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

2019 ◽  
Author(s):  
AK Herbrand ◽  
AM Schmitt ◽  
M Briel ◽  
S Diem ◽  
H Ewald ◽  
...  
Keyword(s):  
Health Care ◽  
Cancer Care ◽  
Clinical Evidence ◽  
Health Care Systems ◽  
Patient Characteristics ◽  
Evidence Based ◽  
Cancer Drugs ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Off Label

AbstractBackgroundOff-label drug use (OLU) 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 health care systems. OLU is frequently regulated by reimbursement restrictions. For evidence-based health care, 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 extract patient characteristics and details on treatment and reimbursement of cancer drugs from over 3000 patients treated in three Swiss hospitals. We 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 health care system.

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.

scholarly journals Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study

2021 ◽  
Vol 6 (1) ◽  
pp. 238146832097840
Author(s):  
Brett Hauber ◽  
Brennan Mange ◽  
Mo Zhou ◽  
Shomesh Chaudhuri ◽  
Heather L. Benz ◽  
...  
Keyword(s):  
Trial Design ◽  
Patient Characteristics ◽  
Risk Tolerance ◽  
Level Of Evidence ◽  
Treatment Benefit ◽  
Study Results ◽  
Potential Benefits ◽  
Risk Thresholds ◽  
Time Motor ◽  
Threshold Technique

Background. Parkinson’s disease (PD) is neurodegenerative, causing motor, cognitive, psychological, somatic, and autonomic symptoms. Understanding PD patients’ preferences for novel neurostimulation devices may help ensure that devices are delivered in a timely manner with the appropriate level of evidence. Our objective was to elicit preferences and willingness-to-wait for novel neurostimulation devices among PD patients to inform a model of optimal trial design. Methods. We developed and administered a survey to PD patients to quantify the maximum levels of risks that patients would accept to achieve potential benefits of a neurostimulation device. Threshold technique was used to quantify patients’ risk thresholds for new or worsening depression or anxiety, brain bleed, or death in exchange for improvements in “on-time,” motor symptoms, pain, cognition, and pill burden. The survey elicited patients’ willingness to wait to receive treatment benefit. Patients were recruited through Fox Insight, an online PD observational study. Results. A total of 2740 patients were included and a majority were White (94.6%) and had a 4-year college degree (69.8%). Risk thresholds increased as benefits increased. Threshold for depression or anxiety was substantially higher than threshold for brain bleed or death. Patient age, ambulation, and prior neurostimulation experience influenced risk tolerance. Patients were willing to wait an average of 4 to 13 years for devices that provide different levels of benefit. Conclusions. PD patients are willing to accept substantial risks to improve symptoms. Preferences are heterogeneous and depend on treatment benefit and patient characteristics. The results of this study may be useful in informing review of device applications and other regulatory decisions and will be input into a model of optimal trial design for neurostimulation devices.

Continental Divide? The Attitudes of US and Canadian Oncologists on the Costs, Cost-Effectiveness, and Health Policies Associated With New Cancer Drugs

2010 ◽  
Vol 28 (27) ◽  
pp. 4149-4153 ◽  
Author(s):  
Scott R. Berry ◽  
Chaim M. Bell ◽  
Peter A. Ubel ◽  
William K. Evans ◽  
Eric Nadler ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Cost Effectiveness ◽  
Health Care Systems ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Care Systems ◽  
Effective Treatments

Purpose Oncologists in the United States and Canada work in different health care systems, but physicians in both countries face challenges posed by the rising costs of cancer drugs. We compared their attitudes regarding the costs and cost-effectiveness of medications and related health policy. Methods Survey responses of a random sample of 1,355 United States and 238 Canadian medical oncologists (all outside of Québec) were compared. Results Response rate was 59%. More US oncologists (67% v 52%; P < .001) favor access to effective treatments regardless of cost, while more Canadians favor access to effective treatments only if they are cost-effective (75% v 58%; P < .001). Most (84% US, 80% Canadian) oncologists state that patient out-of-pocket costs influence their treatment recommendations, but less than half the respondents always or frequently discuss the costs of treatments with their patients. The majority of oncologists favor more use of cost-effectiveness data in coverage decisions (80% US, 69% Canadian; P = .004), but fewer than half the oncologists in both countries feel well equipped to use cost-effectiveness information. Majorities of oncologists favor government price controls (57% US, 68% Canadian; P = .01), but less than half favor more cost-sharing by patients (29% US, 41% Canadian; P = .004). Oncologists in both countries prefer to have physicians and nonprofit agencies determine whether drugs provide good value. Conclusion Oncologists in the United States and Canada generally have similar attitudes regarding cancer drug costs, cost-effectiveness, and associated policies, despite practicing in different health care systems. The results support providing education to help oncologists in both countries use cost-effectiveness information and discuss drug costs with their patients.

