CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fensolvi (subcutaneous) coverage for Central Precocious Puberty and Gender Dysphoria

Defines medical necessity, dosing, authorization length, and billing/coding for Fensolvi (45 mg subcutaneous kit) for pediatric central precocious puberty and for use in puberty suppression for gender dysphoria. Applies to Medicaid, Commercial, and MMP members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFensolvi (subcutaneous) coverage for Central Precocious Puberty and Gender Dysphoria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation to support diagnosis, treatment history, and monitoring for individual consideration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization length

45 mgdosage

every 24 weeksdosing interval

J1951HCPCS

2 NDCsproduct NDCs

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Coverage Criteria for Fensolvi

Initial Therapy — Central Precocious Puberty

Covered when ALL of the following are met

CPP initial criteria: Patient is less than 13 years of age; AND onset of secondary sexual characteristics earlier than age 8 for females or 9 for males associated with pubertal pituitary gonadotropin activation; AND diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native GnRH; AND bone age advanced greater than 2 standard deviations beyond chronological age; AND tumor has been ruled out by diagnostic imaging and appropriate labs (pelvic/testicular/adrenal ultrasound and hCG) to exclude steroid- or hCG-secreting tumors; AND the member has experienced inadequate response, intolerance, or is contraindicated to leuprolide (Lupron Depot-Ped) AND either triptorelin (Triptodur) or histrelin (Supprelin LA); AND will not be used in combination with growth hormone.

Initial Therapy — Gender Dysphoria (puberty suppression)

Covered when ALL of the following are met

Gender dysphoria initial criteria: Patient has experienced pubertal development to at least Tanner stage 2; AND diagnosis of gender dysphoria confirmed by a qualified mental health professional (MHP) or by DSM‑V criteria; AND the qualified MHP has confirmed long‑lasting/intense gender incongruence or dysphoria, that dysphoria worsened with onset of puberty, coexisting problems that could interfere with treatment have been addressed, the patient has sufficient capacity for informed consent, and the patient (and parents/guardians when applicable) have been informed of effects/side effects including potential loss of fertility and have given consent; AND a pediatric endocrinologist or other clinician experienced in pubertal assessment has confirmed agreement in the indication for treatment and that there are no medical contraindications to treatment.

Renewal Criteria

Coverage may be renewed when ALL of the following are met

Renewal general: Patient continues to meet the indication‑specific criteria identified for initial approval; AND for Central Precocious Puberty: there is disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decreased height velocity, decreased bone age to chronological age ratio (BA:CA), and improvement in predicted final height; AND absence of unacceptable toxicity (examples include convulsions, development or worsening of psychiatric symptoms, pseudotumor cerebri); AND will not be used in combination with growth hormone; AND for Gender Dysphoria: beneficial response evidenced by routine monitoring of pubertal development and applicable laboratory parameters and absence of unacceptable toxicity.

Examples of unacceptable toxicity include convulsions, worsening psychiatric symptoms, pseudotumor cerebri (idiopathic intracranial hypertension).

General coverage criteria for Fensolvi

Covered when ALL of the following are met

Alignment with FDA labeling: Use is consistent with FDA‑approved labeling and relevant clinical literature.

Criteria adopted by P&T to ensure appropriate use

Prescriber documentation: Prescriber must submit clinical information to support the request for individual consideration.

Plan will review submitted information

NCD/LCD precedence for Medicare: For INTEGRITY (Medicare‑Medicaid Plan) members, applicable National Coverage Determination (NCD) or Local Coverage Determination (LCD) criteria supersede these plan criteria.

