Synarel (Nafarelin Acetate, Nasal Solution) Policy Number: C4958-A

Prior Authorization Criteria

Synarel (nafarelin acetate, nasal solution) Policy Number: C4958-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 10/2012 07/03/2019 07/03/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J3490 (NOC) RxPA Q3 2019 20190828C4958-A

PRODUCTS AFFECTED: Synarel (nafarelin acetate, nasal solution)

DRUG CLASS: LHRH/GNRH agonist analog pituitary suppressants

ROUTE OF ADMINISTRATION: Intranasal

PLACE OF SERVICE: Specialty Pharmacy The recommendation is that medications in this policy will be for pharmacy benefit coverage and patient self-administered

AVAILABLE DOSAGE FORMS: Synarel SOLN 2MG/ML (8ml bottle)

FDA-APPROVED USES: Treatment of CPP (gonadotropin-dependent precocious puberty) in children of both sexes; Management of endometriosis, including pain relief and reduction of endometriotic lesions.

COMPENDIAL APPROVED OFF-LABELED USES: None

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS: Treatment of CPP (central precocious puberty), Management of endometriosis

REQUIRED MEDICAL INFORMATION: A. CENTRAL PRECOCIOUS PUBERTY(CPP): 1. Diagnosis of central precocious puberty confirmed by (a through c): (a) Elevated basal luteinizing hormone (LH) level > 0.2 - 0.3 mIU/L (dependent on type of assay used) and/or elevated leuprolide-stimulated LH level > 3.3 - 5 IU/I (dependent on type of assay used) (b) Difference between bone age and chronological age was > 1 year and (c) Age at onset of secondary sex characteristics is < 8 years if female, or < 9 years if male AND 2. Member meets the following age requirements: Female: 2 - 11 years; Male: 2 - 12 years AND 3. Dose does not exceed Synarel (nasal spray): 1800 micrograms/day. AND 4. Patient has tried and failed or has a contraindication to Lupron Ped or Triptodur

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Prior Authorization Criteria

B. ENDOMETRIOSIS: 1. Documentation of a diagnosis of endometriosis AND 2. Member age ≥ 18 years AND 3. Documentation that endometriosis as a cause of pain AND 4. Documentation that member has failed a 3-month trial of TWO of the following agents within the last year or has a documented intolerance or contraindication to the agent: (a) nonsteroidal anti- inflammatory drug or (b) An oral or depot contraceptive or (c) A progestin AND 5. At the time of request, member is not pregnant AND 6. Dose does not exceed Synarel (nasal spray): 800 micrograms/day AND 7. Lifetime duration does not exceed 6 months total AND 8. Patient has tried and failed or has a contraindication to Lupron Depot

DURATION OF APPROVAL: CPP-Initial authorization: 12 months, Continuation of Therapy: for up to 12 months ENDOMTERIOSIS: Initial authorization: 6 months, total duration of therapy should not exceed 6 months due to decreases in bone mineral density; retreatment is not recommended by the manufacturer

QUANTITY: see required medical information

PRESCRIBER REQUIREMENTS: CPP- Prescribed by or in consultation with a pediatric endocrinologist

ENDOMETRIOSIS: Prescribed by or in consultation with a gynecologist

AGE RESTRICTIONS: see required medical information

GENDER: Male and female

CONTINUATION OF THERAPY: A. CENTRAL PRECOCIOUS PUBERTY(CPP): 1. Documentation that member is responding positively to therapy (e.g., decreased growth velocity, cessation of menses, softening of breast tissue or testes, arrested pubertal progression) AND 2. Member meets the following age requirement: Female: ≤ 11 years; Male: ≤ 12 y ears AND 3. If request is for a dose increase, new dose does not exceed 1800 micrograms/day.

Prior Authorization Criteria

B. ENDOMETRIOSIS: NA

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: Nafarelin is contraindicated in women with undiagnosed abnormal vaginal bleeding; such women should receive adequate diagnostic tests before use of this drug.

OTHER SPECIAL CONSIDERATIONS: None

BACKGROUND: None

APPENDIX: None

REFERENCES:

1. Synarel Prescribing Information. New York, NY: G.D. Searle, LLC. Division of Pfizer, Inc.; June 2017. 2. Committee on Practice Bulletins - Gynecology. Management of endometriosis. July 2010 (reaffirmed 2016); 116(1): 223-236. 3. Kaplowitz P, Bloch C. Evaluation and referral of children with signs of early puberty. Pediatrics. 2016; 137(1): e20153732.