ModifiedPremera BluecrossPolicy N/A

Gonadotropin Releasing Hormone (GnRH) Analogs

Clinical and pharmacy coverage policy governing medical necessity, prior authorization, and duration limits for GnRH agonists and antagonists for indications including prostate cancer, breast cancer, endometriosis, uterine fibroids, central precocious puberty, gender dysphoria, ovulation suppression, and related uses for Premera Blue Cross.

Policy Summary

PayerPremera Bluecross

PolicyGonadotropin Releasing Hormone (GnRH) Analogs

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications (authorization durations, age/Tanner criteria, coding updates)

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit office visit notes documenting diagnosis, exam or hormone confirmation of Tanner stage, and counseling on fertility and bone effects.

SourceLink

POLICY UPDATE CHANGES

Updated initial authorization duration from up to 6 months to up to 12 months for gender dysphoria.

Clarified investigational vs not medically necessary distinctions for use outside age/diagnosis or other policy criteria.

Specified re-authorization limits: Myfembree and Oriahnn beyond 24 months considered not medically necessary; Zoladex re-authorization beyond 6 months for endometrial thinning prior to ablation considered investigational.

Updated initial gender dysphoria criteria to require individuals be ≥14 years of age and Tanner stage 2 or higher (by exam or specified serum hormone thresholds) and be less than 23 years of age; clarified confirmations of Tanner stage 2 with specific hormone values and added fertility and bone effects counseling requirements.

Added HCPCS code J1954 and later added Vabrinity (leuprolide acetate) and associated coverage criteria; removed withdrawn products Lupaneta Pack and Vantas and removed J9225.

Updated initial authorization duration from up to 6 months to up to 12 months and clarified non-formulary exception review authorizations may be approved up to 12 months.

Clarified that use of GnRH analogs that does not meet age or diagnosis requirements is investigational, whereas use that meets age/diagnosis but not other medical necessity criteria is not medically necessary.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

J1950–J9226HCPCS codes

12 monthsmax initial auth

24 monthsMyfembree/Oriahnn max

3 monthsleuprolide fibroid limit

6 monthsZoladex re-auth limit

<23 yrsgender dysphoria age upper

Coverage Criteria by Indication

Breast cancer — adjuvant and palliative

Covered when specific drug/condition and additional therapy requirements are met

Breast cancer adjuvant (pre-/perimenopausal): Lupron Depot (leuprolide acetate), Trelstar (triptorelin pamoate), or Zoladex (goserelin) may be considered medically necessary for the adjuvant treatment of hormone receptor positive (HR+) early breast cancer in pre- and perimenopausal women when: (1) the individual has HR+ breast cancer AND (2) is receiving treatment with tamoxifen or an aromatase inhibitor (e.g., anastrozole, exemestane, letrozole).

Pre-/perimenopausal status requires documentation of ongoing menses or normal estradiol, FSH, and LH.

Breast cancer — high risk with abemaciclib

Covered when combined with abemaciclib for high-risk, HR+, HER2-negative disease

High-risk adjuvant combination: Lupron Depot (leuprolide acetate), Trelstar (triptorelin pamoate), or Zoladex (goserelin) may be considered medically necessary for HR+, HER2-negative, lymph node–positive early breast cancer at high risk of recurrence with Ki‑67 ≥20% when used in combination with Verzenio (abemaciclib) AND tamoxifen or an aromatase inhibitor.Ki-67 >=20%

High-risk defined per trial: ≥4 positive axillary nodes OR 1–3 nodes with Grade 3 disease OR tumor ≥5 cm OR Ki‑67 ≥20%.

Central precocious puberty

Covered when diagnostic and age criteria met

CPP diagnostic criteria: Fensolvi, generic leuprolide, Lupron Depot PED, Supprelin LA, Synarel, and Triptodur may be considered medically necessary for central precocious puberty when: diagnosis is confirmed by one of the following — pubertal basal LH per laboratory reference ranges OR positive GnRH stimulation test (peak LH ≥5 IU/L) OR bone age advanced ≥1 year beyond chronological age; AND documented onset of secondary sexual characteristics; AND female onset ≤8 years or male onset ≤9 years.peak LH >=5 IU/L; bone age advance >=1 year

Only Trelstar 3.75 mg q4wk or Trelstar 11.25 mg q12wk are acceptable Trelstar regimens per policy.

