Journal: American Society of Clinical Oncology Educational Book

Abbreviation

Am Soc Clin Oncol Educ Book

Publisher

American Society of Clinical Oncology

Journal Volumes

ISSN

1548-8756
1548-8748

Description

Filters

2019 - 201912020 - 20251
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Publications 1 - 2 of 2
  • Proposed Policy Changes to Cancer Care and Oncologic Drug Reimbursement: Exploring the Rationale and Anticipating the Consequences
    Item type: Journal Article
    Huey, Ryan W.; Pritchett, Joshua C.; Vokinger, Kerstin N.; et al. (2025)
    American Society of Clinical Oncology Educational Book
    Although innovation in cancer treatment has improved cure rates and survival, the costs have escalated beyond societies' ability to pay. Cancer care costs in the United States are expected to rise to 245 billion by 2030. In this health policy session, we focused on three cost-containment strategies, and their potential impact on cancer care delivery. Site Neutrality: Curbing the Cost of Cancer Care, but at What Risk?, explores legislation that would introduce payment parity across differing sites of care: elimination of facility fees in hospital owned practices and shift of billing for oncology infusions away from hospital owned practices. Unintended consequences could reduce access to care for vulnerable populations, shift costs to patients, and reduce safety. Post-Pandemic Digital Health Reimbursement: Impact on Access to Care, explores how the emergency waivers, licensure flexibilities, and parity reimbursement necessitated by COVID-19 shepherded innovation that outpaced the regulatory framework needed for long-term sustainability. Today, telehealth services, hospital at home, remote patient monitoring, and decentralized clinical trial enrollment face reintroduction of regulatory and payment barriers. Will we live to see efficacy-based pricing for cancer drugs? Learning from international models, explores how lack of drug price negotiation has led to higher prices in the United States compared with Canada and Europe. Comparative clinical effectiveness pricing systems compare the value of each drug to standard treatments. Comparative cost-effectiveness programs look at the incremental cost per additional unit of health gained above the standard of care. The United States could learn from these approaches used in comparable countries.
  • Patient-Centered Cancer Drug Development: Clinical Trials, Regulatory Approval, and Value Assessment
    Item type: Journal Article
    Gyawali, Bishal; Hwang, Thomas J.; Vokinger, Kerstin Noëlle; et al. (2019)
    American Society of Clinical Oncology Educational Book
    Historically, patient experience, including symptomatic toxicities, physical function, and disease-related symptoms during treatment or their perspectives on clinical trials, has played a secondary role in cancer drug development. Regulatory criteria for drug approval require that drugs are safe and effective, and almost all drug approvals have been based only on efficacy endpoints rather than on quality-of-life (QoL) assessments. In contrast to Europe, information regarding the impact of drugs on patients’ QoL is rarely included in oncology drug labeling in the United States. Until recently, patient input and preferences have not been incorporated into the design and conduct of clinical trials. In recent years, a more in-depth understanding of cancer biology, as well as regulatory changes focused on expediting cancer drug development and approval, has allowed earlier access to novel therapeutic agents. Understanding the implications of these expedited programs is important for oncologists and patients, given the rapid expansion of these programs. In this article, we provide an overview of the role of QoL in the regulatory drug–approval process, key issues regarding trial participation from the patient perspective, and the implications of key expedited approval programs that are increasingly being used by regulatory bodies for cancer care.
Publications 1 - 2 of 2