CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Supprelin La 1973 A 6052 A Sgm P2023A

Defines medical necessity, prior authorization documentation, initial and continuation authorization criteria, durations, and prescribing/provider requirements for Supprelin LA for central precocious puberty (CPP) and specific compendial uses (gender dysphoria, preservation of ovarian function, prevention of menstrual-related attacks in acute porphyria).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySupprelin La 1973 A 6052 A Sgm P2023A

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with required documentation (lab report or medical record of pubertal response to a GnRH agonist test or third-generation LH assay) to initiate review.

SourceLink

POLICY UPDATE CHANGES

No material changes — has_material_change=false

1FDA-approved covered indication

3Compendial covered uses

0Not covered / experimental categories (count)

Coverage Summary

Supprelin LA (histrelin acetate) is a gonadotropin-releasing hormone (GnRH) agonist indicated for treatment of children with central precocious puberty (CPP) and the policy also specifies covered compendial uses for gender dysphoria, preservation of ovarian function, and prevention of recurrent menstrual-related attacks in acute porphyria. Coverage is subject to documentation and provider requirements and the overall coverage stance is mixed (FDA-approved indication plus specified compendial uses).

Initial Therapy Criteria (Authorization)

Covered Indications and Initial Authorization Criteria

Authorization (duration specified) may be granted when ALL of the following are met:

Central precocious puberty (CPP) — female

CPP female criteria
- Intracranial tumor evaluation: Intracranial tumor has been evaluated by appropriate lab tests and diagnostic imaging (e.g., CT scan, MRI).
- Diagnosis confirmation: The diagnosis of CPP has been confirmed by a pubertal response to a gonadotropin releasing hormone (GnRH) agonist test or a pubertal level of a third-generation luteinizing hormone (LH) assay.
- Bone age assessment: The assessment of bone age versus chronological age supports the diagnosis of CPP.
- Age at onset threshold: The member was less than 8 years of age at the onset of secondary sexual characteristics.< 8 years

Central precocious puberty (CPP) — male

CPP male criteria
- Intracranial tumor evaluation: Intracranial tumor has been evaluated by appropriate lab tests and diagnostic imaging (e.g., CT scan, MRI).
- Diagnosis confirmation: The diagnosis of CPP has been confirmed by a pubertal response to a GnRH agonist test or a pubertal level of a third-generation LH assay.
- Bone age assessment: The assessment of bone age versus chronological age supports the diagnosis of CPP.
- Age at onset threshold: The member was less than 9 years of age at the onset of secondary sexual characteristics.< 9 years

Gender dysphoria — pubertal hormonal suppression (adolescent)

Gender dysphoria pubertal suppression criteria
- Diagnosis of gender dysphoria: The member has a diagnosis of gender dysphoria.
- Informed decision: The member is able to make an informed decision to engage in treatment.
- Tanner stage: The member has reached Tanner stage 2 of puberty or greater.>= Tanner stage 2
- Comorbid conditions: The member's comorbid conditions are reasonably controlled.

Gender dysphoria — gender transition (adolescent/adult)

Gender dysphoria transition criteria
- Diagnosis of gender dysphoria: The member has a diagnosis of gender dysphoria.
- Informed decision: The member is able to make an informed decision to engage in treatment.
- Concomitant gender-affirming hormones: The member will receive the requested medication concomitantly with gender-affirming hormones.
- Comorbid conditions: The member's comorbid conditions are reasonably controlled.

Preservation of ovarian function (premenopausal undergoing chemotherapy)

Premenopausal receiving chemotherapy: The member is premenopausal and undergoing chemotherapy.

Prevention of recurrent menstrual related attacks in acute porphyria

Acute porphyria with recurrent menstrual attacks: Member has acute porphyria with recurrent menstrual related attacks.
Prescriber experienced in porphyria: Medication must be prescribed by or in consultation with a provider experienced in management of porphyrias.

