CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Triptodur (triptorelin) (Intramuscular)

Medical benefit coverage and prior authorization criteria for Triptodur (triptorelin) for treatment of central precocious puberty and gender dysphoria for Neighborhood Health Plan members (Medicaid, Commercial, Medicare).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTriptodur (triptorelin) (Intramuscular)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis confirmation, prior failure/intolerance/contraindication to specified comparator drugs, and required monitoring data.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

22.5 mg q24wrecommended dose

6 monthsinitial coverage

6 monthscontinuation interval

J3316HCPCS

2 to <13age range CPP

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inv-01: Initial Therapy - Central Precocious Puberty

Covered when ALL of the following are met for Central Precocious Puberty (CPP):

CPP initial criteria: Patient is between the ages of 2 and less than 13 years; AND will not be used in combination with growth hormone; AND onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys associated with pubertal pituitary gonadotropin activation; AND diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native GnRH; AND bone age advanced greater than 2 standard deviations beyond chronological age; AND tumor has been ruled out by lab tests such as diagnostic imaging of the brain, pelvic/testicular/adrenal ultrasound, and human chorionic gonadotropin (hCG) levels; AND patient must have a documented failure, intolerance, or contraindication to Trelstar (triptorelin pamoate).

FDA-approved indication referenced

inv-02: Initial Therapy - Gender Dysphoria

Covered when ALL of the following are met for Gender Dysphoria:

Gender dysphoria initial criteria: Patient has a diagnosis of gender dysphoria confirmed by a qualified mental health professional or by DSM‑V criteria; AND a qualified mental health professional has confirmed a long‑lasting/intense pattern of gender nonconformity or gender dysphoria, that gender dysphoria worsened with onset of puberty, coexisting problems that could interfere with treatment have been addressed, and the patient has sufficient mental capacity to give informed consent; AND patient must have a documented failure, intolerance, or contraindication to Lupron Depot (leuprolide acetate); AND patient has been informed of effects and side effects including potential loss of fertility and options to preserve fertility and has given informed consent (with parental/guardian involvement when required); AND a pediatric endocrinologist or clinician experienced in pubertal assessment has confirmed agreement in the indication for treatment, that puberty has started (e.g., Tanner stage ≥ G2/B2), and that there are no medical contraindications to treatment.

Compendia recommended indication

inv-03: Continuation Therapy

Continuation of therapy covered when ALL of the following are met:

Continuation criteria general: Patient continues to meet the applicable initial criteria; AND absence of unacceptable toxicity from the drug (examples include psychiatric events, convulsions, signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension).

general continuation safety

CPP response criteria: For CPP: patient is <13 years of age and shows disease response evidenced by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, decrease in the ratio of bone age to chronological age (BA:CA), and improvement in final height prediction.

CPP-specific monitoring

Gender dysphoria response criteria: For Gender Dysphoria: patient has shown a beneficial response as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters.

GD-specific monitoring

Investigational use: All therapies are considered investigational when used at a dose or for a condition other than those that are recognized as medically accepted indications as defined in standard reference compendia (AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs) or peer‑reviewed published medical literature demonstrating sufficient evidence. Neighborhood does not provide coverage for drugs when used for investigational purposes.

Use outside of the stated guidelines may result in non‑payment. Triptodur (triptorelin) is covered under the Medical Benefit only when used within the policy’s specified guidelines; requests for use outside these guidelines must be approved through the plan’s exception process or prior authorization to be considered medically necessary.

Initial Therapy

inv-15: Initial Therapy — Initial therapy dosing and prerequisites

Initial therapy dosing and prerequisites

Dose and administration: 22.5 mg administered by a healthcare professional as a single intramuscular injection once every 24 weeks. Maximum billable units: 6 per 168 days (1 billable unit = 3.75 mg).

billing guidance

CPP prerequisites: Age 2 to <13; diagnostic confirmation as specified (pubertal gonadal sex steroid levels and pubertal LH response to native GnRH); bone age advanced >2 SD; tumor excluded by appropriate imaging/labs; will not be used in combination with growth hormone; documented failure/intolerance/contraindication to Trelstar (triptorelin pamoate).

Gender dysphoria prerequisites: Diagnosis confirmed by a qualified mental health professional or DSM‑V criteria with MHP confirmation of duration/severity, addressed coexisting problems, and capacity to consent; documented failure/intolerance/contraindication to Lupron Depot (leuprolide acetate); informed consent including discussion of potential loss of fertility and options to preserve fertility; pediatric endocrinologist or clinician experienced in pubertal assessment has confirmed indication, that puberty has started (e.g., Tanner stage ≥ G2/B2), and absence of medical contraindications.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Coverage of Triptodur (triptorelin) will be reviewed prospectively via the prior authorization process and requests will be evaluated against the policy criteria, including diagnosis-specific requirements and prior therapy/step-therapy rules. Use outside the specified guidelines may result in non-payment unless approved under an exception process.

