Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Post-menopausal vasomotor symptoms

Treatment: Veozah 45 mg (milligram) tablet for use in the treatment of menopausal and female climacteric states

The insurer denied coverage for Veozah 45 mg (milligram) tablet for use in the treatment of menopausal and female climacteric states

The denial is overturned

The insurer has denied coverage for Veozah 45 mg (milligram) tablet for use in the treatment of menopausal and female climacteric states. In their Final Adverse Determination letter, they write that based on the information they have, the request is denied. They did not receive any documentation that the patient met the criteria. Formulary alternatives are Climara Pro, estradiol patch, estradiol tablet, estradiol norethindrone acetate tablet, estradiol transdermal gel, Jinteli tablet, Menest tablet, Mimvey, norethindrone acetate-ethinyl estradiol tablet, Premarin tablet. The requirement is 3 in a class with 3 or more alternatives, 2 in a class with 2 alternatives, or 1 in a class with only 1 alternative.

The patient is appealing. The patient stated that they have used estradiol, Premarin and Elavil, and estroven but they were not effective.  Only this medication was able to control their hot flashes.  Everything else was never effective.

The patient has a diagnosis of post-menopausal vasomotor symptoms.

For postmenopausal women with moderate to severe vasomotor symptoms (VMS) (and no history of breast cancer or cardiovascular disease nor moderate to high risk of these diseases), low-dose estrogen plus progestin therapy (or estrogen alone if no uterus) is recommended and is standard of care.

For women with moderate to severe hot flashes in whom estrogen is contraindicated, not well tolerated, or for women who have stopped estrogen and are experiencing recurrent symptoms but wish to avoid resuming estrogen, nonhormonal therapies such as selective serotonin reuptake inhibitors (SSRIs), or gabapentin (Grade 2C) are recommended.

VEOZAH is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

In a trial of NK3 receptor antagonists, 80 postmenopausal women with moderate to severe hot flashes were randomly assigned to receive Veozah (90 milligrams (mg) orally twice daily) or placebo for 12 weeks. Results included the following:

In the Veozah group, the mean frequency of moderate/severe vasomotor symptoms (VMS) declined from 80.7 episodes per week (95% confidence interval (CI) 70.6-90.8) at baseline to 5.7 episodes per week at 12 weeks (95% CI 2.4-9.1). This represented a reduction of 93 percent compared with baseline.

In the placebo group, the mean frequency of moderate/severe VMS declined from 72.0 episodes per week (95% CI 63.9-80.1) at baseline to 39.0 episodes per week (95% CI 26.6-51.5). This represented a reduction of 46 percent compared with baseline.

Veozah is a new nonhormonal approach to the management of hot flushes. 

The standard of care is still to use estrogen preparations first. However, based on the submitted information, the patient did not respond to multiple different preparations of estrogen. Therefore, the requested Veozah is indicated for this patient since the patient has reported significant improvement since using it. This improvement was not seen with estrogen preparations.

The formulary drug(s) is unlikely to cause the patient an adverse reaction.

The formulary drug(s) has been ineffective based on the patient's clinical history. According to the provider's note the patient has tried multiple estrogen formulations without helping with their symptoms.

The requested drug appears to be more effective than the formulary drug. While estrogen is very effective in managing vasomotor symptoms it did not work for this patient; however, a trial of Veozah did improve the patient's condition.

The carrier's denial of a request for a Formulary Exception for Veozah 45 mg tablet for use in the treatment of menopausal and female climacteric states is reversed.