Cargando…

Impact of Regulatory Approval Status on CADTH Reimbursement of Oncology Drugs and Role of Real-World Evidence on Conditional Approvals from 2019 to 2021

Real-world evidence (RWE) is health and outcomes data generated from a patient’s journey through the health care system or disease process (i.e., real-world data). RWE is now having an increasingly important role in regulatory/reimbursement decisions. This article examines reimbursement recommendati...

Descripción completa

Detalles Bibliográficos
Autores principales:	Lau, Catherine, Dranitsaris, George
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2022
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9689244/ https://www.ncbi.nlm.nih.gov/pubmed/36354695 http://dx.doi.org/10.3390/curroncol29110635

Ejemplares similares

Health Technology Assessment Process for Oncology Drugs: Impact of CADTH Changes on Public Payer Reimbursement Recommendations
por: Binder, Louise, et al.
Publicado: (2022)

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
por: Maeda, Hideki, et al.
Publicado: (2022)

Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond
por: Lemery, Steven, et al.
Publicado: (2022)

Approval, reimbursement and pricing of high-cost cancer medicines in Australia
por: Vitry, Agnes
Publicado: (2015)

USING REAL-WORLD EVIDENCE TO SUPPORT THE FDA REGULATORY APPROVAL: METHODOLOGICAL CONSIDERATIONS
por: Lu, Kevin, et al.
Publicado: (2022)

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain
por: Poveda, José Luis, et al.
Publicado: (2023)

The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines
por: Gold, Laura S., et al.
Publicado: (2012)

Trial designs using real‐world data: The changing landscape of the regulatory approval process
por: Baumfeld Andre, Elodie, et al.
Publicado: (2019)

Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs
por: Vreman, Rick A., et al.
Publicado: (2018)

Characteristics of clinician input in Canadian funding decisions for cancer drugs: a cross-sectional study based on CADTH reimbursement recommendations
por: Jenei, Kristina, et al.
Publicado: (2023)

Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study
por: Xie, Jinping, et al.
Publicado: (2023)

Oncologic orphan drugs approved in the EU – do clinical trial data correspond with real-world effectiveness?
por: Schuller, Yvonne, et al.
Publicado: (2018)

Regulatory Approval, Reimbursement, and Clinical Use of Cyclin-Dependent Kinase 4/6 Inhibitors in Metastatic Breast Cancer in the Netherlands
por: Luyendijk, Marianne, et al.
Publicado: (2023)

Pre‐approval and post‐approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs
por: Bloem, Lourens T., et al.
Publicado: (2022)

Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World
por: Fernández-Garza, Luis E., et al.
Publicado: (2023)

Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities
por: Feng, Catherine, et al.
Publicado: (2021)

On the Regulatory Approval Pathway of Biosimilar Products
por: Wang, Jun, et al.
Publicado: (2012)

2015 Review of Newly Approved Oncologic Therapies
por: Medina, Patrick, et al.
Publicado: (2016)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU
por: Demirci, Ebru, et al.
Publicado: (2023)

Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness
por: McPhail, Melanie, et al.
Publicado: (2022)

Gene therapy for cancer: regulatory considerations for approval
por: Husain, S R, et al.
Publicado: (2015)

Regulatory approval for COVID-19 across the globe
por: Mahalmani, Vidya, et al.
Publicado: (2020)

FDA approved antibacterial drugs: 2018-2019
por: Andrei, Stefan, et al.
Publicado: (2019)

Biosimilar agents in oncology/haematology: from approval to practice
por: Niederwieser, Dietger, et al.
Publicado: (2011)

Radiation Oncology Device Approval in the United States and Canada
por: Beers, Craig A, et al.
Publicado: (2019)

The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs
por: Vreman, Rick A., et al.
Publicado: (2020)

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014
por: Hatswell, Anthony J, et al.
Publicado: (2016)

Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs
por: Mitra-Majumdar, Mayookha, et al.
Publicado: (2022)

Trends and Characteristics of New Drug Approvals in China, 2011–2021
por: Su, Ling, et al.
Publicado: (2022)

Impact of the therapeutic positioning report in the P&R process in Spain: analysis of orphan drugs approved by the European Commission and reimbursed in Spain from 2003 to 2019
por: Badia, Xavier, et al.
Publicado: (2020)

Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
por: Polak, Tobias B., et al.
Publicado: (2020)

The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications
por: Purpura, Christina A., et al.
Publicado: (2021)

Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities
por: Al‐Huniti, Nidal, et al.
Publicado: (2020)

An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins
por: Heinemann, Lutz, et al.
Publicado: (2015)

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
por: Gherghescu, Ioana, et al.
Publicado: (2020)

Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon
por: Pang, Eric, et al.
Publicado: (2021)

Rituximab in Multiple Sclerosis: Are We Ready for Regulatory Approval?
por: Brancati, Serena, et al.
Publicado: (2021)

Expedited regulatory product approval in the time of COVID-19
por: Novack, Gary D.
Publicado: (2022)

Novel targeted drugs approved by the NMPA and FDA in 2019
por: Wang, Wenjing, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_40eansf8temnsop55j5337949s