CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leuprolide acetate (Eligard, Vabrinty) — coverage criteria

Covers medical authorization criteria for leuprolide acetate (Eligard, Vabrinty) for FDA-approved and compendial indications including advanced prostate cancer, androgen receptor–positive salivary gland tumors, and gender dysphoria. Applies to members of Neighborhood Health Plan of Rhode Island when approval criteria are met and no exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate (Eligard, Vabrinty) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) when criteria for prostate cancer, salivary gland tumor, or gender dysphoria are met and document required prescriber specialty and Tanner stage for pubertal suppression.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

3covered indications

requiredprescriber restriction (minors)

requiredfertility counseling

Coverage Criteria

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Prostate Cancer

Covered for prostate cancer when ALL of the following are met

Prostate Cancer Initial: Treatment of advanced prostate cancer (FDA-approved indication)

Authorization of 12 months may be granted

Prostate Cancer Continuation: Member requesting reauthorization is experiencing clinical benefit (e.g., serum testosterone < 50 ng/dL) and has not experienced unacceptable toxicity

Authorization of 12 months may be granted

Salivary Gland Tumor

Covered for salivary gland tumor when ALL of the following are met

Salivary Gland Tumor Initial: Recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumor; may be used as single agent or in combination with abiraterone and prednisone

Authorization of 12 months may be granted

Salivary Gland Tumor Continuation: For reauthorization: no evidence of unacceptable toxicity or disease progression on current regimen

Authorization of 12 months may be granted

Gender Dysphoria (pubertal suppression and gender transition)

Covered for gender dysphoria when ALL of the following are met

Diagnosis: Member has a diagnosis of gender dysphoria

Capacity: Member is able to make an informed decision to engage in treatment

Pubertal stage: Member has reached or previously reached Tanner stage 2 of puberty or greater (for pubertal suppression)Tanner stage >= 2

Per state regulatory guidelines age restrictions may apply

Comorbid control: Member's comorbid conditions are reasonably controlled

All indications for leuprolide acetate that are not specifically listed in this policy are considered experimental/investigational and not medically necessary.

Use of leuprolide acetate for indications other than the FDA‑approved and compendial uses specified in this policy is considered not medically necessary.

Provider Actions and Authorization Rules

Prior Authorization

Prior authorization — 12-month approvals

Prior authorization may be granted for up to 12 months for the listed indications (prostate cancer; androgen receptor–positive salivary gland tumors; pubertal suppression and gender transition for gender dysphoria) when the specific clinical criteria for each indication are met.

Authorization duration: up to 12 months for approved indications

Note

Providers must obtain prior authorization and ensure that documentation demonstrating the member meets the clinical criteria for the requested indication is retained and available at time of request and audit.

Ensure documentation of diagnosis, informed decision-making, counseling on contraindications/side effects, and fertility preservation discussion where applicable

Documentation Required

Required prescriber specialty and documentation for gender dysphoria

For treatment related to gender dysphoria, the prescriber must be a provider specialized in transgender care or must consult with such a specialist; for members under 18, there must be documented collaborative care with a mental health provider. Documentation must show the specialist involvement and consent/collaboration.

Required prescriber specialties: pediatric endocrinologist, family or internal medicine physician, obstetrician-gynecologist, or other provider specialized in transgender youth care
For members <18 years: documented collaboration with a mental health provider
Document informed decision-making, Tanner stage (when applicable), concomitant gender-affirming hormone use (when applicable), and fertility preservation counseling

Denial Risk

Non-covered indications

Indications not listed under compendial or specified uses (e.g., uses other than prostate cancer, AR‑positive salivary gland tumors, or gender dysphoria) are considered experimental/investigational and not medically necessary and will be denied.

Non-covered: any indication not explicitly listed (considered experimental/investigational)

Definitions and Key Terms

Pubertal suppression — definition and authorization requirements

DefinitionUse of GnRH agonists to pause progression of puberty in adolescents (pubertal hormonal suppression).

Authorization requirement — Tanner stageMember must have reached Tanner stage 2 of puberty or greater (Tanner stage >= 2) for initiation; for reauthorization, member must have previously reached Tanner stage 2 or greater.

Informed consent / decision-making capacityMember must be able to make an informed decision to engage in treatment; documentation of informed decision required.

Education and counselingMember must be educated on contraindications and side effects of therapy and informed of fertility preservation options prior to start of therapy.

Comorbid conditionsMember's comorbid conditions must be reasonably controlled before initiation and for reauthorization.

Androgen receptor–positive salivary gland tumor — definition and context for use

DefinitionRecurrent, unresectable, or metastatic salivary gland tumor that is androgen receptor–positive.

Context for useLeuprolide may be used as a single agent or in combination with abiraterone and prednisone for treatment when the tumor is androgen receptor positive.

Authorization periodPrior authorization may be granted for up to 12 months for treatment of this indication when criteria are met.

Initial Therapy Criteria

Gender Dysphoria Initial Therapy

Initial authorization requirements for gender dysphoria

Gender dysphoria initial: Member diagnosed with gender dysphoria; able to make informed decision; Tanner stage 2 or greater (for pubertal suppression); comorbid conditions reasonably controlled; educated on contraindications and side effects; informed of fertility preservation optionsTanner stage >=2 for pubertal suppression

Prescriber specialty/consultation requirements apply for members <18

Prostate Cancer Initial Therapy

Initial authorization requirements for prostate cancer

Prostate cancer initial: Treatment of advanced prostate cancer (FDA-approved)

Authorization of 12 months may be granted

Salivary Gland Tumor Initial Therapy

Initial authorization requirements for salivary gland tumor

Salivary gland tumor initial: Recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumor; single agent or combined with abiraterone and prednisone

Authorization of 12 months may be granted

Reauthorization / Continuation Therapy

Reauthorization criteria — continued coverage may be granted for 12 months when benefit is demonstrated and no unacceptable toxicity or progression is present.

Prostate reauthorization: Clinical benefit (e.g., serum testosterone < 50 ng/dL) and no unacceptable toxicity

Authorization of 12 months may be granted

Salivary gland reauthorization: No evidence of unacceptable toxicity or disease progression while on current regimen

Authorization of 12 months may be granted

Gender dysphoria reauthorization: Previously met initial criteria (including prior Tanner stage >=2 for pubertal suppression) and continued informed counseling; comorbid conditions reasonably controlled

Authorization of 12 months may be granted

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeuprolide acetate (Eligard, Vabrinty) — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Leuprolide acetate (Eligard, Vabrinty) — coverage criteria

Coverage Criteria

Coding and Drug Names

Provider Actions and Authorization Rules

Background

Definitions and Key Terms

Initial Therapy Criteria

Reauthorization / Continuation Therapy

Eligard	brand name leuprolide acetate
Vabrinty	brand name leuprolide acetate