Developing a framework to incorporate real-world evidence in cancer drug funding decisions: The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration

TY - JOUR

T1 - Developing a framework to incorporate real-world evidence in cancer drug funding decisions

T2 - The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration

AU - Chan, Kelvin

AU - Nam, Seungree

AU - Evans, Bill

AU - Deoliveira, Claire

AU - Chambers, Alexandra

AU - Gavura, Scott

AU - Hoch, Jeffrey

AU - Mercer, Rebecca E.

AU - Dai, Wei Fang

AU - Beca, Jaclyn

AU - Tadrous, Mina

AU - Isaranuwatchai, Wanrudee

N1 - © Author(s) (or their employer(s)) 2020.

PY - 2020/1/7

Y1 - 2020/1/7

N2 - Background Oncology therapy is becoming increasingly more expensive and challenging the affordability and sustainability of drug programmes around the world. When new drugs are evaluated, health technology assessment organisations rely on clinical trials to inform funding decisions. However, clinical trials are not able to assess overall survival and generalises evidence in a real-world setting. As a result, policy makers have little information on whether drug funding decisions based on clinical trials ultimately yield the outcomes and value for money that might be expected. Objective The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration, consisting of researchers, recommendation-makers, decision makers, payers, patients and caregivers, are developing and testing a framework for Canadian provinces to generate and use real-world evidence (RWE) for cancer drug funding in a consistent and integrated manner. Strategy The CanREValue collaboration has established five formal working groups (WGs) to focus on specific processes in the generation and use of RWE for cancer drug funding decisions in Canada. The different RWE WGs are: (1) Planning and Drug Selection; (2) Methods; (3) Data; (4) Reassessment and Uptake; (5) Engagement. These WGs are acting collaboratively to develop a framework for RWE evaluation, validate the framework through the multiprovince RWE projects and help to integrate the final RWE framework into the Canadian healthcare system. Outcomes The framework will enable the reassessment of cancer drugs, refinement of funding recommendations and use of novel funding mechanisms by decision-makers/payers across Canada to ensure the healthcare system is providing clinical benefits and value for money.

AB - Background Oncology therapy is becoming increasingly more expensive and challenging the affordability and sustainability of drug programmes around the world. When new drugs are evaluated, health technology assessment organisations rely on clinical trials to inform funding decisions. However, clinical trials are not able to assess overall survival and generalises evidence in a real-world setting. As a result, policy makers have little information on whether drug funding decisions based on clinical trials ultimately yield the outcomes and value for money that might be expected. Objective The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration, consisting of researchers, recommendation-makers, decision makers, payers, patients and caregivers, are developing and testing a framework for Canadian provinces to generate and use real-world evidence (RWE) for cancer drug funding in a consistent and integrated manner. Strategy The CanREValue collaboration has established five formal working groups (WGs) to focus on specific processes in the generation and use of RWE for cancer drug funding decisions in Canada. The different RWE WGs are: (1) Planning and Drug Selection; (2) Methods; (3) Data; (4) Reassessment and Uptake; (5) Engagement. These WGs are acting collaboratively to develop a framework for RWE evaluation, validate the framework through the multiprovince RWE projects and help to integrate the final RWE framework into the Canadian healthcare system. Outcomes The framework will enable the reassessment of cancer drugs, refinement of funding recommendations and use of novel funding mechanisms by decision-makers/payers across Canada to ensure the healthcare system is providing clinical benefits and value for money.

KW - drug approval

KW - health technology assessment

KW - oncology

KW - real-world data

KW - real-world evidence

KW - regulatory approval

UR - http://www.scopus.com/inward/record.url?scp=85077721640&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-032884

DO - 10.1136/bmjopen-2019-032884

M3 - Article

C2 - 31915169

AN - SCOPUS:85077721640

SN - 2044-6055

VL - 10

JO - BMJ Open

JF - BMJ Open

IS - 1

M1 - e032884

ER -