CurrentUnitedHealthcarePolicy CSIND0038.07

Gonadotropin Releasing Hormone Analogs (for Indiana Only)

UnitedHealthcare Medical Benefit Drug Policy for gonadotropin releasing hormone (GnRH) analogs applicable to Indiana members, defining covered indications (central precocious puberty, endometriosis, endometrial thinning/pre-ablation, fertility preservation, uterine leiomyomata, gender dysphoria and adjunct transgender hormone therapy), product list and applicable procedure/diagnosis codes. Excludes certain histrelin implant products per state Medicaid.

Policy Summary

PayerUnitedHealthcare

PolicyGonadotropin Releasing Hormone Analogs (for Indiana Only)

Policy CodePolicy CSIND0038.07

Change TypeRevised (HCPCS/J-code updates; archived prior version)

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must submit medical records and documentation (e.g., chart notes, laboratory values) confirming diagnoses and required lab/test results as specified per indication.

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits and revised description for J1954.

7Covered Indications (major categories)

9Listed HCPCS drug codes

100+Listed ICD-10 diagnosis codes (endometriosis expansions)

2019Latest Cochrane fertility preservation update year cited

ASCO guideline update year cited

Coverage Summary

Coverage stance: covered_with_criteria for UnitedHealthcare Indiana members per this Medical Benefit Drug Policy (CSIND0038.07) specifying clinical criteria and documentation requirements.

Scope summary: This policy applies to UnitedHealthcare Indiana members and defines covered indications including central precocious puberty (CPP), endometriosis, endometrial thinning/prior to endometrial ablation, fertility preservation during cytotoxic therapy, uterine leiomyomata (preoperative use), and gender dysphoria (pubertal suppression in adolescents and adjunct transgender hormone therapy in adults).

Major covered indications (policy-listed): central precocious puberty (CPP) (Fensolvi, Lupron Depot-PED, Triptodur); endometriosis (Lupron Depot, Zoladex); endometrial thinning/prior to endometrial ablation (Zoladex); fertility preservation (GnRH analogs given to premenopausal women receiving cytotoxic agents); uterine leiomyomata (fibroids) (preoperative use of Lupron Depot); and gender dysphoria/puberty suppression and adjunct transgender therapy (specified adolescent and adult criteria).

Product-list exclusions: Policy notes that certain histrelin implants are excluded per state Medicaid (examples: Vantas, Supprelin LA).

Time-limited authorization overview (policy thresholds): initial and reauthorization durations are time-limited: CPP initial authorization ≤ 12 months with reauthorization intervals ≤ 12 months; endometriosis initial treatment ≤ 6 months with total initial+recurrent duration for Lupron Depot ≤ 12 months total; endometrial thinning/pre-ablation ≤ 2 depots (Zoladex); uterine leiomyomata preoperative authorization ≤ 3 months; fertility preservation authorization ≤ 12 months; and gender dysphoria continuations reauthorized ≤ 12 months. (Also note Lupron Depot plus add-back therapy total duration limit of ≤ 12 months per prescribing information.)

Authorization thresholds and policy identifiers

policy_numberCSIND0038.07

effective_dateJuly 1, 2025

has_material_changetrue

Initial authorization duration - Central precocious puberty≤ 12 months

Continuation reauthorization interval - Central precocious puberty≤ 12 months

Initial treatment duration - Endometriosis≤ 6 months

Total duration for initial + recurrent endometriosis treatment (Lupron Depot)≤ 12 months total

Authorization duration - Uterine leiomyomata preoperative use

Initial Therapy Criteria

Central Precocious Puberty (Fensolvi, Lupron Depot-PED, Triptodur)

Fensolvi, Lupron Depot-PED, and Triptodur are proven and medically necessary for the treatment of central precocious puberty when ALL of the following criteria are met:

ALL of the following

Diagnosis of central precocious puberty (idiopathic or neurogenic).
Onset of secondary sexual characteristics in one of the following: - Females ≤ 8 years of age; or - Males ≤ 9 years of age.
Confirmation of diagnosis by one of the following: - Pubertal basal level of luteinizing hormone (based on laboratory reference ranges); or - A pubertal luteinizing hormone response to a GnRH stimulation test; or - Bone age advanced one year beyond the chronological age.
Initial authorization will be for no more than 12 months

Continuation / Retreatment Criteria

Central Precocious Puberty - Continuation

For continuation of therapy, ALL of the following must be met:

ALL of the following

Patient is currently receiving therapy for central precocious puberty
Documentation of positive clinical response to therapy
Patient is currently younger than the appropriate time point
- Females younger than 11 years of age
- Males younger than 12 years of age

Unproven / Limitations

Evidence limitations: The policy explicitly states that clinical evidence supporting GnRH analog use for gender dysphoria and transgender individuals is limited and lacks long-term safety data; robust randomized controlled trials are needed to determine benefit versus risk.

