Deriving more value from RWE to ensure timely access of medicines by patients

Wamala-Andersson, Sarah; Kyhlstedt, Mattias

doi:10.2217/cer-2017-0030

“…As population-level analyses, RWE can provide valuable insights on drugs for rare indications. The results of RWE studies can also improve payers’ ability to negotiate with industry, including establishing postmarket commitments and requirements, conditional approvals or reimbursement and risk-sharing agreements 17 18. Recommendation-makers, such as HTA agencies, can also use comparative RWE evidence to reassess their past recommendations and provide updated guidance to decision makers/payers 19.…”

Section: What Is Rwe and Why Is It Needed?mentioning

confidence: 99%

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

Chan

¹

,

Nam

²

,

Evans

³

et al. 2020

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BackgroundOncology 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.ObjectiveThe 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.StrategyThe 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.OutcomesThe 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.

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“…About the implications of moving from traditional RCT to RWE and the implications that comes with this. i.e one should actively consider the confounders, not only identify that is a potential problem. Table 1: Being the co-author of the article : “Deriving more value from RWE to ensure timely access of medicines by patients” 2 . I think this would be an appropriate reference.…”

mentioning

confidence: 99%

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Khosla

¹

,

White

²

,

Medina

³

et al. 2018

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Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.

show abstract

“…i.e one should actively consider the confounders, not only identify that is a potential problem. Table 1: Being the co-author of the article : “Deriving more value from RWE to ensure timely access of medicines by patients” 2 . I think this would be an appropriate reference.…”

mentioning

confidence: 99%

“…Table 1: Being the co-author of the article : “Deriving more value from RWE to ensure timely access of medicines by patients” 2 . I think this would be an appropriate reference.…”

mentioning

confidence: 99%

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Khosla

¹

,

White

²

,

Medina

³

et al. 2018

View full text Add to dashboard Cite

Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.

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Deriving more value from RWE to ensure timely access of medicines by patients

Cited by 3 publications

References 17 publications

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

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

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

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