Continuation / Reauthorization Criteria

Authorization may be renewed (durations specified) when ALL of the following are met:

CPP — female continuation

Continuation criteria female
- Age limit female: Member is currently less than 12 years of age.< 12 years
- Currently receiving medication: Member is currently receiving the requested medication through a paid pharmacy or medical benefit.
- No treatment failure: Member is not experiencing treatment failure (e.g., clinical pubertal progression, lack of growth deceleration, continued excessive bone age advancement).

CPP — male continuation

Continuation criteria male
- Age limit male: Member is currently less than 13 years of age.< 13 years
- Currently receiving medication: Member is currently receiving the requested medication through a paid pharmacy or medical benefit.
- No treatment failure: Member is not experiencing treatment failure (e.g., clinical pubertal progression, lack of growth deceleration, continued excessive bone age advancement).

Gender dysphoria — pubertal suppression continuation

Gender dysphoria pubertal suppression reauth criteria
- Diagnosis of gender dysphoria: Member has a diagnosis of gender dysphoria.
- Informed decision: Member is able to make an informed decision to engage in treatment.
- Prior Tanner stage: Member has previously reached Tanner stage 2 of puberty or greater.>= Tanner stage 2
- Comorbid conditions: Member's comorbid conditions are reasonably controlled.

Gender dysphoria — gender transition continuation

Gender dysphoria transition reauth criteria
- Diagnosis of gender dysphoria: Member has a diagnosis of gender dysphoria.
- Informed decision: Member is able to make an informed decision to engage in treatment.
- Concomitant gender-affirming hormones: Member will receive the requested medication concomitantly with gender-affirming hormones.
- Comorbid conditions: Member's comorbid conditions are reasonably controlled.

All other indications — continuation

Must meet initial criteria: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Documentation Required for Prior Authorization

Submission of the following is necessary to initiate prior authorization review:

Documentation required for PA

Lab report for CPP: For central precocious puberty, laboratory report or medical record of a pubertal response to a GnRH agonist test or a pubertal level of a third-generation luteinizing hormone (LH) assay.
Provider specialty/consultation documentation when required (e.g., pediatric endocrinologist, family/internal medicine, OB-GYN for transgender youth; mental health collaboration for members <18; provider experienced in porphyria management for porphyria indication).

Prior Authorization

Prior authorization required

Submission of prior authorization with required documentation (laboratory report or medical record of a pubertal response to a GnRH agonist test or a pubertal level of a third‑generation LH assay) is necessary to initiate prior authorization review to begin evaluation for coverage.

Documentation Required

Assessment required

Assessment of bone age versus chronological age must be documented to support the diagnosis of central precocious puberty (CPP).

Documentation Required

Specialist prescribing/consultation requirements

For gender dysphoria, medication must be prescribed by or in consultation with a provider specialized in the care of transgender youth and that has collaborated care with a mental health provider for members less than 18 years of age. For porphyria indications, medication must be prescribed by or in consultation with a provider experienced in the management of porphyrias.

Denial Risk

Experimental/Investigational exclusion

All other indications not listed (outside the FDA‑approved indication and specified compendial uses) are considered experimental/investigational and not medically necessary.

Background & Clinical Evidence

Primary manufacturer reference: Supprelin LA [package insert], April 2022 is cited as the principal source for the product information and approved indication for treatment of central precocious puberty.

Background clinical context: Supprelin LA is a GnRH agonist used to treat CPP in children; the policy permits specified compendial uses (gender dysphoria, preservation of ovarian function, and prevention of menstrual-related porphyria attacks) when required documentation and provider consultation requirements are met, including laboratory confirmation of pubertal activation for CPP and specialist prescribing/consultation for gender dysphoria and porphyria indications.

Pubertal response to a GnRH agonist testLaboratory evidence consistent with activation of the hypothalamic-pituitary-gonadal axis as demonstrated by a GnRH agonist stimulation test or a third-generation LH assay showing pubertal levels.

1973-A	Supprelin LA reference number
6052-A	Supprelin LA reference number

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