For fertility preservation, the policy cites a 2019 Cochrane update concluding GnRH agonists appear to protect ovarian function for maintenance/resumption of menstruation and reduce premature ovarian failure, but evidence is insufficient to assess protection of fertility measured by pregnancy rates and insufficient to compare agonists versus antagonists; larger well-designed RCTs with longer follow-up are needed.

Policy explicit exclusions: the Medical Benefit Drug Policy does not apply to certain histrelin implant products and refers to state Medicaid clinical policy for those products (specifically Vantas (J9225) and Supprelin LA (J9226)).

Applicable Codes

The brief indicates this code group is empty. Providers should reference the updated HCPCS/J-codes per the Provider Actions section and the 2025-07-01 update.

Provider Actions

Prior Authorization

Prior authorization required with time-limited approvals

Initial and continuation authorizations for GnRH analog therapy require prior authorization and are time-limited. Providers must submit supporting documentation for the indication to receive an authorization. Common duration limits vary by indication (see items). Reauthorizations require submission of the documentation specified for continuation criteria.

Central precocious puberty: initial and reauthorization durations ≤ 12 months (Initial authorization will be for no more than 12 months; reauthorization will be for no more than 12 months) — [[SOURCE cited above]]
Endometriosis: initial treatment course limited to a maximum of ≤ 6 months; total initial + recurrent (Lupron Depot) ≤ 12 months — [[SOURCE cited above]]
Uterine leiomyomata preoperative use: authorization ≤ 3 months
Fertility preservation: initial and reauthorization durations ≤ 12 months
Gender dysphoria (adolescents and adults): initial and reauthorization durations ≤ 12 months

Clinical Evidence & Guidelines

RR 0.26, 95% CI 0.14-0.49Cochrane 2019 meta-analysis: reduced amenorrhea/ovarian failure with GnRH agonists

OR 0.09; HR 0.09 (95% CI 0.01-0.8)Somers SLE cohort: lower ovarian failure with depot leuprolide vs controls (5% vs 30%)

16.9% vs 28.7%, p<0.01Song et al. breast cancer RCT: early menopause 16.9% (chemo+LA) vs 28.7% (chemo only)

Clinical evidence summary: For endometriosis, Cochrane and randomized trials demonstrate that GnRH analogues provide benefit for pain associated with endometriosis and reduction of lesions; harms include bone mineral density loss which is mitigated by add-back therapy, and ACOG supports empiric three-month GnRH agonist therapy after failure of first-line treatments with add-back recommended for continued therapy.

For fertility preservation, meta-analyses and randomized/observational trials report GnRH agonists reduce rates of chemotherapy-related amenorrhea and premature ovarian failure and can improve resumption of menses; however the 2019 Cochrane update and guideline statements (ASCO) conclude evidence is conflicting/insufficient to definitively demonstrate protection of fertility (pregnancy rates) and to compare agonist versus antagonist approaches, and ASCO offers conditional guidance to consider GnRHa when established preservation methods are not feasible.

For gender dysphoria and pubertal suppression, Endocrine Society and WPATH guidance recommend use of GnRH analogs to suppress puberty in appropriately assessed adolescents (multidisciplinary confirmation, Tanner stage criteria, monitoring intervals) and observational cohorts report improvements in psychological functioning with puberty suppression plus support; nevertheless evidence is limited by study design, size, and lack of long-term randomized data.

Background

Background: GnRH analogs include agonists and antagonists that suppress gonadotropin secretion. Agonists (e.g., leuprolide, triptorelin, goserelin, histrelin) act as potent inhibitors of gonadotropin secretion when given continuously and cause downregulation of GnRH receptors with reduction of LH/FSH and suppression of ovarian and testicular sex steroid production; degarelix is a GnRH receptor antagonist that reduces gonadotropin release and testosterone.

