with an appropriate specialist; treatment initiation and discontinuation should be individualized.

Policy Summary

PayerCigna

PolicyTriptodur coverage policy

Policy CodePolicy IP0134

Change TypeAdded dosing for gender‑dysphoria indicationtitle update

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation that criteria are met; approvals (initial and reauthorization) are for up to 12 months.

SourceLink

On This Page

OpenPayer

Triptodur

Coverage Criteria

Initial Therapy Dosing & Prescriber Requirements

Continuation / Reauthorization Criteria

Coding

Provider Actions & Requirements

Definitions

Step Therapy

Quantity Limits

Site of Care / Administration

Background