Health Services Research (HSR) in oncology in a selected indication: Cancer therapies for lung patients

Support in data evaluation and processing: DexHelpp
Duration: October 2018 – December 2019

Background:
In Austria, not all approved cancer drugs are included in the national hospital benefit catalogue. Currently, only 33 oncological therapies are listed. Decisions on specific oncological treatment schemes are exclusively taken within the regional public hospital cooperation’s. Those regional public hospitals are collecting detailed clinical information (so called “onco-decurs”, clinical histories) about their cancer patients. Many new and cost intense lung cancer treatments have been approved in the last years – only a minority of these therapies have shown a clinical relevant benefit analysed with the Magnitude of Clinical Benefit Scale of the European Society for Medical Oncology (ESMO-MCBS) [1, 2].

Project aim and research question:
The project aims at providing a detailed analysis of all lung cancer patients treated with some of the lung cancer drugs approved in recent years (Nivolumab, Pembrolizumab, Atezolizumab, and Gefitinib etc.). The results of the real-world data-analyses (patient characteristics: age, tumour-stage, additional medication, survival time etc.) will be compared with the information from oncological studies to conclude on the performance of the drugs.

Methods:
Analysis of available information of lung cancer patients:

1. Patient related clinical and intervention data
2. Contrasting the real-world data with the information from approval studies

Time management (Completion year 2):

• Feb–March 2018 Definition data-requirements, -acquisition (1 hospital coop)
• April–Dec 2019: Data-analysis (1 coop)
• Oct–Jan-June 2019: refining and data-acquisition (2–4 further hospitals)
•  Jan–March 2019: Data-analysis (2–4 further hospitals)
• April–Sept 2019: Reporting, Peer-Review

Literature:

[1]    Grössmann, N., et al. (2017) Five years of EMA-approved systemic cancer therapies for solid tumours – a comparison of two thresholds for meaningful clinical benefit. European Journal of Cancer 82C, pp. 66-71. http://www.ejcancer.com/article/S0959-8049(17)30984-X/fulltext

[2]    Wild C., Grössmann, N. (2017): Entscheidungsunterlagen für KAGes „Medizinisches Innovationsboard“ zu low-frequency und high-frequency Tumorentitäten, zugelassenen Medikamenten und ESMO-Einstufungen. unpublished.