CurrentMass General Brigham Health PlanPolicy N/A

Supprelin LA (histrelin acetate) — Coverage and Prior Authorization

Defines prior authorization, quantity/step therapy, specialty pharmacy routing, and clinical coverage criteria for Supprelin LA (histrelin acetate) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicySupprelin LA (histrelin acetate) — Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming diagnosis-specific criteria (e.g., CPP confirmation, Tanner stage, bone age, or oncology status) and route dispensing to a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

3 monthsovarian preservation approval

Specialtysite

CPPcovered indication

Coverage and Authorization Criteria

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Initial therapy — Central precocious puberty (CPP)

Authorization may be granted for treatment of CPP when ALL of the following are met (separate female and male criteria):

Female CPP initial criteria: Female member: (1) Confirmation of CPP by pubertal response to a GnRH agonist test or a pubertal level on a third-generation LH assay; (2) Assessment of bone age versus chronological age supports the diagnosis of CPP; (3) Imaging (CT or MRI) as clinically indicated; (4) Onset of secondary sexual characteristics before 8 years of age.all

female-specific

Male CPP initial criteria: Male member: (1) Confirmation of CPP by pubertal response to a GnRH agonist test or a pubertal level on a third-generation LH assay; (2) Assessment of bone age versus chronological age supports the diagnosis of CPP; (3) Intracranial tumor evaluated with appropriate laboratory testing and diagnostic imaging (CT or MRI) as indicated; (4) Onset of secondary sexual characteristics before 9 years of age.all

male-specific

Initial therapy — Gender dysphoria (pubertal suppression and gender transition)

Authorization may be granted for pubertal suppression or gender transition when ALL of the following are met:

Pubertal suppression for gender dysphoria: Member has a diagnosis of gender dysphoria; member has reached Tanner stage 2 or greater; member's comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; member has been informed of fertility preservation options; medication prescribed by or in consultation with a provider specialized in care of transgender youth with collaborative mental health care for patients <18 years.all

pubertal suppression

Gender transition use: Member has a diagnosis of gender dysphoria; member will receive Supprelin LA concomitantly with gender-affirming hormones; member's comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; member has been informed of fertility preservation options; medication prescribed by or in consultation with a provider specialized in care of transgender youth with collaborative mental health care for patients <18 years.all

gender transition

Initial therapy — Preservation of ovarian function

Authorization may be granted when ALL of the following are met:

Ovarian preservation: Member is premenopausal and undergoing chemotherapy; treatment is prescribed to preserve ovarian function.all

initial approval 3 months

Initial therapy — Prevention of recurrent menstrual-related attacks in acute porphyria

Authorization may be granted when ALL of the following are met:

Porphyria-related prevention: Member has acute porphyria with recurrent menstrual-related attacks and the medication is prescribed by or in consultation with a physician experienced in management of porphyrias.all

Continuation / Reauthorization

Authorization may be granted for continuation when ALL applicable conditions are met:

CPP continuation female: Member is currently receiving the requested medication through a paid pharmacy or medical benefit; member is less than 12 years of age; member is not experiencing treatment failure (no clinical pubertal progression, appropriate growth deceleration, no continued excessive bone age advancement).all

continuation criteria female

CPP continuation male: Member is currently receiving the requested medication through a paid pharmacy or medical benefit; member is less than 13 years of age; member is not experiencing treatment failure (no clinical pubertal progression, appropriate growth deceleration, no continued excessive bone age advancement).all

continuation criteria male

Gender dysphoria continuation: Member has a diagnosis of gender dysphoria; member previously reached Tanner stage 2 or greater; member's comorbid conditions are reasonably controlled; member has been educated on contraindications and side effects to therapy; member was informed of fertility preservation options prior to start of therapy; for gender transition, member will receive Supprelin LA concomitantly with gender-affirming hormones.all

continuation for gender dysphoria

General continuation requirement: All members requesting continuation (including new members) must meet all initial authorization criteria.all

applies to all indications

Initial authorization

Initial authorization requires meeting diagnosis-specific clinical criteria (see detailed nodes in coverage.criteria_sets).

CPP initial female: See coverage.criteria_sets: female CPP initial criteria.all

chunk 4-5

CPP initial male: See coverage.criteria_sets: male CPP initial criteria.all

chunk 4-5

Gender dysphoria initial: See coverage.criteria_sets: gender dysphoria pubertal suppression and gender transition criteria.all

chunk 6

Ovarian preservation initial: Member premenopausal and undergoing chemotherapy.all

chunk 7

Porphyria prevention initial: Prescribed by or in consultation with physician experienced in porphyria management.all

chunk 8

Initial Therapy Requirements (by indication)

Initial therapy — Central precocious puberty (CPP)

Authorization may be granted for treatment of CPP when ALL of the following are met (separate female and male criteria):

female-specific

male-specific

Initial therapy — Gender dysphoria (pubertal suppression and gender transition)

