Supprelin LA (histrelin) (Subcutaneous Implant)
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Policy IC-0118 defines prior authorization, dosing limits, indications, renewal criteria, and billing/coding for Supprelin LA (histrelin) implants for members of Viva Health.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy - Central Precocious Puberty
Covered when ALL of the following are met
Initial Therapy - Gender Dysphoria
Covered when ALL of the following are met
Continuation / Renewal Criteria
Renewal provided when ALL of the following are met
For the Central Precocious Puberty (CPP) initial approval pathway, the policy explicitly excludes concurrent administration with growth hormone. The coverage criteria state that the implant will not be used in combination with growth hormone, and all other CPP initial criteria (age, biochemical confirmation, advanced bone age, and tumor exclusion) must be met for coverage to be considered.
In the list of covered ICD-10 diagnosis codes, F64.9 (Gender identity disorder, unspecified) is noted as discontinued effective 10/1/26. The appendix replaces or updates related gender identity disorder codes effective on that date, including the introduction of F64.A (Gender identity disorder, in remission).
Initial Therapy and Dosing
Initial Therapy / Dosing
Initial dosing and indication rules
Continuation and Renewal
Continuation Therapy
Renewal/continuation requirements
Billing & Coding
| J9226 | Histrelin implant (Supprelin LA), 50 mg; 1 billable unit = 50 mg |
| 67979-0002-xx | Supprelin LA 50 mg implant NDC |
| E30.1 | Precocious puberty |
| E30.8 | Other disorders of puberty |
| F64.0 | Transsexualism |
| F64.1 | Dual role transvestism |
| F64.2 | Gender identity disorder of childhood |
| F64.8 | Other gender identity disorders |
| F64.9 | Gender identity disorder, unspecified (Discontinued effective 10/1/26) |
| F64.A | Gender identity disorder, in remission (Effective 10/1/26) |
| No codes listed |
Provider Actions & Requirements
Prior authorization validity
Prior authorization is required for Supprelin LA. Initial prior authorization validity will be provided for 12 months (365 days) and may be renewed every 12 months (365 days) thereafter.
PA applies for covered diagnoses (see Appendix 1)
Prior authorization is applied to Supprelin LA with covered diagnoses listed in Appendix 1; the NQTL checklist indicates PA was considered for the indication and for drug cost.
- Covered diagnoses are those listed in Appendix 1 (e.g., E30.1, E30.8, F64.0, F64.1, F64.2, F64.8, F64.9, F64.A).
No step therapy requirement documented
No step therapy or prerequisite medication failures are specified in this policy for Supprelin LA.
Step therapy not specified — PA considered by NQTL
The policy does not provide a specific step therapy algorithm; the NQTL review notes that prior authorization may be considered based on indication and cost.
Required documentation for Gender Dysphoria
For the Gender Dysphoria indication, documentation must include a diagnosis confirmed by a qualified mental health professional (or DSM-5-TR criteria), confirmation of persistent/intense gender dysphoria and worsening with puberty, assessment of capacity to consent, informed consent including discussion of potential loss of fertility and options to preserve fertility, parental/guardian involvement when applicable, and for adolescents agreement from a pediatric endocrinologist or clinician experienced in pubertal assessment.
- Diagnosis confirmed by a qualified MHP or DSM-5-TR criteria
- MHP confirmation of persistent/intense dysphoria and that puberty worsened dysphoria
- Documentation of informed consent and fertility counseling
- Pediatric endocrinologist or experienced clinician confirmation for adolescents
Required documentation for Central Precocious Puberty (CPP)
For Central Precocious Puberty (CPP), documentation must confirm pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to native GnRH stimulation, bone age advanced >2 standard deviations beyond chronological age, and diagnostic imaging/laboratory testing ruling out intracranial or steroid/chorionic gonadotropin–secreting tumors.
- Pubertal gonadal sex steroid levels and pubertal LH response to GnRH stimulation
- Bone age >2 SD advanced beyond chronological age
- Imaging and labs to rule out tumors (brain imaging, pelvic/testicular/adrenal ultrasound, hCG levels)
Medicare coverage determinations must be followed
Medicare members are subject to applicable Medicare coverage determinations (NCD/LCD/LCA) and must follow those policies where relevant; additional indications may be applied at the discretion of the health plan.
- Medicare Part B covered diagnosis codes: N/A (per Appendix 2)
- Search NCD/LCD/LCA via CMS Medicare Coverage Database when applicable
Renewal may be denied for unacceptable toxicity
Renewal may be denied if there is unacceptable toxicity from the drug; examples include severe implant site reactions, convulsions/seizures, severe psychiatric events, severe cutaneous adverse reactions (e.g., SJS/TEN, DRESS, AGEP), and signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension.
- Severe implant site reactions
- Convulsions/seizures
- Psychiatric events (emotional lability, aggression, etc.)
- Severe cutaneous adverse reactions (SJS/TEN, DRESS, AGEP)
- Signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension (headache, papilledema, visual changes)
PA may be applied based on NQTL findings (indication & cost)
The NQTL checklist indicates prior authorization may be used based on the indication and the cost of the drug; utilization management methods like PA were considered in the NQTL assessment.
- NQTL conclusions: Indication — Consider for PA; Cost of drug — Consider for PA
Office insertion every 12 months (site-of-care)
The histrelin implant (Supprelin LA) is administered as 1 implant (50 mg) inserted subcutaneously every 12 months; the policy specifies the office as the site of care for insertion.
- Dose/frequency: 1 implant (50 mg) every 12 months
- Site-of-care: office (implant inserted subcutaneously)
Step Therapy
| Step | Requirement |
|---|---|
| 1 | No step therapy or prerequisite medication failures specified in this portion of the policy. |
| Step | Policy note |
|---|---|
| 1 | No specific step therapy algorithm provided; prior authorization consideration is driven by indication and drug cost per the NQTL checklist. |
Definitions
Background
Supprelin LA is a subcutaneous histrelin implant used for indications that include suppression of puberty. For Central Precocious Puberty (CPP), the policy requires age and biochemical confirmation, advanced bone age, and exclusion of tumors prior to coverage. The policy’s Appendix 1 lists covered diagnosis codes for CPP and related puberty and gender identity disorders to guide billing and authorization.
Quantity Limits
Site of Care
Office insertion every 12 months (site-of-care)
The histrelin implant (Supprelin LA) is administered as 1 implant (50 mg) inserted subcutaneously every 12 months; the policy specifies the office as the site of care for insertion.
- Dose/frequency: 1 implant (50 mg) every 12 months
- Site-of-care: office (implant inserted subcutaneously)
Revision History
Policy IC-0118 (Supprelin LA) last reviewed and NQTL checklist updated to note that indication and cost were considered 'Consider for PA' for prior authorization design; utilization management methods may include prior authorization.
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