scholarly journals An Evaluation of the Five Most Used Evidence Based Bedside Information Tools in Canadian Health Libraries

2008 ◽  
Vol 3 (2) ◽  
pp. 3 ◽  
Author(s):  
Alison Farrell
Keyword(s):  
Electronic Mail ◽  
Clinical Evidence ◽  
Resource Assessment ◽  
Ease Of Use ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Levels Of Evidence ◽  
Information Tools ◽  
Canadian Health ◽  
Clinical Questions

Objective – This project sought to identify the five most used evidence based bedside information tools used in Canadian health libraries, to examine librarians’ attitudes towards these tools, and to test the comprehensiveness of the tools. Methods – The author developed a definition of evidence based bedside information tools and a list of resources that fit this definition. Participants were respondents to a survey distributed via the CANMEDLIB electronic mail list. The survey sought to identify information from library staff regarding the most frequently used evidence based bedside information tools. Clinical questions were used to measure the comprehensiveness of each resource and the levels of evidence they provided to each question. Results – Survey respondents reported that the five most used evidence based bedside information tools in their libraries were UpToDate, BMJ Clinical Evidence, First Consult, Bandolier and ACP Pier. Librarians were generally satisfied with the ease of use, efficiency and informative nature of these resources. The resource assessment determined that not all of these tools are comprehensive in terms of their ability to answer clinical questions or with regard to the inclusion of levels of evidence. UpToDate was able to provide information for the greatest number of clinical questions, but it provided a level of evidence only seven percent of the time. ACP Pier was able to provide information on only 50% of the clinical questions, but it provided levels of evidence for all of these. Conclusion – UpToDate and BMJ Clinical Evidence were both rated as easy to use and informative. However, neither product generally includes levels of evidence, so it would be prudent for the practitioner to critically appraise information from these sources before using it in a patient care setting. ACP Pier eliminates the critical appraisal stage, thus reducing the time it takes to go from forming a clinical question to implementing the answer, but survey respondents did not rate it as high in terms of usability. There remains a need for user-friendly, comprehensive resources that provide evidence summaries relying on levels of evidence to support their conclusions.

Corruption in health-care systems and its effect on cancer care in Africa

2015 ◽  
Vol 16 (8) ◽  
pp. e394-e404 ◽  
Author(s):  
Saskia Mostert ◽  
Festus Njuguna ◽  
Gilbert Olbara ◽  
Solomon Sindano ◽  
Mei Neni Sitaresmi ◽  
...  
Keyword(s):  
Health Care ◽  
Cancer Care ◽  
Health Care Systems ◽  
Care Systems

scholarly journals Structural Barriers to Diagnosis and Treatment of Cancer in Low- and Middle-Income Countries: The Urgent Need for Scaling Up

2016 ◽  
Vol 34 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Eduardo Cazap ◽  
Ian Magrath ◽  
T. Peter Kingham ◽  
Ahmed Elzawawy
Keyword(s):  
Health Care ◽  
Access To Care ◽  
Cancer Care ◽  
Health Care Systems ◽  
Diagnosis And Treatment ◽  
Middle Income ◽  
Health Crisis ◽  
Middle Income Countries ◽  
Care Systems ◽  
Low And Middle Income

Noncommunicable diseases are now recognized by the United Nations and WHO as a major public health crisis. Cancer is a main part of this problem, and health care systems are facing a great challenge to improve cancer care, control costs, and increase systems efficiency. The disparity in access to care and outcomes between high-income countries and low- and middle-income countries is staggering. The reasons for this disparity include cost, access to care, manpower and training deficits, and a lack of awareness in the lay and medical communities. Diagnosis and treatment play an important role in this complex environment. In different regions and countries of the world, a variety of health care systems are in place, but most of them are fragmented or poorly coordinated. The need to scale up cancer care in the low- and middle-income countries is urgent, and this article reviews many of the structural mechanisms of the problem, describes the current situation, and proposes ways for improvement. The organization of cancer services is also included in the analysis.

scholarly journals Cancer Drug Prices in Argentina and United Kingdom: A Comparison Study