Authorization may be granted for pubertal suppression or gender transition when ALL of the following are met:

pubertal suppression

gender transition

Initial therapy — Preservation of ovarian function

Authorization may be granted when ALL of the following are met:

Ovarian preservation: Member is premenopausal and undergoing chemotherapy; treatment is prescribed to preserve ovarian function.all

initial approval 3 months

Initial therapy — Prevention of recurrent menstrual-related attacks in acute porphyria

Authorization may be granted when ALL of the following are met:

Continuation / Reauthorization Criteria

Continuation / Reauthorization

Authorization may be granted for continuation when ALL applicable conditions are met:

continuation criteria female

continuation criteria male

continuation for gender dysphoria

General continuation requirement: All members requesting continuation (including new members) must meet all initial authorization criteria.all

applies to all indications

Continuation criteria

Continuation/reauthorization criteria mirror initial criteria with age and treatment response limits for CPP and require meeting initial criteria for new members on therapy.

Continuation CPP female: Member currently receiving Supprelin LA; less than 12 years old; not experiencing treatment failure (no pubertal progression, adequate growth deceleration, no excessive bone age advancement).all

Continuation CPP male: Member currently receiving Supprelin LA; less than 13 years old; not experiencing treatment failure (no pubertal progression, adequate growth deceleration, no excessive bone age advancement).all

Provider Requirements and Operational Notes

Prior Authorization

Specialty pharmacy requirement

This medication is designated specialty and must be filled at a contracted specialty pharmacy. Contact the specialty pharmacy for prior authorization and dispensing instructions.

Medical and Specialty Medications — Phone: 877-519-1908, Fax: 855-540-3693
Non-Specialty Medications — Phone: 800-711-4555

Denial Risk

Experimental / investigational requests

Requests for indications that are not FDA‑approved or listed as compendial (including all indications not enumerated as covered such as other uses beyond preservation of ovarian function, gender dysphoria, and prevention of recurrent menstrual-related attacks in acute porphyria) are considered experimental/investigational and are not medically necessary.

Documentation Required

CPP documentation specifics

For central precocious puberty (CPP), documentation must support the diagnosis and therapy need. Required documentation includes: appropriate brain imaging when indicated (CT or MRI) to evaluate for intracranial pathology; confirmation of CPP by pubertal response to a GnRH agonist stimulation test or a pubertal level on a third‑generation LH assay; assessment showing advanced bone age relative to chronological age; and documentation of age at onset of secondary sexual characteristics (<8 years for females, <9 years for males).

Step Therapy and Benefit Programs

Program type	Details
Step Therapy	Program type listed; specific step requirements (e.g., required trials, failure criteria, or step agents) are not provided in the document.
Quantity Limit	Quantity limit program type is indicated for the pharmacy benefit, but specific numeric limits or refill intervals are not specified in the document.
Specialty Limitations	Medication is designated specialty and must be filled at a contracted specialty pharmacy; specialty dispensing/contact information provided.

Quantity Limits and Dispensing

Quantity limit / Dispensing

DrugSupprelin LA (histrelin acetate)

Program typeQuantity Limit; Pharmacy Benefit; Step Therapy (per benefit)

Specialty dispensingDesignated specialty — must be filled at a contracted specialty pharmacy (contact phone: 877-519-1908; fax: 855-540-3693)

Benefit settingsPharmacy benefit and medical benefit; specialty limitations apply

Effective date01/01/2024

Note

Site‑of‑care: specialty pharmacy dispensing required

This medication has been designated specialty and must be filled at a contracted specialty pharmacy; specialty‑designated medications are required to be dispensed through the contracted specialty pharmacy.

Background and Drug Information

Supprelin LA (histrelin acetate) is a gonadotropin-releasing hormone (GnRH) agonist indicated by the FDA for the treatment of central precocious puberty (CPP) in children. The agent is also used in certain compendial contexts including preservation of ovarian function during chemotherapy, pubertal suppression and gender transition for gender dysphoria, and prevention of recurrent menstrual-related attacks in acute porphyria.

Definitions and Clinical Terms

Central precocious puberty (CPP) — definition and supporting criteria

DefinitionOnset of secondary sexual characteristics before age 8 in females or before age 9 in males, supported by: pubertal response to a GnRH agonist stimulation test or pubertal third‑generation LH assay, and bone age assessment advanced versus chronological age; intracranial pathology evaluated as indicated.

Confirmatory testingPubertal response to a gonadotropin releasing hormone (GnRH) agonist test or pubertal level of a third‑generation luteinizing hormone (LH) assay.

ImagingCT scan or MRI performed as clinically indicated to evaluate for intracranial pathology (required for males as noted).

Bone ageAssessment of bone age versus chronological age that supports the diagnosis of CPP.

Age thresholdsFemale: onset of secondary sexual characteristics <8 years; Male: onset <9 years.

Policy Summary

PayerMass General Brigham Health Plan

PolicySupprelin LA (histrelin acetate) — Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

SourceLink

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