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Use of the ESMO-Magnitude of Clinical Benefit Scale to guide HTA recommendations on coverage and reimbursement for cancer medicines: a retrospective analysis.
Lancet Oncol
December 2024
Department of Health Policy and LSE Health-Medical Technology Research Group, London School of Economics and Political Science, London, UK.
Background: Recommendations by countries' health technology assessment (HTA) agencies are used to decide which new therapies warrant the allocation of limited health-care resources to make them available through publicly funded health systems. This process is of public health importance for balancing the dual aims of optimising patient outcomes while ensuring financial sustainability. We evaluated which factors affect HTA outcomes and the time to positive HTA outcome, focussing on the role of clinical benefit evaluated with the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).
View Article and Find Full Text PDFClinical value of guideline recommended molecular targets and genome targeted cancer therapies: cross sectional study.
BMJ
August 2024
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Article Synopsis
- The study aimed to evaluate the effectiveness and potential clinical relevance of genome-targeted cancer drugs recommended by the National Comprehensive Cancer Network (NCCN) using established scales for actionability and clinical benefit.
- A total of 411 drug recommendations were analyzed, with most being linked to clinical trials, particularly early-phase studies, but many did not provide strong evidence of substantial clinical benefit.
- Only 12% of the evaluated trials demonstrated high clinical benefit (grades 4-5), while approximately 33% showed promise but were unproven, highlighting a need for more rigorous research in this area.
List prices and clinical value of anticancer drugs in China, Japan, and South Korea: a retrospective comparative study.
Lancet Reg Health West Pac
June 2024
HEOA Group, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.
Background: High prices of anticancer drugs have raised concerns due to their financial impact on patients and healthcare systems. This study aimed to assess the initial and latest list prices and clinical value of reimbursed anticancer drugs in China, Japan, and South Korea.
Methods: We identified anticancer drugs newly approved by the National Medical Products Administration of China from January 2012 to June 2022, and by the Pharmaceuticals and Medical Devices Agency of Japan and the Ministry of Food and Drug Safety of South Korea up until June 2022.
Clinical Value of Molecular Targets and FDA-Approved Genome-Targeted Cancer Therapies.
JAMA Oncol
May 2024
Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Importance: The number of new genome-targeted cancer drugs has increased, offering the possibility of personalized therapy, often at a very high cost.
Objective: To assess the validity of molecular targets and therapeutic benefits of US Food and Drug Administration-approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.
Design And Settings: In this cohort study, all genome-targeted cancer drugs that were FDA-approved between January 1, 2015, and December 31, 2022, were analyzed.
Publicly Funded Cancer Care: Are Adjuvant Therapies Prioritized Over Treatment of Metastatic Cancer? The Israeli Experience.
JCO Oncol Pract
December 2024
Maccabi Health Services Headquarters, Tel-Aviv, Israel.
Purpose: In Israel, a public committee advises which new medications should be reimbursed subject to an annual budget allocation. The committee considers clinical trial outcomes, professional societies' preferences, projected budget impacts, and other social and ethical aspects. The Israeli oncologists' society places a strong emphasis on prioritizing adjuvant therapies because of their potential to advance cure.
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