Bibliographic Details
| Title: |
Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project |
| Authors: |
Matthias Briel, Lars G Hemkens, Amanda Katherina Herbrand, Andreas Michael Schmitt, Stefan Diem, Hannah Ewald, Anouk Hoogkamer, Markus Joerger, Kimberly Alba Mc Cord, Urban Novak, Sirintip Sricharoenchai, Benjamin Kasenda |
| Source: |
ESMO Open, Vol 4, Iss 6 (2019) |
| Publisher Information: |
Elsevier, 2019. |
| Publication Year: |
2019 |
| Collection: |
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| Subject Terms: |
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| More Details: |
Background Off-label use (OLU) of a drug reflects a perceived unmet medical need, which is common in oncology. Cancer drugs are often highly expensive and their reimbursement is a challenge for many healthcare systems. OLU is frequently regulated by reimbursement restrictions. For evidence-based healthcare, treatment ought to be reimbursed if there is sufficient clinical evidence for treatment benefit independently of patient factors not related to the treatment indication. However, little is known about the reality of OLU reimbursement and its association with the underlying clinical evidence. Here, we aim to investigate the relationship of reimbursement decisions with the underlying clinical evidence.Methods/ design We will extract patient characteristics and details on treatment and reimbursement of cancer drugs from over 3000 patients treated in three Swiss hospitals. We will systematically search for clinical trial evidence on benefits associated with OLU in the most common indications. We will describe the prevalence of OLU in Switzerland and its reimbursement in cancer care, and use multivariable logistic regression techniques to investigate the association of approval/rejection of a reimbursement requests to the evidence on treatment effects and to further factors, including type of drug, molecular predictive markers and the health insurer.Discussion Our study will provide a systematic overview and assessment of OLU and its reimbursement reality in Switzerland. We may provide a better understanding of the access to cancer care that is regulated by health insurers and we hope to identify factors that determine the level of evidence-based cancer care in a highly diverse western healthcare system. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2059-7029 |
| Relation: |
https://esmoopen.bmj.com/content/4/6/e000596.full; https://doaj.org/toc/2059-7029 |
| DOI: |
10.1136/esmoopen-2019-000596 |
| Access URL: |
https://doaj.org/article/365cc5ad7c53403990eeeb7dade1e65b |
| Accession Number: |
edsdoj.365cc5ad7c53403990eeeb7dade1e65b |
| Database: |
Directory of Open Access Journals |
