Annemans Lieven, Caekelbergh Karin, Roelandts Rik, Boonen Hugo, Leys Christoph, Nikkels Arjen F, van Den Haute V, van Quickenborne L, Verhaeghe Evelien, Leroy Bernard
Faculty of Medicine, University of Ghent, De Pintelaan 185, Ghent, Belgium.
Eur J Dermatol. 2008 Sep-Oct;18(5):539-46. doi: 10.1684/ejd.2008.0469. Epub 2008 Aug 8.
Clinical trials have shown that photodynamic therapy using methyl aminolevulinate (MAL-PDT) is an effective treatment for actinic keratosis (AK), and nodular and superficial basal cell carcinoma (nBCC and sBCC) unsuitable for other available therapies. Economic evaluation models have shown that it is a cost effective intervention as well. The objectives of this prospective, observational, one arm study were (i) to verify in a real-life practice study the results obtained in previous clinical trials with MAL-PDT in the treatment of AK, nBCC and sBCC; (ii) to calculate the real-life cost of treatment and validate predictions from an economic evaluation model. Patients with AK and/or BCC were selected according to Belgian reimbursement criteria for treatment with MAL-PDT. Clinical response, cosmetic outcome and tolerability were assessed. MAL-PDT cost was calculated and compared to published model cost data. Data were collected from 247 patients (117 AK, 130 BCC). A complete clinical response was obtained for 83% of AK (85/102) and BCC (97/116) patients. A good or excellent cosmetic outcome was obtained for 95% of AK patients and 93% of BCC patients. Tolerability was good: only 2 patients withdrew for adverse events. Clinical results were similar to previous studies. Total cost of care per patient was euro 381 for AK, euro 318 for nBCC, and euro 298 for sBCC. Total cost per lesion was euro 58 for AK (identical to model prediction), euro 316 for nBCC and euro 178 for sBCC (both within 20% of model prediction). The clinical results of MAL-PDT in this real-life practice study confirm those demonstrated in previous clinical trials. Costs calculated from this study confirm predicted cost-effectiveness in the original model for MAL-PDT in the management of AK and BCC.
临床试验表明，使用甲基氨基酮戊酸的光动力疗法（MAL-PDT）是治疗光化性角化病（AK）以及不适用于其他现有疗法的结节性和浅表性基底细胞癌（nBCC和sBCC）的有效方法。经济评估模型表明，它也是一种具有成本效益的干预措施。这项前瞻性、观察性、单臂研究的目的是：（i）在一项实际应用研究中验证先前使用MAL-PDT治疗AK、nBCC和sBCC的临床试验结果；（ii）计算实际治疗成本并验证经济评估模型的预测。根据比利时MAL-PDT治疗报销标准选择AK和/或BCC患者。评估临床反应、美容效果和耐受性。计算MAL-PDT成本并与已发表的模型成本数据进行比较。收集了247例患者的数据（117例AK，130例BCC）。83%的AK（85/102）和BCC（97/116）患者获得了完全临床缓解。95%的AK患者和93%的BCC患者获得了良好或极佳的美容效果。耐受性良好：只有2例患者因不良事件退出。临床结果与先前研究相似。AK患者的人均护理总成本为381欧元，nBCC患者为318欧元，sBCC患者为298欧元。每个病变的总成本，AK为58欧元（与模型预测相同），nBCC为316欧元，sBCC为178欧元（均在模型预测的20%以内）。这项实际应用研究中MAL-PDT的临床结果证实了先前临床试验中所证明的结果。本研究计算的成本证实了原始模型中MAL-PDT治疗AK和BCC的预测成本效益。
