Introduction

In a move to build more consistent review of cancer drugs across the country, a collaboration of all provinces (except Quebec) is introducing a cross-jurisdictional process for a single review of cancer drugs.

The Joint Oncology Drug Review (JODR), implemented on March 1, 2007 will be in place for approximately one and a half years, after which an evaluation will take place and recommendations for a permanent cross-jurisdictional process will be made to the Deputy Ministers of Health. All participating provinces will have access to recommendations made by both the Committee to Evaluate Drugs (CED) and the CED-Cancer Care Ontario (CCO) Subcommittee with respect to the listing of oncology drugs effective March 1, 2007. The final funding decision for all oncology drugs reviewed through this interim process will remain the responsibility of each participating jurisdiction.

During this interim process, all drugs used for active treatment of cancer will be submitted through Ontario and follow the Ontario Guidelines for Drug Submission and Evaluation. The Canadian Agency for Drugs and Technologies in Health (CADTH) will not be accepting submissions for ambulatory based oncology drugs through the Common Drug Review (CDR) process until further notice. Submissions for supportive agents will not be reviewed through the JODR process; submissions for these products should continue to be made to CDR if they are ambulatory new chemical entities (NCE’s) funded through public drug plans, or directly to the provinces through their respective established processes if they are non-CDR drugs. CDR will continue to provide clinical and pharmacoeconomic reviews for ambulatory NCE’s used in active cancer treatment for the JODR.

Process

The following provinces are participating in the interim JODR process: Manitoba, Saskatchewan, British Columbia, Alberta, Nova Scotia, Newfoundland, Prince Edward Island and New Brunswick. Representatives from participating JODR provinces observe the discussions during Ontario’s CED-CCO Subcommittee and CED meetings.

• For further details and submission requirements for an ambulatory oncology drug product, please refer to the Ontario Guidelines for Drug Submission and Evaluation.
• For details and submission requirements for an intravenously administered oncology drug product, please refer to the Committee to Evaluate Drugs/Cancer Care Ontario (CED/CCO) Joint Drug Review Process and Guidelines for Drug Submission to the New Drug Funding Program Formulary.

In addition to the requirements specified in the guidelines, each drug submission must be accompanied by unlocked (or executable) copies of the pharmacoeconomic model and budget impact analysis (BIA) model that can be manipulated. The following must also be included :

• Details of the methods used in the modeling exercise;
• Basic user information to enable manipulation of the model including the ability to vary individual parameters, view the calculations and run the model to generate results.

Once a submission is screened, a Notice of Drug Submission Status (NDSS) is issued by the Ontario Public Drug Programs (OPDP). After a submission is deemed complete by the OPDP, the manufacturer is required to provide one complete copy of the drug submission, including a BIA specific to that province, to the provincial drug program and cancer agency in each JODR participating province. In addition, for ambulatory NCE’s, the manufacturer is required to provide six copies of the drug submission to CDR within five days of receipt of the NDSS.

Please do not include assumptions from the BIA or any conditional listing proposals in the pharmacoeconomic analysis – these should be submitted confidentially to the Executive Officer, Ontario Public Drug Programs.

All completed drug submissions will be reviewed by Ontario’s CED-CCO Subcommittee with CCO’s Program in Evidence-Based Care (PEBC) guidelines incorporated. For further information regarding the PEBC guideline, please visit CCO’s website.

The CED-CCO Subcommittee includes membership from both the CED and CCO. The Subcommittee reviews, evaluates, and provides advice to the CED on which products should be reimbursed through either the Ontario Drug Benefit (ODB) program or CCO’s New Drug Funding Program (NDFP).

Cancer drugs reviewed by the interim JODR process since March 2007

Additional information is available in the Submission Guidelines for Oncology Drugs.