Lynkuet®

Drug - Lynkuet® (elinzanetant) [Bayer HealthCare Pharmaceuticals, Inc.]

August 2026

Therapeutic Area - Estrogen Agents; Oral/Transdermal

Initial approval criteria

Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
Patient is menopausal; AND
Diagnosis of vasomotor symptoms (VMS); AND
Patient’s symptoms are moderate to severe (e.g., ≥ 7episodes per day or ≥ 50 episodes per week); AND
BOTH of the following:
- Baseline hepatic function (e.g., serum alanine aminotransferase [ALT], serum aspartate aminotransferase [AST], serum alkaline phosphatase [ALP], serum bilirubin [total and direct]) has been evaluated; AND
- Hepatic transaminases AND total bilirubin are < 2 times the upper limit of normal (ULN); AND
Patient of reproductive potential must have a confirmed negative pregnancy test before initiation of Lynkuet and must use effective contraception during treatment and for 2 weeks after discontinuation of therapy; AND
Prescriber has reviewed Lynkuet Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate
Initial approval is for 3 months

Patient must continue to meet above criteria; AND
Patient must demonstrate clinical benefit with Lynkuet treatment (e.g., reduction in frequency and/or severity of VMS); AND
Patient has not experienced any treatment-restricting adverse effects (e.g., signs or symptoms of liver injury [e.g., new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, abdominal pain]); AND
ALL of the following:
- Hepatic function (e.g., serum ALT, serum AST, serum ALP, serum bilirubin [total and direct]) has been evaluated since starting therapy; AND
- Hepatic transaminases are < 5 times ULN; AND
- Hepatic transaminase elevations are < 3 times ULN AND total bilirubin level is < 2 times ULN.
Renewal approval is for 12 months

Provider Call Center: (844) 575-7887