The Pathway for New Cancer Drug Access in Canada
Round 1
Reviewer 1 Report
The article is very interesting and describes appropriately the complex process for approval, evaluation, funding, and use of new cancer drugs in Canada.
Comments on the article are minor.
Perhaps the most appropriate title should be the pathway for new cancer drug approval, evaluation and funding in Canada.
The authors should clarify the relationship between Health Canada (HC) and Health Products and Food Branch (HPFB). HPFP appears to be the specific regulatory agency in Canada that evaluates new drugs with similar function to the FDA in the United States, and the EMA in the European Union. If so and if not, then this should specify.
It should be explained what the Canadian Public Plans are and what the difference are between the province territories plans and the federal drug programs.
It is commented that the Canadian Agency for Drugs and Technologies in Health (CADTH) evaluates the clinical evidence (efficacy and safety) but it is not commented that it also evaluates the patient input, drug plan input, economic evidence (costs and cost-effectiveness, and budget impact), as well as ethical considerations of the new cancer drugs.
The discussion should briefly comment on the main similarities and differences in the pathway for new cancer drugs approval and funding between Canada and other developed countries with National Health Services.
The authors reported the lack of transparency in the process, but authors not reported that the pharmaceutical companies establish as a condition that this negotiation process to funding the new drugs is confidential.
In addition, the costs of new cancer drugs are becoming more and more expensive, often with uncertainty about the magnitude of the clinical benefit, and with a very high cost-effectiveness ratio. Therefore, this explains why the negotiation process and decision-making on funding new cancer in Public Health Plans is a long and very difficult process.
The article is very interesting and describes appropriately the complex process for approval, evaluation, funding, and use of new cancer drugs in Canada.
Comments on the article are minor.
Perhaps the most appropriate title should be the pathway for new cancer drug approval, evaluation and funding in Canada.
The authors should clarify the relationship between Health Canada (HC) and Health Products and Food Branch (HPFB). HPFP appears to be the specific regulatory agency in Canada that evaluates new drugs with similar function to the FDA in the United States, and the EMA in the European Union. If so and if not, then this should specify.
It should be explained what the Canadian Public Plans are and what the difference are between the province territories plans and the federal drug programs.
It is commented that the Canadian Agency for Drugs and Technologies in Health (CADTH) evaluates the clinical evidence (efficacy and safety) but it is not commented that it also evaluates the patient input, drug plan input, economic evidence (costs and cost-effectiveness, and budget impact), as well as ethical considerations of the new cancer drugs.
The discussion should briefly comment on the main similarities and differences in the pathway for new cancer drugs approval and funding between Canada and other developed countries with National Health Services or Public Health Plans.
The authors reported the lack of transparency in the process, but authors not reported that the pharmaceutical companies establish as a condition that this negotiation process to funding the new drugs is confidential.
In addition, the costs of new cancer drugs are becoming more and more expensive, often with uncertainty about the magnitude of the clinical benefit, and with a very high cost-effectiveness ratio. Therefore, this explains why the negotiation process and decision-making on funding new cancer in Public Health Plans is a long and very difficult process.
Author Response
Please see attached file.
Author Response File: 
Author Response.docx
Reviewer 2 Report
This article is intended to describe the tortuous process for approving and funding new cancer drugs in Canada. It largely achieves its objective.
I have 2 general criticisms:
1. The authors discuss the role of the PMPRB just after describing the regulatory role of Health Canada, which some reading may assume that the PMPRB's job starts after Health Canada approval. The PMPRB starts its work once a drug is sold in Canada, which can be at any stage between regulatory approval if purchased by a patient out-of-pocket and after funding approval by a province. This means that manufacturers price their drug for the first sale but this may be rejected by the PMPRB and a lower price required, which can create uncertainty for manufacturers. This issue should be mentioned.
2. The authors also do not discuss the fact that CADTH and INESSS are both creatures of their funding governments. Thus, although they claim to be independent agencies, they are in fact providing recommendations for the governments that own, fund and manage them, which is a conflict of interest. This fact should be mentioned in the article.
I have some small issues:
- On lines 64 and 65, the authors say "drugs rejected by pCPA participating plans ...". The pCPA does not "reject" drugs. Do they mean drugs for which the pCPA decides not to negotiate or drugs for which a successful negotiation could not be reached? Greater clarity in what they mean is required.
- On lines 105-112, the authors describe Project Orbis but do offer any comment on the project's benefits or outcomes. Only on line 118 do they mention the project again. Have there been any results or benefits from Project Orbis or is it still an unknown?
- The authors mention that the system leads to variation in access across Canada in terms of coverage, timeliness of coverage and how much patients have to pay. Can they provided concrete examples to illustrate these differences?
- Finally, the font changes in several places.
Author Response
Please see attached file.
Author Response File: Author Response.docx
