Heralded as the first and only treatment thus far to block a source of hot flashes in menopausal women, recently approved Veozah’s monthly list price of $550 implies that insurance coverage and a patient assistance program will be critical to access. But both are limited in scope.
The Food and Drug Administration approved the once-daily oral tablet in May as a therapeutic to treat hot flashes and night sweats during menopause. Though Veozah (fezolinetant) is not the first drug licensed by the FDA to treat menopause, it is qualitatively distinct from what predates it. 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.
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.
In clinical trials versus placebo, Veozah demonstrated a statistically significant reduction in the number and severity of day and night hot flashes. This was based on studies measuring efficacy at four and 12 weeks. In trials, the majority of women recorded a 50% or higher drop in the number of hot flashes they experienced on a daily basis.
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.
Veozah could offer relief to women who do not wish to take hormone therapy to treat their symptoms.
The company sponsor of the drug, Astellas Pharma, touts the product as a milestone in addressing the root cause of what physicians call menopause’s vasomotor symptoms. It’s clear that Astellas is actively marketing Veozah as a breakthrough. You may have seen the direct-to-consumer advertisements on television.
The biggest challenge now is patient access. Veozah has a Wholesale Acquisition Cost or list price of $6,600 a year, or $550 a month. 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.
Further impediments to access include limited coverage at present in the commercial market. If the product is covered, it often faces barriers including strict prior requirements.
It’s too early to fully gauge payer reimbursement of Veozah, as it’s only been on the market for a few months. There often is a lag between a product’s launch and its posting to an insurer’s formulary, which is a list of drugs that it covers.
Astellas does expect Veozah to achieve widespread coverage over time. But 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. However, it’s their favorable or unfavorable position on the formulary that matters most.
When payers impose reimbursement conditions, they consider access issues such as levels of patient cost-sharing, prior authorization protocols, limits on how long a drug can be reimbursed, and restrictions on which patient sub-groups will be eligible for coverage. The latter can include age-related limitations, for example.
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.
The Institute for Clinical and Economic Review, for instance, 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. The Wholesale Acquisition Cost price of $6,600 is substantially higher, which may figure in payers’ decisions on pricing and reimbursement.
Notably, ICER’s report described a substantial degree of heterogeneity in terms of benefits that accrue to different sub-populations, defined by race, ethnicity, body mass index and age, among other characteristics. This suggests possible variation in the cost-effectiveness of fezolinetant, depending on individual patient profiles.
Many women experience menopausal hot flashes that are severe enough to impair quality of life or interfere with normal activities. In addition, vasomotor symptoms can have both direct healthcare costs and indirect economic costs due to missed work.
Future analyses could therefore consider Veozah’s differential effectiveness across patient sub-groups. In turn, this may suggest more favorable cost-effectiveness in certain women: Specifically, those who are contraindicated for hormone therapy, don’t wish to be exposed to its risks or belong to a patient sub-group that has better than average clinically meaningful benefits on fezolinetant. It follows that this stratification of patients could inform how insurers formulate reimbursement policies for Veozah.
Read the full article here