The Difference Between Regulatory And Market Access Decisions On Treatment Availability For New Drugs In Six Common Cancers Across Australia, Canada, And Europe

McKendrick, John H.; Malcolm, Bill; Sheahan, Kate; Katsoulis, IA; Song, Xiaoying; Loon, Joyce van

doi:10.1016/j.jval.2017.08.390

Cited by 4 publications

(2 citation statements)

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Section: Discussionmentioning

confidence: 93%

“…Other studies have demonstrated similar trends in which fewer drugs were submitted to Canada for regulatory approval compared with other countries in other disease areas, including cancer [14][15][16] and antibacterials [17]. The reasons for these discrepancies are not entirely clear, however it was suggested by Outterson [16] noted that variation in availability to cancer drugs across countries was partially due to different willingness-to-pay thresholds. Similarly, Tunis et al [18] identified a similar trend with cell and gene therapies, where fewer were available to patients in Canada and European countries compared to the United States, because of stricter decisions in the face of limited evidence.…”

Section: Discussionmentioning

confidence: 93%

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An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries

Ward

Chambers

Mechichi

et al. 2022

Orphanet J Rare Dis

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Background The Canadian government has committed to developing a national strategy for drugs for rare diseases starting in 2022. Considering this announcement, we conducted a comparative analysis to examine patient access to therapies for rare disease in Canada relative to Europe and the U.S. Methods Given its similarity to the Canadian health care system, we used Europe as the reference point to analyze all of the therapies with an orphan drug designation approved by the European Medicine Agency (EMA) from 1 January 2015 to 31 March 2020. We then contrasted access to these drugs in Canada (Health Canada) and the U.S. (Food and Drug Administration, FDA). We focused on: (1) the number of therapies for rare diseases entering the Canadian market; (2) the percentage of these therapies that are publicly available to Canadians; and (3) the timelines for patients to access these therapies in Canada. Results Sixty-three approved therapies with an orphan drug designation from the EMA were identified. Fifty-three (84%) of these drugs had also been submitted to the FDA for approval, and 41 (65%) were submitted to Health Canada for approval. In Europe, Germany, Denmark, and the U.K. had the highest percentage of publicly reimbursed orphan drugs (84%, 70%, 68%, respectively). In comparison, Ontario (32%), Quebec (25%), and Alberta (25%) had the highest percentage of drugs reimbursed among the Canadian provinces. The shortest median duration (in months) from EMA approval to jurisdictional decision on reimbursement was in Austria (3.2), followed by Germany (4.1), and Finland (6.0). In Canada, the shortest median duration (in months) from regulatory approval to reimbursement was in British Columbia (17.3), Quebec (19.6) and Manitoba (19.6), while the longest duration was in P.E.I (38.5), followed by Nova Scotia (25.9), and Newfoundland (25.1). Conclusions Our comparative analysis found that relative to the EU Canadians had less frequent and timely access to therapies for rare diseases. This highlights the need for a rare disease strategy in Canada that allows for clear identification and transparent tracking of the pathway for rare disease drugs, and ultimately optimizes the number of patients with access to these therapies.

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Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 93%

An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries

Ward

Chambers

Mechichi

et al. 2022

Orphanet J Rare Dis

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Beschleunigte Zulassung von Arzneimitteln: Herausforderungen für Patient:innen, Datenqualität und faire Preise

Haas

Mayer

Tebinka-Olbrich

et al. 2021

Arzneimittel-Kompass 2021

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Zusammenfassung Zusammenfassung Beschleunigte Zulassungen stellen die Nutzenbewertung und Erstattung von Arzneimitteln vor besondere Herausforderungen. Der Artikel setzt sich in Form eines narrativen Reviews mit den Auswirkungen dieser Zulassungen auf Patient:innen, Angehörige der Gesundheitsberufe und die Solidargemeinschaft sowie mit den möglichen Lösungsstrategien auseinander. Die Autor:innen geben dazu anhand aktueller Literatur zunächst einen Überblick über die Zulassung von Arzneimitteln mit „conditional marketing authorisation“, „approval under exceptional circumstances“ sowie Orphan Drugs. Anschließend stellen sie den Einfluss beschleunigter Zulassungen auf die Nutzenbewertung dar und bewerten diesen. Zum Schluss beschreiben sie in diesem Zusammenhang Herausforderungen im Hinblick auf Arzneimittelpreise.

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Access to medicines in the United Kingdom: a document analysis regarding health technology assessment recommendations for innovative medicines (2017–2020)

Abbas,

Javid,

Babar

2024

Drugs Ther Perspect

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The Difference Between Regulatory And Market Access Decisions On Treatment Availability For New Drugs In Six Common Cancers Across Australia, Canada, And Europe

Cited by 4 publications

References 0 publications

An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries

An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries

Beschleunigte Zulassung von Arzneimitteln: Herausforderungen für Patient:innen, Datenqualität und faire Preise

Access to medicines in the United Kingdom: a document analysis regarding health technology assessment recommendations for innovative medicines (2017–2020)

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