Factors Associated With Off-Label Oncology Prescriptions: The Role of Cost and Financing in a Universal Healthcare System

Purpose: Various solutions have been put forward for prescribing and reimbursing treatments outside their registered indications within universal healthcare systems. However, most off-label oncology prescriptions are not reimbursed by health funds. This study characterized the financing sources of off-label oncology use and the predictors of the decision to forego treatment.Materials and Methods: All 708 off-label oncology requests submitted for approval in a large tertiary cancer center in Israel between 2016 and 2018 were examined for disease and patient sociodemographic characteristics, costs and financing sources, and the factors predicting actual off-label drug administration using multivariate logistic regression analysis.Results: The mean monthly cost of a planned off-label treatment was ILS54,703 (SD = ILS61,487, median = ILS39,928) (approximately US$ 15,500). The main sources of funding were private health insurance (25%) and expanded access pharma company plans (30%). Approximately one third (31%) of the requests did not have a financing source at the time of approval. Of the 708 requests, 583 (or 82%) were filled and treatment was initiated. Predictors for forgoing treatment were the impossibility of out-of-pocket payments or the lack of a financing solution (OR = 0.407; p = 0.005 and OR = 0.400; p < 0.0005).Conclusion: Although off-label recommendations are widespread and institutional approval is often granted, a large proportion of these prescriptions are not filled. In a universal healthcare system, the financing sources for off-label treatments are likely to influence access.

Introduction

Shared decision making between doctors and patients has become the norm in medical decision making. There are three good reasons why there has been a shift from the traditional paternalistic model to a more bilateral and patient-centered model. First, the nature of medical knowledge has changed. Better understanding of the natural history of disease led to situations in which doctors had knowledge about their patients’ illnesses before the patients themselves had any symptoms of disease. In those situations, doctors need to disclose the diagnosis and the risks of forgoing treatment. Second, many modern therapies are initially worse than the diseases they treat. Again, explanations are necessary to convince the patient that the short-term risks and side effects are worth it to achieve the long-term benefits. Finally, there is often no single best treatment. Reasonable people can disagree about whether they’d trade off a slight increase in the chance of long-term survival for a worse quality of life. All of these changes create a health care environment in which both doctors and patients have more information than they have ever had before. That information makes decisions more complex. This chapter introduces the chapters in this book by which clinicians and philosophers try to clarify, critique, and understand the concept of shared decision making. In doing so, they use terms like “labyrinth,” “overwhelming,” “uncertainty,” and “dread.” Shared decision making as an ideal is inspiring and empowering but also frightening and somewhat ambiguous. This book tries to help doctors and patients navigate the complexities.

Ethical Justification in Medical Futility and Advanced Medical Directive from The Islamic Perspective

Introduction: Medical futility and advanced medical directive are related issues in end-of-life medical decisions that present challenge to doctors and patients in terminal condition and to doctors and family members of patients who are critically ill in the ICU. Materials and Methods: A qualitative study comprises of literature search and an in-depth interview of experts was carried out to determine the clinical situations in medical futility and the ethical considerations from the Islamic perspective that justify forgoing medical treatment and also the practice of advanced medical directives in the country. Results: In such scenarios, clinical data must be interpreted alongside patient values, as well as the physicians’ ethical commitments. From the Islamic perspective, doctors are the authorised person to diagnose medical futility and forgo medical treatment. Forgoing treatment is permissible as long as it conforms to the maqasid and qawaid al-shariah principles that guide the decision-making process. The practice of advanced medical directive is still at its infancy in this country. From the Islamic perspective, upon considering the maqasid and qawaid al-shariah principles, it should be permissible and its practice should be encouraged as it assists the doctors and the surrogate decision-maker to decide to the withdrawal of treatment. Conclusion: Ethical justification on medical futility conforms to the maqasid and qawaid al-shariah principles and forgoing medical treatment is permissible in Islam. Advanced medical directive assists in the decision-making of forgoing treatment in the presence of utility and thus its practice should be promoted.