Yuting Zhang1, Hana Chantel Hueser2, Inmaculada Hernandez3. 1. 1 Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania. 2. 2 Department of Biological Sciences, Dietrich School of Arts and Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania. 3. 3 Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania.
Abstract
BACKGROUND: Global pharmaceutical sales for anticancer drugs were $74.4 billion in 2014, ranking first for drugs by therapeutic class. Countries may differ substantially in the approval and coverage decisions for anticancer drugs. OBJECTIVE: To compare the approval and coverage decisions for new anticancer drugs between the United States and 4 other countries: the United Kingdom, France, Australia, and Canada. METHODS: We identified all new anticancer drug indications approved by the FDA between January 1, 2009, and December 31, 2013. For each country, we reviewed the organizations, processes, criteria, and special considerations used to make approval and coverage decisions for the drug indications approved. We further quantified and compared the variations across the 5 countries in the approval and coverage decisions as of June 30, 2014, for new anticancer drug indications. RESULTS: "Of 45 anticancer drug indications approved in the United States between January 1, 2009, and December 31, 2013, 67% (30) were approved by the European Medicines Agency, and 53% (24) were approved in Canada and Australia before December 31, 2013. The U.S. Medicare program covered all 45 drug indications, and as of June 30, 2014, the United Kingdom covered 87% (26) of those approved in Europe- 58% (26) of the drug indications covered by Medicare. France, Canada, and Australia covered 42% (19), 29% (13), and 24% (11) of the drug indications covered by Medicare, respectively". [corrected]. CONCLUSIONS: Approval and reimbursement decisions vary substantially by country. The United States had the fewest access restrictions, and Australia was the most restrictive of the 5 countries that were examined. DISCLOSURES: No outside funding supported this study, and the authors report no conflicts of interest. Study concept and design were contributed primarily by Zhang, along with Hernandez and Hueser. All authors participated in data collection, and data interpretation was performed by Zhang and Hernandez, along with Hueser. The manuscript was written and revised by Zhang and Hernandez, along with Hueser.
BACKGROUND: Global pharmaceutical sales for anticancer drugs were $74.4 billion in 2014, ranking first for drugs by therapeutic class. Countries may differ substantially in the approval and coverage decisions for anticancer drugs. OBJECTIVE: To compare the approval and coverage decisions for new anticancer drugs between the United States and 4 other countries: the United Kingdom, France, Australia, and Canada. METHODS: We identified all new anticancer drug indications approved by the FDA between January 1, 2009, and December 31, 2013. For each country, we reviewed the organizations, processes, criteria, and special considerations used to make approval and coverage decisions for the drug indications approved. We further quantified and compared the variations across the 5 countries in the approval and coverage decisions as of June 30, 2014, for new anticancer drug indications. RESULTS: "Of 45 anticancer drug indications approved in the United States between January 1, 2009, and December 31, 2013, 67% (30) were approved by the European Medicines Agency, and 53% (24) were approved in Canada and Australia before December 31, 2013. The U.S. Medicare program covered all 45 drug indications, and as of June 30, 2014, the United Kingdom covered 87% (26) of those approved in Europe- 58% (26) of the drug indications covered by Medicare. France, Canada, and Australia covered 42% (19), 29% (13), and 24% (11) of the drug indications covered by Medicare, respectively". [corrected]. CONCLUSIONS: Approval and reimbursement decisions vary substantially by country. The United States had the fewest access restrictions, and Australia was the most restrictive of the 5 countries that were examined. DISCLOSURES: No outside funding supported this study, and the authors report no conflicts of interest. Study concept and design were contributed primarily by Zhang, along with Hernandez and Hueser. All authors participated in data collection, and data interpretation was performed by Zhang and Hernandez, along with Hueser. The manuscript was written and revised by Zhang and Hernandez, along with Hueser.
Authors: V Higenell; R Fajzel; G Batist; P K Cheema; H L McArthur; B Melosky; D Morris; T M Petrella; R Sangha; M F Savard; S S Sridhar; J Stagg; D J Stewart; S Verma Journal: Curr Oncol Date: 2019-04-01 Impact factor: 3.677
Authors: David O'Reilly; Ronan McLaughlin; Cian Ronayne; Anne Marie De Frein; Bojan Macanovic; Ryan W Chu; Sinead A Noonan; Roisin M Connolly; Derek G Power; Richard M Bambury; Seamus O'Reilly; Dearbhaile Catherine Collins Journal: Ir J Med Sci Date: 2022-04-21 Impact factor: 1.568