CurrentHawaii Medical Service Association (HMSA)Policy N/A

Leuprolide

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This policy governs HMSA prior authorization and coverage criteria for leuprolide products, including Lupron Depot, Lupron Depot-PED, generic leuprolide acetate, and Fensolvi. It applies to HMO, PPO, and QUEST members and addresses FDA-approved and compendial indications, initial approval, continuation, documentation, and exclusions.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLeuprolide

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required; submit documentation establishing the indication, approval criteria, and required clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Leuprolide

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

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Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLeuprolide

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required; submit documentation establishing the indication, approval criteria, and required clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5Named leuprolide products

3 monthsFibroid initial authorization

6 monthsEndometriosis initial authorization

12 monthsGender dysphoria authorization

2Maximum treatment courses

18 yearsCPP continuation age

Coverage Criteria and Exclusions

Initial therapy: uterine fibroids

Covered when all of the following are met.

Initial therapy for uterine fibroids

Iron deficiency anemia: The member has a diagnosis of iron deficiency anemia secondary to vaginal bleeding associated with uterine leiomyomas.Hct < 33% and/or Hgb < 11 g/dL
Preoperative hematologic improvement: It is essential to increase hemoglobin or hematocrit before leiomyoma removal surgery.

Initial therapy: endometriosis

Covered when the indication and member requirements are met.

Initial therapy for endometriosis: Authorization of 6 months may be granted for initial treatment of symptomatic endometriosis in an adult female member.Member age ≥ 18 years

Product: Lupron Depot 3.75 mg or 11.25 mg.

Initial therapy: female central precocious puberty

Covered when all of the following are met.

Initial therapy for female central precocious puberty

CPP diagnostic and clinical criteria
- Confirmed CPP: CPP is confirmed by a GnRH test or third-generation basal LH assay.
- Advanced bone age: The member has advanced bone age.Bone age at least 1 year greater than chronological age
- Intracranial tumor excluded: An intracranial tumor has been excluded with diagnostic imaging of the brain.

Initial therapy: male central precocious puberty

Covered when all of the following are met.

Initial therapy for male central precocious puberty

CPP diagnostic and clinical criteria
- Confirmed CPP: CPP is confirmed by a GnRH test or third-generation basal LH assay.
- Advanced bone age: The member has advanced bone age.Bone age at least 1 year greater than chronological age
- Intracranial tumor excluded: An intracranial tumor has been excluded with diagnostic imaging of the brain.

Initial therapy: gender dysphoria

Covered for 12 months when all of the following are met.

Initial therapy for gender dysphoria

Clinical criteria
- Persistent, documented gender dysphoria: The patient has persistent, well-documented gender dysphoria as defined by current DSM criteria and gender identity disorder as defined by current ICD criteria, diagnosed by a qualified health professional.
  See policy appendices A and B.
- Puberty has begun: The patient has exhibited the first physical changes of puberty.Minimum Tanner stage 2
- Assent and consent: Clinical records document patient assent and a fully informed decision and consent by the parent or guardian.

Initial therapy: stimulation test for CPP diagnosis

Covered for the stated diagnostic use.

CPP stimulation test: Authorization may be granted for one dose for use as a stimulation test to confirm the diagnosis of central precocious puberty.One dose

Product: generic leuprolide.

Continuation and reauthorization

Continuation requires the applicable initial criteria plus the following indication-specific requirements.

Indication-specific continuation
- Uterine fibroids: A delay in leiomyoma removal surgery has occurred and appropriate documentation is provided.3-month additional course; maximum 2 courses total
  All initial criteria must also be met.
- Endometriosis: Retreatment is clinically necessary and appropriate documentation is provided.6-month additional course; maximum 2 courses total
  All initial criteria must also be met.
- Central precocious puberty:

Gender dysphoria reauthorization

Continuation therapy for gender dysphoria may be authorized when all criteria are met.

Prior authorization: The member was previously authorized by HMSA/CVS.
Continued clinical need: There is a continued need to delay puberty until the age of 18 years old.Until age 18
Documentation: Appropriate documentation is provided.

DSM-5 adults and adolescents

For adults and adolescents, the DSM-5 criteria require all listed diagnostic elements.