Endometriosis

Covered for adult individuals meeting age and diagnosis

Endometriosis — GnRH agents: Generic leuprolide, brand leuprolide depot, Lupron Depot, Synarel (nafarelin), and Zoladex (goserelin) may be considered medically necessary for treatment of endometriosis in individuals aged ≥18 with a confirmed diagnosis when used for management of pain and reduction of endometriotic lesions.

Product-specific agents such as Myfembree and Orilissa have separate criteria and duration limits.

Endometriosis — oral combination drugs

Covered when criteria and duration limits are met

Myfembree for endometriosis: Myfembree (relugolix/estradiol/norethindrone acetate) is medically necessary when age ≥18, premenopausal, treated for moderate to severe endometriosis pain, without osteoporosis, dose ≤40 mg relugolix/day (relugolix 40 mg/estradiol 1 mg/norethindrone acetate 0.5 mg once daily), and total treatment duration ≤24 months.<=24 months

Requests after 24 months are considered not medically necessary; approval may be granted for labeled duration.

Orilissa for endometriosis: Orilissa (elagolix) is medically necessary for individuals ≥18 who are premenopausal treated for moderate to severe pain, without osteoporosis or severe hepatic impairment, with treatment duration limits per dose (150 mg once daily up to 24 months; 200 mg twice daily up to 6 months).150 mg x24 months; 200 mg x6 months

Requests exceeding labeled durations are considered not medically necessary.

Prostate cancer

Covered for palliative, adjuvant, recurrent, or metastatic prostate cancer per staging and response

Prostate cancer indications: Camcevi (leuprolide mesylate), Firmagon (degarelix), Eligard, generic and brand leuprolide, Orgovyx (relugolix), Trelstar (triptorelin pamoate), Vabrinity (leuprolide acetate), Lutrate Depot, and Zoladex (goserelin) may be medically necessary when used as adjuvant therapy for specified stages (e.g., T2b–T4 N0 M0 or T1–4 N1 M0) OR for recurrence/metastatic disease (T1–4 N0–2 M1) OR for rising PSA after curative intent therapy; coverage requires documentation of positive clinical response and tolerability.

Non-formulary exception and other reviews may be approved up to 12 months for prostate cancer; managed primarily as a medical benefit for listed products.

Uterine fibroids

Covered for limited indications and durations

Fibroids — anemia or pre-op size reduction: Generic leuprolide, brand leuprolide depot, and Lupron Depot may be medically necessary to treat anemia due to uterine fibroids not controlled by a 1‑month trial of iron OR to reduce fibroid size prior to surgery. Initial approval is for 90 days; coverage for 4‑ and 6‑month Lupron Depot formulations is prohibited.initial approval 90 days; maximum 3 months total for leuprolide agents

Continuous use beyond 90 days is not recommended due to bone toxicity per FDA labeling; re-authorization will not be granted.

Uterine fibroids — oral combination products

Covered when contraceptive trial and duration limits met

Myfembree for fibroids: Myfembree is medically necessary for heavy menstrual bleeding due to uterine fibroids when age ≥18, premenopausal, has tried and failed one contraceptive for symptom management, dose ≤40 mg relugolix/day (with estradiol/norethindrone acetate per product labeling), and total treatment duration ≤24 months.<=24 months

Re-authorization beyond 24 months is considered not medically necessary; non‑formulary exception reviews may be approved up to 12 months.

Oriahnn for fibroids: Oriahnn (elagolix/estradiol/norethindrone acetate) is medically necessary when age ≥18, premenopausal, treated for heavy menstrual bleeding due to fibroids, has tried and failed one contraceptive, dose per labeling (total elagolix ≤600 mg/day split per regimen), and total treatment duration ≤24 months.<=24 months

Re-authorization beyond 24 months is considered not medically necessary.

Gender dysphoria

Covered for puberty suppression when comprehensive diagnostic and consent criteria met

Gender dysphoria general criteria: Eligard, Fensolvi, generic leuprolide, brand leuprolide depot, Lupron Depot PED, Supprelin LA, Synarel, Trelstar, Triptodur, and Zoladex may be medically necessary for gender dysphoria when all of the following are met: (1) one of: individual is ≥14 years of age OR Tanner stage 2 or higher by physical exam OR Tanner stage 2 or higher by specified serum hormone thresholds; (2) individual has not undergone gonadectomy; (3) confirmation of the diagnosis of gender dysphoria per current DSM criteria; (4) documentation regarding comorbid psychiatric disorders or that gender incongruence is not due to psychiatric disorders; (5) medication prescribed by or in consultation with an appropriate specialist; AND (6) documentation that potential adverse effects have been discussed including effects on fertility and, if not taking or not starting cross‑sex hormones, possible effects on bone mineralization and bone density.

