Elinzanetant (Lynkuet) coverage
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Defines medical necessity and prior authorization criteria for elinzanetant (Lynkuet) for treatment of moderate to severe vasomotor symptoms due to menopause for QualChoice lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria — Elinzanetant (Lynkuet)
Initial Therapy (Vasomotor Symptoms)
Covered when ALL of the following are met:
For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395
Continuation Therapy (Vasomotor Symptoms)
Covered when ALL of the following are met:
Refer to state specific addendums for continuity of care where applicable
Other Indications
Other indications (must meet 1 or 2):
References to specific related policies provided in the policy document
Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for the documentation standards and evidence requirements needed to consider coverage for off‑label uses.
Pregnancy is a contraindication to use of elinzanetant; the drug is listed as contraindicated in pregnant individuals and should not be prescribed or authorized for members who are pregnant.
Use of elinzanetant for non‑FDA approved indications without adequate supporting documentation of efficacy and safety may be considered not medically necessary. Providers requesting coverage for off‑label uses must follow the referenced off‑label use policies and submit the clinical evidence required by those policies to justify medical necessity.
Coding and Dosage Information
Provider Actions and Prior Authorization
Prior authorization requires documentation of meeting all approval criteria
Prior authorization requests must include evidence that the member meets all initial approval criteria: diagnosis of vasomotor symptoms associated with menopause, age ≥ 18 years, documentation of prior estrogen failures or contraindication/intolerance (when applicable), and that the requested dose does not exceed 120 mg (2 capsules) per day.
- Confirm diagnosis: vasomotor symptoms associated with menopause.
- Confirm age: member is ≥ 18 years.
- Document prior therapy: failure of two formulary estrogen products or documentation of contraindication/intolerance.
- Confirm dosing: requested dose ≤ 120 mg/day (2 capsules).
Failure of two formulary estrogens required before approval
Approval for elinzanetant requires prior failure of two formulary estrogen products (excluding contraceptives) unless the member has a documented contraindication or clinically significant adverse effects; note Illinois HIM requests are exempt from step therapy per IL HB 5395 effective 1/1/2026.
- Do not count contraceptives toward the two-formulary-estrogen requirement.
- If contraindication or intolerance to estrogens is documented, step therapy may be bypassed.
- For Illinois HIM requests dated on/after 1/1/2026, the step therapy requirement does not apply per IL HB 5395.
Required clinical documentation must be submitted with PA
Submit supporting clinical documentation with the prior authorization request, such as office chart notes, laboratory results, or other clinical information that demonstrates the member has met all approval criteria.
- Include chart notes documenting diagnosis and symptom response.
- Provide records of prior estrogen therapies and reasons for failure or contraindication.
- Include dosing information to confirm the requested dose does not exceed 120 mg/day.
Non‑FDA indications may be denied without sufficient evidence
Requests for uses that are not FDA‑approved and not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the referenced off‑label use policies.
- If requesting a non‑FDA indication, include evidence of efficacy and safety consistent with off‑label use policies CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), or CP.PMN.53 (Medicaid).
- Absence of adequate supporting documentation may result in denial or designation as not medically necessary.
Background
Elinzanetant is a neurokinin 1 and 3 receptor antagonist approved for treatment of moderate to severe vasomotor symptoms due to menopause. The approved dosing regimen is 120 mg orally once daily, supplied as 60 mg capsules; prior authorization and coverage decisions reference this approval context and dosing limit.
Definitions
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