Evidence Building Program (EBP)

For a cancer drug to be included in the program there must be developing, but incomplete evidence of benefits. This allows Cancer Care Ontario to fund the drug on a time-limited basis to collect real-world data on its clinical and cost effectiveness. This data will be used by the Ministry of Health and Long-Term Care to help bring about a final change to existing funding criteria. The duration of funding through the program depends on many factors, including how many patients are treated with the drug for this diagnosis and the time required to collect and analyze the real-world data. 

To receive drug coverage under the program, patients must be residents of Ontario and have a valid Ontario Health Card. Reimbursement is for the drug costs of those patients who meet the program eligibility criteria for the specific approved cancer drug. Patients do not have to pay anything to participate in the program.

If you are a patient and want to know whether or not you meet the eligibility criteria for Evidence Building Program drug funding, we recommend that you speak with your healthcare team. Any forms that may need to be filled out during the process will be completed by your doctor.

The following drugs are currently covered by the EBP:

• Trastuzumab (Herceptin): when used in conjunction with chemotherapy, this drug is used to treat breast tumours of less than or equal to 1 centimetre in women who are node negative and HER2 positive.
• Oxaliplatin: when used in combination with surgery for the treatment of metastatic colorectal cancer for specific conditions.

Cancer Care Ontario continues to collaborate with the Ministry of Health and Long‐Term Care, and provincial disease site drug advisory committees to introduce other drugs into the EBP.

Program Inclusion Criteria

The inclusion criteria determines which drugs/indications will be considered under the EBP. Drugs that do not meet all of the inclusion criteria will not be considered for EBP funding:

• The drug must have been reviewed provincially or at the pan-Canadian level. 
• The drug currently must be funded publicly and the indication for which funding is being sought is an extension/expansion/modification of the current funding criteria. 
• There must be questions about a drug’s clinical- or cost-effectiveness in a specific patient population (beyond the current reimbursement criteria) that can be resolved through the collection of real-world utilization data over the proposed study period. For example, if the issue is one of cost-effectiveness or budget impact that can be resolved through other mechanisms, such as a product listing agreement, the drug would not be considered under the EBP.
• The collection and analysis of the real-world data is expected to be sufficient to inform a future funding decision.
• There are no studies underway that are expected to address the issue within the EBP funding period. 
• The disease site drug advisory committee supports inclusion of the drug in the EBP.
• Research ethics board approval is not required. 

Required Information

Patient demographic, clinical provider and healthcare facility information is required for any New Drug Funding Program (NDFP) reimbursement.

This information is submitted to Cancer Care Ontario, which administers the EBP, for the purposes of determining a patient’s eligibility to have his/her cancer treatment funded. As is the case with all NDFP drugs, the eligibility criteria must be met, but this program also requires prior approval to participate (to get funding) and may require the submission of additional patient clinical information. Patient outcome data may be requested over the course of the patient’s involvement with the EBP.

Required Documents

There are several documents that must be submitted as part of the enrolment and reimbursement process:

• Completed enrolment forms and supporting clinical documents (when required), must be submitted by the prescribing healthcare provider before treatments begin.
• Treatment claims and supporting documentation, if applicable, must be submitted to Cancer Care Ontario according to the monthly submission schedule.
• All enrolment forms, treatment claims and supporting clinical documents must be submitted through Cancer Care Ontario’s eClaims – a web-based tool for submitting reimbursement claims.

To find the eligibility forms for a particular drug, go to the Drug Formulary and use the search or refine filters to find the relevant drug. The drug listing will indicate if the drug is funded through the Evidence Building Program. Select the drug name to view drug information and forms.

As a condition of participating in the program, supplemental forms are required and must be submitted at specific times to ensure continued reimbursement. Supplemental forms are also required following the completion of therapy. They assist with continued real-world data collection, in order to do the analyses that inform permanent funding decisions.

Please see Supplemental Forms for respective Evidence Building Program drugs in eClaims for additional detail. Only current eClaims users will be able to access and see these forms.

Requests for drug funding through the New Drug Funding Program or Evidence Building Program may not be approved if the patient does not meet eligibility criteria. The program will accept a request for a resubmission or appeal, to be considered on a case-by-case basis.

Information on the eligibility criteria, filing process and review process are detailed in the NDFP/EBP Resubmissions and Appeals Policy. Resubmissions and appeals must be submitted by the most responsible physician or delegate.

Evidence Building Program Policy 

Read the Evidence Building Program policy for information on the program’s objectives, principles and inclusion criteria.

View Evidence Building Program Policy

Summary and Response to Stakeholder Consultation

This document summarizes the consultations that were held with clinicians, researchers, pharmacists, industry, associations, members of the public and academia during the development of the Evidence Building Program policy. 

View Summary and Response to Stakeholder Consultation, 2011

Cancer Drug Funding and Administration in Ontario

Find an overview of the drug evaluation process in Ontario and the steps required before a cancer drug becomes a publicly-funded benefit in Ontario.

View Backgrounder: Cancer Drug Funding and Administration in Ontario

Program Status: EBP Trastuzumab (Herceptin) Update

The document provides an update on the status of the EBP trastuzumab (Herceptin) policy, including a summary of data collected during the period from May 2011 to March 2013.

View Program Status: EBP Trastuzumab (Herceptin) Update, July 2013