Centene triptorelin coverage Prior Auth update

Coverage Criteria

Initial Therapy — Prostate Cancer

Covered when ALL of the following are met for Prostate Cancer

Prostate Cancer initial: 1. Diagnosis of prostate cancer; 2. Request is for Trelstar; 3. Prescribed by or in consultation with an oncologist or urologist; 4. Age > 18 years; 5. Dose does not exceed 3.75 mg per 4 weeks, 11.25 mg per 12 weeks, or 22.5 mg per 24 weeks; 6. Prescribed regimen must be FDA‑approved or recommended by NCCN OR dose is supported by practice guidelines or peer‑reviewed literature.dose limits as stated

Approval duration: Commercial 6 months; HIM/Medicaid 12 months.

Initial Therapy — Central Precocious Puberty

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

CPP initial: 1. Diagnosis of central precocious puberty (CPP) confirmed by: a) Elevated basal luteinizing hormone (LH) > 0.2–0.3 mIU/mL (assay dependent) and/or elevated leuprolide‑stimulated LH > 3.3–5 IU/L (assay dependent); b) Bone age exceeds chronological age by > 1 year; c) Age at onset of secondary sex characteristics: female < 8 years, male < 9 years; 2. Request is for Triptodur; 3. Prescribed by or in consultation with a pediatric endocrinologist; 4. Member meets age requirement: female 2–11 years, male 2–12 years; 5. Dose does not exceed 22.5 mg per 24 weeks.LH and bone age thresholds as stated

Approval duration: Commercial 6 months; HIM/Medicaid 12 months.

Initial Therapy — Gender Dysphoria / Gender Transition (off-label)

Covered when ALL of the following are met for Gender Dysphoria/Gender Transition (off-label)

Gender dysphoria initial: 1. Diagnosis of gender dysphoria or request for gender transition; 2. Prescribed by or in consultation with both: an endocrinologist and a provider with expertise in transgender medicine or a mental health professional; 3. Age and pubertal development criteria met: either member < 18 years who has reached or passed Tanner Stage 2 ranges (approximate age ranges noted in policy) OR member ≥ 18 years who has failed to achieve physiologic hormone levels with gender‑affirming hormonal therapy unless contraindicated; 4. If psychiatric comorbidity is present, member is followed by a mental health provider; 5. Provider attestation of understanding current State regulations regarding transgender‑related health care and that such care is coverable under those regulations; 6. Psychosocial support will be provided during treatment; 7. Dose is within FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).age and Tanner stage criteria

Approval duration: Commercial 6 months; HIM/Medicaid 12 months.

Continued Therapy — Continued therapy criteria (Covered when ALL of the following are met)

Continued therapy criteria (Covered when ALL of the following are met)

Continued therapy general: 1. Member is currently receiving the medication via the Centene benefit or documentation supports current receipt/prior Centene coverage; 2. Member is responding positively to therapy (meeting individual goals or demonstrating clinical response); 3. If request is for a dose increase, the new dose must not exceed stated FDA limits or must be supported by practice guidelines or peer‑reviewed literature; 4. For prostate cancer: request is for Trelstar and dosing limits same as initial; 5. For CPP: request is for Triptodur and dosing limit not to exceed 22.5 mg per 24 weeks; 6. For gender dysphoria: member continues to meet individual goals of therapy.as above

Approval durations: Commercial 6 months; HIM/Medicaid 12 months.

Indications (documented in this segment)

Indications and general coverage context referenced in this section of the document

Indication set: Triptorelin pamoate is used for advanced prostate cancer (Trelstar), central precocious puberty (Triptodur) in pediatric patients, and for management related to gender dysphoria/gender transition when policy criteria and applicable state regulations are met.

Specific medical necessity criteria (diagnostic confirmation, prescriber specialty, age limits, dosing) are provided in the indication‑specific sections of the policy.

Non‑FDA approved indications that are not specifically addressed by this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or other applicable evidence of coverage documents.