Product-specific labeled indications (informational only): listed products include Camcevi, Eligard, Fensolvi, Firmagon, Leuprolide acetate depot, Lupron Depot (including pediatric Lupron Depot-PED), Trelstar, Triptodur, and Zoladex with FDA-labeled uses such as CPP (pediatric formulations), management of endometriosis (Lupron Depot, Zoladex), and oncology indications for prostate cancer for several products; the policy emphasizes FDA indications are informational and not the basis for coverage decisions.

Definitions (policy): The term "GnRH analogs" in this policy includes Firmagon, Lupaneta Pack, Lupron Depot, Lupron Depot-PED, Trelstar, Triptodur, and Zoladex, and the policy explicitly states it excludes certain histrelin implants (Vantas, Supprelin LA) per state Medicaid.

FDA-labeled indications (informational only): The policy lists FDA-approved indications for specific GnRH products: several products (Camcevi, Eligard, Firmagon, Leuprolide Acetate Depot, Trelstar) have oncology (prostate cancer) indications; pediatric formulations (Fensolvi, Lupron Depot-PED, Supprelin LA, Triptodur) are indicated for central precocious puberty; Lupron Depot labeling includes management of endometriosis (monthly or three-month dosing), use with norethindrone acetate (add-back) with a limitation that total duration of Lupron plus add-back should not exceed 12 months, preoperative hematologic improvement with iron for fibroid-related anemia (limited uses), and varied prostate cancer dosing; Zoladex labeling includes endometriosis, endometrial thinning prior to ablation, and oncology indications.

Clarification: These FDA-labeled indications are provided for informational purposes only and are not the basis for coverage decisions; coverage is determined by the policy's clinical criteria and documentation requirements for UnitedHealthcare Indiana members.

Revision History

2025-07-01material_changeLatest

Archived previous policy version CSIND0038.06; Updated list of applicable HCPCS codes to reflect quarterly edits and revised description for J1954.

Policy Summary

PayerUnitedHealthcare

PolicyGonadotropin Releasing Hormone Analogs (for Indiana Only)

Policy CodePolicy CSIND0038.07

Change TypeRevised (HCPCS/J-code updates; archived prior version)

Effective DateJul 1, 2025

Next Review Date

Key ActionProviders must submit medical records and documentation (e.g., chart notes, laboratory values) confirming diagnoses and required lab/test results as specified per indication.

On This Page

Fertility preservation authorization≤ 12 months

Continuation reauthorization interval - gender dysphoria/adult adjunct≤ 12 months

Duration limit for Lupron Depot plus add-back therapyTotal duration should not exceed 12 months

Tanner stage for pubertal suppression initiation (WPATH)Tanner stage 2

Endometriosis (Lupron Depot, Zoladex)

Lupron Depot and Zoladex are proven and medically necessary for the treatment of endometriosis when ALL of the following criteria are met:

ALL of the following

Diagnosis of endometriosis or endometriosis is suspected.
One of the following:
- Contraindication, intolerance, or failure of initial treatment with both of the following: - Oral contraceptives or depo medroxyprogesterone (e.g., Depo Provera); and - Non-steroidal anti-inflammatory drugs (NSAIDs).
- Patient has had surgical ablation to prevent recurrence.
Initial treatment course is limited to a maximum of six months<= 6 months

Retreatment (Lupron Depot only)

Diagnosis of endometriosis or suspected endometriosis.
Recurrence of symptoms following an initial course of therapy.
Concurrently to be used with add-back therapy (e.g., progestin, estrogen, or bone sparing agents).
Duration of both the initial and recurrent course of therapies is no longer than 12 months total<= 12 months

Fertility Preservation (GnRH analogs)

GnRH analogs are proven and medically necessary for fertility preservation when ALL of the following criteria are met:

ALL of the following

For use in pre-menopausal women.
Patient is receiving a cytotoxic agent that is associated with causing primary ovarian insufficiency (premature ovarian failure) (e.g., cyclophosphamide, procarbazine, vinblastine, cisplatin).
Initial authorization will be for no more than 12 months<= 12 months

Continuation of therapy

Patient is currently receiving GnRH analog therapy for the purpose of fertility preservation.
Patient continues to receive a cytotoxic agent that is associated with causing primary ovarian insufficiency (premature ovarian failure) (e.g., cyclophosphamide, procarbazine, vinblastine, cisplatin).
Reauthorization will be for no more than 12 months<= 12 months

Uterine Leiomyomata (Fibroids) (Lupron Depot)

Lupron Depot is proven and medically necessary for the treatment of uterine leiomyomata when ONE of the following is met. Preoperative use is limited to a maximum authorization of three months.