Required manifestations: At least two of the six manifestations are present: incongruence involving sex characteristics; desire to be rid of sex characteristics; desire for the other gender's sex characteristics; desire to be another gender; desire to be treated as another gender; or conviction of having typical feelings and reactions of another gender.Two or more of six manifestations
Functional impact: The condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning.

DSM-5 children

For children, the DSM-5 criteria require all listed diagnostic elements.

Required manifestations: At least six of the eight manifestations are present, and one must be criterion A.1: a strong desire to be the other gender or an insistence that one is the other gender.Six or more of eight manifestations; criterion A.1 required
The manifestations also address clothing, cross-gender roles, toys or activities, playmates, rejection of stereotyped activities, dislike of sexual anatomy, and dislike of matching primary or secondary sex characteristics.
Functional impact: The condition is associated with clinically significant distress or impairment in social, school, or other important areas of functioning.

Coverage is excluded for pregnancy, breastfeeding, and undiagnosed abnormal vaginal bleeding.

For HMSA Fed 087 and Postal Plan coverage, gender-reassignment hormonal drugs used for gender transition are not covered for benefit years beginning January 1, 2026. Members who received these drugs during benefit year 2025 may apply for a 2026 coverage exception if they were active enrolled members in the applicable HMSA Fed 087 or Postal Plan program during 2025. The policy states that the 2026 exception process does not include members under age 19 who were in mid-treatment for gender-identity services or hormone treatment in 2025.

Clinical Thresholds and Definitions Used in Review

Anemia associated with uterine fibroids

ConditionIron deficiency anemia secondary to vaginal bleeding associated with uterine leiomyomas

Hematocrit thresholdHct < 33%

Hemoglobin thresholdHgb < 11 g/dL

Advanced bone age

CriterionAdvanced bone age

Bone-age thresholdAt least 1 year greater than chronological age

Applicable conditionCentral precocious puberty

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for leuprolide. The member must meet the applicable approval criteria for the requested indication, have no exclusion to therapy, and submit the information necessary to initiate review.

Submit the applicable initial-therapy documentation and clinical records supporting the requested indication.
Approval is subject to the indication-specific criteria and exclusions in this policy.

Note

Oncology Policy Routing

Route all oncology indications, including compendial oncology uses, to the HMSA Global Oncology Policy for review.

Prior Authorization

Precertification Required

Policy Background

Leuprolide products are covered, when applicable criteria are met, for selected gynecologic conditions such as endometriosis and uterine fibroids; central precocious puberty; gender dysphoria and pubertal suppression; a diagnostic stimulation test to confirm central precocious puberty; and oncology indications, including compendial uses. Oncology indications and reauthorization are handled under HMSA's Global Oncology Policy.

Key Terms

Add-back therapy

MedicationNorethindrone acetate

Regimen5 mg daily

PurposeUsed with specified Lupron Depot regimens to reduce loss of bone mineral density and vasomotor symptoms

Central precocious puberty (CPP)

ConditionA pediatric condition involving early pubertal development

Applicable productsLupron Depot-PED, Fensolvi, and generic leuprolide

Diagnostic requirementsPolicy criteria include diagnostic confirmation, advanced bone age, brain imaging, and age-of-onset requirements

Initial Therapy by Indication

Initial therapy: uterine fibroids

Covered when all of the following are met.

Uterine fibroids

Iron deficiency anemia: The member has iron deficiency anemia secondary to vaginal bleeding associated with uterine leiomyomas.Hct < 33% and/or Hgb < 11 g/dL
Preoperative hematologic improvement: It is essential to increase hemoglobin or hematocrit before leiomyoma removal surgery.

Initial therapy: endometriosis

Covered when the indication and member requirements are met.

Continuation and Reauthorization

Continuation and reauthorization

Continuation requires the applicable initial criteria plus the indication-specific requirements below.

Indication-specific requirements
- Uterine fibroids: A delay in leiomyoma removal surgery has occurred and appropriate documentation is provided.One additional 3-month course; maximum 2 courses total
- Endometriosis: Retreatment is clinically necessary and appropriate documentation is provided.One additional 6-month course; maximum 2 courses total
- Central precocious puberty:

Product-Specific Authorization Limits

Generic leuprolide

ProductGeneric leuprolide

Quantity limitOne dose

UseStimulation test to confirm the diagnosis of central precocious puberty

Lupron Depot

ProductLupron Depot

Additional treatmentOne additional treatment course

Maximum totalTwo courses total

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLeuprolide

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Last ReviewJun 1, 2025

Next Review DateN/A

Key ActionPrior authorization is required; submit documentation establishing the indication, approval criteria, and required clinical information.

