CurrentMolina HealthcarePolicy C20611-A

Supprelin LA (histrelin acetate) Implant Coverage Criteria

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Coverage and prior authorization requirements for Supprelin LA, a subcutaneous histrelin acetate implant used to treat children with central precocious puberty.

Policy Summary

PayerMolina Healthcare

PolicySupprelin LA (histrelin acetate) Implant Coverage Criteria

Policy CodePolicy C20611-A

Change TypeNo material clinical or coverage changes

Effective DateAugust 30, 2026

Next Review DateJuly 1, 2027

Key ActionObtain prior authorization and document a qualifying six-month trial and failure of leuprolide depot before requesting initial Supprelin LA coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yearsMinimum age

1 implant/yearQuantity limit

12 monthsAuthorization duration

6 monthsLeuprolide trial

<8 / <9 years

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CurrentMolina HealthcarePolicy C20611-A

Supprelin LA (histrelin acetate) Implant Coverage Criteria

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Get alerted when Policy C20611-A changes without checking for updates manually.

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Coverage and prior authorization requirements for Supprelin LA, a subcutaneous histrelin acetate implant used to treat children with central precocious puberty.

Policy Summary

PayerMolina Healthcare

PolicySupprelin LA (histrelin acetate) Implant Coverage Criteria

Policy CodePolicy C20611-A

Change TypeNo material clinical or coverage changes

Effective DateAugust 30, 2026

Next Review DateJuly 1, 2027

Key ActionObtain prior authorization and document a qualifying six-month trial and failure of leuprolide depot before requesting initial Supprelin LA coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yearsMinimum age

1 implant/yearQuantity limit

12 monthsAuthorization duration

6 monthsLeuprolide trial

<8 / <9 years

Puberty onset threshold

Coverage Criteria

Initial Therapy Criteria

Initial therapy is covered when all of the following are met:

Initial therapy

Diagnosis and age: Member has a documented diagnosis of central precocious puberty and is currently less than 13 years of age.Age <13 years
Onset of secondary sexual characteristics: Secondary sexual characteristics began before the applicable sex-specific threshold.Females ≤8 years; males ≤9 years
Diagnostic confirmation: One qualifying diagnostic finding is documented: pubertal basal luteinizing hormone based on laboratory reference ranges; pubertal luteinizing hormone response to a GnRH stimulation test; or bone age advanced one year beyond chronological age.Bone age advanced one year beyond chronological age when that diagnostic pathway is used
Documentation is required.
Prior leuprolide depot trial and failure: Member has had a documented trial and failure of leuprolide depot, defined as progression in breast or testicular development or failure to see a decline in growth velocity of bone age advancement.Trial lasting at least 6 months
Minimum age: Member is 2 years of age or older.Age ≥2 years

Continuation Therapy Criteria

Continuation therapy is covered when all of the following are met:

Continuation therapy

Disease response: Documentation shows lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, and improvement in final height prediction.
Tolerability and safety: The prescriber attests to, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity.
Examples include convulsions and development or worsening of psychiatric symptoms.
Age or continued-treatment justification: Member is not currently older than age 12, or the prescriber provides contributing factors supporting continued treatment, which may include bone age and height age, predicted height, and a discontinuation plan or date.Age ≤12 years unless supporting factors are provided

Experimental or Investigational Uses

Uses outside the covered indication are excluded from coverage as follows:

Experimental or investigational uses: Any use of Supprelin LA (histrelin acetate) other than treatment of central precocious puberty is considered experimental or investigational and follows Molina's Off-Label policy.

No compendial approved off-label uses are identified for Supprelin LA (histrelin acetate).

Supprelin LA is contraindicated for members with a history of hypersensitivity to gonadotropin-releasing hormone (GnRH) or GnRH analogs.

Pregnancy is a contraindication to Supprelin LA coverage.

Uses of Supprelin LA other than the covered indication are considered experimental or investigational and follow Molina's Off-Label policy.

Coding and Clinical Parameters

HCPCSHCPCS

J9226

Histrelin implant (supprelin la), 50 mg

Age at Onset of Secondary Sexual Characteristics

Female onset threshold≤ 8 years of age

Male onset threshold≤ 9 years of age

RequirementSecondary sexual characteristics must begin before the applicable sex-specific threshold.

