Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Bangkok, Thailand.
Pharmaceutical Division, Department of Health Philippines, Manila, Philippines.
BMC Health Serv Res. 2019 Nov 21;19(1):874. doi: 10.1186/s12913-019-4715-8.
Breast cancer is the leading malignancy among Filipino women, with about 23.50% of cases characterized by human epidermal growth factor receptor-2 (HER2) overexpression. Trastuzumab, in addition to standard chemotherapy, is currently recommended as primary treatment for HER2-positive early-stage breast cancer (EBC) in the adjuvant settings, and has been listed in the Philippine National Formulary (PNF) since 2008, but with no current evidence yet on its value for money, to date. Hence, despite several policy enablers, its accessibility remains to be limited in the Philippines. We performed an economic evaluation to assess the cost-effectiveness and budget impact of adjuvant trastuzumab therapy for HER2-positive EBC in the Philippines, using healthcare system and societal perspectives, in aid of guiding coverage decisions.
A Markov model-based cost-utility and budget impact analyses were conducted to estimate the total costs incurred and outcomes gained in using 1 year of adjuvant trastuzumab added to standard chemotherapy versus standard chemotherapy alone, over a lifetime horizon. We discounted both costs and outcomes at 3.5% per annum. Parameters were estimated using country survival data, systematic review and meta-analysis of the relative treatment effect, local and international cost data, and published utility data. Univariate and probabilistic sensitivity analyses were used to account for parameter uncertainty.
Trastuzumab therapy was dominated with an incremental cost-effectiveness ratio (ICER) at PHP 453,505 per QALY gained from a healthcare system perspective or PHP 458,686 per QALY gained from a societal perspective, with 10% cost-effectiveness probability at the country cost-effectiveness threshold of PHP 120,000 per QALY gained. National implementation will cost an additional amount of PHP 13,909 million in year one alone, plus about PHP 2000 to 3000 million annually for the succeeding fiscal years.
At its current cost, 1 year of adjuvant trastuzumab therapy compared to standard chemotherapy alone for HER2-positive EBC does not represent value for money in the Philippines. Its current cost will have to significantly lower down by one-half to achieve cost-effectiveness.
乳腺癌是菲律宾女性中最常见的恶性肿瘤，约 23.50%的病例存在人表皮生长因子受体-2（HER2）过表达。曲妥珠单抗除了标准化疗外，目前被推荐作为 HER2 阳性早期乳腺癌（EBC）的辅助治疗方法，自 2008 年以来已列入菲律宾国家处方集（PNF），但迄今为止，尚无关于其性价比的证据。因此，尽管有多项政策支持，但曲妥珠单抗在菲律宾的可及性仍然有限。我们进行了一项经济评估，以评估在菲律宾，使用曲妥珠单抗辅助治疗 HER2 阳性 EBC 的成本效益和预算影响，从医疗保健系统和社会角度出发，以帮助指导覆盖范围的决策。
采用基于马尔可夫模型的成本-效用和预算影响分析，从医疗保健系统和社会角度，在终身范围内估计使用 1 年曲妥珠单抗辅助标准化疗与单独使用标准化疗相比，所产生的总成本和获得的结果。我们将成本和结果均以每年 3.5%的速度贴现。使用国家生存数据、相对治疗效果的系统评价和荟萃分析、当地和国际成本数据以及已发表的效用数据来估计参数。使用单变量和概率敏感性分析来考虑参数的不确定性。
从医疗保健系统的角度来看，曲妥珠单抗治疗的增量成本效益比（ICER）为每 QALY 增加 453,505 菲律宾比索，从社会角度来看，每 QALY 增加 458,686 菲律宾比索，在国家成本效益阈值为每 QALY 增加 120,000 菲律宾比索的情况下，具有 10%的成本效益概率。仅在第一年，国家实施将额外增加 139.09 亿菲律宾比索，之后每年将增加 20 亿至 30 亿菲律宾比索。
按照目前的成本，曲妥珠单抗辅助治疗 HER2 阳性 EBC 与单独使用标准化疗相比，在菲律宾并不具有性价比。其当前成本必须降低一半以上才能具有成本效益。
