Woman having vasomotor symptoms of menopause.
Drug maker Astellas spent more than $24 million on commercials featuring the menopausal drug Veozah during the 2023 NFL season, culminating in a 60-second spot last night during the Super Bowl.
Direct-to-consumer marketing efforts have been aimed at raising awareness about vasomotor symptoms, which comprise hot flashes and night sweats associated with menopause. The sponsor of Veozah speaks of “empowering women to talk openly about their menopause experiences.”
The Food and Drug Administration approved the once-daily oral tablet last May as a therapeutic to address women’s moderate to severe VMS. Hot flashes are commonly caused by menopause. As many as 80% of women experience them, usually when they’re in their 40s, 50s and 60s. They’re described as sudden feelings of warmth in the upper body to the point of perspiration, often most intense over the face, neck and chest. In clinical trials, the majority of women taking Veozah recorded a 50% or higher drop in the number of hot flashes they experienced on a daily basis.
Though Veozah (fezolinetant) is not the first drug licensed by the FDA to treat menopause, it is qualitatively distinct from the options which predate it. Veozah is not a hormonal agent. Rather, the product’s active ingredient, fezolinetant, a selective neuokinin-3 inhibitor, works to block a chemical in the brain that affects how the body’s temperature is regulated.
For decades, hormone replacement therapy has been the treatment recommended by experts for severe symptoms from menopause. Though it’s long been a mainstay of care, menopausal hormone therapy carries with it serious risks including cancer.
And so, offering an alternative addresses an unmet need. Nonetheless, Veozah sales have thus far disappointed. The launch of the menopausal drug in 2023 isn’t achieving the uptake that was initially expected. Accordingly, Astellas adjusted its fiscal-year sales projection for 2023 to $50 million instead of the original figure of $375 million, according to Endpoints News.
Demand has been hampered by the hesitance of doctors to prescribe the medicine. This may be related to insurance issues. In statements released to the media and posted by Fierce Pharma, Astellas hinted at healthcare providers encountering coverage problems with insurers.
Veozah has a Wholesale Acquisition Cost or list price of $6,600 a year, or $550 a month. Insurance coverage and a patient assistance program to help with co-payments are critical to access. But both are limited in scope. While Astellas offers patient assistance for uninsured and those insured by commercial carriers, the program has an annual cap of $1,300. Moreover, such programs are prohibited in the public insurance markets, Medicare and Medicaid.
Astellas expects Veozah to achieve widespread coverage over time, but that’s not a foregone conclusion. Moreover, insurer coverage isn’t merely a binary decision of yes or no. The majority of newly marketed drugs eventually find a place on the formulary or list of products covered by payers. However, it’s their favorable or unfavorable position on the formulary that matters most.
For a covered drug, payers often impose reimbursement restrictions, such as high levels of patient cost-sharing, prior authorization protocols and quantity or duration limits.
Payers arrive at coverage and reimbursement decisions by evaluating a host of factors, including a product’s clinical- and cost-effectiveness, its price per patient, financial exposure if (potentially) reimbursing for a large portion of the eligible population and therapeutic interchangeability with other drugs.
When determining a therapeutic’s positioning on formulary, in addition to an internal review, payers will look to external entities to inform their coverage decisions: For instance, the Institute for Clinical and Economic Review. This entity is a drug pricing watchdog that assesses the value of treatments from a cost-effectiveness perspective.
ICER conducted a cost-effectiveness analysis comparing fezolinetant to the standard of care, hormone therapy. Findings suggest that fezolinetant would be considered cost-effective if priced at around $2,000 annually. But the WAC of $6,600 is substantially higher, which may figure in payers’ decisions on pricing and reimbursement.
Many women experience menopausal hot flashes that are severe enough to impair quality of life or interfere with normal activities. In addition, VMS can have both direct healthcare costs and indirect economic costs due to missed work.
By addressing the root cause of VMS, Veozah may provide a treatment option to menopausal women, in particular, those who are contra-indicated for or do not wish to take hormonal medications.
How successful the drug’s ad campaign is will determine to some extent demand for the product. In turn, its uptake will depend on how the degree to which the coverage and reimbursement barriers imposed by insurers can be overcome.
