FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment
Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for F...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-01-01
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| Series: | Current Oncology |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1718-7729/29/2/36 |
| _version_ | 1797481439206309888 |
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| author | Cheryl Ho Howard J. Lim Dean A. Regier |
| author_facet | Cheryl Ho Howard J. Lim Dean A. Regier |
| author_sort | Cheryl Ho |
| collection | DOAJ |
| description | Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA’s AA of malignant hematology and oncology from January 2000–December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada’s approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada. |
| first_indexed | 2024-03-09T22:14:36Z |
| format | Article |
| id | doaj.art-ba95e61053b94117b9bebb4846cb2478 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-09T22:14:36Z |
| publishDate | 2022-01-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-ba95e61053b94117b9bebb4846cb24782023-11-23T19:26:21ZengMDPI AGCurrent Oncology1198-00521718-77292022-01-0129240241010.3390/curroncol29020036FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian EnvironmentCheryl Ho0Howard J. Lim1Dean A. Regier2Department of Medical Oncology, BC Cancer, Vancouver, BC V5Z 4E6, CanadaDepartment of Medical Oncology, BC Cancer, Vancouver, BC V5Z 4E6, CanadaCancer Control Research, BC Cancer Research Institute, Vancouver, BC V5Z 1L3, CanadaAccelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA’s AA of malignant hematology and oncology from January 2000–December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada’s approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada.https://www.mdpi.com/1718-7729/29/2/36accelerated approvalFDAHealth Canadahealth technology assessmentCADTH |
| spellingShingle | Cheryl Ho Howard J. Lim Dean A. Regier FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment Current Oncology accelerated approval FDA Health Canada health technology assessment CADTH |
| title | FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment |
| title_full | FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment |
| title_fullStr | FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment |
| title_full_unstemmed | FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment |
| title_short | FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment |
| title_sort | fda accelerated approval for malignant hematology and oncology indications in the canadian environment |
| topic | accelerated approval FDA Health Canada health technology assessment CADTH |
| url | https://www.mdpi.com/1718-7729/29/2/36 |
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