2018 ◽  
Vol 4 (Supplement 2) ◽  
pp. 72s-72s
Author(s):  
J . ◽  
V .
Keyword(s):  
Health Care ◽  
United Kingdom ◽  
Drug Price ◽  
Health Care Systems ◽  
Stage Iv ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Good Decision ◽  
Care Systems ◽  
The Difference

Background: Cancer drugs challenge health-care systems because of their high prices. Drugs prices, health-care systems and GDP are no uniform throughout the world. United Kingdom (UK) has a 320% better GDP than Argentina (ARG). Aim: We aimed to compare the prices of cancer drugs in both countries, including originals, generics/copies and biosimilars available in ARG by July 2017. Methods: We surveyed official list prices per unit at ex-factory price level of 52 original cancer drugs in UK and ARG. Drugs were grouped in low (LPD) (10), medium (MPD) (7) and high prices (HPD) (35). We included prices of generics/copies (74 generics brands of 7 LPD and 46 generics brands of 6 MPD and HPD) and biosimilars (2) available in ARG and compared with those from originals. Surveyed prices did not include negotiated discounts as authorities and third payers use these undiscounted official lists to set health care. We calculated appropriate discounts to equate prices. Results: In ARG the difference of a drug price between generics/copies and originals has an average of 10.6% less for nonoriginals (range +5% to −24%). No nonoriginals drugs cost less than 24% of originals. Great variations of prices (57%) among generics. The difference of price between biosimilars and originals was 13.8% less for biosimilars. The differences of a drug price between UK and ARG showed that: a) LPD prices in ARG were 53% (−39% to +68%) more expensive than in UK, b) 86% of MPD are more expensive in ARG than in UK, with an average of 222% (−49% to +707%), c) 100% of HPD are more expensive in ARG than in UK, with an average of 123% (+8% to +408%). When translating to currency (all in US$) differences were an average of: a) LPD +141 (−353 to +412), b) MPD +1295 (−164 to +2531), and c) HPD +2649 (+471 to +10,359) more expensive in ARG than in UK per unit. Average discounts necessary to equate undiscounted official ARG list to undiscounted official UK list are: LPD 45% (24-64), MPD 71% (60-87), HPD 51% (13-80). Conclusion: a) Our results show great variations in prices between both countries. b) Prices are inversely related to GDP. c) 100% of HPD and 86% of MPD have overprices in ARG respect to UK with an average of 123% and 222% respectively. d) In currency these represent an average overpayment of US$ 2649 and US$ 1295 per unit respectively. e) Appropriate discounts to equate ARG list to UK list should be around 50%–70%. f) In ARG, differences of prices between generics/copies/biosimilars and originals are less than 24%, with an average of 10%–13%. g) By using undiscounted lists there is a high risk of overpayment. Unpublished final prices list may preclude a good decision making process even at physician level, considering that many of MPD and HPD are directed to stage IV noncurative patients with marginal quality of life advantages for some of these treatments. h) Our findings provide an evidence base for policy makers in nonhigh income countries.

scholarly journals Evidence-Based Integrative Health Care to Promote Quality of Life in Older Adults With Cancer

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 609-610
Author(s):  
Robin Majeski ◽  
Delia Chiaramonte
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Health Care ◽  
Cancer Care ◽  
Symptom Burden ◽  
Integrative Approach ◽  
Evidence Based ◽  
Cancer Symptoms ◽  
Integrative Health

Abstract Cancer disproportionately affects older adults and presents significant challenges to patients’ quality of life. Use of complementary medicine is increasing among older adults with cancer and these modalities have the potential for both benefit and harm. Thus, it is important that health care professionals are knowledgeable about the evidence-supported benefits and risks of complementary and integrative health approaches in the care of older adults with cancer. Integrative cancer care provides a comprehensive approach to reducing symptom burden in patients suffering with cancer symptoms and side effects of cancer treatment. Symptoms such as pain, fatigue, nausea, sleep disturbance, mood disorder, perceived stress, and reduced quality of life are common in this population.This session will discuss an evidence-based integrative approach to cancer care which incorporates both pharmacologic and non-pharmacologic modalities to decrease symptom burden, enhance patient well-being, and improve quality of life. Non-pharmacologic modalities used in the integrative approach to care will be described and relevant evidence for risks, benefits and indications will be presented. Case studies will be discussed to demonstrate the integration of these techniques into conventional western medical treatment plans for older adults with cancer. Diversity and inclusion issues relevant to integrative medicine for underserved cancer patients will be addressed, as well as recommendations for future research to expand access of underserved populations to evidence-supported integrative cancer care. A resource list will be provided to participants.

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