Veozah — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following: (A) The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR (B) The patient has a diagnosis of vasomotor symptoms AND ALL of the following: (1) The patient is menopausal AND (2) The patient's symptoms are moderate to severe (7 or more episodes per day or 50 or more episodes per week) AND (3) Baseline hepatic function (ALT, AST, serum bilirubin total and direct) has been evaluated AND (4) Hepatic transaminases < 2× ULN and total bilirubin is normal AND (5) ONE of the following: (A) Tried and inadequate response to ≥1 menopausal hormone therapy (ET or EPT including oral, transdermal, sprays, gels, vaginal ring) OR (B) Intolerance or hypersensitivity to ≥1 menopausal hormone therapy OR (C) FDA-labeled contraindication to ALL menopausal hormone therapies OR (D) Patient age > 60 years or onset of menopause ≥ 10 years prior AND (6) ONE of the following: (A) Currently stable on requested agent OR (B) Tried and inadequate response to ≥1 nonhormonal therapy for vasomotor symptoms (paroxetine, escitalopram, citalopram, venlafaxine, desvenlafaxine, duloxetine, gabapentin, oxybutynin) OR (C) Discontinued one such therapy due to lack of efficacy, adverse event, or diminished effect OR (D) Intolerance or hypersensitivity to ≥1 such therapy OR (E) FDA-labeled contraindication to ALL such therapies OR (F) One such therapy expected to be ineffective, unsafe, or create adherence/comorbidity risk OR (G) One such therapy not in best interest based on medical necessity OR (H) Tried another drug in same class/mechanism discontinued due to lack of efficacy/adverse event) OR (C) The patient has another FDA-labeled indication for the requested agent and route of administration AND the patient does NOT have any FDA-labeled contraindications to the requested agent.
• Alternate approval for Ohio residents: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (1) No FDA-labeled contraindications AND (2) ONE of the following: (a) Another FDA-labeled indication for requested agent and route of administration OR (b) Indication supported in compendia (DrugDex level 1–2B, AHFS-DI supportive narrative) OR (c) Prescriber submits TWO peer-reviewed medical journal articles (JAMA, NEJM, Lancet) supporting safe and effective use; acceptable designs include randomized, double-blind, placebo-controlled; case studies not acceptable.

Reauthorization criteria

• The patient was previously approved for the requested agent through the plan’s PA process.
• The patient has had clinical benefit with the requested agent.
• BOTH of the following: (A) Hepatic function (ALT, AST, serum bilirubin total/direct) evaluated since starting therapy AND (B) Hepatic transaminases < 2× ULN and total bilirubin is normal.
• The patient does NOT have any FDA-labeled contraindications to the requested agent.

Approval duration

initial 3 months (BCBSIL 12 months); renewal 12 months