CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

leuprolide acetate (Eligard, Vabrinty) coverage

Defines coverage, authorization durations, prescriber requirements, and criteria for FDA and compendial indications for leuprolide acetate products for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyleuprolide acetate (Eligard, Vabrinty) coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) and document diagnosis, required criteria (e.g., Tanner stage ≥2 for pubertal suppression), and prescriber specialty when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

3 listedcovered indications

specialty consultprescriber requirement

Coverage Criteria

Prostate Cancer

Covered when ALL of the following are met for prostate cancer

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Salivary Gland Tumor

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

Salivary gland tumor — initial: Recurrent, unresectable, or metastatic salivary gland tumor that is androgen receptor positive; may be used as a single agent or in combination with abiraterone and prednisone; authorization of 12 months may be granted.

Gender Dysphoria

Covered when ALL of the following are met for gender dysphoria (pubertal suppression and gender transition)

Gender dysphoria — initiation criteria: Member has a diagnosis of gender dysphoria; is able to make an informed decision; has reached Tanner stage 2 or greater (for pubertal suppression); comorbid conditions reasonably controlled; educated on contraindications and side effects; informed of fertility preservation options.

Gender transition — concomitant hormones: Member will receive the requested medication concomitantly with gender-affirming hormones (for gender transition indication).

Prescriber requirement for minors: Medication must be prescribed by or in consultation with a provider specialized in care of transgender youth and collaborative care with a mental health provider for members <18 years.

Initial Therapy Criteria

Initial Therapy

Initial authorization rules

Prostate cancer initial: Treatment of advanced prostate cancer; prior authorization may be granted for 12 months.

Salivary gland tumor initial: For recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumor as a single agent or in combination with abiraterone and prednisone; prior authorization may be granted for 12 months.

Gender dysphoria initial: Pubertal suppression: member has diagnosis, informed decision, Tanner stage >=2, comorbid conditions controlled, education on contraindications/side effects, informed of fertility preservation options. Gender transition: similar criteria plus concomitant gender-affirming hormones.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization criteria for continued treatment

Prostate cancer reauthorization: Authorization of 12 months may be granted for continued treatment when member is experiencing clinical benefit (e.g., serum testosterone <50 ng/dL) and has not experienced unacceptable toxicity.

Salivary gland tumor reauthorization: Authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression while on current regimen.

Gender dysphoria reauthorization: Authorization of 12 months may be granted when prior criteria continue to be met (diagnosis, informed decision, prior Tanner stage >=2, controlled comorbidities, education on risks, and prior counseling on fertility preservation).

Coding and Clinical Thresholds

Policy reference numbersmixed

1966-A	Reference number
6043-A	Reference number

inv-07: Serum testosterone — less than 50 ng/dL

Reauthorization criterionSerum testosterone < 50 ng/dL demonstrates clinical benefit for continued prostate cancer treatment

ContextUsed as evidence of response when assessing 12-month reauthorization requests for prostate cancer

ApplicationRequired documentation should show serum testosterone measurement supporting <50 ng/dL

Provider Actions & Documentation Requirements

Prior Authorization

Prostate cancer — 12‑month approvals

Authorization of up to 12 months may be granted for treatment of prostate cancer.

Prior authorization required for initial and continued therapy; reauthorization requires documentation of clinical benefit (e.g., serum testosterone <50 ng/dL) and absence of unacceptable toxicity.

Note

Provider action highlight

Reference numbers: 1966-A, 6043-A.

Documentation Required

Gender dysphoria — documentation & 12‑month approvals

For gender dysphoria in minors, the medication must be prescribed by or in consultation with a provider specialized in the care of transgender youth (e.g., pediatric endocrinologist, family or internal medicine physician, obstetrician‑gynecologist) and the provider must have collaborated care with a mental health provider for members <18 years of age.

Authorization of up to 12 months may be granted for pubertal suppression when ALL of the following are met: diagnosis of gender dysphoria; informed decision by the member; Tanner stage ≥2; comorbid conditions reasonably controlled; member educated on contraindications/side effects; member informed of fertility preservation options.
Authorization of up to 12 months may be granted for gender transition when ALL of the following are met: diagnosis of gender dysphoria; informed decision by the member; concomitant use of gender‑affirming hormones; comorbid conditions reasonably controlled; member educated on contraindications/side effects; member informed of fertility preservation options.

Prior Authorization

Salivary gland tumor — 12‑month approvals & reauthorization

Authorization of up to 12 months may be granted for treatment of recurrent, unresectable, or metastatic androgen receptor–positive salivary gland tumor as single agent or in combination with abiraterone and prednisone when AR‑positive. Reauthorization may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Prior authorization required for initial and continued therapy; documentation of AR‑positive tumor required.
Reauthorization requires evidence of ongoing clinical benefit and absence of unacceptable toxicity.

Denial Risk

Not covered indications

All indications not listed as FDA‑approved or compendial (e.g., prostate cancer, androgen receptor–positive salivary gland tumors, gender dysphoria) are considered experimental/investigational and not medically necessary.

Definitions

inv-14: Pubertal hormonal suppression — Use of GnRH agonists to halt progression of puberty in adolescents with gender dysphoria once Tanner stage 2 is reached; requires informe...

DefinitionUse of GnRH agonists to halt progression of puberty in adolescents with gender dysphoria once Tanner stage 2 is reached; requires informed decision-making and counseling on fertility preservation.

Minimum pubertal stageTanner stage 2 or greater required to initiate pubertal hormonal suppression

Required counseling and consentMember must be able to make an informed decision and be educated on contraindications, side effects, and fertility preservation options

Comorbid conditionsComorbid conditions must be reasonably controlled prior to initiation

inv-15: Androgen receptor–positive salivary gland tumor — Recurrent, unresectable, or metastatic salivary gland tumor that expresses androgen receptor where leuprolide can be used as single agent...

IndicationRecurrent, unresectable, or metastatic salivary gland tumor that is androgen receptor positive

Therapy optionsMay be used as a single agent or in combination with abiraterone and prednisone

Authorization durationPrior authorization may be granted for up to 12 months when criteria are met

Reauthorization requirementContinued treatment authorizations require documentation of no unacceptable toxicity or disease progression