Developing a Canadian Real-World Evidence Action Plan across the Drug Life Cycle

Tadrous, Mina; Ahuja, Tarry; Ghosh, Basanti; Kropp, R.

doi:10.12927/hcpol.2020.26225

Cited by 9 publications

(10 citation statements)

References 14 publications

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“…The pharmaceutical industry promotes data generated through patient support programs as a source of “real world evidence” and an alternative to clinical trials data that can inform public decision-making processes related to drug pricing or reimbursement (Oncology industry taskforce RWE working group, 2020; Real-World Evidence and Outcomes-Based Agreements Working Group, 2021). Policymakers are also interested in data sources that can link public decision-making around pharmaceuticals to health outcomes (Plueschke et al, 2018; Seeley & Kesselheim, 2017; Tadrous et al, 2020). However, research is required to understand whether and how data specifically from industry patient support programs should inform collective decisions around health resource allocation so that public interests are prioritized.…”

Section: Discussionmentioning

confidence: 99%

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines

Grundy

Huyer

Parker

et al. 2022

Policy, Politics, & Nursing Practice

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An increasing proportion of new drugs approved for market worldwide are now high cost, specialty medicines. Pharmaceutical marketers face the challenge of convincing payers, prescribers, and patients that the cost and complexity of care associated with specialty medicines is worth the trouble, and now offer patient support programs, free of charge, to patients prescribed their drug. We conducted a secondary, qualitative, interpretive analysis of 24 interviews with leaders of patient groups and members of hospital formulary committees in Australia to describe the work of pharmaceutical company-employed or contracted nurses who provide support to patients prescribed specialty medicines, and to prompt discussion around the policy implications of relying on industry-funded nursing care within publicly funded health systems. Participants affirmed the value of specialist, holistic, person-centered nursing care, but perceived gaps within the public health system related to the availability and provision of nursing care for people living with chronic disease. Consequently, participants described the pharmaceutical industry as addressing health system gaps through sponsorship or direct provision of medication-related nursing care, but recognized that care was contingent on commercial interest. Participants highlighted a number of ethical and policy concerns stemming from industry-funded nursing care of people prescribed specialty medicines related to patient safety, continuity of care, inducement to prescribe, and health equity. This analysis suggests that outsourcing necessary medication-related care to pharmaceutical companies has implications for the health system and equitable, sustainable pharmaceutical policy that extend far beyond the care encounter.

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Section: Discussionmentioning

confidence: 99%

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines

Grundy

Huyer

Parker

et al. 2022

Policy, Politics, & Nursing Practice

View full text Add to dashboard Cite

show abstract

“…Like all forms of evidence, quality is what counts, and RWE can have significant limitations, "including conflicts with the funding source, fragmentation of patient populations among competing registries and incomplete data capture" (Sirrs et al 2023a: 19). Recognition of these quality issues is behind the Canadian Agency for Drugs and Technologies in Health's initiative to develop a Canadian action plan to optimize the process for the integration of RWE into both regulatory and reimbursement decision making in Canada (Tadrous et al 2020).…”

Section: Evidence Behind Edrdsmentioning

confidence: 99%

Expensive Drugs for Rare Diseases: “Canada, We Have a Problem Here”

Lexchin¹

2023

hcpap

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“…There are few standard processes to reevaluate technologies over the on-market life-cycle (LC) or to support value-based price renegotiation in response to these changes. 10,[22][23][24][25][26][27][28][29][30][31][32][33] Where conditional funding recommendations are made, there is the need to reevaluate technologies for which additional evidence was required at the recommendation stage, such as managed access agreements. 7,[34][35][36]…”

Section: Evolving Evidencementioning

confidence: 99%

A Conceptual Framework for Life-Cycle Health Technology Assessment

et al. 2022

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Health technology assessment (HTA) uses evidence appraisal and synthesis with economic evaluation to inform adoption decisions. Standard HTA processes sometimes struggle to (1) support decisions that involve significant uncertainty and (2) encourage continued generation of and adaptation to new evidence. We propose the life-cycle (LC)-HTA framework, addressing these challenges by providing additional tools to decision makers and improving outcomes for all stakeholders.Methods: Under the LC-HTA framework, HTA processes align to LC management. LC-HTA introduces changes in HTA methods to minimize analytic time while optimizing decision certainty. Where decision uncertainty exists, we recommend risk-based pricing and research-oriented managed access (ROMA). Contractual procurement agreements define the terms of reassessment and provide additional decision options to HTA agencies. LC-HTA extends value-of-information methods to inform ROMA agreements, leveraging routine, administrative data, and registries to reduce uncertainty.Results: LC-HTA enables the adoption of high-value high-risk innovations while improving health system sustainability through risk-sharing and reducing uncertainty. Responsiveness to evolving evidence is improved through contractually embedded decision rules to simplify reassessment. ROMA allows conditional adoption to obtain additional information, with confidence that the net value of that adoption decision is positive. Conclusions:The LC-HTA framework improves outcomes for patients, sponsors, and payers. Patients benefit through earlier access to new technologies. Payers increase the value of the technologies they invest in and gain mechanisms to review investments. Sponsors benefit through greater certainty in outcomes related to their investment, swifter access to markets, and greater opportunities to demonstrate value.

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Developing a Canadian Real-World Evidence Action Plan across the Drug Life Cycle

Abstract: Développement d'un plan d' action canadien fondé sur les données probantes du monde réel tout au long du cycle de vie des médicaments

Cited by 9 publications

References 14 publications

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines

Expensive Drugs for Rare Diseases: “Canada, We Have a Problem Here”

A Conceptual Framework for Life-Cycle Health Technology Assessment

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