If starting at age ≥23 or after Tanner stage 5/irreversible secondary sexual development, document that GnRH analog is necessary to prevent or stop further development or to suppress characteristics not evident on exam (e.g., menses, penile erections).

Gender dysphoria monitoring & reauthorization: Re-authorization may be granted up to 12 months when the individual has not undergone gonadectomy AND there is documentation of suppression of secondary sex characteristics by exam or report AND annual testing of bone age or bone density unless concurrently on cross‑sex hormones AND documentation of positive clinical response and tolerability. For first re-authorization under Company plan, if prior coverage was under a non‑Company plan, documentation that initial authorization requirements were met is required.

Ovulation suppression

Covered for frozen embryo transfer (FET) when documented

Ovulation suppression for FET: Generic leuprolide may be considered medically necessary to suppress ovulation for a frozen embryo transfer when documentation of positive clinical response and tolerability are provided; coverage is subject to infertility and assisted reproduction benefits.up to 12 months

Non‑formulary exception reviews and other reviews for generic leuprolide may be approved for up to 12 months.

Ovulation suppression (FET)

Covered when ALL of the following are met

FET ovulation suppression: Use of generic leuprolide for ovulation suppression for a frozen embryo transfer may be approved for up to 12 months when documentation of positive clinical response and tolerability are provided.up to 12 months

Coverage subject to infertility and assisted reproduction benefits; provider should document response and tolerability.

Prostate cancer (alternate listing)

Covered when ALL of the following are met

Prostate cancer treatment: Camcevi, Eligard, Firmagon, generic leuprolide, brand leuprolide depot, Lupron Depot, Lutrate Depot, Orgovyx, Trelstar, Vabrinity, and Zoladex may be approved for up to 12 months for treatment of prostate cancer when documentation of positive clinical response and tolerability are provided.up to 12 months

These products are primarily managed through the medical benefit for the listed agents.

Uterine fibroids (leiomyomas)

Covered when ALL of the following are met

Uterine fibroids leuprolide: Treatment of uterine fibroids with generic leuprolide, brand leuprolide depot, and Lupron Depot can only be approved for a maximum of 3 months total; re‑authorization will not be granted.maximum 3 months total

Initial approval for fibroid indications is typically 90 days; continuous use beyond 90 days is not recommended due to bone toxicity.

Endometrial thinning prior to ablation

Zoladex for endometrial thinning: Re-authorization of Zoladex for endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding beyond the initial 6 months is considered investigational.initial 6 months only

Authorization beyond 6 months is investigational due to lack of safety data for retreatment per FDA labeling.

Myfembree and Oriahnn duration limits

Myfembree/Oriahnn re-authorization: Re-authorization of Myfembree and Oriahnn beyond 24 months is considered not medically necessary; non‑formulary exception reviews may be approved up to 12 months.re-authorization not >24 months

Requests beyond labeled maximums are considered not medically necessary as specified in policy.

Initial Therapy - Gender Dysphoria

Covered when ALL of the following are met

Age and Tanner stage: Individual is ≥14 years of age, is less than 23 years of age, and has Tanner stage 2 or higher puberty onset based on physical exam OR confirmed by serum hormone thresholds (see policy thresholds).

Tanner confirmation should use lab‑reported reference ranges when available; specified non‑overlapping numeric thresholds apply when lab ranges are not provided.

Diagnosis confirmation: Documentation that the diagnosis of gender dysphoria is confirmed, including verification that all diagnostic criteria per the current DSM are met.

No gonadectomy: Documentation that the individual has not undergone a gonadectomy.

Counseling and informed consent: Documentation that potential adverse effects have been discussed including specifically possible effects on fertility and, if the individual is not taking or not going to start a cross‑sex (gender affirming) hormone, possible effects on bone mineralization and bone density.

Re-authorization - Gender Dysphoria

Re-authorization covered when ALL of the following are met

Evidence of suppression: Documentation of suppression of secondary sex characteristics based on physical examination OR documentation of suppression of characteristics not evident on exam (e.g., menses or penile erections) OR individual's/parent's report; suppression may be prevention of progression or regression of Tanner stage.