Bone Age Advancement

Required advancementOne year beyond chronological age

UseQualifying diagnostic confirmation for central precocious puberty

Documentation

Authorization, Documentation, and Denial Risks

Prior Authorization

Initial Authorization Required

Prior authorization is required for initial Supprelin LA coverage. When approved, the initial authorization is valid for 12 months.

Submit documentation supporting all applicable coverage criteria with the initial request.
Initial authorization duration: 12 months.

Prior Authorization

Reauthorization Requirements

Reauthorization requires documentation of continued clinical benefit, tolerability, and applicable age-related or clinical justification. Continuation authorization is valid for 12 months.

Document disease response, including lack or stabilization of secondary sexual characteristic progression, decreased height velocity, and improved final height prediction.
Prescriber must attest to, or the clinical reviewer must find, no intolerable adverse effects or drug toxicity.
If the member is older than age 12, provide contributing factors such as bone age, height age, predicted height, and a discontinuation plan or date.

Product Background

Supprelin LA contains histrelin acetate and is administered as a subcutaneous implant. It belongs to the LHRH/GnRH agonist analog pituitary suppressant class and is used to treat children with central precocious puberty. Coverage requires objective diagnostic confirmation; continuation therapy also requires documented clinical response and acceptable tolerability.

Clinical Definitions

Central Precocious Puberty

ConditionOnset of secondary sexual characteristics before age 8 in females or before age 9 in males.

Female thresholdBefore or at 8 years of age

Male thresholdBefore or at 9 years of age

Diagnostic confirmationOne of the following is required: pubertal basal luteinizing hormone based on laboratory reference ranges; pubertal luteinizing hormone in response to a GnRH stimulation test; or bone age advanced one year beyond chronological age.

Leuprolide Depot Trial and Failure

Required trialAt least 6 months of leuprolide depot

Initial Therapy

Initial Therapy Criteria

Initial therapy is covered when all of the following requirements are met:

Initial therapy

Central precocious puberty and age: Member has a documented diagnosis of central precocious puberty and is currently less than 13 years of age.Age <13 years
Onset of secondary sexual characteristics: Secondary sexual characteristics began before the applicable sex-specific threshold.Females ≤8 years; males ≤9 years
Diagnostic confirmation: One qualifying finding is documented: pubertal basal luteinizing hormone based on laboratory reference ranges; pubertal luteinizing hormone response to a GnRH stimulation test; or bone age advanced one year beyond chronological age.

Continuation Therapy

Continuation Therapy Criteria

Continuation therapy is covered when all of the following requirements are met:

Continuation therapy

Response to treatment: Documentation shows lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, and improvement in final height prediction.
Acceptable tolerability: The prescriber attests to, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity.
Examples include convulsions and development or worsening of psychiatric symptoms.
Age or clinical justification: Member is not currently older than age 12, or the prescriber provides contributing factors supporting continued treatment, which may include bone age and height age, predicted height, and a discontinuation plan or date.

Required Prior Therapy

Step	Required prior therapy	Minimum duration	Failure definition
1	Documented trial and failure of leuprolide depot before initial Supprelin LA therapy	At least 6 months	Progression in breast or testicular development, or failure to see a decline in growth velocity of bone age advancement

Quantity and Frequency Limits

Supprelin LA Quantity Limit

ProductSupprelin LA (histrelin acetate)

Implant strength50 mg

Quantity limitOne implant every 12 months

Administration and Site of Care

Billing Rule

Use the appropriate benefit and administration setting

Implant medications may be covered under the pharmacy or medical benefit. Subcutaneous implant products should be administered in a non-hospital facility-based location.

Policy Summary

PayerMolina Healthcare

PolicySupprelin LA (histrelin acetate) Implant Coverage Criteria

Policy CodePolicy C20611-A

Change TypeNo material clinical or coverage changes

Effective DateAugust 30, 2026

Next Review DateJuly 1, 2027

Key ActionObtain prior authorization and document a qualifying six-month trial and failure of leuprolide depot before requesting initial Supprelin LA coverage.

SourceLink

On This Page

Bone age advancement must be documented when this diagnostic pathway is used.

Leuprolide Depot Trial

MedicationLeuprolide depot

Minimum trial durationAt least 6 months

RequirementA documented trial and failure is required before initial Supprelin LA coverage.

Member Age

Minimum member age2 years of age and older

Applies toSupprelin LA coverage for central precocious puberty

Age restrictionMembers younger than 2 years do not meet the minimum age requirement.

