2007 Meeting of the American Association for Cancer Research Monday, April 16 2007, 9:30-12:00 Balancing Cost and Clinical Benefits of New Anti-Cancer Agents: A Societal Dilemma Lowell Schnipper, MD and Walter Wolf, PhD co-Chairs Making Cancer a Chronic Disease: The Ethical Predicaments of Progress? Alexander M. Capron, LLB, University of Southern California, Los Angeles, California 90089-0071 Abstract: Until recently cancer was an acute and usually fatal condition, but it seems to be on its way to being a chronic disease, like diabetes or high blood pressure. Today, there are 10 million cancer survivors in this country (roughly three times the number of 30 years ago), thanks to better screening and earlier diagnosis, more effective treatment (even when the cancer itself may remain), and an aging population. Among the many survivors who live for decades are some who do not need further treatment (beyond regular screening; think Lance Armstrong) and others who require continuing care, often tailored to their specific genotype. Yet while some live much longer, others receive treatment costing in excess of $100,000 to gain only a few months of added life (think Avastin for breast and lung cancer). This paper addresses some of the ethical issues involved, including: 1. how should health and disease be defined (biologically, socially, psychologically)? 2. can treatments that provide only marginal benefit be limited, or withheld entirely from certain patients? 3. should drug and biotech companies set drug prices based on the incremental cost of production or the value of the treatment to patients and, if so, how should this value be determined (the absolute value of all lives; a particular value for extra months or years; quality-adjusted life years)? 4. as therapies become more targeted (e.g., pharmacogenetics), what happens to access in less developed countries? and 5. what effects on national budgets can be expected if a large number of people need on-going treatment for cancer? Economic Value of innovative Targeted Therapies: The Case of Herceptin Susan Desmond-Hellman, MD, South San Francisco, California 94080-4990 Abstract: When seeking to understand the economic impact of targeted therapies, we should give greater attention to the dynamic, long term relationship between innovation, and the necessary time needed for drug development and testing in multiple lines of therapy and across patient populations. Traditional drug development approaches where initial trials involve the sickest patients present significant challenges to distinguish the cost-effectiveness of new therapies, evaluated for a specific indication. It is not until later trials involving earlier stage patients where the greatest benefits in survival can be demonstrated, and thus the total costs and benefits of a therapy may not be realized for many years. Targeted therapies present the opportunity to identify patients where the therapy is likely to deliver more benefit. However, such therapies may require greater investment in order to identify and validate diagnostic markers as well as higher per patient costs to enable a positive return on that investment. Targeted therapies do present the potential to enhance the cost-effectiveness of cancer therapy. The development of Herceptin exemplifies the important interdependence between targeted therapy and continued drug development resulting in greater benefits over time. Continued investments in the development of Herceptin over its life cycle have generated a broader understanding of the costs and benefits of Herceptin across multiple patient populations. In metastatic disease, estimates of the cost-effectiveness of Herceptin were as high as $140,000 per quality adjusted life year (QALY). However, in the adjuvant setting the cost effectiveness is approximately $26,000 per QALY, well below generally accepted thresholds. The Impact of Cost-Effectiveness Analyses on US Cancer Care Deborah Schrag, MD, Memorial Sloan Kettering Cancer Center, New York City, New York 10021 Abstract: As chemotherapy costs escalate, financial concerns have become relevant for more cancer patients. Yet, little is known about how oncologists communicate about coping with chemotherapy treatment costs. To understand how medical oncologists view these issues, we developed a survey eliciting their attitudes and behaviors surrounding discussing costs of therapy in the context of treatment decision-making. The survey was piloted at a national meeting and then mailed to a random sample of actively practicing 2005 ASCO members from 50 US states. Survey items used a 5-point Likert scale designed to elicit oncologists’ practices and attitudes regarding discussion of chemotherapy costs with patients. In broad term, the study revealed considerable heterogeneity in oncologists’ attitudes towards discussion of costs of care in clinical encounters. Results from this survey will be presented and more broadly, this session will cover challenges related to the high costs of chemotherapy. Specific topics to be covered include: treatment costs in clinical encounters 2) Patient perspectives on discussing costs of cancer treatment. 