ANY of the following

For treatment of uterine leiomyomata related anemia
- For the treatment of uterine leiomyomata related anemia.
- Patient did not respond to iron therapy of one month duration.
- For use prior to surgery.
Preoperative size reduction
- For use prior to surgery to reduce the size of fibroids to facilitate a surgical procedure (e.g., myomectomy, hysterectomy).

Authorization will be for no more than three months (preoperative use)<= 3 months

Preoperative use limited to 3 months maximum.

Gender Dysphoria in Adolescents

GnRH analogs may be covered for the treatment of gender dysphoria in adolescents when ALL of the following documentation and clinical criteria are met:

ALL of the following

Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of gender dysphoria according to current DSM criteria by a mental health professional with expertise in child and adolescent psychiatry.
Medication is prescribed by or in consultation with an endocrinologist or a medical provider experienced in gender dysphoria hormone therapy.
Patient has experienced pubertal development to at least Tanner stage 2 (stage 2 through 4).
Laboratory confirmation (one of the following):
- Pubertal levels of estradiol in females.
- Pubertal levels of testosterone in males.
- Pubertal basal level of luteinizing hormone (based on laboratory reference ranges).
- A pubertal luteinizing hormone response to a GnRH stimulation test.
A letter from the prescriber and/or formal documentation stating all of the following: - Patient has experienced pubertal changes that have resulted in an increase of their gender dysphoria that has significantly impaired psychological or social functioning; and - Coexisting psychiatric and medical comorbidities or social problems that may interfere with the diagnostic procedures or treatment have been addressed or removed; and - Current enrollment, attendance, and active participation in psychological and social support treatment program; and - Patient demonstrates knowledge and understanding of the expected outcomes of treatment and related transgender therapies.
Initial authorization will be for no longer than 12 months<= 12 months

Continuation of therapy

Documentation (within the last six months) of LH suppression assessing for appropriate suppression or a change in dosing.
Documented diagnosis of gender dysphoria, according to current DSM criteria, by a mental health professional with expertise in child and adolescent psychiatry.
Medication is prescribed by or in consultation with an endocrinologist or a medical provider experienced in gender dysphoria hormone therapy.
A letter from the prescriber and/or formal documentation stating ongoing goals, strong affinity for desired gender, that discontinuation would impair psychological functioning, and that comorbidities continue to be addressed; and continued enrollment in psychological/social support programs.
Reauthorization will be for no longer than 12 months<= 12 months

Adjunct for Gender-Affirming Hormonal Therapy for Transgender Adults - Initial

GnRH analogs may be covered as an adjunct for gender-affirming hormonal therapy in transgender adults when ALL of the following are met:

ALL of the following

Diagnosis of gender dysphoria according to current DSM criteria by a mental health professional.
Medication is prescribed by or in consultation with an endocrinologist or a medical provider experienced in transgender hormone therapy.
Gonads (i.e., testes, ovaries) have not been removed.
Initial authorization documentation (e.g., chart notes, laboratory values) supports medical necessity for adjunct GnRH analog therapy.
Initial authorization will be for no longer than 12 months<= 12 months

Endometriosis - Retreatment (Lupron Depot only)

For retreatment, ALL of the following must be met:

ALL of the following

Diagnosis of endometriosis or suspected endometriosis
Recurrence of symptoms following an initial course of therapy
Concurrently to be used with add-back therapy (e.g., progestin, estrogen, or bone sparing agents)

Fertility Preservation - Continuation

For continuation of therapy, ALL of the following are required:

ALL of the following

Patient is currently receiving GnRH analog therapy for fertility preservation
Patient continues to receive a cytotoxic agent associated with causing primary ovarian insufficiency
Reauthorization will be for no more than 12 months
GnRH therapy should be discontinued upon the completion of cytotoxic treatment