SourceLink

On This Page

Early puberty onset: Onset of secondary sexual characteristics occurred before age 8 years.< 8 years

Early puberty onset: Onset of secondary sexual characteristics occurred before age 9 years.< 9 years

Comorbid conditions controlled: Comorbid medical and mental health conditions, if present, are reasonably well-controlled.

Safe administration: Puberty suppression therapy will be administered safely, appropriately, and under medical supervision.

There is a continued need to delay puberty, such as extreme short stature, and appropriate documentation is provided.

12-month extension beyond age 12 in females or age 13 in males, until age 18

Gender dysphoria: The member was previously authorized by HMSA/CVS, there is a continued need to delay puberty, and appropriate documentation is provided.12 months, until age 18

Oncology: Refer to HMSA's Global Oncology Policy.

Applies to all oncology indications, including compendial uses.

Female CPP age of onset

CriterionOnset of secondary sexual characteristics

Female thresholdBefore age 8 years

Applicable conditionFemale central precocious puberty

Male CPP age of onset

CriterionOnset of secondary sexual characteristics

Male thresholdBefore age 9 years

Applicable conditionMale central precocious puberty

Gender dysphoria pubertal development

CriterionPuberty has begun

Minimum Tanner stageTanner stage 2

TherapyPubertal hormonal suppression therapy

Continuation puberty suppression age

Continuation therapyPuberty suppression for gender dysphoria

Age limitUntil the age of 18 years old

Authorization period12 months

DSM-5 adults and adolescents duration

PopulationAdults and adolescents

Minimum durationAt least 6 months

Associated requirementClinically significant distress or impairment

DSM-5 adults and adolescents manifestations

PopulationAdults and adolescents

Required manifestationsTwo or more of six manifestations

Functional impactClinically significant distress or impairment in social, occupational, or other important areas of functioning

DSM-5 children duration

PopulationChildren

Minimum durationAt least 6 months

Associated requirementClinically significant distress or impairment

DSM-5 children manifestations

PopulationChildren

Required manifestationsSix or more of eight manifestations

Required criterionOne manifestation must be criterion A.1

Precertification is required for leuprolide. Refer to the HMSA medical specialty drug policy website for the required fax form.

Documentation Required

Retreatment Documentation

Retreatment requires documentation in addition to meeting all applicable initial criteria. A second course is limited to one additional treatment course, for a maximum of two courses total.

Uterine leiomyoma: document that leiomyoma-removal surgery has been delayed and provide the reason for the delay.
Endometriosis: retreatment must be clinically necessary; provide documentation explaining the reason for retreatment.

Documentation Required

CPP Diagnostic and Continuation Documentation

For central precocious puberty (CPP), submit diagnostic confirmation and documentation supporting the need for treatment continuation or puberty delay.

Diagnosis must be confirmed by a GnRH agonist stimulation test or a third-generation basal LH assay.
For CPP treatment, document the applicable advanced bone age, exclusion of an intracranial tumor by brain imaging, and age at onset of secondary sexual characteristics.
For continuation beyond the standard age limit, document the continued need to delay puberty, such as extreme short stature.

Documentation Required

Gender Dysphoria Consent Documentation

For gender dysphoria pubertal hormonal suppression, clinical records must document the patient’s assent to treatment and the parent or guardian’s fully informed decision and consent to treatment.

Documentation Required

Continuation Beyond Standard CPP Age Limits

For CPP continuation beyond the standard age limits, submit documentation supporting the continued need to delay puberty. A 12-month extension may be authorized until age 18 when criteria are met.

Female members: continuation beyond age 12.
Male members: continuation beyond age 13.
Document the continued clinical need for treatment and appropriate supporting records.

Documentation Required

Gender Dysphoria Continuation Documentation

Gender dysphoria continuation requires prior authorization and supporting documentation. A 12-month authorization may be granted when the member was previously authorized by HMSA/CVS, continues to need puberty delay through age 18, and appropriate documentation is provided.

