CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fensolvi

Coverage and utilization management policy for Fensolvi 45 mg subcutaneous kit for treatment of central precocious puberty and gender dysphoria across Medicaid, Commercial, and MMP lines; includes initial and renewal criteria, dosing, quantity limits, billing codes, and supporting evidence.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFensolvi

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2025

Next Review Date

Key ActionAuthorization is provided for 12 months and may be renewed if renewal criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes identified.

2Covered Indications

12 moAuthorization Length

45 mgDose Strength

168Days Supply per Injection

Coverage Summary

Scope: Coverage and utilization management policy for Fensolvi 45 mg subcutaneous kit for treatment of central precocious puberty (CPP) and gender dysphoria across Medicaid, Commercial, and MMP lines of business. Dose strength is 45 mg administered once every 6 months with a days supply of 168 days (Quantity = 1 injection per 168 days). Authorization is provided for 12 months and may be renewed. For MMP members who have previously received this medication within the past 365 days, step therapy requirements do not apply. Effective date: 2025-03-01; Last review: 01/2025.

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met (with exception for MMP members previously treated within 365 days):

ALL of the following

For MMP members who have previously received this medication within the past 365 days, Step Therapy Requirements do not apply.
Indication
- Central Precocious Puberty (CPP)
  - Patient is less than 13 years of age
  - Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation
  - Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native growth hormone-releasing hormone (GnRH)
  - Bone age advanced greater than 2 standard deviations (SD) beyond chronological age> 2 SD
  - Tumor has been ruled out by diagnostic imaging of the brain, pelvic/testicular/adrenal ultrasound, and human chorionic gonadotropin levels
  - The member has experienced an inadequate treatment response, intolerance, or is contraindicated to treatment with Lupron Depot-Ped (leuprolide) AND either Triptodur (triptorelin) or Supprelin LA (histrelin)
  - Will not be used in combination with growth hormone
- Gender Dysphoria
  - Patient has experienced puberty development to at least Tanner stage 2
  - Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP) OR meets DSM‑V criteria for gender dysphoria
  - MHP confirmation
    Patient has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed)
    Gender dysphoria worsened with the onset of puberty
    Any coexisting psychological, medical, or social problems that could interfere with treatment have been addressed and the adolescent's situation and functioning are stable enough to start treatment

ref

Continuation (Renewal) Criteria

Renewal Criteria

Coverage may be renewed when ALL of the following are met:

ALL of the following

Patient continues to meet the indication-specific relevant criteria identified in Initial Approval Criteria
Indication-specific renewal
- Central Precocious Puberty (CPP)
  - Patient is less than 13 years of age
  - Disease response indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, a decrease in the ratio of bone age to chronological age (BA:CA), and improvement in final height prediction
  - Absence of unacceptable toxicity from the drug (examples: convulsions, development/worsening of psychiatric symptoms, pseudotumor cerebri)
  - Will not be used in combination with growth hormone
- Gender Dysphoria
  - Patient has shown a beneficial response to treatment evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters
  - Absence of unacceptable toxicity from the drug (examples: convulsions, development/worsening of psychiatric symptoms, pseudotumor cerebri)

ref

Provider Actions & Billing Rules

Prior Authorization

Authorization length and renewal

Authorization is provided for 12 months and may be renewed per the policy renewal criteria.

Billing Rule

Quantity limits (NDC unit)

Covered NDCs: 62935-0153-xx, 62935-0163-xx. Quantity limits: 1 injection per 168 days (Fensolvi 45 mg; days supply = 168).

NDC: 62935-0153-xx
NDC: 62935-0163-xx
Quantity = 1 injection
Days supply = 168 days
Max = 1 injection per 168 days

Billing Rule

Max billable units (HCPCS)

HCPCS code J1951 is used for Fensolvi 45 mg kit. Billable units = 180 over 168 days per the policy.

HCPCS: J1951
HCPCS J1951 billable units = 180 over 168 days

Documentation Required

Diagnostic confirmation and documentation required

Required documentation differs by indication. For Central Precocious Puberty (CPP): record patient age (<13), timing of onset of secondary sexual characteristics (earlier than age 8 in females, 9 in males), pubertal gonadal sex steroid levels and pubertal LH response to GnRH stimulation, advanced bone age (>2 SD beyond chronological age), tumor exclusion testing (brain imaging; pelvic/testicular/adrenal ultrasound; hCG levels), and documentation of inadequate response/intolerance/contraindication to listed alternative GnRH agonists. For Gender Dysphoria: document pubertal stage (Tanner ≥2), a qualified MHP confirmation or DSM‑V criteria with elements showing long‑lasting/intense gender dysphoria worsened by puberty, that coexisting issues were addressed, assessment of capacity to consent, informed discussion of effects/side effects including fertility preservation options, written informed consent and caregiver involvement as appropriate, and confirmation from a pediatric endocrinologist or clinician experienced in pubertal assessment that there are no medical contraindications.

CPP examples: age, onset timing, sex steroid labs, stimulated LH response, advanced bone age (>2 SD), brain/pelvic/testicular/adrenal imaging, hCG, prior trial/intolerance to alternatives
Gender Dysphoria examples: Tanner stage ≥2, MHP confirmation/DSM‑V criteria, documentation of duration/severity, capacity to consent, informed consent including fertility discussion, pediatric endocrinology assessment

Denial Risk

Contraindicated combinations

Claims may be denied if Fensolvi is used in combination with growth hormone; the policy prohibits combination therapy with growth hormone for both initial approval and renewal.

Documentation Required

Qualified MHP credentials

A qualified mental health professional (MHP) must be licensed, hold at minimum a master’s degree or equivalent in a relevant clinical field, be competent with ICD diagnosis where required, be able to identify coexisting mental health or psychosocial concerns and assess capacity to consent, have experience or qualification to assess gender dysphoria, and participate in continuing education related to gender dysphoria.

Minimum master's degree or equivalent and licensure
Competence with ICD diagnosis where required
Ability to assess coexisting conditions and capacity to consent
Experience/qualification in gender dysphoria assessment and continuing education

Billing Rule

Administration requirement

Fensolvi must be administered by a healthcare provider per the dosing and administration section of the policy.

Administration requirement: provider‑administered

Background & Definitions

Background: Fensolvi is a GnRH agonist indicated for pediatric patients aged ≥2 years with central precocious puberty. Efficacy was supported by a 12-month open-label trial showing hormonal suppression and reduction in growth velocity and bone age progression. The plan's P&T committee adopted coverage criteria to align with FDA labeling and relevant clinical literature. The policy covers Medicaid, Commercial, and MMP lines, and includes an exception for MMP members previously treated within the past 365 days who are not subject to step therapy requirements.

Term	Definition
Qualified mental health professional (MHP)
Licensed clinician with at minimum a master's degree or equivalent in a clinical field, competent in ICD diagnosis where required, able to assess coexisting conditions, capacity to consent, and experienced in gender dysphoria assessment.
Central precocious puberty (CPP)
Early onset pubertal changes due to activation of the hypothalamic‑pituitary‑gonadal axis.

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

OpenPayer

Fensolvi

Coverage Summary

Initial Therapy Criteria

Continuation (Renewal) Criteria

Provider Actions & Billing Rules

Applicable Codes

Clinical Evidence & Metrics

Background & Definitions

Revision History

62935-0153-xx	Fensolvi 45 mg NDC (package identifiers with trailing xx)
62935-0163-xx	Fensolvi 45 mg NDC (alternate package identifiers with trailing xx)