CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nafarelin acetate (Synarel) prior authorization and coverage criteria

This document defines coverage indications, prior authorization requirements, documentation, and duration limits for Synarel (nafarelin acetate) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNafarelin acetate (Synarel) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnostic documentation; durations authorized vary by indication (e.g., CPP up to 12 months, endometriosis and hirsutism 6 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsCPP auth

6 monthsEndometriosis/hirsutism

Up to 3 moFibroids initial

3 monthsOvarian preservation

21References

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Initial therapy — Central precocious puberty

Covered when ALL of the following are met for initial authorization of CPP (authorization of 12 months may be granted):

CPP initial authorization criteria: The diagnosis of central precocious puberty (CPP) has been confirmed by a pubertal response to a gonadotropin releasing hormone (GnRH) agonist test or a pubertal level on a third-generation luteinizing hormone (LH) assay.

CPP initial authorization criteria: Assessment of bone age versus chronological age supports the diagnosis of CPP.

Age at onset criteria: Member meets either: female with onset of secondary sexual characteristics before 8 years of age OR male with onset of secondary sexual characteristics before 9 years of age.

CPP initial authorization criteria: The pathologic cause of CPP has been assessed (for example, imaging screening for intracranial tumors or genetic testing for familial CPP such as MKRN3 or DLK1 mutations).

Authorization of 12 months may be granted when all are met.

Continuation therapy — Central precocious puberty

Covered when ALL of the following are met for continuation of therapy for CPP (authorization up to 12 months):

CPP continuation criteria: Member is currently receiving the requested medication through a paid pharmacy or medical benefit.

CPP continuation criteria: Member meets age thresholds for continuation: female less than 12 years of age OR male less than 13 years of age.

CPP continuation criteria: Member is not experiencing treatment failure (for example, clinical pubertal progression, lack of growth deceleration, or continued excessive bone age advancement).

Authorization up to 12 months may be granted.

Endometriosis

Covered when criteria for endometriosis are met:

Endometriosis: Authorization of a total of 6 months may be granted for treatment of endometriosis.

Uterine leiomyomata (fibroids)

Covered when ANY of the following are met for uterine leiomyomata (fibroids):

Fibroids initial criteria: Member has anemia due to uterine leiomyomata.

Authorization of up to 3 months may be granted for initial treatment; lifetime maximum of 6 months total when continuation criteria are met.

Fibroids initial criteria: The requested medication will be used prior to surgery for uterine leiomyomata.

Authorization of up to 3 months may be granted for initial treatment; lifetime maximum of 6 months total when continuation criteria are met.

Hirsutism

Covered when criteria for hirsutism are met:

Hirsutism: Authorization of a total of 6 months may be granted for treatment of hirsutism.

Compendial use.

Preservation of ovarian function during chemotherapy

Covered when criteria for ovarian preservation are met:

Ovarian preservation: Authorization of 3 months may be granted when the member is premenopausal and undergoing chemotherapy.

Compendial use.

Prevention of menstrual-related attacks in acute porphyria

Covered when criteria for prevention of recurrent menstrual-related porphyria attacks are met:

Acute porphyria: Authorization of 12 months may be granted for prevention of recurrent menstrual related attacks in members with acute porphyria.

Must be prescribed by or in consultation with a provider experienced in porphyria management.

Assisted reproductive technology (ART) and ovulation induction

Covered when criteria for ART/ovulation induction uses are met:

ART uses: Authorization of 12 months may be granted for inhibition of premature LH surges or for oocyte maturation and ovulation trigger in members undergoing ovulation induction or assisted reproductive technology (ART).

Supplemental Specialty PA coverage will be bypassed if Synarel is requested for a procedure approved under the member's medical benefit plan; a medical authorization number and confirmation of the approved procedure(s) will be required.

All indications for Synarel (nafarelin acetate) that are not specifically listed in the policy — i.e., uses outside the FDA‑approved indications and identified compendial uses — are considered experimental/investigational and are not covered under this policy.

The reference lists cited in this policy provide literature and compendial sources for covered uses but do not themselves enumerate additional explicit coverage exclusions beyond those stated; no separate explicit exclusion lists are provided in the references.

Consistent with the policy's coverage stance, any indication for Synarel that is not an FDA‑approved indication or a recognized compendial use is considered not medically necessary and therefore not covered.

Although the policy frames non‑listed indications as not medically necessary, the bibliographic references themselves do not contain explicit 'not medically necessary' statements; the determination of medical necessity is a policy conclusion based on approved and compendial uses.

Prior Authorization, Documentation, and Provider Requirements

Note

Prior Authorization Not Specified

Prior authorization is not specified within this reference section. The listed references and compendial uses provide evidence and authorized durations by indication, but no operational prior authorization rules or submission pathways are defined here.

Denial Risk

Experimental / Investigational Exclusions

All indications not explicitly listed under "Compendial Uses" (e.g., uterine leiomyomata, hirsutism, preservation of ovarian function, prevention of porphyria attacks, CPP, endometriosis, ART-related uses) are considered experimental/investigational and are therefore not medically necessary and not covered.

Denial Risk

No Authorization or Denial Criteria Present

This section contains literature references only; there are no operational authorization or denial criteria, decision trees, or stepwise approval algorithms included for adjudication purposes.

Documentation Required

No Documentation Requirements Specified

No documentation requirements for indications other than central precocious puberty are specified in this reference section. The CPP-specific documentation requirement (see separate callout) is the only documentation item referenced here.

Definitions and Reference Notes

Central precocious puberty (CPP) — definition

DefinitionCentral precocious puberty (CPP) — gonadotropin-dependent precocious puberty treated with gonadotropin‑releasing hormone (GnRH) agonists.

Affected populationChildren of both sexes with early activation of the hypothalamic‑pituitary‑gonadal axis.

Therapeutic approachTreatment uses GnRH agonists (e.g., nafarelin) to suppress pubertal progression.

Diagnostic confirmationCPP diagnosis is confirmed by pubertal response to a GnRH agonist stimulation test or a pubertal level on a third‑generation LH assay (see coverage criteria).

References — GnRH agonist literature

Reference count21 bibliographic citations supporting clinical recommendations on GnRH agonist use.

Key guideline (2009)Carel J, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin‑releasing hormone analogs in children. Pediatrics. 2009;123:e752‑e762.

Pediatric CPP reviews (2021–2024)Cheuiche AV et al. Eur J Pediatr. 2021;180(10):3073‑3088; Bangalore Krishna K & Silverman LA. Endocrinol Metab Clin North Am. 2024;53(2):217‑227.

Ovarian preservation and chemotherapyClowse MEB et al. J Womens Health. 2009;18(3):311‑319; Moore HCF et al. N Engl J Med. 2015;372:923‑932.

ART and ovulation induction literatureWong JM et al. Hum Reprod Update. 2001;7:92‑101; Elgendy M et al. Hum Reprod. 1998;13:2382‑2385.

Range of publication years2009–2024 (selected foundational and recent studies).

OpenPayer

Nafarelin acetate (Synarel) prior authorization and coverage criteria

Coverage Criteria and Indications

Prior Authorization, Documentation, and Provider Requirements

Drug Background and Policy Scope

Definitions and Reference Notes