Documentation of regression to a lower Tanner stage or prevention of progression is acceptable.

Monitoring: Documentation of annual testing of bone age or bone density unless the individual is concurrently taking a cross‑sex (gender affirming) hormone; for first re‑authorization under Company plan, if prior coverage was under a non‑Company plan, include documentation that initial authorization requirements were met.

All other uses of gonadotropin-releasing hormone (GnRH) analogs that are not specifically described as covered in this policy are considered investigational. This includes any indication, regimen, or use that is not listed in the Medical Necessity / Covered Indications sections of the policy.

Authorization or re-authorization requests that exceed the product-specific labeled maximum durations described in this policy will not be approved. Examples include: Myfembree and Oriahnn — total treatment duration > 24 months, and product-dose-specific limits for Orilissa. Where applicable, non-formulary exception reviews for Myfembree and Oriahnn may be approved for up to 12 months only; otherwise requests beyond labeled maximums are considered not medically necessary or investigational as specified.

Use of GnRH analogs that does not meet the age or diagnosis requirements specified in the Medical Necessity section of this policy is considered investigational. Age and diagnostic thresholds (for example, age limits for central precocious puberty or the age/Tanner stage limits for gender dysphoria) must be met for coverage to be considered.

When an individual’s requested use fails to meet policy criteria, the distinction between coverage outcomes is explicit: uses that do not meet age or diagnosis requirements are designated investigational, whereas uses that meet age and diagnosis but fail other Medical Necessity criteria (for example, lack of required prior trials, missing documentation, or exceedance of indication‑specific limits) are designated not medically necessary.

Specific products have defined maximum labeled durations and re-authorization rules. Notable examples in this policy include: Myfembree and Oriahnn — total treatment duration ≤ 24 months (re-authorization beyond 24 months is considered not medically necessary); Orilissa — dose-specific duration limits; and Zoladex — re-authorization as an endometrial-thinning agent beyond the initial 6 months is considered investigational.

The policy separates uses that are investigational from those that are not medically necessary. Failure to meet required age or diagnosis elements results in an investigational determination. In contrast, if the age and diagnosis requirements are satisfied but other Medical Necessity criteria (such as prior trial requirements, dosing, or duration limits) are not met, the request is deemed not medically necessary.

If an individual meets the policy’s age and diagnosis requirements but does not satisfy other specified Medical Necessity criteria (for example, required contraceptive trial for Myfembree/Oriahnn, dosing limits, or indication‑specific monitoring/documentation), the use is considered not medically necessary. Re-authorization requests exceeding established duration limits (e.g., Myfembree/Oriahnn beyond 24 months or leuprolide for uterine fibroids beyond a maximum of 3 months total) will be denied as not medically necessary.

Coding and Laboratory Thresholds

HCPCS CodesHCPCS

J1950	Injection, leuprolide acetate (for depot suspension), (Lupron Depot 11.25 mg, 3.75; Lupron Depot PED 11.25, 15 mg, 30 mg, 7.5 mg ) per 3.75 mg.
J1951	Injection, leuprolide acetate for depot suspension (Fensolvi), 0.25 mg.
J1952	Leuprolide injectable, camcevi, 1 mg.
J1954	Injection, leuprolide acetate for depot suspension (Cipla), 7.5 mg.
J3315	Injection, triptorelin pamoate (Trelstar), 3.75 mg.
J3316	Injection, triptorelin, extended-release (Triptodur), 3.75 mg.
J3490	Unclassified drugs (use to report: Synarel and Vabrinity).
J9155	Injection, degarelix (Firmagon), 1 mg.
J9202	Goserelin acetate implant (Zoladex), per 3.6 mg.
J9217	Leuprolide acetate (for depot suspension) (Lupron Depot 22.5 mg, 30 mg, 45 mg, 7.5 mg and (Eligard)), 7.5 mg.

1–10 of 12

1/2

HCPCS coding changesHCPCS

J1954	HCPCS code added (document notes)
J3490	HCPCS code parenthetical updated to include Vabrinity (leuprolide acetate)
J9225	HCPCS code removed when Vantas withdrawn

inv-27: Tanner stage 2 hormone thresholds (when lab ranges not provided)

Males (assigned male at birth)Total testosterone ≥24 ng/dL (0.17–0.8 nmol/L) OR estradiol ≥14 pg/mL OR estrone ≥17 pg/mL when laboratory reference ranges are not provided.

