Budget impact of suzetrigine for the treatment of moderate-to-severe acute pain in Medicaid-insured adults

Opioids are commonly used to treat moderate-to-severe acute pain in the United States (US) but are associated with serious and costly outcomes including opioid use disorder (OUD). Suzetrigine is the first oral nonopioid treatment approved in the US in over 20 years for the treatment of moderate-to-severe acute pain in adults. The objective of this analysis was to estimate the budget impact of adding suzetrigine to a state Medicaid formulary. A budget impact model (BIM) compared scenarios before and after suzetrigine was available from the perspective of a hypothetical Medicaid plan with 1 million (M) members. The population consisted of adults with moderate-to-severe acute pain managed with prescription medication. Inputs included drug costs and medical costs of treating nausea/vomiting adverse events (AEs) and OUD/opioid abuse. The budget impact of suzetrigine was calculated as the difference in total costs and costs per member per month (PMPM) between the scenarios. Assuming between 3 and 10 thousand (k) adults with moderate-to-severe acute pain are treated with suzetrigine in place of prescription opioids in the first two years on formulary, suzetrigine was estimated to increase drug costs by $827k to $2.5 M, which was offset by $3.6 M to $10.8 M in savings from avoided nausea/vomiting AEs and OUD/opioid abuse. The addition of suzetrigine to formulary was estimated to result in a budget impact of −$2.8 M to −$8.3 M over two years, or −$0.11 to −$0.34 PMPM, translating to cost savings of $827 per patient treated with suzetrigine rather than an opioid over two years. While suzetrigine was estimated to increase drug costs, the associated avoidance of common opioid AEs and OUD/opioid abuse was estimated to result in cost savings for a state Medicaid plan in the first two years on formulary. Approximately half of patients with acute pain in the United States (US) receive prescription opioids. Though effective in managing pain, opioids pose tolerability concerns and carry risks of misuse and addiction, which can lead to higher risk of death, negative impact on quality of life, and higher healthcare costs. Suzetrigine is a new oral nonopioid medication approved in the US to treat moderate-to-severe acute pain in adults. This study calculated the financial impact to a hypothetical Medicaid plan’s budget of making suzetrigine available to patients. The calculations included the costs of acute pain medications and the costs of treating health problems associated with those medications, including opioid use disorder (OUD), opioid abuse, and nausea/vomiting. The number of patients expected to use suzetrigine following approval is unknown, so the analysis considered a range of potential utilization over a two-year time period. The budget impact was calculated as the difference in costs before and after suzetrigine was available under a Medicaid plan. The study found that depending on the number of patients using suzetrigine, having suzetrigine available would lead to a budget impact of −$0.11 to −$0.34 per member each month over two years, equal to a cost savings of $827 per patient treated with suzetrigine rather than an opioid in a Medicaid plan. Use of suzetrigine led to a reduction in the number of patients using opioids and a corresponding decrease in the number of patients who experience OUD/opioid abuse or nausea/vomiting. The increased drug costs from using suzetrigine compared to prescription opioids were offset by the cost savings from avoiding these negative health problems.

阿片类药物（Opioids）在美国是治疗中重度急性疼痛的常用药物，但与包括阿片类使用障碍（Opioid Use Disorder, OUD）在内的严重且代价高昂的不良结局密切相关。苏泽替林（Suzetrigine）是美国20余年来首款获批用于成人中重度急性疼痛治疗的口服非阿片类治疗药物。本分析的核心目标为评估将苏泽替林纳入州医疗补助计划（Medicaid）处方集后的预算影响。
本研究采用预算影响模型（Budget Impact Model, BIM），从拥有100万参保成员的假设性医疗补助计划视角，对比了苏泽替林获批前后的两种模拟场景。研究人群为接受处方药物治疗的中重度急性疼痛成人患者。模型输入参数涵盖药物成本，以及治疗恶心/呕吐不良事件（Adverse Events, AEs）、阿片类使用障碍/阿片类滥用的医疗成本。苏泽替林的预算影响通过两种场景下的总成本及每成员每月（Per Member Per Month, PMPM）成本差值计算得出。
假设在苏泽替林纳入处方集的前两年内，有3000至10000名中重度急性疼痛成人患者使用苏泽替林替代处方阿片类药物，估算结果显示，苏泽替林将使药物成本增加82.7万至250万美元，但该增量可通过避免恶心/呕吐不良事件及阿片类使用障碍/阿片类滥用带来的360万至1080万美元成本节约实现抵消。将苏泽替林纳入处方集的预算影响估算为两年内-280万至-830万美元，即每成员每月-0.11至-0.34美元，换算为每接受苏泽替林治疗而非阿片类药物的患者，两年内可实现827美元的成本节约。
尽管估算显示苏泽替林会增加药物成本，但避免常见阿片类不良事件及阿片类使用障碍/阿片类滥用所带来的成本节约，可使纳入苏泽替林的州医疗补助计划在处方集启用前两年获得整体成本节约。美国约有半数急性疼痛患者接受处方阿片类药物治疗。阿片类药物虽可有效缓解疼痛，但存在耐受性问题，且存在误用及成瘾风险，可导致死亡风险升高、生活质量下降及医疗成本增加。苏泽替林是美国获批用于成人中重度急性疼痛治疗的新型口服非阿片类药物。
本研究计算了将苏泽替林纳入假设性医疗补助计划预算后带来的财务影响，计算内容涵盖急性疼痛治疗药物成本，以及治疗相关健康问题的成本，包括阿片类使用障碍、阿片类滥用及恶心/呕吐。获批后预计使用苏泽替林的患者人数尚不明确，因此分析覆盖了两年周期内的一系列潜在使用率场景。预算影响通过医疗补助计划中苏泽替林获批前后的成本差值计算得出。
研究发现，根据使用苏泽替林的患者人数不同，纳入苏泽替林可在两年内实现每成员每月-0.11至-0.34美元的预算影响，相当于医疗补助计划中每接受苏泽替林治疗而非阿片类药物的患者可节约827美元成本。使用苏泽替林可减少阿片类药物使用者人数，并相应减少出现阿片类使用障碍/阿片类滥用或恶心/呕吐的患者人数。与处方阿片类药物相比，使用苏泽替林带来的药物成本增加，可通过避免上述负面健康问题所产生的成本节约实现抵消。