CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Eligard (leuprolide acetate) — Coverage Criteria for Prostate Cancer, Salivary Gland Tumors, and Gender Dysphoria

Defines coverage and authorization criteria for Eligard (leuprolide acetate) for FDA-approved palliative treatment of advanced prostate cancer, compendial uses including recurrent androgen receptor–positive salivary gland tumors, and treatment related to gender dysphoria for transgender and gender diverse members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEligard (leuprolide acetate) — Coverage Criteria for Prostate Cancer, Salivary Gland Tumors, and Gender Dysphoria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) and document diagnosis, pubertal status (if applicable), counseling including fertility preservation, and specialty collaboration when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

3covered indications

Tanner ≥2pubertal threshold

requiredfertility discussion

Coverage and Medical Necessity Criteria

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Indication-specific medical necessity criteria

Covered when ALL of the following are met (per indication groups):

Prostate cancer (FDA-approved): Palliative treatment of advanced prostate cancer.

Authorization of up to 12 months may be granted for treatment; see reauthorization criteria for monitoring (e.g., serum testosterone targets).

Recurrent androgen receptor–positive salivary gland tumors: Tumor is androgen receptor positive and treatment is provided as a single agent.

Authorization of up to 12 months may be granted for initial and continued treatment when clinical benefit is documented and unacceptable toxicity is absent.

Gender dysphoria — pubertal suppression (initial): Member has a diagnosis of gender dysphoria; member is able to make an informed decision to engage in treatment; member has reached Tanner stage 2 or greater; comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; member has been informed of fertility preservation options.Tanner stage >=2

Authorization of up to 12 months may be granted. For members <18, medication must be prescribed by or in consultation with a provider specialized in care of transgender youth with collaboration with a mental health provider.

Gender dysphoria — gender transition (initial): Member has a diagnosis of gender dysphoria; member is able to make an informed decision to engage in treatment; member will receive the requested medication concomitantly with gender-affirming hormones; comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; member has been informed of fertility preservation options.

Authorization of up to 12 months may be granted.

Reauthorization for gender dysphoria (pubertal suppression): Member has a diagnosis of gender dysphoria; member is able to make an informed decision to continue treatment; member previously reached Tanner stage 2 or greater; comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; prior to initiation of therapy the member was informed of fertility preservation options.

Authorization of up to 12 months may be granted.

Reauthorization for gender dysphoria (gender transition): Member has a diagnosis of gender dysphoria; member is able to make an informed decision to continue treatment; member will receive the medication concomitantly with gender-affirming hormones; comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; prior to initiation of therapy the member was informed of fertility preservation options.

Authorization of up to 12 months may be granted.

All indications for Eligard (leuprolide acetate) that are not specifically listed as FDA-approved or compendial uses in this policy are considered experimental/investigational and are not medically necessary. This includes any use outside the enumerated covered indications (prostate cancer; recurrent androgen receptor–positive salivary gland tumors; and gender dysphoria).

Use of Eligard for indications other than the FDA-approved palliative treatment of advanced prostate cancer or the listed compendial uses (prostate cancer, recurrent androgen receptor–positive salivary gland tumors, and gender dysphoria) is excluded from coverage. Such uses are considered experimental/investigational and therefore not medically necessary. Providers requesting authorization should ensure the indication matches one of the covered categories.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization: 12-month approvals

Authorization of 12 months may be granted for initial and continued treatment when criteria are met.

Initial and reauthorization approvals may be granted for up to 12 months for prostate cancer, gender dysphoria (pubertal suppression and gender transition), and androgen receptor–positive recurrent salivary gland tumors.

Denial Risk

Experimental / Investigational exclusions

All other indications not listed as FDA-approved or compendial uses are considered experimental/investigational and are not medically necessary.

Documentation Required

Documentation for salivary gland tumor reauthorization

For members requesting reauthorization of treatment for recurrent salivary gland tumors, include documentation that the tumor is androgen receptor–positive and that the member is experiencing clinical benefit from therapy with no unacceptable toxicity.

Tumor must be documented as androgen receptor–positive.
Clinical benefit must be documented in the medical record.
No unacceptable toxicity should be documented for continued approval.

Documentation Required

Required clinical documentation for gender dysphoria

Authorization and reauthorization for gender dysphoria (pubertal suppression and gender transition) require documentation of: diagnosis of gender dysphoria; capacity to make an informed decision; pubertal status (Tanner stage ≥2 for initiation, prior Tanner ≥2 for reauthorization of suppression); receipt or plan to receive concomitant gender-affirming hormones for transition; comorbid conditions reasonably controlled; education on contraindications and side effects; and informed discussion of fertility preservation before starting therapy.

Diagnosis of gender dysphoria documented in the chart.
Assessment of informed decision-making capacity.
Tanner stage documented (≥2 for initiation; prior ≥2 for reauthorization of suppression).
Documentation of counseling on contraindications and side effects.
Documentation that fertility preservation options were discussed prior to therapy start.
For members <18 years, prescription by or in consultation with a provider experienced in care of transgender youth and collaborative care with a mental health provider.

Documentation Required

Documentation for prostate cancer reauthorization

Include evidence of clinical benefit (for example, serum testosterone < 50 ng/dL for prostate cancer) and documentation of absence of unacceptable toxicity when requesting reauthorization for prostate cancer.

Document clinical response such as serum testosterone < 50 ng/dL.
Document absence of unacceptable toxicity to support continued therapy.

Note

Provider action (source placeholder)

Include any emphasized provider action text from source chunk 0 as applicable to provider responsibilities.

Definitions and Terminology

inv-13: Gender dysphoria — terminology note

TerminologyGender Dysphoria, also referred to as transgender and gender diverse (TGD) persons

Policy roleListed as a compendial use for Eligard under covered indications

Coverage implicationTreatment related to gender dysphoria is considered a covered compendial use when all criteria are met

inv-14: Pubertal hormonal suppression — definition and use

DefinitionPubertal hormonal suppression: use of GnRH agonist therapy in adolescents who have reached Tanner stage 2 or greater to suppress pubertal progression as part of gender-affirming care

AuthorizationAuthorization of 12 months may be granted for pubertal hormonal suppression when all specified criteria are met

Required criteriaIncludes diagnosis of gender dysphoria, ability to make informed decision, comorbid conditions controlled, counseling on contraindications/side effects, and discussion of fertility preservation options

OpenPayer

Eligard (leuprolide acetate) — Coverage Criteria for Prostate Cancer, Salivary Gland Tumors, and Gender Dysphoria

Coverage and Medical Necessity Criteria

Key Clinical Thresholds and Diagnostic Targets

Authorization, Documentation, and Provider Requirements

Background and Clinical Context

Definitions and Terminology