Gender Dysphoria in Adolescents - Continuation

For continuation of therapy, ALL of the following must be documented:

ALL of the following

Documentation (within the last six months) of LH suppression assessing for appropriate suppression or a change in dosing
Documented diagnosis of gender dysphoria according to current DSM (DSM-5) criteria by a mental health professional with expertise in child and adolescent psychiatry
Medication prescribed by or in consultation with an endocrinologist or provider experienced in gender dysphoria hormone therapy
Letter/formal documentation that patient continues to meet individual goals of therapy, continues to have strong affinity for desired gender, and that discontinuation would impair psychological functioning
Continued enrollment, attendance, and active participation in psychological and social support treatment program

Adjunct for Gender-Affirming Hormonal Therapy for Transgender Adults - Continuation

For continuation, ALL of the following must be documented:

ALL of the following

Documentation (within the last six months) of LH suppression assessing for appropriate suppression or a change in dosing
Documented diagnosis of gender dysphoria according to DSM-5 by a mental health professional
Medication is prescribed by or in consultation with an endocrinologist or provider experienced in transgender hormone therapy
Gonads (i.e., testes, ovaries) are intact
Patient is currently receiving hormonal therapy to achieve desired gender
Inability of cross-sex hormone therapy to inhibit natal secondary sex characteristics, LH, or gonadotropins
Letter/formal documentation must state
- Transgender patient continues to meet goals of gender-affirming hormone therapy
- Coexisting psychiatric and medical comorbidities or social problems continue to be addressed or removed
- Current enrollment, attendance, and active participation in psychological and social support treatment program and intent to continue participation

Documentation Required

Document diagnosis and confirmatory testing

Submit medical records and laboratory values to document the diagnosis and confirmatory testing as specified for the indication. Documentation should include objective test results and chart notes supporting the diagnosis.

Basal luteinizing hormone (LH) level (pubertal basal LH based on lab reference ranges)
GnRH stimulation test results showing a pubertal LH response
Pubertal sex steroid levels (estradiol in females, testosterone in males)
Bone age report showing advancement (e.g., bone age advanced ≥ 1 year beyond chronological age)

Documentation Required

Behavioral health documentation for gender dysphoria

For gender dysphoria indications, obtain and submit formal letters and documentation from mental health professionals and treating endocrinologists or experienced prescribers. Documentation must address diagnostic confirmation, impairment, treatment goals, comorbidities, and ongoing psychosocial support as specified below.

Letter/formal documentation from a mental health professional with expertise documenting a DSM-5 diagnosis of gender dysphoria (adolescents) or gender dysphoria (adults)
Prescriber/endocrinologist documentation that medication is prescribed by or in consultation with an endocrinologist or provider experienced in gender dysphoria hormone therapy
Statements that coexisting psychiatric/medical comorbidities or social problems have been addressed or removed
Evidence of current enrollment, attendance, and active participation in psychological and social support treatment program

Documentation Required

Multidisciplinary confirmation for pubertal suppression

Before initiating pubertal suppression, multidisciplinary confirmation is required. Documentation must show Tanner stage at or above the threshold, informed consent and discussion of fertility effects, and mental health assessment and support involvement.

Tanner stage documented as ≥ 2 (Tanner stage 2 required for initiation of pubertal suppression)
Informed consent/informed discussion documenting the expected outcomes and reproductive effects, including fertility preservation options
Documentation of mental health assessment and confirmation by a multidisciplinary team of persistence of gender dysphoria and capacity for informed consent

Documentation Required

LH suppression monitoring for continuation

For continuation/reauthorization of therapy for gender dysphoria (adolescents and adults) and adjunct transgender adult therapy, submit recent LH suppression monitoring results. Documentation of LH suppression within the last six months is required to assess adequacy of suppression or the need for dosing changes.

LH suppression documentation dated within the last six months demonstrating appropriate suppression or indicating need for dose adjustment

Billing Rule

Applicable codes updated

The list of applicable HCPCS/J-codes was updated effective 2025-07-01. Providers should use the updated HCPCS/J-codes when billing for GnRH analogs per the policy revision.

Use the updated HCPCS / J-codes listed in the policy (e.g., J1950, J1951, J1952, J1954, J3315, J3316, J9155, J9202, J9217) per the July 1, 2025 policy update