■为了评估在现有的pembrolizumab方案中添加toripalimab方案作为治疗选项的预算影响,包括吉西他滨和顺铂,在未经治疗的复发/转移性鼻咽癌(R/MNPC)中,使用已发布的批发获取成本(WAC)和平均销售价格(ASP)。
■预算影响分析比较了在美国符合条件的年度事件R/MNPC人群中的治疗组合“无”与“与”toripalimab方案,三年的时间范围,托里帕利玛/派姆单抗市场拆分60/40(Y1)和80/20(Y2/3),和停药或进展的药物调整。成本投入包括药物,administration,和不良事件(AE)管理。这些模型被复制为假设的100万成员健康计划,其中估计了每个成员每月的成本(PMPM)和每个成员每年的成本(PMPY)。进行了单向(OWSA)和概率敏感性分析(PSA)以及情景分析。
■在“无”场景中,pembrolizumab方案的3年基于WAC的费用总计1,449,695,333美元(治疗费用为1,305,632,448美元,管理AE费用为144,062,885美元).在\“with\”场景中,pembrolizumab的3年总费用下降至380,012,135美元,toripalimab增加885,505,900美元(治疗为779,206,567美元,AE管理为106,299,333美元).年度净节省从2024年的46,526,152美元到2026年的71,194,214美元不等,3年节省了184,177,298美元。100万会员健康计划中的相关净节省在3年内为543,068美元,节省0.045美元的PMPM和0.543美元的PMPY。基于ASP的模型显示了类似的模式,在美国事件人群中,3年净节省了174,235,983美元,在100万会员的健康计划中,节省了0.043美元的PMPM和0.514美元的PMPY。PSA支持基本案例调查结果;OWSA和情景分析揭示了参数变异性如何影响结果。
■与类似的pembrolizumab方案相比,通过在第1年治疗60%的R/MNPC患者,在第2年和第3年治疗80%,可以节省1.74亿美元至1.84亿美元。
Toripalimab,一种靶向PD-1的人单克隆抗体,最近被美国食品和药物管理局(FDA)批准用于转移性或复发性成人的一线治疗,局部晚期鼻咽癌(NPC),联合吉西他滨和顺铂。我们评估了付款人将支付FDA批准的托利帕利单抗加吉西他滨和顺铂方案(托利帕利单抗方案)与非FDA批准的派姆单抗加吉西他滨和顺铂方案(派姆单抗方案)的费用。由于没有此类pembrolizumab方案的试验数据,我们假设它在疗效和安全性方面与托里帕利马单抗方案相当.我们的模型采用了3年的时间范围,并假设第1年的市场份额为60/40,第2年和第3年的市场份额为80/20。它包括两个美国成本投入:批发采购成本(WAC)或进入市场时的“标价”,由于toripalimab在几个季度内没有平均销售价格(ASP),托里帕利玛的价格为80%的派姆单抗ASP。我们对癌症进展或停止治疗的患者进行了调整,以确定完全治疗的患者等同物的数量。我们发现,用toripalimab方案代替pembrolizumab方案治疗1年60%的NPC患者,2年和3年80%的NPC患者产生,对于整个调整后的患者群体,节省的费用从使用ASP时的1.74亿美元到使用WAC时的1.84亿美元不等。
UNASSIGNED: To estimate the budget impact of adding a toripalimab regimen as a treatment option to the existing pembrolizumab regimen, both including gemcitabine and cisplatin, in untreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) using the published wholesale acquisition cost (WAC) and average sales price (ASP).
UNASSIGNED: Budget impact analysis comparing a treatment mix \"without\" versus \"with\" the toripalimab regimen in the US eligible annual incident R/M NPC population, a 3-year time horizon, toripalimab/pembrolizumab market splits of 60/40 (Y1) and 80/20 (Y2/3), and medication adjustments for discontinuation or progression. Cost inputs included drugs, administration, and adverse event (AE) management. The models were replicated for a hypothetical 1-million-member health plan in which costs per-member-per-month (PMPM) and per-member-per-year (PMPY) were estimated. One-way (OWSA) and probabilistic sensitivity analyses (PSA) as well as scenario analyses were performed.
UNASSIGNED: In the \"without\" scenario, the 3-year WAC-based costs for the pembrolizumab regimen total $1,449,695,333 ($1,305,632,448 for treatment and $144,062,885 for managing AEs). In the \"with\" scenario, total 3-year costs for pembrolizumab decline to $380,012,135 with toripalimab adding $885,505,900 ($779,206,567 for treatment and $106,299,333 for AE management). Annual net savings range from $46,526,152 in 2024 to $71,194,214 in 2026, for 3-year savings of $184,177,298. Associated net savings in a 1-million-member health plan are $543,068 over 3 years with savings of $0.045 PMPM and $0.543 PMPY. The ASP-based model shows similar patterns with 3-year net savings of $174,235,983 in the US incident population and savings of $0.043 PMPM and $0.514 PMPY in a 1-million-member health plan. The PSA support base case findings; OWSA and scenario analyses reveal how parameter variability impacts results.
UNASSIGNED: Savings between $174 million and $184 million can be achieved from treating 60% of R/M NPC patients in year 1 and 80% in years 2 and 3 with the toripalimab regimen over a similar pembrolizumab regimen.
Toripalimab, a human monoclonal anti-body that targets PD-1, was recently approved by the US Food and Drug Administration (FDA) for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC), in combination with gemcitabine and cisplatin. We evaluated how much it would cost a payor to cover the FDA-approved toripalimab plus gemcitabine and cisplatin regimen (the toripalimab regimen) to a non-FDA-approved pembrolizumab plus gemcitabine and cisplatin regimen (the pembrolizumab regimen). With no trial data available for such pembrolizumab regimen, we assumed that it would be comparable to the toripalimab regimen in efficacy and safety. Our model adopted a 3-year time horizon and assumed a 60/40 market share split in year 1 and an 80/20 market split in years 2 and 3. It included two US cost inputs: the wholesale acquisition cost (WAC) or “list price” at market entry and, as no average sales price (ASP) will be available for toripalimab for several quarters, a toripalimab price point of 80% of the pembrolizumab ASP. We adjusted for patients whose cancer progressed or who discontinued treatment to determine the number of fully-treated-patient-equivalents. We found that treating 60% of NPC patients in year 1 and 80% in years 2 and 3 with the toripalimab regimen instead of the pembrolizumab regimen generates, for the entire adjusted patient population, savings ranging from $174 million when using ASP to $184 million when using WAC.