Submit records supporting ongoing treatment and the continued need to delay puberty.
The member must have been previously authorized by HMSA/CVS.

Documentation Required

Qualified Professional Credentials

Documentation must identify a qualified professional whose credentials and experience support diagnosis and treatment of gender dysphoria or gender incongruence.

Qualified mental health professional: master’s degree or equivalent in a clinical behavioral-science field from an appropriately accredited institution; relevant licensing-board credentials; competence using the DSM and/or ICD; ability to identify coexisting mental-health concerns and distinguish them from gender dysphoria; supervised psychotherapy or counseling training; knowledge of gender-nonconforming identities and gender dysphoria assessment and treatment; and continuing education in this area.
Qualified physician: MD/DO degree from an appropriately accredited institution, active state license, competence using the DSM and/or ICD, ability to diagnose gender dysphoria/gender incongruence and distinguish related conditions such as body dysmorphic disorder, training in related psychiatric conditions, ability to provide or refer for appropriate treatment, ability to assess understanding, mental health, and social conditions affecting gender-affirming hormone therapy, and regular attendance at relevant professional meetings.

Documentation Required

DSM-5 Diagnostic Documentation

The records must document persistent gender dysphoria under current DSM criteria, including the required duration, manifestations, and clinically significant distress or impairment.

Adults and adolescents: for at least 6 months, document a marked incongruence between experienced/expressed gender and assigned gender, manifested by at least two specified features, including incongruence with sex characteristics, desire to eliminate or acquire sex characteristics, desire to be another gender, desire to be treated as another gender, or conviction of typical feelings and reactions of another gender.
Adults and adolescents: document clinically significant distress or impairment in social, occupational, or other important areas of functioning.
Children: for at least 6 months, document a marked incongruence manifested by at least six specified features, with the first criterion required, including desire or insistence regarding another gender, cross-gender preferences in clothing, roles, play, toys, or playmates, rejection of gender-typical activities or toys, dislike of sexual anatomy, or dislike of matching primary or secondary sex characteristics.
Children: document clinically significant distress or impairment in social, school, or other important areas of functioning.

Denial Risk

Exclusions and Plan-Specific Gender-Transition Restriction

Leuprolide is excluded when the member is pregnant, breastfeeding, or has undiagnosed abnormal vaginal bleeding. For HMSA Fed 87 and Postal Plan coverage, gender-reassignment hormonal drugs for gender transition are not covered for benefit years beginning January 1, 2026, subject to the stated exception process.

The 2026 exception process does not include members under age 19 who are in mid-treatment for gender-identity services or hormone treatments in 2025.
Members who received gender-reassignment hormonal drugs for gender transition during 2025 may apply for a 2026 exception only if they were actively enrolled in an HMSA Fed 87 or Postal Plan program during 2025.

Denial Risk

Failure to Meet Initial Criteria

Initial authorization may be denied when the member does not satisfy every criterion for the requested indication or when required supporting documentation is absent.

Uterine fibroids: deny if the member does not have iron-deficiency anemia secondary to vaginal bleeding from uterine leiomyomas (Hct < 33% and/or Hgb < 11 g/dL) or if it is not essential to increase hemoglobin/hematocrit before leiomyoma-removal surgery.
Endometriosis: deny if the member is not an adult female member age 18 or older with symptomatic endometriosis.
Central precocious puberty: deny if the required GnRH test or third-generation basal LH confirmation, advanced bone age, brain imaging excluding intracranial tumor, or age-of-onset criterion is not met. Onset must be before age 8 in females or before age 9 in males.
Gender dysphoria: deny if persistent, well-documented DSM-defined gender dysphoria and applicable ICD-defined gender identity disorder are not established by a qualified professional; Tanner stage is below 2; required patient assent or parent/guardian informed consent is not documented; comorbid conditions are not reasonably controlled; or treatment cannot be administered safely, appropriately, and under medical supervision.
CPP stimulation testing: deny authorization for more than one diagnostic dose or when the dose is not being used to confirm CPP.

Denial Risk

Failure to Meet Continuation Criteria

Reauthorization may be denied when initial criteria are not still met or when the indication-specific continuation requirements and documentation are not provided.

