基于模型的帕尼单抗联合 FOLFIRI 二线治疗野生型 Ras 转移性结直肠癌的成本效果分析。

Model-Based Cost-Effectiveness Analysis of Panitumumab Plus FOLFIRI for the Second-Line Treatment of Patients with Wild-Type Ras Metastatic Colorectal Cancer.

机构信息

Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.

Department of Pharmacy, Xiangya Hospital Central South University, Changsha, Hunan, China.

出版信息

Adv Ther. 2020 Feb;37(2):847-859. doi: 10.1007/s12325-019-01214-y. Epub 2020 Jan 4.

DOI:10.1007/s12325-019-01214-y

PMID:31902066

Abstract

INTRODUCTION

The NCT00339183 trial demonstrated that adding panitumumab to fluorouracil, leucovorin and irinotecan (FOLFIRI) as a second-line therapy of wild-type RAS metastatic colorectal cancer (mCRC) increases the median progression-free survival (PFS). Nevertheless, panitumumab is not yet approved in China, and the costs and outcomes of the therapy are still unclear. We estimated the cost-effectiveness of this intervention from the perspective of Chinese health care systems by constructing two pricing scenarios for panitumumab. Scenario 1: Pricing is based on the price of a similar product (cetuximab) in China. Scenario 2: We estimated the value-based price.

METHODS

A partitioned survival model was created based on the results of the NCT00339183 trial, which evaluated panitumumab plus FOLFIRI versus FOLFIRI. The model simulated the disease progression. We calculated medical costs from the perspectives of the Chinese health care systems. The primary outcome measures were costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).

RESULTS

In scenario 1, compared with FOLFIRI alone, FOLFIRI with panitumumab arm had an ICER of ¥1,539,988/QALY. The most influential factors were the mean overall survival (OS), utility before progression and cost of panitumumab. The probability of panitumumab plus FOLFIRI being cost-effective in China was 0% when the willingness-to-pay (WTP) threshold was ¥193,932/QALY. In scenario 2, when the cost of panitumumab was assumed to be ¥4032.61 or ¥5218.96 per cycle, the ICERs approximated the WTP thresholds of ¥193,932/QALY or ¥420,633/QALY, respectively. In this value-based pricing scenario, panitumumab plus FOLFIRI is estimated to be cost-effective.

CONCLUSION

We construct two pricing scenarios in China. In scenario 1, panitumumab plus FOLFIRI as a second-line therapy of mCRC provided an incremental benefit, but simultaneously increased costs (at the current price) even further. In scenario 2, when the value-based price was adopted, panitumumab plus FOLFIRI was estimated to be cost-effective. Our study establishes a pricing framework for new anticancer drugs to reflect the economics of drugs.

TRIAL REGISTRATION NUMBER

NCT00339183.

摘要

简介

NCT00339183 试验表明，在野生型 RAS 转移性结直肠癌（mCRC）的二线治疗中添加帕尼单抗联合氟尿嘧啶、亚叶酸钙和伊立替康（FOLFIRI）可延长中位无进展生存期（PFS）。然而，帕尼单抗尚未在中国获得批准，其治疗的费用和结果尚不清楚。我们通过为帕尼单抗构建两种定价方案，从中国医疗保健系统的角度评估了这种干预措施的成本效益。方案 1：定价基于中国类似产品（西妥昔单抗）的价格。方案 2：我们估计基于价值的价格。

方法

根据 NCT00339183 试验的结果，创建了一个分区生存模型，该模型评估了帕尼单抗联合 FOLFIRI 与 FOLFIRI 相比的效果。该模型模拟了疾病进展。我们从中国医疗保健系统的角度计算了医疗成本。主要观察指标为成本、质量调整生命年（QALYs）和增量成本效益比（ICERs）。

结果

在方案 1 中，与单独使用 FOLFIRI 相比，FOLFIRI 联合帕尼单抗组的 ICER 为 1539988 元/QALY。最具影响力的因素是平均总生存期（OS）、进展前效用和帕尼单抗的成本。当支付意愿（WTP）阈值为 193932 元/QALY 时，在中国，FOLFIRI 联合帕尼单抗的概率为 0%。在方案 2 中，当帕尼单抗的成本假设为每周期 4032.61 元或 5218.96 元时，ICER 分别接近 WTP 阈值 193932 元/QALY 或 420633 元/QALY。在这种基于价值的定价方案中，帕尼单抗联合 FOLFIRI 被估计为具有成本效益。

结论

我们在中国构建了两种定价方案。在方案 1 中，帕尼单抗联合 FOLFIRI 作为 mCRC 的二线治疗提供了额外的益处，但同时进一步增加了成本（在当前价格下）。在方案 2 中，采用基于价值的定价时，帕尼单抗联合 FOLFIRI 被估计为具有成本效益。我们的研究为新的抗癌药物建立了一个定价框架，以反映药物的经济学。