4CPS-295 Immunotherapy for cancer therapeutic positioning reports: knowledge, expectations and experiences through a national survey

M. González, J. M. Pozo, E. G. Peña, A. C. Lleti
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Abstract

Background and importance In our country, considerable progress has been made in recent years since the establishment of the clinical therapeutic position reports (TPR) in 2013, but more research is needed about their impact on decision making. Aim and objectives To determine the value of immunotherapy for cancer therapeutic positioning reports (ITc-TPR) in clinical practice. Material and methods A nationwide survey was designed for hospital pharmacists and clinical oncologists of the ITc-TPR, published between May 2013 and March 2020. The main variables collected were: sociodemographics of the hospitals and health professionals, approval criteria and variables related to the acceptance of the ITc-TPR recommendations. Results During the study period, 46 ITc-TPR of 22 active substances were published. 27 health professionals answered the survey, 81.5% hospital pharmacists and 18.5% oncologists, ascribed to 24 hospitals in the national territory. 33.3% of the professionals had participated in the development of some TPR-ITc. In 45.8% of hospitals, incorporation of ITc was decided at the regional level, and in 66.7% of hospitals the drug and therapeutic indication with ITc-TPR published should be re-evaluated by the pharmacy and therapeutics hospital commission. In 50%, the authorised indications were the same as those of the ITc-TPR and 70.8% followed the recommendations of the ITc-TPR. 48.1% of the professionals who responded to the survey believed that ITc-TPR have eliminated barriers for access of patients to ITc, have decreased the variability of clinical care and promoted equity in the national territory. 66.7% believed the incorporation of the drug into clinical practice was faster if there was a published ITc-TPR. The main limitations for patients to access ITc were: not financed by the national health system (55.6%), high cost (37.1%) and the restrictions at the autonomic level (29.6%). The aspects of the ITc-TPR that should be improved were: pharmacoeconomic evaluation (66.7%), conclusions useful for clinical practice (70.4%), a single evaluation at the national level (70.4%) and decisions binding (80.5%). Conclusion and relevance ITc-TPR is a useful and well established tool at the national level for the positioning of a new drug. The results of the survey will allow the development of strategies to improve ITc-TPR. References and/or acknowledgements Acknowledgements: AEMPS, GEDEFO, participants, directors, teachers and tutors of Master Inmunoterapia del Cancer. Conflict of interest No conflict of interest
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4CPS-295免疫疗法对癌症的治疗定位报告:通过全国调查得出的认识、期望和经验
背景与重要性在我国,自2013年建立临床医位报告制度以来,近年来取得了相当大的进展,但其对决策的影响尚待进一步研究。目的和目的探讨免疫治疗在肿瘤治疗定位报告(tc - tpr)中的临床应用价值。材料与方法在2013年5月至2020年3月期间,对ITc-TPR的医院药剂师和临床肿瘤学家进行全国性调查。收集的主要变量是:医院和保健专业人员的社会人口统计数据、批准标准以及与接受技术咨询委员会-技术咨询和方案建议有关的变量。结果研究期间共发表了22种活性物质的46种tc - tpr。27名卫生专业人员回答了调查,其中81.5%是医院药剂师,18.5%是肿瘤学家,来自全国24家医院。33.3%的专业人员参与了一些TPR-ITc的开发。45.8%的医院在区域一级决定纳入ITc, 66.7%的医院公布的ITc- tpr的药物和治疗指征需由药学和治疗学医院委员会重新评估。50%的临床适应症与ITc-TPR相同,70.8%的临床适应症遵循了ITc-TPR的建议。48.1%接受调查的专业人员认为,ITc- tpr消除了患者获得ITc的障碍,减少了临床护理的可变性,促进了国家范围内的公平。66.7%的人认为如果有已公布的tc - tpr,药物进入临床实践的速度会更快。患者获得ITc的主要限制是:没有国家卫生系统资助(55.6%)、费用高(37.1%)和自主层面的限制(29.6%)。ITc-TPR需要改进的方面为:药物经济学评价(66.7%)、结论对临床有用(70.4%)、国家层面的单一评价(70.4%)和决策约束性(80.5%)。在国家一级,ITc-TPR是一种有用且成熟的新药定位工具。调查的结果将有助于制定战略,以改善信息技术- tpr。致谢:AEMPS、GEDEFO、参与者、董事、教师和导师。利益冲突无利益冲突
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