3) Physician perspectives on discussing costs of cancer treatment 4) Knowledge gaps in how economics are handled in clinical encounters 5) Evidence that economic concerns result in undertreatment or premature cessation of treatment 6) Strategies for coping with the high costs of cancer chemotherapy Why is there so much interest in the cost of cancer care? Neal J. Meropol, MD Fox Chase Cancer Center, Philadelphia Pennsylvania 19111-2497 Abstract: • Drug and diagnostic costs have risen dramatically recently. o Colon cancer as example o Currently marketplace drives price-contrast other countries where dominant government payor negotiates price • Although cancer only makes up a fraction of healthcare budget, there are several issues that capture attention o Benefits appear marginal relative to cost (I suspect Schrag will deal with this in more detail) o Cancer is “special” in terms of the healthcare system. Why? Historically little scrutiny of prescribing behavior and resource utilization. • Cancer care highlights the inadequacy of our current insurance system o Insurance is necessary for catastrophic illness like cancer, but leads to inefficient resource utilization o Increasing under- and uninsured o Leads to disparities in care and outcome o There are many points of view (e.g. patient, doctor, insurer, government, drug company, biotech company) that must be considered in policy deliberations – this is complex • Anecdotal: Patient concerns about out-of-pocket expenses are increasing, and this creates a new reality for physician practice – considerations of cost are creeping into treatment decision making • We need research o Who benefits from what therapy? o Do patient access programs work? For whom? o Impact of providing incentives for best practices o Successes/failures of other nations’ delivery systems o Relationship of price control to innovation Personal Financial Conflicts of Interest among Authors of Cancer Clinical Trials and Editorials: Scope and Relationship to Study Funding Rachel P. Riechelmann, MD and coworkers For full details see abstract # 948 Abstract: The growing involvement of the pharmaceutical industry in clinical cancer research has led to concerns regarding scientific integrity of the research enterprise. Here we describe the epidemiology of potential personal financial conflicts of interest (COI) disclosed by authors of clinical cancer studies. Personal financial COI are common among authors of clinical cancer studies and usually take the form of honoraria, consultancy fees and/or research funds. Source of funding is significantly associated with disclosure of COI. Ethical issues in cancer chemoprevention trials: Considerations for IRBs and investigators Julia Slutsman, PhD and coworkers. For full details see abstract # 950 Abstract: Cancer chemoprevention trials test the efficacy of pharmaceutical agents in preventing cancer in “at-risk” research subjects who are neither patients diagnosed with disease nor typical healthy volunteers. Such trials present some unique challenges to investigators and IRB reviewers in the assessment of appropriate eligibility criteria, the evaluation of risks and benefits, and in the conduct of informed consent. Yet, relatively little attention has been paid to cancer chemoprevention research in the research ethics literature and there is not a great deal of guidance available for IRBs reviewing such trials. We conclude that investigators and IRBs should pay particular attention to eligibility criteria used to define at-risk subjects and carefully assess the strength of evidence supporting these criteria, as this is critical to assessment of the risk-benefit ratio. IRBs and investigators should also pay special attention to the manner of presentation of risk and benefit information during the informed consent process. To assist IRB members and investigators in doing this, we present a framework of specific questions for consideration that can be used in the preparation and human subjects review of chemoprevention trial protocols. Ethical framework of informed consent in oncology trials: A Summit Series on Cancer Clinical Trials transdisciplinary perspective Susan Samson, MPH and coworkers For full details see abstract #949 Abstract: Although informed consent in clinical trials is viewed as a cornerstone and routine component of the ethical conduct of clinical research, it provides an imperfect approach to encouraging informed and voluntary subject participation. Representing a unique collaboration of stakeholders from institutional review boards (IRBs), non-profits, industry, law, advocacy, academic, philanthropic and regulatory agencies, the Summit Series on Cancer Clinical Trials workgroup, "Moving from Informed Consent to Informed Choice," has explored problems and potential solutions related to informed consent. The workgroup met over the past two years to develop guidelines for retooling the design, conduct and monitoring of scientifically and ethically acceptable informed consent processes in oncology clinical trials. Oncology clinical trials present unique challenges to the process of ethics and informed consent. The Summit transdisciplinary approach to advancing ethics in clinical trials holds promise as a way to impact reform in cancer clinical trials. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.