Cigna updated IP0415 (effective 2026-03-15) to define coverage and utilization limits for Synarel (nafarelin acetate) for central precocious puberty and endometriosis. Central precocious puberty coverage requires objective lab confirmation (basal LH ≥0.2 mIU/mL or GnRH stimulation test), onset before age 8 in females or 9 in males, and is approved for 1 year; product-preference rules apply. Endometriosis coverage is for adults ≥18 years for 6 months after failure or contraindication to a contraceptive or progestin (unless prior GnRH agonist/antagonist use), with employer-specific exceptions allowing alternate prior-therapy pathways. Synarel is explicitly not covered for peripheral (GnRH-independent) precocious puberty; employer plans may impose additional step-therapy or product-preference requirements.
March 15, 2026 Revision: Cigna `IP0415` Criteria for Synarel
This revision documents the coverage criteria and utilization limits for Synarel (nafarelin acetate nasal solution) under Cigna’s policy IP0415, effective 2026-03-15. The document reiterates indications, required diagnostic criteria, duration of approval, and product-preference conditions for the two approved uses: central precocious puberty and endometriosis. Employer-specific exceptions to the standard criteria are also included for specified products and prior-therapy requirements.
No explicit line-item “changes from prior version” language is present in the source text. The effective date 2026-03-15 is the only dated element provided; therefore the reader should treat this document as the authoritative criteria set as of that date rather than as a summary of incremental changes.
Approved Indications and Required Clinical Criteria for `Synarel`
The policy defines two medically necessary indications for Synarel: central precocious puberty and endometriosis. For central precocious puberty, coverage is approved for 1 year when ALL conditions A–C are met. Diagnostic confirmation requires either a pubertal basal luteinizing hormone (LH) ≥ 0.2 mIU/mL or a pubertal LH response to a GnRH stimulation test; onset of secondary sexual characteristics must be before age 8 in females or before age 9 in males. Additionally, the product must meet the policy’s preferred product criteria as listed in the internal table.
For endometriosis, coverage is approved for 6 months when ALL conditions A–C are met. The patient must be older than 18 years, and must have tried one of: a contraceptive (examples include combined oral contraceptives or levonorgestrel-releasing IUDs), an oral progestin (e.g., norethindrone), or a depot medroxyprogesterone injection, unless contraindicated. An exception to the trial requirement is noted when the patient has previously used another GnRH agonist (e.g., Lupron Depot) or antagonist (e.g., Orilissa). Preferred product criteria must also be met.
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