Females (assigned female at birth)Total testosterone ≥11 ng/dL (0.36 nmol/L) OR estradiol ≥21 pg/mL OR estrone ≥30 pg/mL when laboratory reference ranges are not provided.

General guidanceWhen available, use the laboratory-specific reference ranges reported by the provider; these numeric cutoffs apply only if lab ranges are not provided.

inv-28: GnRH stimulation test positive threshold

Positive GnRH stimulation testPeak LH concentration ≥5 IU/L.

Use

Prior Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for drugs listed in this policy. Initial authorizations may be approved up to 12 months unless otherwise noted. Re-authorization limits: Myfembree and Oriahnn approvals are limited to a total treatment duration of 24 months; re-authorization beyond 24 months is not medically necessary. Generic leuprolide and leuprolide depot products for uterine fibroids are limited to a maximum of 3 months total treatment duration and re-authorization will not be granted. Zoladex for endometriosis or as an endometrial-thinning agent may not be authorized beyond 6 months for those indications per safety data and investigational determinations.

Initial authorizations: up to 12 months (unless otherwise specified).
Myfembree (relugolix/estradiol/norethindrone acetate) and Oriahnn (elagolix/estradiol/norethindrone acetate): maximum total treatment duration = 24 months; no re-authorization beyond 24 months.
Generic leuprolide / leuprolide depot for uterine fibroids: maximum total treatment duration = 3 months; re-authorization not granted.
Zoladex (goserelin) for endometriosis or prior-to-ablation endometrial thinning: approval beyond 6 months is not medically necessary or is investigational for the pre-ablation use.

Note

Initial Therapy Requirements and Drug Coverage

Initial therapy requirements (general)

Covered when ALL of the following are met

Initial authorization general: Initial approvals for drugs listed in this policy may be approved for up to 12 months unless noted otherwise; some indications have shorter maximums (e.g., leuprolide for uterine fibroids: 90 days; Zoladex for certain uses: 6 months).up to 12 months

Product‑specific initial duration limits are described in individual indication criteria.

Gender dysphoria initial therapy

Covered when ALL of the following are met

Gender dysphoria initial authorization: Initial authorization duration for gender dysphoria updated to up to 12 months; diagnosis confirmation per DSM and age/Tanner criteria required per policy.up to 12 months

Re-Authorization and Ongoing Use

Continuation Therapy — re-authorization requirements summary

Re-authorization requirements summary

Suppression evidence: Ongoing coverage for gender dysphoria requires documentation of continued suppression of natal secondary sex characteristics by exam or report or suppression of characteristics not evident on exam.

Annual bone age or bone density testing is required unless the individual is concurrently taking a cross‑sex hormone.

inv-55: Ongoing use / re-authorization (duplicate placement for continuity)

Re-authorization covered when ALL of the following are met

Suppression can be prevention of progression or regression; documentation of regression to a lower Tanner stage or prevention of progression is acceptable.

Required Trials Before Approval

Step	Requirement	Failure criteria
1	Trial and failure of one contraceptive prior to approval of Myfembree for uterine fibroids (relugolix/estradiol/norethindrone acetate).	Has tried and failed one contraceptive for management of symptoms as documented in the medical record.
1	Trial and failure of one contraceptive prior to approval of Oriahnn for uterine fibroids (elagolix/estradiol/norethindrone acetate).	Has tried and failed one contraceptive for management of symptoms as documented in the medical record.

Step	Requirement	Failure criteria
1	No explicit step therapy requirements stated in these policy sections for other listed GnRH agents or indications.	N/A

Benefit Assignment and Administration

Billing Rule

office | infusion center | pharmacy — benefit assignment and billing guidance

Administer and bill products according to the member's benefit assignment: some drugs are medical-benefit administered (office/infusion billing), others are pharmacy-dispensed, and some may be managed under both benefits.

Medical benefit examples (administer/bill in office/infusion): Camcevi, Firmagon, Trelstar, Vabrinity, Zoladex, etc.
Pharmacy benefit examples (dispense via pharmacy): Myfembree, Orgovyx, Oriahnn, Orilissa.
Products listed as managed by both benefits must be billed according to the payer's instruction for the specific claim.

