Centers for Medicare & Medicaid Services: Off-Label Use of Colorectal Cancer Drugs Allowed in Select Clinical Trials

2005 ◽  
Vol 1 (1) ◽  
pp. 12-14 ◽  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Cancer Drugs ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan

2020 ◽  
pp. OP.20.00131
Author(s):  
Seiko Bun ◽  
Kan Yonemori ◽  
Hiroko Sunadoi ◽  
Rena Nishigaki ◽  
Emi Noguchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pharmaceutical Products ◽  
National Cancer Center Hospital ◽  
Phase Iii ◽  
Cancer Center ◽  
Off Label Use ◽  
Pharmaceutical Development ◽  
Off Label ◽  
Center Hospital ◽  
Label Use

PURPOSE: In Japan, for pharmaceutical products to be covered by public medical insurance, their efficacy and safety must first be confirmed in clinical trials. To our knowledge, this study is the first investigation into the off-label use of pharmaceutical products at a high-volume cancer treatment center in Japan. The objective of this study is to explore the framework necessary for future pharmaceutical development and regulatory approval in the field of oncology by surveying the frequency of and indications for off-label use of pharmaceutical products at the National Cancer Center Hospital in Tokyo, Japan. MATERIALS AND METHODS: The pharmaceutical products used off-label in daily practice from 2003 to 2015 at the National Cancer Center Hospital were retrospectively examined based on applications that had been submitted to an internal review committee requesting off-label use. RESULTS: A total of 1,390 applications were submitted during the study period. The most frequently used supporting documents were the results of phase II trials, followed by case series and phase III trials. The cancer most frequently treated with off-label drugs was sarcoma (15.1%), followed by urologic cancer (9.2%) and GI cancer (7.6%). CONCLUSION: As reported in previous studies, pharmaceutical products were generally used off-label for the treatment of rare cancers, for which large-scale clinical trials are difficult to conduct. Continued discussion of the types of frameworks that are needed to guide pharmaceutical development is necessary.

State mandated insurance benefits and off-label use of cancer drugs.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. 6536-6536
Author(s):  
Fabrice Smieliauskas ◽  
Hari Sharma ◽  
Jonas A. De Souza ◽  
Ya-Chen T. Shih
Keyword(s):  
Cancer Drugs ◽  
Off Label Use ◽  
Insurance Benefits ◽  
Off Label ◽  
Label Use

Off-Label Use of Cancer Drugs: A Benchmark Is Established

2013 ◽  
Vol 31 (9) ◽  
pp. 1125-1127 ◽  
Author(s):  
Monika K. Krzyzanowska
Keyword(s):  
Cancer Drugs ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Contrasting evidence to reimbursement reality for off-label use (OLU) of drug treatments in cancer care: rationale and design of the CEIT-OLU project

ESMO Open ◽  
2019 ◽  
Vol 4 (6) ◽  
pp. e000596
Author(s):  
Amanda Katherina Herbrand ◽  
Andreas Michael Schmitt ◽  
Matthias Briel ◽  
Stefan Diem ◽  
Hannah Ewald ◽  
...  
Keyword(s):  
Cancer Care ◽  
Clinical Evidence ◽  
Patient Characteristics ◽  
Evidence Based ◽  
Cancer Drugs ◽  
Off Label Use ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Off Label ◽  
Label Use

BackgroundOff-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/ designWe 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.DiscussionOur 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.

Chapter 6 - Clinical trials and off-label use of drugs

2016 ◽  
Vol 17 (3-4) ◽  
pp. 409-430
Author(s):  
Giovanni Maria Cavo
Keyword(s):  
Clinical Trials ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Quantifying the increasing use of anti-vascular endothelial growth factor therapy in ophthalmology

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Jonathan Micieli ◽  
Andrew Micieli
Keyword(s):  
Clinical Trials ◽  
Growth Factor ◽  
Case Reports ◽  
Retinal Pigment ◽  
Phase Iii ◽  
Off Label Use ◽  
Off Label ◽  
Phase Iii Clinical Trials ◽  
Age Related ◽  
Label Use

Introduction: Bevacizumab (Avastin; genetech Inc., South San fran- cisco, CA) and ranibizumab (Lucentis, genetech Inc.) are two anti-Vascular Endo- thelial growth factor (VEgf) agents used in increasing amounts off-label to treat  ocular conditions. To date, no study has quantifed how far reaching these therapies have been in treating eye disease and compared their off-label use to the number of clinical trials performed. Method: A systematic search of Ovid MEdLINE using the keywords bevacizumab and ranibizumab limited to “Case Reports” was used as an index of the number of diseases treated. Each keyword was also limited to “Clinical Trials, All” and “Phase III Clinical Trials” to discern the quality of evidence for these uses.Results: Bevacizumab has been utilized for the treatment of 58 different ocular conditions, but only 14 conditions were studied in a trial, and none were part of a phase III clinical trial. Ranibizumab has been used for 17 different eye conditions,  with only 6 studied in a trial and only 1 disease, “wet” age-related macular degenera- tion reported in 4 phase III trials. In the case reports, there were 21 different adverse  events ascribed to bevacizumab and 2 to ranibizumab with retinal pigment epithelial tears being the most common. Conclusion: Bevacizumab is one of the most far reaching drugs in ophthalmology and even medicine, but it is not yet supported by high quality evidence. The much higher cost of ranibizumab may be responsible for bevacizumab’s popularity among eye specialists. Patients should be fully informed about the off-label use of bevacizumab and the associated risks with its use.

scholarly journals Association of Supporting Trial Evidence and Reimbursement for Off-Label Use of Cancer Drugs

2021 ◽  
Vol 4 (3) ◽  
pp. e210380
Author(s):  
Amanda Katherina Herbrand ◽  
Andreas M. Schmitt ◽  
Matthias Briel ◽  
Hannah Ewald ◽  
Marius Goldkuhle ◽  
...  
Keyword(s):  
Cancer Drugs ◽  
Off Label Use ◽  
Off Label ◽  
Trial Evidence ◽  
Label Use
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