Women with vasomotor symptoms of menopause.
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Pharmaceutical manufacturer Astellas Pharma spent more than $24 million on commercials featuring its menopause treatment drug Veozah during the 2023 NFL season, culminating in a 60-second spot during last night's Super Bowl.
The direct-to-consumer initiative aims to raise awareness about the vasomotor symptoms associated with menopause, such as hot flashes and night sweats. Veozah's sponsors talk about “enabling women to talk openly about their experiences with menopause.”
Last May, the Food and Drug Administration approved a once-daily oral pill to treat moderate to severe VMS in women. Hot flashes are commonly caused by menopause. Up to 80% of women experience it, usually in their 40s, 50s, or 60s. It is described as a sudden, sweaty, warm sensation in the upper body, often felt most strongly in the face, neck, and chest. In clinical trials, the majority of women who took Veozah recorded a 50% or more reduction in the number of hot flashes they experienced each day.
Veozah (fesolinetant) is not the first drug approved by the FDA to treat menopause, but it is qualitatively different from previous options. Veozah is not a hormone. Rather, the product's active ingredient, fezolinetant (selective neukinin-3 inhibitor), works to block chemicals in the brain that affect the regulation of body temperature.
For decades, hormone replacement therapy has been the treatment recommended by experts for the severe symptoms of menopause. Menopausal hormone therapy has long been a mainstay of treatment, but it comes with significant risks, including cancer.
Therefore, providing alternatives can address unmet needs. Despite this, Veozah's sales have been disappointing so far. Menopausal disorder treatment drugs to be released in 2023 have not reached the penetration rate that was initially expected. As a result, Astellas Pharma announced that it has adjusted its sales forecast for fiscal 2023 from the original $375 million to $50 million. Endpoint news.
Demand is hampered by doctors' reluctance to prescribe the drug. This may be related to insurance issues. In a statement released and posted to the media, fierce pharmaceutical companyAstellas Pharma indicated that healthcare providers are facing coverage issues with insurance companies.
Veozah's wholesale acquisition cost or list price is $6,600 per year or $550 per month. Patient assistance programs to assist with insurance coverage and copays are essential. However, both are limited in scope. Astellas provides patient assistance to the uninsured and those with commercial airline insurance, but the program has an annual cap of $1,300. Additionally, such programs are prohibited in the public insurance markets, Medicare and Medicaid.
Astellas expects Veozah to become widely available over time, but that is not a foreseeable conclusion. Additionally, insurance company coverage is not a simple “yes” or “no” decision. Most newly marketed drugs end up on formularies or payers' covered product lists. But what matters most is whether their position on the formula is favorable or unfavorable.
For covered drugs, payers often impose reimbursement restrictions such as high patient cost-sharing, prior authorization protocols, and quantity or duration limits.
Payers are concerned with many factors, including a product's clinical and cost-effectiveness, price per patient, financial burden of (potentially) reimbursing a large portion of the target population, and therapeutic compatibility with other drugs. factors to arrive at coverage and reimbursement decisions. .
In addition to internal reviews, payers look to external agencies, such as the Institute for Clinical and Economic Review, to inform coverage decisions when determining the position of a therapeutic on a formulation. This organization is a drug price watchdog that evaluates the value of treatments from a cost-effectiveness perspective.
ICER conducted a cost-effectiveness analysis comparing fesolinetan to standard-of-care hormone therapy. The findings suggest that fesolinetant may be considered cost-effective at a price of approximately $2,000 per year. However, the $6,600 WAC is quite high, which may influence payer decisions regarding pricing and reimbursement.
Many women experience menopausal hot flashes that are severe enough to impair their quality of life and interfere with normal activities. Additionally, VMS can incur both direct medical costs and indirect economic costs through work absences.
By addressing the root cause of VMS, Veozah may offer a treatment option for menopausal women, especially those who are contraindicated or unwilling to take hormones.
How successful the drug's advertising campaign is will partly determine the demand for the product. In turn, its adoption will depend on the extent to which it can overcome coverage and reimbursement barriers imposed by insurance companies.
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