Billing Rule

office — product dosing and administration per FDA prescribing information

Medications listed in the policy are subject to the product's FDA dosing and administration prescribing information; providers must follow FDA prescribing information for dosing and administration when giving these agents in the office.

Background and Definitions

GnRH agonists and antagonists are peptide analogs that act at the pituitary GnRH receptor to suppress production of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby reducing downstream sex hormone levels. Agonists typically produce an initial physiologic surge in gonadotropins followed by receptor down-regulation and suppression; antagonists directly block GnRH receptors and produce a rapid reduction in LH/FSH without an initial surge. Clinically, these agents are used to suppress or prevent progression of secondary sex characteristics (for example, in gender dysphoria or central precocious puberty), to reduce sex‑hormone–driven disease activity (for example, endometriosis or hormone‑sensitive breast and prostate cancer), to reduce uterine fibroid size or bleeding preoperatively, and to suppress ovulation for assisted reproductive procedures such as frozen embryo transfer.

inv-46: GnRH agonist vs antagonist (key differences)

Mechanism — agonistsGnRH agonists initially stimulate LH/FSH release causing a transient hormone surge, then downregulate pituitary receptors leading to suppression of LH/FSH and sex hormones.

Mechanism — antagonistsGnRH antagonists directly block pituitary GnRH receptors to rapidly reduce LH/FSH and sex hormones without an initial surge.

Clinical implicationAntagonists achieve suppression faster and avoid the initial hormone surge seen with agonists, though overall efficacy is similar.

Policy Summary

PayerPremera Bluecross

PolicyGonadotropin Releasing Hormone (GnRH) Analogs

Policy CodePolicy N/A

Change TypeMaterial revisions and clarifications (authorization durations, age/Tanner criteria, coding updates)

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit office visit notes documenting diagnosis, exam or hormone confirmation of Tanner stage, and counseling on fertility and bone effects.

SourceLink

On This Page

Suppression may be prevention of progression or regression of Tanner stage; physical exam, parent/guardian or patient report, or documentation of suppression of non‑observable characteristics are acceptable.

Special circumstances for older or later‑stage starts: If starting at age ≥23, after Tanner stage 5, or after irreversible secondary sexual development, documentation that a GnRH analog is necessary to prevent or stop further development of natal secondary sex characteristics OR to suppress characteristics not evident on physical exam (e.g., menses or penile erections).

One acceptable diagnostic confirmation for central precocious puberty when combined with clinical findings and age criteria.

Reference noteIf available, pubertal basal LH per laboratory reference ranges or advanced bone age may also confirm diagnosis.

inv-29: Basal Luteinizing Hormone reference ranges

Appendix referenceBasal LH reference ranges are age- and sex-specific as listed in the policy appendix (see laboratory reference tables).

Examples (females)<1 year: <0.02–18.3 IU/L; 1–8 years: <0.02–0.3 IU/L; 9–10 years: <0.02–4.8 IU/L; 11–13 years: <0.02–11.7 IU/L; 14–17 years: <0.02–16.7 IU/L.

Examples (males)<1 year: <0.02–5.0 IU/L; other age bands provided in appendix—use the lab's reported ranges for interpretation.

inv-30: Tanner stage 2 confirmation hormone thresholds (assigned sex specific)

Assigned male at birthConfirm Tanner stage 2 with total testosterone ≥24 ng/dL (0.17–0.8 nmol/L) OR estradiol ≥14 pg/mL OR estrone ≥17 pg/mL when lab ranges are not provided.

Assigned female at birthConfirm Tanner stage 2 with total testosterone ≥11 ng/dL (0.36 nmol/L) OR estradiol ≥21 pg/mL OR estrone ≥30 pg/mL OR LH >0.3 IU/L OR FSH >4.1 IU/L when lab ranges are not provided.

Interpretation notePrefer laboratory-specific reference ranges when reported; these cutoffs apply only if the provider does not report lab reference ranges.

Prior Authorization and Benefit Assignment

Coverage and benefit assignment: management of products is routed to the appropriate benefit. Drugs managed under the medical benefit require submission through medical benefit channels; drugs managed under the pharmacy benefit require pharmacy routing. Some products are managed under both benefits — verify correct submission pathway.

Medical benefit examples: Camcevi, Fensolvi, Firmagon, Supprelin LA, Trelstar, Triptodur, Vabrinity, Zoladex (see policy list).
Pharmacy benefit examples: Myfembree, Orgovyx, Oriahnn, Orilissa (see policy list).
Both pharmacy and medical benefit: Eligard, generic leuprolide acetate, Lupron Depot PED, Lupron Depot, brand leuprolide depot.

