WHA
 

Non-hormonal Therapies for Vasomotor Symptoms

Indications for Prior Authorization

Lynkuet (elinzanetant), Veozah (fezolinetant)
  • For diagnosis of Moderate to severe vasomotor symptoms (VMS)
    Indicated for the treatment of moderate to severe VMS due to menopause.

Criteria

Lynkuet, Veozah

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

  • Diagnosis of moderate to severe vasomotor symptoms (VMS) due to menopause [A]
    • AND
  • Trial and failure, contraindication, or intolerance to one of the following: [3-5, 9]
    • Menopausal hormone therapy (e.g., Premarin, Bijuva, etc.)
    • Non-hormonal therapy with a different mechanism of action (e.g., paroxetine, venlafaxine, clonidine, gabapentin, etc.)
    AND
  • Prescriber attests that baseline serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST) and total bilirubin levels are less than 2 times the upper limit of normal (ULN) prior to initiating requested drug [B, C]
Lynkuet

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

  • Patient demonstrates positive clinical response to therapy (e.g., decrease in frequency and severity of vasomotor symptoms from baseline, etc.)
    • AND
  • One of the following:
    • If patient has been on therapy for less than 3 months, provider attests to one of the following within the past 3 months: [B]
      • For patients with total bilirubin levels less than or equal to 2 times the ULN, transaminase elevations do not exceed 5 times the ULN
      • For patients with total bilirubin levels greater than 2 times the ULN, transaminase elevations do not exceed 3 times the ULN
      OR
    • If patient has been on therapy for greater than or equal to 3 months, provider attests to both of the following:
      • No hepatic issues arose during the first 3 months of therapy
      • Patient does not currently have any hepatic related issues (e.g., signs or symptoms of hepatic strain)
Veozah

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

  • Patient demonstrates positive clinical response to therapy (e.g., decrease in frequency and severity of vasomotor symptoms from baseline, etc.)
    • AND
  • One of the following:
    • If patient has been on therapy for less than 9 months, provider attests to one of the following within the past 3 months: [C]
      • For patients with total bilirubin levels less than or equal to 2 times the ULN, transaminase elevations do not exceed 5 times the ULN
      • For patients with total bilirubin levels greater than 2 times the ULN, transaminase elevations do not exceed 3 times the ULN
      OR
    • If patient has been on therapy for greater than or equal to 9 months, provider attests to both of the following:
      • No hepatic issues arose during the first 9 months of therapy
      • Patient does not currently have any hepatic related issues (e.g., signs or symptoms of hepatic strain)

  • Guideline ID
    GL-632190

  • Formulary
    Premium

  • Effective date
    Sep 1, 2026

  • P&T approval date
    Jul 19, 2023

P & T Revisions

2026-07-06, 2025-12-17, 2025-07-15, 2024-10-21, 2024-10-16, 2024-05-30, 2023-10-16, 2023-07-11

  1. Veozah Prescribing Information. Astellas Pharma US, Inc. Northbrook, IL. February 2026.
  2. Lynkuet Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. October 2025.
  3. ACOG Practice Bulletin No. 141: management of menopausal symptoms. Obstet Gynecol. 2014 Jan [reaffirmed 2024];123(1):202-216.
  4. Stuenkel CA, Davis SR, Gompel A, et al. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Nov;100(11):3975-4011.
  5. Casper RF, Barbieri RL, Mulder JE. Menopausal hot flashes. Wolters Kluwer. Updated January 6, 2026 [current through May 2026]. Accessed June 17, 2026. Available from: https://www.uptodate.com.
  6. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024;332(16):1343–1354.
  7. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. Published online September 08, 2025.
  8. Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: A phase 3 RCT. J Clin Endocrinol Metab. 2023; 108(8):1981-1997.
  9. The 2022 Hormone Therapy Position Statement of The North American Menopause Society” Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022; 29(7):767-794.
  1. In pivotal studies, VMS severity was defined based on the 2003 US Food and Drug Administration Guidance for Industry, where moderate is defined as a “sensation of heat with sweating, able to continue activity” and severe is defined as “a sensation of heat with sweating, causing cessation of activity”. [6-8]
  2. Lynkuet is not recommended for use in patients with moderate (i.e., Child-Pugh Class B) to severe (i.e., Child-Pugh Class C) hepatic impairment. Moderate hepatic impairment increased Lynkuet exposure. Lynkuet was not studied in individuals with severe hepatic impairment. Across the pivotal studies, there were elevations in serum transaminase (ALT/AST) concentrations equal to or greater than 3x upper limit of normal occurred in 0.6% of patients receiving Lynkuet and 0.4% of patients receiving placebo (not statistically significant). [2, 6, 7]
  3. Veozah carries a boxed warning for hepatotoxicity risk due to significant cases of hepatotoxicity and jaundice reported in the postmarketing setting. Child-Pugh Class A or B impairment increased Veozah exposure across pivotal studies. Veozah was not studied in individuals with Child-Pugh Class C hepatic impairment and is contraindicated in patients with cirrhosis. [1]
  • 2026-07-06: Revised reauthorization safety criterion to include bypass of required lab values if members have been on Lynkuet for more than 3 months or Veozah for more than 9 months, in line with FDA label warning recommendations. Annual Review 2026 - Removed Estrogel as example of menopausal hormone therapy trial requirement. Background updates
  • 2025-12-17: Addition of Lynkuet to guideline. Updated guideline name. Updated reauth to decrease redundancy of safety criterion. Addition of operational note for state mandated plans where ST is not applicable.
  • 2025-07-15: Annual review 2025. No criteria changes
  • 2024-10-21: Updates to criteria based on new FDA safety communication for hepatotoxicity
  • 2024-10-16: Updates to criteria based on new FDA safety communication for hepatotoxicity
  • 2024-05-30: 2024 annual review. Updated reauth language to standard verbiage. No changes to clinical intent.
  • 2023-10-16: Updated trial requirements
  • 2023-07-11: New Program