Non‑FDA approved indications not addressed in this policy are considered excluded unless the request is accompanied by adequate supporting documentation demonstrating efficacy and safety per the plan's off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or the member's evidence of coverage.

Uses of triptorelin pamoate for non‑FDA approved indications that do not include sufficient documentation of efficacy and safety as required by the referenced off‑label policies are not covered under this policy.

Requests for triptorelin for non‑FDA approved indications that lack the required supporting documentation per the off‑label use policies may be considered not medically necessary and subject to denial.

Initial Therapy

Initial Therapy — Initial authorization requires meeting the detailed criteria per indication including diagnosis confirmation, prescriber specialty, age and other items

Initial authorization requires meeting the detailed criteria per indication including diagnosis confirmation, prescriber specialty, age and lab thresholds, and dosing limits.

Initial therapy nodes: See the indication‑specific initial therapy sections for required documentation: diagnosis confirmation, appropriate prescriber specialty or consultation, age requirements, relevant laboratory thresholds (e.g., LH measurements for CPP), and dosing within stated limits.

Prior authorization required; providers must submit supporting documentation (office notes, labs, etc.).

Initial dosing — Product-specific initial dosing regimens listed in the document

Product-specific initial dosing regimens listed in the document

Trelstar dosing regimens: IM 3.75 mg every 4 weeks; IM 11.25 mg every 12 weeks; IM 22.5 mg every 24 weeks.

Maximum dose = see regimen.

Continuation / Renewal Criteria

Continuation Therapy — Criteria for continued therapy mirror initial criteria and require documentation of clinical benefit or prior Centene coverage

Criteria for continued therapy mirror initial criteria and require documentation of clinical benefit or prior Centene coverage

Continuation nodes: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria; 2. Member responding positively to therapy as evidenced by individual clinical parameters (e.g., stabilization/arrest of pubertal progression in CPP, clinical benefit in prostate cancer, continued attainment of goals for gender dysphoria); 3. Dose increases must remain within stated maximums or be supported by practice guidelines or peer‑reviewed literature; 4. Continuity of care provisions apply for members enrolled in states/products with such regulations.

See specific indication sections for dose limits and evidence requirements.

Continuation for gender dysphoria — Continuation guidance updates noted for gender dysphoria

Continuation guidance updates noted for gender dysphoria

Continuation example: For gender dysphoria, continuation of therapy requires documentation that the member continues to meet individual goals of therapy; an example of positive response to therapy was added in 4Q 2023 reviews.

Coding

HCPCS CodesHCPCS

J3315	Injection, triptorelin pamoate, 3.75 mg
J3316	Injection, triptorelin, extended-release, 3.75 mg

Basal LH — lab threshold guidance

Basal LH threshold> 0.2–0.3 mIU/mL (dependent on assay)

Use in CPP diagnosisElevated basal LH may be used alone or with leuprolide‑stimulated LH to confirm central precocious puberty

Assay dependenceExact cutoff depends on type of LH assay used by the laboratory

Leuprolide‑stimulated LH — lab threshold guidance

Leuprolide‑stimulated LH threshold> 3.3–5 IU/L (dependent on assay)

Role in CPP workupAn elevated leuprolide‑stimulated LH supports diagnosis of central precocious puberty when interpreted with clinical findings

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests for triptorelin injections (including HCPCS J3315 and J3316) must follow the plan's prior authorization process and include documentation demonstrating the diagnosis, appropriate prescriber specialty or consultation, and that age and dosing criteria are met.

HCPCS J3315 and J3316 require prior authorization
Include prescriber specialty or documentation of consultation (e.g., oncologist, urologist, pediatric endocrinologist, endocrinologist, or provider with transgender medicine expertise as applicable)
Confirm age and dosing criteria per indication

Documentation Required

Provider must submit supporting documentation with the prior authorization request. Lack of adequate documentation may result in denial.