Documentation Required

Required Medical Record Documentation

Providers must submit clinical documentation showing medical necessity with every prior authorization request. Records should include office visit notes with diagnosis, relevant history, physical exam, lab values, and documentation that specific policy criteria are met. For re-authorization requests where prior coverage occurred under a non-Company plan, documentation that initial authorization requirements were met is required.

Office visit notes: diagnosis, history, physical evaluation, pertinent labs.
If prior coverage was under a different plan, include documentation that initial criteria were met.
Documentation must show positive clinical response and tolerability when required (e.g., ongoing cancer therapy).

Documentation Required

Hormone Level Documentation Guidance

When gender dysphoria or puberty suppression criteria rely on Tanner staging by laboratory values, use the reporting laboratory's reference ranges when provided. If the lab reference ranges are not reported, use the policy's specified thresholds. Note that Tanner stage 2 must be confirmed by values that do not overlap with Tanner stage 1.

If lab reference ranges are provided by the reporting lab, use those ranges to determine Tanner stage 2.
If lab reference ranges are not provided, use the policy thresholds (see hormone level guidance).
Tanner stage 2 confirmation requires values that do not overlap with Tanner stage 1.

Documentation Required

Tanner Stage Confirmation Documentation

Tanner stage confirmation and related documentation: when serum hormone levels are used to confirm Tanner stage 2 and the lab does not supply reference ranges, providers must document values meeting the policy thresholds that do not overlap with Tanner stage 1. For individuals assigned male at birth, acceptable confirming values include total testosterone ≥ 24 ng/dL (or ≥ 0.17–0.8 nmol/L), or serum estradiol ≥ 14 pg/mL, or serum estrone ≥ 17 pg/mL. For individuals assigned female at birth, acceptable confirming values include total testosterone ≥ 11 ng/dL (or 0.36 nmol/L), or serum estradiol ≥ 21 pg/mL, or serum estrone ≥ 30 pg/mL, or LH > 0.3 IU/L, or FSH > 4.1 IU/L.

Male-assigned at birth: total testosterone ≥ 24 ng/dL (≥ 0.17–0.8 nmol/L) OR estradiol ≥ 14 pg/mL OR estrone ≥ 17 pg/mL.
Female-assigned at birth: total testosterone ≥ 11 ng/dL (0.36 nmol/L) OR estradiol ≥ 21 pg/mL OR estrone ≥ 30 pg/mL OR LH > 0.3 IU/L OR FSH > 4.1 IU/L.
When lab reference ranges are reported, those ranges take precedence; otherwise use the values above to confirm Tanner stage 2.

Denial Risk

Coverage Triggers for Denial

Prior authorization denials may be issued if requested use is outside of FDA labeling, does not meet policy age or diagnosis requirements, or lacks required documentation (including failed contraceptive trial for Myfembree/Oriahnn when applicable). Use of GnRH analogs for indications not listed in this policy is investigational. Ensure all criteria in the Medical Necessity section are documented to avoid denial.

Requests for uses not outlined in the policy = investigational (denial risk).
Requests that meet age/diagnosis but fail other medical necessity criteria = not medically necessary (denial risk).
For Myfembree/Oriahnn: document trial and failure of one contraceptive for symptom management to meet policy criteria.

Prior Authorization

Re-authorization Limits

Re-authorization operational notes: re-authorization of Myfembree and Oriahnn is limited to the labeled total duration (24 months). Generic leuprolide and brand leuprolide products used for uterine fibroids are not eligible for re-authorization beyond the 3-month maximum. Zoladex re-authorization for endometrial-thinning prior to ablation beyond 6 months is investigational.

Myfembree/Oriahnn: total treatment duration ≤ 24 months; re-authorization beyond 24 months not medically necessary.
Leuprolide (generic and depot) for uterine fibroids: max 3 months total; no re-authorization.
Zoladex for pre-ablation endometrial thinning: re-authorization beyond 6 months is investigational.

Initial gender dysphoria criteria require documentation of age/Tanner stage, DSM diagnosis confirmation, no gonadectomy, and counseling as specified in policy.