Continuation authorization duration: 12 months.

Step Therapy

Leuprolide Depot Step Therapy

Before initial Supprelin LA coverage, document a minimum six-month trial and failure of leuprolide depot.

Failure is defined as progression in breast or testicular development, or failure to see a decline in growth velocity or bone-age advancement.

Unsupported block type: documentationớary

Documentation Required

Diagnosis and Diagnostic Confirmation

Document a diagnosis of central precocious puberty (CPP) in a member who is currently younger than 13 years, with the required diagnostic confirmation.

Document onset of secondary sexual characteristics before age 8 in females or before age 9 in males.
Provide at least one confirmation: pubertal basal luteinizing hormone based on laboratory reference ranges; pubertal luteinizing hormone response to a GnRH stimulation test; or bone age advanced at least one year beyond chronological age.

Documentation Required

Initial Therapy Documentation

For initial therapy, document the age at onset of secondary sexual characteristics and the required prior leuprolide depot trial and failure.

Females: onset before or at age 8; males: onset before or at age 9.
Document at least six months of leuprolide depot treatment and the qualifying failure outcome.

Documentation Required

Continuation Therapy Documentation

For continuation therapy, submit evidence of response and ongoing safety, together with the required age-related or clinical rationale when applicable.

Document lack or stabilization of secondary sexual characteristic progression, decreased height velocity, and improved final height prediction.
Attest that there are no intolerable adverse effects or drug toxicity, including convulsions or development or worsening of psychiatric symptoms.
For members older than age 12, provide contributing factors and a discontinuation plan or date.

Documentation Required

Pediatric Endocrinologist Requirement

Supprelin LA must be prescribed by, or in consultation with, a board-certified Pediatric Endocrinologist.

If prescribed in consultation, submit the consultation notes with both the initial request and reauthorization requests.

Documentation Required

Member-Specific Dosing Data

When dosing or medical-necessity review depends on a member-specific measurement, submit the required measurement with the request.

Provide weight, body surface area, or another applicable member-specific dosing measurement.

Denial Risk

Insufficient Supporting Documentation

Molina may deny reimbursement or take other appropriate action when submitted documentation does not establish medical necessity, non-investigational status, or coverage under the member’s benefits.

Ensure records and test results support the requested service.
Incomplete or insufficient documentation may result in denial or nonpayment.
Inappropriate or excessive billing patterns may trigger additional action.

Denial Risk

Clinical Criteria Not Met

Coverage may be denied when CPP, age, diagnostic confirmation, step-therapy, continuation, or other applicable criteria are not met or documented.

Member is not within the applicable age requirements.
Required onset-age or diagnostic evidence is absent.
At least six months of leuprolide depot trial and qualifying failure is not documented.
Continuation response, safety, or required age-related justification is not documented.

Denial Risk

Experimental Use or Contraindication

Uses other than the covered CPP indication are considered experimental or investigational and follow Molina’s Off-Label policy. Do not use Supprelin LA in members with a listed contraindication.

Contraindications include hypersensitivity to GnRH or GnRH analogs and pregnancy.
Noncovered experimental or investigational use may be denied under the Off-Label policy.

Billing Rule

Incorrect Billing or Noncovered Benefit

Submit claims using accurate, industry-standard coding and verify that the service is a covered benefit. Molina may reject or deny improperly billed claims and recover payments already made.

HCPCS J9226: histrelin implant (Supprelin LA), 50 mg.
Codes are for reference only and do not guarantee coverage; confirm the applicable benefit document and current code status.
Incorrect billing or billing for a noncovered benefit may result in claim denial and payment recovery.

Failure—development

Progression in breast or testicular development

Failure—bone ageFailure to see a decline in growth velocity of bone age advancement

Coverage timingThe documented trial and failure is required before initial Supprelin LA coverage.

Bone age advanced one year beyond chronological age when that diagnostic pathway is used

Documentation is required.

Prior leuprolide depot trial and failure: Member has had a documented trial and failure of leuprolide depot, defined as progression in breast or testicular development or failure to see a decline in growth velocity of bone age advancement.At least 6 months

Minimum age: Member is 2 years of age or older.Age ≥2 years

Specialist requirement: The prescriber is a board-certified Pediatric Endocrinologist or prescribes in consultation with one.

Submit consultation notes with the initial request when the prescriber is consulting rather than the specialist.

Age ≤12 years unless supporting factors are provided