Office chart notes documenting diagnosis and clinical course

Background

Triptorelin pamoate is a gonadotropin‑releasing hormone (GnRH) receptor agonist. This policy addresses the drug's FDA‑approved uses — including treatment of advanced prostate cancer and central precocious puberty (CPP) — and outlines coverage criteria, dosing limits, and documentation requirements for those indications as well as certain off‑label uses when supported by evidence and applicable policies.

Definitions

GnRH receptor agonist used for advanced prostate cancer and central precocious puberty

Agent classTriptorelin pamoate — gonadotropin‑releasing hormone (GnRH) receptor agonist

Primary FDA indicationsAdvanced prostate cancer (Trelstar) and central precocious puberty (Triptodur)

Clinical usesUsed for suppression of pituitary gonadotropins in indicated conditions

Central precocious puberty (CPP) — definition and context

DefinitionCentral precocious puberty (CPP): early activation of the hypothalamic‑pituitary‑gonadal axis

Diagnostic criteria (policy)Diagnosis confirmed by elevated basal LH (>0.2–0.3 mIU/mL) and/or elevated leuprolide‑stimulated LH (>3.3–5 IU/L), bone age > chronological age by >1 year, and early onset of secondary sex characteristics (female <8 years; male <9 years)

Step Therapy / Routing

Step	Routing instruction
1	When the requested use is not specifically listed in this policy, route the request to the applicable formulary/non‑formulary or off‑label use policy for the member's line of business to determine required steps or coverage criteria.

Policy references	Applicability / notes
CP PMN.255	Use for Medicaid formulary/no coverage determinations when drug is on formulary or PDL; refer per policy language for step therapy or coverage exceptions.
CP.CPA.190	Refer for commercial non‑formulary determinations when drug is not on the commercial formulary; follow that policy for any required steps or prior authorization rules.
HIM.PA.103	Refer for health insurance marketplace non‑formulary determinations when drug is not on the marketplace formulary; follow that policy for required steps.
CP CPA.09	Refer to commercial off‑label use policy when the requested use (diagnosis, age, dosing) is not listed and criterion 1 does not apply; off‑label policy specifies documentation and step requirements.
HIMPA.154	Refer to marketplace off‑label use policy when the requested use is not listed and criterion 1 does not apply; follow that policy for alternative agent or step therapy requirements.
HIM.PA.33 / CP PMN.16 / CP.PMN.53	See related references in the policy text for additional Medicaid/marketplace/commercial policy cross‑references when label changes or special formulary scenarios apply.

Quantity Limits

Triptorelin pamoate — Dose limits specified per interval

Dose limits by interval3.75 mg per 4 weeks; 11.25 mg per 12 weeks; 22.5 mg per 24 weeks (Trelstar maximums as listed)

Maximum per 24 weeks22.5 mg per 24 weeks is the listed maximum regimen

Quantity limit basisPolicy specifies dose limits per interval for authorization and continuation decisions

Triptorelin pamoate (product-specific) — per product dosing kit

Trelstar product kitsSingle‑dose vial kits for reconstitution with Mixject system: 3.75 mg, 11.25 mg, 22.5 mg

Triptodur product kitSingle‑dose vial for reconstitution (kit): 22.5 mg

Site of Care

Note

Injection is intramuscular; office site noted

Injection dosing for triptorelin is described as intramuscular; no site‑of‑care restrictions are specified in this policy window (office setting noted).

Trelstar dosing regimens: IM 3.75 mg every 4 weeks; 11.25 mg every 12 weeks; 22.5 mg every 24 weeks.
Triptodur dosing: 22.5 mg IM every 24 weeks.

OpenPayer

Triptorelin Pamoate (Trelstar, Triptodur)

Coverage Criteria

Initial Therapy

Continuation / Renewal Criteria

Coding

Provider Actions & Requirements

Background

Definitions

Step Therapy / Routing

Quantity Limits

Site of Care