Initial Therapy - Drug Coverage (age, Tanner stage, diagnosis, no prior gonadectomy, counseling)

Initial therapy coverage requires meeting age, Tanner stage, diagnosis confirmation, no prior gonadectomy, and counseling documentation

Age/Tanner/Diagnosis: See Initial Therapy - Gender Dysphoria criteria set for required elements: age ≥14 and <23, Tanner stage ≥2 by exam or confirmed by non‑overlapping serum hormone thresholds, DSM diagnosis confirmation, and no prior gonadectomy.

Tanner confirmation may use lab reference ranges when provided; otherwise specified numeric thresholds apply.

Ongoing use / re-authorization (initial therapy context)

Re-authorization rules and required documentation

General re-authorization: Re-authorization may be granted for up to 12 months for ongoing treatment when documentation of positive clinical response and tolerability is provided; indication‑specific re‑authorization limits and monitoring apply (e.g., bone age monitoring for gender dysphoria).

Specific products have unique re‑authorization limits per policy (see Myfembree/Oriahnn, Zoladex, leuprolide for fibroids).

Monitoring: Annual testing of bone age or bone density is required unless the individual is concurrently taking a cross‑sex hormone; for first re‑authorization under Company plan, if prior coverage was under a non‑Company plan, documentation that initial authorization requirements were met is required.

Continuation therapy — re-authorization rules

Re-authorization rules

Continuation/reauthorization: Continuation may be approved when documentation of positive clinical response and tolerability are provided, subject to specific duration limits per indication (e.g., up to 12 months for prostate cancer and ovulation suppression; uterine fibroid leuprolide limited to 3 months; Myfembree/Oriahnn limited to 24 months).

See individual indication sections for product‑specific limits.

Ensure dosing and administration align with the FDA labeling for the specific product being administered.
Refer to each product's prescribing information for frequency, route, and preparation.

inv-47: Pre-/perimenopausal status definition and requirements

DefinitionPre- or perimenopausal status requires documentation of ongoing menses OR normal estradiol, FSH, and LH levels.

Use caseRequired to establish pre-/perimenopausal status for certain breast cancer indications when considering adjuvant or palliative GnRH therapy.

DocumentationProviders should include menstrual history or serum hormone results in submitted medical records to verify status.

inv-48: Central precocious puberty definition

DefinitionCentral precocious puberty (CPP) is development of secondary sex characteristics before age 8 in girls and before age 9 in boys due to early activation of the hypothalamic–pituitary–gonadal axis.

Diagnostic featuresCPP is characterized by advanced bone age and pubertal levels of LH and FSH; confirmation can be by pubertal basal LH (per lab ranges), positive GnRH stimulation test (peak LH ≥5 IU/L), or bone age advanced ≥1 year.

Typical causesMost cases in girls are idiopathic; CNS lesions, tumors, trauma, or congenital defects may cause CPP and warrant evaluation as appropriate.

inv-49: Gender dysphoria definition

DefinitionGender dysphoria is psychological distress caused by incongruence between gender identity and sex assigned at birth, with clinically significant distress as specified in DSM criteria.

DiagnosisTypically diagnosed by a mental health professional using current DSM criteria; core components include longstanding distress and functional impairment associated with divergence between gender identity and natal sexual characteristics.

Treatment contextTreatment options may include psychotherapy, hormone therapy, and surgery; GnRH analogs may be used for puberty suppression when medical necessity criteria are met.

inv-50: Uterine fibroids definition

DefinitionUterine fibroids (leiomyomas) are benign smooth muscle tumors of the myometrium that commonly cause heavy or prolonged menstrual bleeding, pelvic pressure, urinary or bowel symptoms, and may contribute to infertility.

Clinical diagnosisDiagnosis is based on pelvic examination and ultrasound imaging alongside symptom history.

Epidemiology noteFibroids are common in women of reproductive age and often shrink after menopause; incidence varies by population and can be associated with significant quality-of-life impact.

inv-51: Purpose of GnRH analog treatment (puberty suppression, menses suppression)

Primary purposeTo suppress observable secondary sex characteristics of the gender assigned at birth or to suppress characteristics not evident on physical exam (e.g., menses or penile erections).

Intended effectsUsed to prevent progression or induce regression of natal secondary sex characteristics and to delay puberty in eligible individuals (puberty suppression).

Clinical notePolicy emphasizes suppression of observable characteristics rather than achieving target laboratory values alone; documentation of suppression by exam or report is required for continuation.