Is Veozah (fezolinetant) medically necessary for a patient with menopausal symptoms (N95.1) and a history of estrogen receptor positive breast cancer, who is contraindicated to hormone therapy?

Medical Necessity Determination for Veozah (Fezolinetant)

Yes, Veozah (fezolinetant) is medically necessary for this patient with estrogen receptor-positive breast cancer experiencing severe menopausal symptoms, as hormone therapy is absolutely contraindicated and non-hormonal pharmacologic treatment is the appropriate first-line approach for cancer survivors with vasomotor symptoms.

Absolute Contraindication to Hormone Therapy

The patient's clinical scenario represents a textbook contraindication to estrogen-based therapy:

• History of hormone-dependent cancer is an absolute contraindication to menopausal hormone therapy (MHT), as explicitly stated by NCCN guidelines 1
• Estrogen-based medications are contraindicated in patients with estrogen receptor-positive breast cancer due to risk of cancer recurrence 1
• The patient is currently on estrogen blockers (aromatase inhibitors or tamoxifen), which further precludes any estrogen-based therapy 1, 2

Non-Hormonal Treatment as Standard of Care

For breast cancer survivors with menopausal symptoms, the treatment algorithm is clear:

• NCCN guidelines explicitly prefer non-hormonal pharmacologic treatments as first-line therapy for cancer survivors with menopausal symptoms disruptive to quality of life 1
• Non-hormonal pharmacologic categories include antidepressants, anticonvulsants, neuronal inhibitors, and certain antihypertensives 1
• Fezolinetant, as a neurokinin 3 receptor antagonist, falls within the category of neuronal inhibitors recommended by NCCN 3

Fezolinetant's Specific Role and FDA Approval

Fezolinetant represents a significant advancement in non-hormonal treatment:

• FDA approved fezolinetant specifically for treatment of moderate to severe vasomotor symptoms due to menopause 4
• The mechanism of action—blocking neurokinin 3 receptors in the hypothalamic thermoregulatory center—addresses the underlying pathophysiology of hot flashes without hormonal effects 5, 6, 3
• Clinical trials (Skylight 2 and 4) demonstrated statistical efficacy and acceptable safety profile for vasomotor symptoms 5
• Fezolinetant provides a critical option for women unable to use hormonal therapies, particularly those with estrogen-sensitive cancers 3

Quality of Life Impact Justifies Treatment

The patient's symptom burden meets the threshold for intervention:

• Severe hot flashes, chronic joint pain, and insomnia directly related to hot flashes significantly impact quality of life and daily functioning
• NCCN guidelines state that survivors with menopausal symptoms disruptive to their quality of life should be assessed and treated 1
• The patient has already demonstrated clinical response to Veozah with good effect and no adverse reactions over several months of use

Safety Monitoring Requirements

While approving coverage, ensure appropriate hepatic monitoring per FDA requirements:

• Baseline hepatic laboratory tests (ALT, AST, ALP, total and direct bilirubin) must be performed before initiating treatment 4
• Do not start if ALT or AST ≥ 2 x ULN or total bilirubin ≥ 2 x ULN 4
• Monthly hepatic laboratory monitoring for first 3 months, then at 6 and 9 months 4
• Hepatotoxicity has occurred in postmarketing surveillance, with cases of drug-induced liver injury within 40 days of starting treatment 4
• Patients must be counseled to discontinue immediately if signs of liver injury develop (fatigue, nausea, jaundice, dark urine, abdominal pain) 4

Contraindications to Verify

Confirm the patient does not have:

• Known cirrhosis 4
• Severe renal impairment or end-stage renal disease 4
• Concomitant use with CYP1A2 inhibitors 4

Alternative Options Are Inadequate

Other non-hormonal options have significant limitations for this patient:

• SSRIs/SNRIs, gabapentin, and clonidine are less effective than fezolinetant and may have more side effects 3
• The patient has already failed to achieve adequate symptom control with standard approaches (implied by the need for Veozah)
• The patient has demonstrated clinical response to Veozah, establishing it as the most effective option for her specific case

Billing and Coverage Justification

The use of J3490 (unclassified drug code) is appropriate:

• Fezolinetant is FDA-approved but may not yet have a specific J-code assigned
• Diagnosis code N95.1 (menopausal and female climacteric states) is accurate and appropriate 4
• Medical necessity is established by: (1) absolute contraindication to standard hormone therapy, (2) severe symptoms impacting quality of life, (3) documented clinical response, and (4) alignment with NCCN guidelines for non-hormonal treatment in cancer survivors

The request should be approved based on the absolute contraindication to hormone therapy, guideline-supported use of non-hormonal pharmacologic treatment in breast cancer survivors, FDA approval for this indication, documented clinical efficacy in this patient, and significant quality of life impact.