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Heralded as the first and only treatment thus far to block a source of hot flashes in menopausal women, recently approved Veozah (fezolinetant) faces patient access challenges. The monthly list price of $550 implies that insurance coverage and a patient assistance program will be critical to access..

最近批准的Veozah（fezolinetant）被认为是迄今为止第一个也是唯一一个阻止更年期妇女潮热的治疗方法，面临着患者进入的挑战。每月550美元的标价意味着保险范围和患者援助计划对于访问至关重要。。

The Food and Drug Administration approved the once-daily oral tablet, Veozah, in May as a therapeutic to treat hot flashes and night sweats during menopause. Though Veozah 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.

美国食品和药物管理局于5月批准每日一次的口服片剂Veozah作为治疗更年期潮热和盗汗的治疗剂。虽然Veozah不是FDA批准用于治疗更年期的第一种药物，但它在质量上与之前的药物截然不同。几十年来，激素替代疗法一直是专家推荐的治疗更年期严重症状的治疗方法。

Though it’s long been a mainstay of care, menopausal hormone therapy carries with it serious risks including cancer..

虽然它长期以来一直是护理的中流砥柱，但更年期激素治疗带来包括癌症在内的严重风险。。

Veozah is not a hormonal agent. Rather, the product works to block a chemical in the brain that affects how the body’s temperature is regulated.

Veozah不是荷尔蒙代理人。相反，该产品的作用是阻止大脑中影响体温调节方式的化学物质。

The active ingredient fezolinetant is a selective neurokinin-3 inhibitor. 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..

活性成分fezolinetant是一种选择性神经激肽-3抑制剂。在临床试验中与安慰剂Veozah相比，昼夜潮热的次数和严重程度在统计学上显着降低。这是基于在4周和12周时测量疗效的研究。在试验中，大多数女性每天经历的潮热次数下降了50%或更多。。

Hot flashes are commonly caused by menopause. And as many as 80% of women experience hot flashes, usually when they’re in their 40s, 50s and 60s.

潮热通常是由更年期引起的。多达80%的女性经历潮热，通常是在40多岁，50多岁和60多岁时。

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Veozah could offer relief to women who do not wish to take hormone therapy to treat their symptoms.

Veozah可以缓解不希望接受激素治疗来治疗症状的女性。

The company sponsor of the drug, Astellas, 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..

该药物的公司赞助商Astellas吹捧该产品，作为解决医生称之为更年期血管舒缩症状的根本原因的里程碑。很明显，Astellas正在积极推广Veozah作为突破。您可能已经在电视上看到了直接面向消费者的广告。。

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 a 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..

现在最大的挑战是患者访问。Veozah的批发收购成本或标价为每年6600美元，或每月550美元。虽然Astellas为未投保的人和商业承运人投保的人提供患者帮助，但该计划的年上限为1300美元。此外，公共保险市场，医疗保险和医疗补助计划禁止此类计划。。

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.

进入的进一步障碍包括目前商业市场的覆盖范围有限。如果产品被覆盖，它往往面临障碍，包括严格的事先要求。

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.

现在完全衡量Veozah的付款人报销还为时过早，因为它只在市场上销售了几个月。产品发布与发布到保险公司处方集之间经常存在滞后现象。

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..

Astellas确实期望Veozah随着时间的推移实现广泛的覆盖。但保险公司的承保范围不仅仅是是是或否的二元决定。大多数新上市的药物最终都在处方集上找到了位置。然而，最重要的是它们在处方集上的有利或不利地位。。

Access is a function of the conditions of reimbursement that payers impose, such as levels of patient cost-sharing, use of prior authorization protocols, quantity or duration of therapy limits and indication restrictions. And these conditions depend on a host of factors including a product’s price per patient, financial exposure to insurers if reimbursing for a large portion of the eligible population, therapeutic interchangeability with other drugs and clinical- and cost-effectiveness..

访问是付款人施加的报销条件的函数，例如患者费用分摊水平，使用事先授权协议，治疗限制的数量或持续时间以及适应症限制。这些条件取决于许多因素，包括产品每位患者的价格，如果支付大部分合格人群的财务风险，与其他药物的治疗互换性以及临床和成本效益。。

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.

在确定治疗方案在处方集上的位置时，除了内部审查之外，付款人还将向外部实体寻求通知其承保范围决定。

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.

例如，临床和经济审查研究所是一家药品定价看门狗，从成本效益的角度评估治疗的价值。ICER进行了成本效益分析，比较了fezolinetant与护理标准，激素治疗。

Findings suggest that fezolinetant would be considered cost-effective if priced at around $2,000 annually. The WAC price of $6,600 is substantially higher, which may figure in payers’ decisions on pricing and reimbursement.

调查结果表明，如果每年定价约2000美元，那么fezolinetant将被视为具有成本效益。WAC 6600美元的价格要高得多，这可能会影响付款人对定价和报销的决定。

Notably, ICER’s report described a substantial degree of heterogeneity in terms of benefits across different sub-populations. This suggests variation in the cost-effectiveness of fezolinetant, which depends not only on price but also individual patient profiles and preferences.

值得注意的是，ICER的报告描述了不同亚人群的益处方面的显着程度的异质性。这表明fezolinetant的成本效益存在差异，这不仅取决于价格，还取决于个体患者的个人资料和偏好。

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.

许多女性经历更年期潮热，其严重程度足以损害生活质量或干扰正常活动。此外，由于错过工作，血管舒缩症状可能同时具有直接医疗成本和间接经济成本。

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 contra-indicated for hormone therapy, don’t wish to be exposed to its risks and belong to a patient sub-group that has better than average clinically meaningful benefits on fezolinetant.

因此，未来的分析可以考虑Veozah在患者亚组中的差异有效性。反过来，这可能表明某些女性的成本效益更高：具体而言，那些禁用激素治疗的患者不希望暴露于其风险，并且属于临床上优于平均水平的患者亚组对fezolinetant有意义的好处。

It follows that this stratification of patients could inform how insurers formulate reimbursement policies for Veozah..

因此，这种患者分层可以告知保险公司如何为Veozah制定报销政策。。