Uterine fibroids: deny retreatment if initial criteria are not met, surgery has not been delayed, or appropriate documentation of the delay is missing; maximum two courses total.
Endometriosis: deny retreatment if initial criteria are not met, retreatment is not clinically necessary, or appropriate documentation of the reason for retreatment is missing; maximum two courses total.
CPP: deny continuation beyond age 12 for females or age 13 for males if there is no documented continued need to delay puberty or appropriate supporting documentation.
Gender dysphoria: deny continuation if the member was not previously authorized by HMSA/CVS, continued need to delay puberty through age 18 is not established, or appropriate documentation is missing.
Oncology reauthorization: route to and apply the HMSA Global Oncology Policy.

Denial Risk

Gender Dysphoria Continuation Criteria Not Met

Gender dysphoria continuation authorization may be denied when the member does not have prior HMSA/CVS authorization, the continued need to delay puberty through age 18 is not documented, or appropriate ongoing-treatment support is absent.

Authorization is for 12 months when continuation criteria are met.
Submit documentation supporting continued treatment and the ongoing need for puberty suppression.

Prior Authorization

Leuprolide Precertification Rule

Precertification is required for leuprolide. Requests submitted without the required precertification and applicable HMSA specialty-drug fax form may not be authorized.

Use the HMSA medical specialty drug policy website to obtain the fax form.
Submit the request through the required precertification process.

Qualified mental health professional

EducationMaster's degree or equivalent in a clinical behavioral science field from an appropriately accredited institution

CredentialsDocumented credentials from a relevant licensing board or equivalent

CompetenciesDSM and/or ICD diagnostic competence, psychotherapy or counseling training, ability to recognize coexisting mental health concerns, and knowledge and continuing education in gender dysphoria

Qualified physician

CredentialMD or DO degree from an appropriately accredited institution

LicensureActive license in the state of practice

Diagnostic competencyDSM and/or ICD competence, ability to diagnose gender dysphoria or gender incongruence and distinguish similar conditions, and training in related psychiatric conditions

Authorization of 6 months may be granted for initial treatment of symptomatic endometriosis in an adult female member.

Product: Lupron Depot 3.75 mg or 11.25 mg.

Initial therapy: gender dysphoria

Covered for 12 months when all of the following are met.

Gender dysphoria

Clinical criteria
- The patient has persistent, well-documented gender dysphoria meeting current DSM criteria and gender identity disorder meeting current ICD criteria, diagnosed by a qualified health professional.
- The patient has exhibited the first physical changes of puberty.Minimum Tanner stage 2
- Clinical records document patient assent and a fully informed decision and consent by the parent or guardian.
- Comorbid medical and mental health conditions, if present, are reasonably well-controlled.
- Puberty suppression therapy will be administered safely, appropriately, and under medical supervision.

Initial therapy: stimulation test for CPP diagnosis

Covered for the stated diagnostic use.

CPP stimulation test: Authorization of one dose may be granted for use as a stimulation test to confirm the diagnosis of central precocious puberty.One dose

Product: generic leuprolide.

Initial therapy: oncology indications

Oncology indications are routed for review under the applicable oncology policy.

Oncology indications: All oncology indications, including compendial uses, are handled under HMSA's Global Oncology Policy.

Lupron Depot 7.5 mg, 22.5 mg, 30 mg, 45 mg and generic leuprolide are identified for prostate cancer.

There is a continued need to delay puberty, such as extreme short stature, and appropriate documentation is provided.

12-month extension beyond age 12 in females or age 13 in males, until age 18

Gender dysphoria: The member was previously authorized by HMSA/CVS, there is a continued need to delay puberty, and appropriate documentation is provided.12 months, until age 18

Oncology: Refer to HMSA's Global Oncology Policy.

Applies to all oncology indications, including compendial uses.

Gender dysphoria continuation

For gender dysphoria, continuation authorization may be granted when all listed requirements are met.

Prior authorization: The member was previously authorized by HMSA/CVS.
Continued clinical need: There is a continued need to delay puberty until the age of 18 years old.Until age 18
Documentation: Appropriate documentation is provided.

Oncology reauthorization

For all oncology indications, including compendial uses, reauthorization is handled under the HMSA Global Oncology Policy.

Oncology reauthorization: Refer to HMSA's Global Oncology Policy for reauthorization of all oncology indications, including compendial uses.

Leuprolide

ProductLeuprolide

Authorization period12 months

UseContinuation therapy for gender dysphoria