Medical benefit authorization required
Requests reviewed against policy criteria and diagnosis-specific requirements

Step Therapy

Step Therapy Requires Documented Failure/Intolerance/Contraindication

Step therapy requires documented failure, intolerance, or contraindication to specified alternatives before Triptodur will be approved. For Central Precocious Puberty (CPP), patient must have a documented failure, intolerance, or contraindication to Trelstar (triptorelin pamoate). For Gender Dysphoria, patient must have a documented failure, intolerance, or contraindication to Lupron Depot (leuprolide acetate). Medicare members who have previously received this medication within the past 365 days are not subject to step therapy requirements.

CPP: documented failure/intolerance/contraindication to Trelstar (triptorelin pamoate)
Gender dysphoria: documented failure/intolerance/contraindication to Lupron Depot (leuprolide acetate)
Medicare exemption: prior receipt within 365 days exempts from step therapy

Documentation Required

Documentation Requirements

Documentation requirements — Providers must document confirmation of the diagnosis and supporting clinical information in the prior authorization submission. For CPP, documentation must include laboratory confirmation of pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to GnRH stimulation, bone age assessment showing advancement >2 SD, and imaging/labs to rule out tumors (brain imaging, pelvic/testicular/adrenal ultrasound, and hCG levels). For Gender Dysphoria, documentation must include confirmation by a qualified mental health professional (per policy definition) or DSM‑5 criteria, evidence the MHP has confirmed duration and intensity of gender dysphoria, onset/worsening with puberty, assessment and stabilization of coexisting conditions, capacity to consent, informed consent discussions (including fertility preservation), and confirmation by a pediatric endocrinologist or clinician experienced in pubertal assessment (e.g., Tanner staging, absence of medical contraindications).

CPP: lab confirmation of pubertal sex steroid levels and pubertal LH response to GnRH stimulation
CPP: bone age >2 SD above chronological age
CPP: imaging and labs to rule out intracranial or steroid-secreting tumors (brain imaging, pelvic/testicular/adrenal ultrasound, hCG)
Gender dysphoria: confirmation by qualified MHP or DSM‑5 criteria; MHP documentation of long-lasting/intense pattern, puberty-related worsening, addressed coexisting issues, capacity to consent
Gender dysphoria: informed consent including fertility preservation discussion and parental/caregiver involvement when applicable
Gender dysphoria: pediatric endocrinologist or experienced clinician confirmation (Tanner stage ≥G2/B2, no medical contraindications)

Denial Risk

Denial Risk Reminder

Denial risk reminder — Use outside the specified guidelines may result in non-payment; coverage decisions are made prospectively via prior authorization based on the clinical criteria above. Failure to provide required documentation, evidence of step‑therapy failure/intolerance/contraindication, or use outside age/indication limits may result in denial of the request.

Non-compliance with age or indication criteria may be denied
Incomplete documentation or missing prior therapy evidence may lead to denial

Step	Requirement	Medicare exception
1	Documented failure, intolerance, or contraindication to Trelstar (triptorelin pamoate) for Central Precocious Puberty or to Lupron Depot (leuprolide acetate) for Gender Dysphoria	Medicare members who received this medication within the past 365 days are exempt from step therapy

Definitions

Central Precocious Puberty (CPP)

DefinitionA condition characterized by premature activation of the hypothalamic-pituitary-gonadal axis resulting in early onset of puberty; diagnosis confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH.

Age range referencedPediatric patients, generally ages 2 to <13 for policy criteria

Diagnostic confirmationConfirmed by pubertal gonadal sex steroid levels and a pubertal LH response to GnRH stimulation

Gender Dysphoria

DefinitionMarked incongruence between experienced/expressed gender and natal gender with duration and criteria as defined in DSM‑V; diagnosis should be confirmed by a qualified mental health professional.

DSM‑V requirementMarked incongruence present for at least 6 months and manifested by at least two specified criteria (per DSM‑V)

Assessment and consentDiagnosis confirmation by qualified MHP; MHP must confirm duration, onset/worsening with puberty, addressed coexisting problems, capacity to consent, and informed consent including fertility counseling

OpenPayer

Triptodur (triptorelin) (Intramuscular)

Coverage Criteria

Initial Therapy

Continuation Therapy

Coding

Provider Actions & Requirements

Step Therapy Requirements

Quantity Limits

Site of Care

Background

Definitions