Plan criteria apply only in the absence of NCD/LCD

Coverage for Fensolvi for central precocious puberty (CPP) is granted only when all program criteria are met. Key limits and restrictions include: the patient must be less than 13 years of age; onset of secondary sexual characteristics must have occurred earlier than age 8 for females or 9 for males and be associated with pituitary gonadotropin activation; diagnosis must be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation; bone age must be advanced > 2 standard deviations beyond chronological age; tumor causes must be excluded with appropriate imaging and labs (brain imaging, pelvic/testicular/adrenal ultrasound, hCG); and the member must have had an inadequate response, intolerance, or contraindication to leuprolide (Lupron Depot‑Ped) AND either triptorelin or histrelin. Fensolvi will not be used in combination with growth hormone.

For Medicare members, National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) issued by CMS take precedence where applicable. When an NCD or LCD applies to a request, compliance with that CMS policy is required and the plan criteria apply only in the absence of such CMS determinations. Providers may use the CMS search tools referenced in the plan documentation to identify applicable NCD/LCD/LCA policy guidance.

Requests for Fensolvi that lack required diagnostic confirmation or supporting evaluations will be considered not medically necessary. Examples include patients who do not meet age thresholds, lack confirmation of pubertal pituitary activation (sex steroid levels and stimulated LH), do not have bone age advancement > 2 SD, have not had tumor exclusion testing, or—for puberty suppression in gender dysphoria—lack documentation from a qualified mental health professional, pediatric endocrinology confirmation, informed consent (including fertility counseling), and parental/guardian involvement when applicable.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be reviewed per the plan's coverage criteria. Coverage decisions are based on FDA labeling and relevant clinical literature; Neighborhood will give individual consideration to requests based on information submitted by the prescriber and available to the plan. Coverage is provided for up to 12 months and may be renewed.

Prior authorization required per coverage criteria
Authorization length: up to 12 months, renewable

Step Therapy

Therapy Requirements / Step Therapy

Therapy requirements apply unless the member is an MMP member who received the medication within the prior 365 days. For non-exempt members, patients must have had an inadequate treatment response, intolerance, or contraindication to Lupron Depot-Ped (leuprolide) AND either Triptodur (triptorelin) or Supprelin LA (histrelin) before approval for CPP.

MMP member exemption: prior receipt within 365 days bypasses step requirement
For CPP: prior inadequate response/intolerance/contraindication to leuprolide AND either triptorelin or histrelin required

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J1951

Fensolvi 45 mg kit

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

Product NDCsNDC

62935-0153-XX	Fensolvi NDC
62935-0163-XX	Fensolvi NDC

inv-11: Stimulated LH suppression

Stimulated LH suppression thresholdLH < 4 IU/L

Clinical trial attainment at 6 months87% of patients achieved stimulated LH < 4 IU/L by 6 months

Clinical trial maintenance at 12 months86% of patients maintained stimulated LH < 4 IU/L at 12 months

inv-12: Estradiol suppression (females)

Estradiol suppression threshold (females)Estradiol < 73.4 pmol/L

Clinical trial attainment86% of patients maintained estradiol < 73.4 pmol/L at 12 months

Background and Drug Information

Fensolvi is a gonadotropin‑releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients ≥ 2 years of age with central precocious puberty (CPP). Clinical trial evidence summarized in the plan shows suppression of stimulated LH and sex steroids to prepubertal levels and improvements in progression of puberty, growth velocity, and bone age advancement. Common adverse reactions observed include fever, headache, cough, abdominal pain, injection site erythema, gastrointestinal symptoms, upper respiratory infections, and bronchospasm. The Neighborhood Health Plan of Rhode Island Pharmacy & Therapeutics Committee reviewed Fensolvi and adopted the coverage criteria to align use with FDA labeling and relevant clinical literature.

Definitions and Clinical Criteria

inv-23: Fensolvi efficacy summary

Primary hormonal efficacy endpointBy 6 months, 87% of patients achieved suppression of stimulated LH to < 4 IU/L

Sustained LH suppression86% of patients maintained LH < 4 IU/L at 12 months

Sex steroid suppression97% of females and 100% of males achieved estradiol/testosterone suppression to prepubertal levels by 6 months

Maintenance of sex steroid suppressionAt 12 months, 86% maintained estradiol < 73.4 pmol/L and 98% of females/100% of males maintained testosterone < 1 nmol/L

Clinical outcomes beyond hormonesTreatment arrested or reversed progression of puberty with reductions in growth velocity and bone age advancement

inv-24: Gender dysphoria (DSM‑V)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFensolvi (subcutaneous) coverage for Central Precocious Puberty and Gender Dysphoria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation to support diagnosis, treatment history, and monitoring for individual consideration.

