Veozah – NC Standard

Restricted Product(s)

• VeozahTM (fezolinetant)

FDA Approved Use

• For the treatment of moderate to severe vasomotor symptoms due to menopause

Criteria for Approval of Restricted Product(s)

Initial Coverage Criteria

1. The patient has been diagnosed with moderate to severe vasomotor symptoms due to menopause; AND 
2. The patient has tried and failed at least ONE estrogen therapy; OR 
   1. The patient has a clinical contraindication/intolerance or is not a candidate for ALL estrogen therapies; AND 
3. ONE of the following: 
   1. The patient has tried and failed at least ONE of the following non-hormonal treatment options: 
      1. SSRI/SNRIs (paroxetine, escitalopram, citalopram, venlafaxine) 
      2. GABA analogue (gabapentin (Neurontin®) or pregabalin (Lyrica®)); OR 
   2. The patient has a clinical contraindication/intolerance to ALL of the above treatment options; AND 
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 1 year (365 days)

Continuation Coverage Criteria

1. The patient was approved through Blue Cross NC initial coverage criteria or would have met initial criteria for approval at the time they started therapy; AND 
2. The patient has had clinical benefit (e.g., reduction of 2 or more hot flashes over 24 hours) with the requested agent; AND 
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 1 year (365 days)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 1 year (365 days)

References

All information referenced is from FDA package insert unless otherwise noted below.

Stuenkel CA, Davis SR, Gompel A, Lumsden MA, Murad MH, Pinkerton JV, Santen RJ. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Nov;100(11):3975-4011. doi: 10.1210/jc.2015-2236. Epub 2015 Oct 7. PMID: 26444994.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

May 2023: Original utilization management policy issued.