CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fensolvi (subcutaneous) coverage and administration policy

Defines Medicaid, Commercial, and MMP coverage, authorization length, quantity limits, clinical initial and renewal criteria, dosing, billing codes/NDCs, and exclusions for Fensolvi (45 mg) for Central Precocious Puberty and Gender Dysphoria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFensolvi (subcutaneous) coverage and administration policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit documentation confirming age, diagnostic testing (gonadal sex steroid levels, LH stimulation response), bone age, tumor exclusion imaging/labs, prior intolerance or contraindication to listed alternatives, or MHP and pediatric endocrinologist confirmations for gender dysphoria.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

2Covered Indications

12Authorization Length (months)

45 mgDose Strength

168Days Supply per injection

Coverage Summary

Scope: This policy covers Fensolvi (subcutaneous 45 mg kit) for Central Precocious Puberty (CPP) and for Gender Dysphoria across Medicaid, Commercial, and MMP plans, with applicable HCPCS (J1951) and NDCs (62935-0153-xx, 62935-0163-xx). Coverage stance is covered_with_criteria.

Covered indications: pediatric CPP (patients <13 years with early secondary sexual characteristics — females <8 years, males <9 years — confirmed by gonadal sex steroids and a pubertal LH stimulation response; tumor exclusion and bone age > 2 SD required) and Gender Dysphoria (meeting DSM‑V/MHP confirmation and other behavioral/consent requirements).

Authorization and dosing: initial and renewal authorization length is 12 months; dosing is 45 mg administered subcutaneously once every 6 months with a quantity limit of 1 injection per dose and a days supply of 168 days (HCPCS billable units = 180 per 168 days).

Key exclusions/requirements: will not be used in combination with growth hormone (explicit contraindicated combination) and MMP members who received Fensolvi within the prior 365 days are exempt from step therapy; prior authorization documentation requirements include age, diagnostic testing, bone age, tumor exclusion imaging/labs, evidence of prior intolerance/contraindication to specified alternatives, or MHP/pediatric endocrinologist confirmations for gender dysphoria.

Key thresholds and quick facts

Age limit for CPPPatient is less than 13 years of age

Onset ages for secondary sexual characteristicsFemales < 8 years; Males < 9 years

Bone age advancement criterion> 2 standard deviations beyond chronological age

LH suppression efficacy (clinical trial)Peak stimulated LH < 4 IU/L — 87% at 6 months; 86% at 12 months

Days supply per injection168 days per 45 mg injection

Dose strength45 mg subcutaneous once every 6 months

Length of Authorization12 months (may be renewed)

Initial Approval Criteria

Coverage is provided when ALL of the following are met (except where alternate paths or exceptions noted):

Member exceptions

MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements
exception to step therapy for MMP members

Central Precocious Puberty (CPP) criteria

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
Tumor has been ruled out by lab tests such as diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), and human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor)
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
explicit contraindicated combination

Gender Dysphoria criteria

Patient has experienced puberty development to at least Tanner stage 2
Diagnosis confirmation
- Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP)
- Diagnosis meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria
Qualified MHP must confirm
- 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

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 (section IV)
CPP renewal specifics
- 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 or worsening of psychiatric symptoms, pseudotumor cerebri/idiopathic intracranial hypertension)
- Will not be used in combination with growth hormone
Gender Dysphoria renewal specifics
- Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters
- Absence of unacceptable toxicity from the drug (examples: convulsions, development or worsening of psychiatric symptoms, pseudotumor cerebri/idiopathic intracranial hypertension)

Provider Actions & Requirements

Prior Authorization

Initial prior authorization required with criteria documentation

Initial prior authorization is required. Submit documentation confirming age, diagnostic testing (gonadal sex steroid levels, LH stimulation response), bone age, tumor exclusion imaging/labs, prior intolerance or contraindication to listed alternatives (leuprolide, triptorelin, histrelin), or MHP and pediatric endocrinologist confirmations for gender dysphoria.

J1951
E30.1
F64.0

Documentation Required

Qualified Mental Health Professional documentation

For gender dysphoria, document MHP qualifications and attestations including duration/pattern of dysphoria, worsening with puberty, addressed coexisting issues, capacity to consent, and informed consent/parental involvement as applicable. Include confirmation by a qualified mental health professional as defined (licensed, minimum master's degree, competence with ICD, ability to assess coexisting concerns and capacity to consent, experience/continuing education in gender dysphoria care).

F64.0
F64.2

Billing Rule

Quantity limits and days supply

Quantity and days supply limits apply: Fensolvi 45 mg is limited to 1 injection per dosing period with a days supply of 168 days. Billable HCPCS units for J1951 are limited to 180 units per 168 days.

J1951
62935-0153-xx
62935-0163-xx
Quantity = 1 injection
Days supply = 168 days
HCPCS units = 180 per 168 days

Prior Authorization

Step therapy exception for MMP members

MMP members who have previously received Fensolvi within the past 365 days are exempt from Step Therapy requirements. Document prior receipt within the past 365 days to support the exception.

MMP members receiving Fensolvi in the past 365 days are exempt and must document prior receipt

Denial Risk

Denial risk for combination with growth hormone

There is a denial risk if Fensolvi is used in combination with growth hormone. Ensure no concurrent growth hormone therapy is prescribed or billed when requesting coverage.

Applicable Codes

Covered HCPCSHCPCSCovered

J1951

Leuprolide acetate, depot suspension, 3.75 mg (HCPCS used for Fensolvi billing per policy)

Covered NDCsNDCCovered

62935-0153-xx	Fensolvi 45 mg kit NDC (listed with xx suffix)
62935-0163-xx	Fensolvi 45 mg kit NDC (listed with xx suffix)

Covered ICD-10 Diagnosis CodesICD-10Covered

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

Clinical Evidence & Trial Outcomes

64Trial population: 64 pediatric patients (62F, 2M), ages 4–9, GnRH‑naïve

87%Peak stimulated LH <4 IU/L at 6 months

97%/100%Estradiol (females)/Testosterone (males) suppressed to prepubertal levels at 6 months

86%Maintained LH suppression (<4 IU/L) at 12 months

Background trial design: efficacy was evaluated in a 12‑month, open‑label, single‑arm clinical trial of 64 pediatric patients (62 females, 2 males; ages 4–9) with CPP who were naïve to prior GnRH agonists.

Common adverse reactions reported in the trial/public summary include: pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, and bronchospasm.

Background & Definitions

Indication and mechanism: Fensolvi is a gonadotropin‑releasing hormone (GnRH) agonist indicated for treatment of pediatric patients aged ≥2 years with Central Precocious Puberty; efficacy demonstrated by suppression of peak stimulated LH (<4 IU/L in the trial) and reductions in sex steroids and pubertal progression.

Dosing/administration notes: Fensolvi is provided as a 45 mg subcutaneous kit to be administered by a healthcare provider once every 6 months; quantity limits specify 1 injection per dosing interval with a days supply of 168 days and associated HCPCS/NDC billing codes (HCPCS = J1951, NDCs = 62935-0153-xx, 62935-0163-xx).

Term	Definition
Qualified Mental Health Professional (MHP)
Are licensed by their statutory body and hold, at minimum, a master's degree or equivalent training in a clinical field; competent in diagnosis using ICD where required; able to identify co-existing mental health or psychosocial concerns and distinguish these from gender dysphoria; able to assess capacity to consent; experienced or qualified to assess clinical aspects of gender dysphoria and undergo continuing education in gender dysphoria care.
CPP
Central Precocious Puberty