SourceLink

On This Page

Documentation Required

Required Documentation

Required documentation must be provided by the prescriber to support medical necessity. Requests lacking sufficient documentation may be delayed or denied.

Diagnostic confirmation of CPP: pubertal gonadal sex steroid levels and a pubertal LH response to GnRH stimulation
Bone age assessment demonstrating advancement >2 standard deviations beyond chronological age
Imaging and labs to exclude tumor: brain imaging, pelvic/testicular/adrenal ultrasound as appropriate, and human chorionic gonadotropin (hCG) levels
Documentation of prior therapy trials and reasons for inadequate response, intolerance, or contraindication (for step therapy)
For gender dysphoria indications: documentation from a qualified mental health professional confirming diagnosis and capacity/consent per policy criteria

Denial Risk

Denial Triggers for CPP

Requests will be denied if the submitted information does not support the coverage criteria or if key diagnostic elements are missing. Examples of denial triggers for CPP are listed below.

Patient age inconsistent with indication (must be <13 years for CPP)
Onset of secondary sexual characteristics not consistent with CPP (earlier than age 8 in females, 9 in males)
Lack of laboratory confirmation (pubertal sex steroid levels and pubertal LH response to stimulation)
Bone age not advanced >2 SD beyond chronological age
Failure to rule out hormone- or tumor-related causes (missing appropriate imaging or hCG testing)
No documentation of prior therapy trial or reason for exemption when required

Denial Risk

Denial Risk from Insufficient Information

Requests may be denied or returned for additional information if clinical documentation is insufficient to demonstrate medical necessity. The plan will review all information submitted and may require additional records or clarification before making a determination.

Insufficient diagnostic data (labs, stimulation testing, bone age)
Incomplete documentation of prior therapies or rationale for contraindication/intolerance
Missing clinician attestations or specialist confirmations when required (e.g., qualified MHP for gender dysphoria, pediatric endocrinologist for pubertal assessment)
Absence of testing to exclude tumors when clinically indicated

Note

Preference for Alternative Drug Options First

The plan prefers that alternative, appropriate drug options be trialed before approving this therapy when clinically reasonable to do so.

Where appropriate, trial of formulary alternatives and standard therapies (e.g., leuprolide, triptorelin, histrelin) should be documented prior to approval

Clinical trial 6‑month response97% of females achieved estradiol suppression to prepubertal levels by 6 months

inv-13: Testosterone suppression

Testosterone suppression thresholdTestosterone < 1 nmol/L

Clinical trial attainment (males)100% of males achieved testosterone suppression to < 1 nmol/L by 6 months

Clinical trial maintenance98% of females and 100% of males maintained testosterone < 1 nmol/L at 12 months

Core definitionMarked incongruence between experienced/expressed gender and assigned sex, lasting at least 6 months

Symptom requirementsAt least two characteristic manifestations (e.g., strong desire to be rid of primary/secondary sex characteristics; strong desire for characteristics of the other gender; strong desire to be treated as the other gender)

Functional impactCondition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning

SpecificationSpecify presence or absence of post‑transition status or coexisting disorder of sex development as applicable

inv-25: NCD/LCD

DefinitionNational Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) are CMS documents that may govern Medicare coverage and claims payment

Precedence for Medicare membersFor INTEGRITY (Medicare‑Medicaid Plan) members, NCD or LCD criteria supersede plan criteria when applicable

Plan applicationPlan coverage criteria apply only in the absence of an applicable NCD or LCD; compliance with NCD/LCD is required where applicable