Neighborhood Health Plan RI Synarel Prior Auth

Coverage Criteria for Nafarelin (Synarel)

Central Precocious Puberty — Initial Therapy

Authorization of 12 months may be granted for treatment of central precocious puberty (CPP) when ALL of the following are met:

CPP initial therapy criteria: Diagnosis of CPP confirmed by a pubertal response to a GnRH agonist test or a pubertal level on a third-generation LH assay.

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

CPP initial therapy criteria: Member meets age-at-onset criteria: female with onset of secondary sexual characteristics < 8 years OR male with onset < 9 years.

CPP initial therapy criteria: Pathologic cause of CPP has been assessed (e.g., imaging for intracranial tumors, genetic testing for familial CPP such as MKRN3 or DLK1 mutations).

Authorization of 12 months.

Central Precocious Puberty — Continued Therapy

Authorization of up to 12 months may be granted for continued treatment for CPP when ALL of the following are met:

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

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

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

Authorization up to 12 months for continuation.

Endometriosis

Authorization of a total of 6 months may be granted for:

Endometriosis: Treatment of endometriosis in women.6 months total authorization

Uterine Leiomyomata (Fibroids) — Initial Therapy

Authorization of up to 3 months may be granted for initial treatment of uterine leiomyomata (fibroids) when ANY of the following are met:

Fibroids initial therapy: Member has anemia due to uterine leiomyomata.up to 3 months (lifetime max 6 months)

Initial authorization up to 3 months; lifetime maximum of 6 months total if continued.

Fibroids initial therapy: Requested medication will be used prior to surgery for uterine leiomyomata.up to 3 months (lifetime max 6 months)

Initial authorization up to 3 months; lifetime maximum of 6 months total if continued.

Hirsutism

Authorization of a total of 6 months may be granted for:

Hirsutism: Treatment of hirsutism.6 months total authorization

Preservation of Ovarian Function in Patients with Cancer

Authorization of 3 months may be granted for:

Ovarian preservation: Premenopausal member undergoing chemotherapy for cancer for preservation of ovarian function.3 months authorization

Prevention of Recurrent Menstrual Related Attacks in Acute Porphyria

Authorization of 12 months may be granted for:

Prevention of menstrual-related porphyria attacks: Members with acute porphyria for prevention of recurrent menstrual-related attacks.12 months authorization

Assisted Reproductive Technology (ART)

Authorization of 12 months may be granted for:

ART: Inhibition of premature LH surges: Members undergoing ovulation induction or assisted reproductive technology to inhibit premature luteinizing hormone (LH) surges.12 months authorization

Supplemental Specialty PA review will be bypassed if procedure is approved under the member's medical benefit; medical authorization number and confirmation of approved procedure(s) required.

ART: Oocyte maturation and ovulation trigger: Members undergoing ovulation induction or assisted reproductive technology for oocyte maturation and ovulation trigger.12 months authorization

Supplemental Specialty PA review will be bypassed if procedure is approved under the member's medical benefit; medical authorization number and confirmation of approved procedure(s) required.

All indications for nafarelin (Synarel) that are not specifically listed in this policy — beyond FDA‑approved uses and the compendial uses enumerated here — are considered experimental/investigational and not medically necessary.

The reference sections cited for compendial uses list specific conditions (e.g., fibroids, hirsutism, ovarian preservation, prevention of porphyria attacks, and assisted reproductive technology uses) but do not provide additional explicit exclusion conditions; reviewers should rely on the policy's stated covered indications and referenced literature for clinical context.

Uses of nafarelin outside the policy's enumerated FDA‑approved indications and the specified compendial uses are considered not medically necessary and therefore are not eligible for authorization under this policy.

While the document includes multiple clinical references (package insert and peer‑reviewed literature) that support covered uses and clinical decision‑making, the cited chunks do not contain separate, additional statements explicitly labeling any other uses as not medically necessary beyond the policy language itself.

Drug and Age Coding / Key Thresholds

Referenced drugNDC | mixed

Synarel / nafarelin acetate

Referenced drug (brand and generic names and all dosage forms/strengths unless stated)

Age thresholds for central precocious puberty (CPP)

Female — initiation ageOnset of secondary sexual characteristics before 8 years of age

Male — initiation ageOnset of secondary sexual characteristics before 9 years of age

Female — continuation therapy age limitMember is eligible for continued treatment if female and less than 12 years of age

Male — continuation therapy age limitMember is eligible for continued treatment if male and less than 13 years of age

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization: None stated in the source reference chunks for this section. If a payer-specific PA is required, it is not specified here.

Step Therapy

No step therapy requirements are specified in the source reference chunks for this section.

Documentation Required

Medical Benefit Alignment

When Synarel is requested for a procedure already approved under the member's medical benefit plan, supplemental specialty PA coverage review will be bypassed. Provide the medical authorization number and confirmation of the approved procedure(s). Note that some plans may opt out of medical benefit alignment; members in those plans must meet the coverage criteria.

Background on Nafarelin (Synarel)

Nafarelin (Synarel) is a gonadotropin‑releasing hormone (GnRH) agonist primarily indicated for the treatment of central precocious puberty (CPP) in children of both sexes and for management of endometriosis in adult women. The agent also has recognized compendial uses including treatment of uterine leiomyomata (fibroids), hirsutism, preservation of ovarian function during chemotherapy, prevention of menstrual‑related attacks in acute porphyria, and specific roles in assisted reproductive technology (ART) such as inhibition of premature LH surges and triggering oocyte maturation. The policy references the Synarel package insert and multiple clinical reviews and meta‑analyses to support these indications.

Definitions and Key Terms

Central precocious puberty (CPP) — diagnostic criteria and confirmation tests

Diagnostic definition of CPPGonadotropin-dependent precocious puberty; diagnosis confirmed by a pubertal response to a GnRH agonist test or a pubertal level on a third‑generation luteinizing hormone (LH) assay

Supporting assessmentBone age assessment versus chronological age should support the diagnosis of CPP

Evaluation for pathologic causesAssessment for pathologic causes (e.g., intracranial imaging for tumors; genetic testing for familial CPP such as MKRN3 or DLK1 mutations) is required

GnRH agonists — definition and referenced therapeutic contexts

Definition of GnRH agonistsAgents that act as gonadotropin‑releasing hormone (GnRH) agonists used to suppress the hypothalamic‑pituitary‑gonadal axis for indications such as central precocious puberty and management of endometriosis

OpenPayer

Nafarelin (Synarel) — Prior Authorization and Coverage Criteria

Coverage Criteria for Nafarelin (Synarel)

Drug and Age Coding / Key Thresholds

Prior Authorization & Documentation Requirements

Background on Nafarelin (Synarel)

Definitions and Key Terms