6.5 Drug Review Process
Last updated on July 16, 2024General policy description
PharmaCare seeks to provide coverage for drugs that support the health and well-being of B.C. residents and that offer strong value for dollar.
Before a drug can be included in the PharmaCare formulary, it undergoes a thorough review to determine whether it meets these two requirements. The review process helps ensure the PharmaCare program remains fair, effective and sustainable.
Policy details
National and provincial drug review processes
Drug reviews have three stages.
Stage one – Health Canada
All drugs sold in Canada must have received a Health Canada Notice of Compliance (NOC). Before issuing an NOC, Health Canada reviews the
- Drug’s safety
- Effect of the drug when compared to taking no drug at all, and
- Quality of the drug's manufacturing process
>> Learn more about Health Canada’s drug review process.
Stage two – CADTH reimbursement review and recommendation
The CADTH drug reimbursement review process involves a thorough and objective evaluation of the clinical, economic, patient and clinician evidence on drugs, and uses these evaluations to provide reimbursement recommendations and advice to Canada's provincial and territorial drug plans, including BC PharmaCare.
Drug submissions reviewed by CADTH include new drugs introduced in Canada or new Health Canada-approved uses of existing drugs.
The review process considers
- How well the drug works when compared to similar drugs that are used to treat the same condition, and
- Whether the drug provides value for money
A team of independent experts is assembled to review each drug, and, based on their findings, the committee will issue a recommendation to cover the drug, cover it if certain conditions are met, or not cover it.
>> Learn more on the CADTH website.
Stage three – Ministry of Health drug review
The Ministry of Health conducts its own review before making a coverage decision. This review builds on the work done by Health Canada and CADTH.
>> Read more information about patented drug submission requirements
B.C. drug review process
The review process in B.C. involves two entities: the Drug Benefit Council (DBC) and the Ministry of Health.
>> Learn more about the Drug Benefit Council on the PharmaCare Drug Review web page.
The DBC is an independent advisory committee made up of nine professional members with expertise in critical appraisal, medicine, ethics, pharmacy and health economics, and three members from the public. Their task is to review drug submissions and make recommendations to the Ministry.
1. Drug Review Resource Committee (DRRC)
When the patented drug has gone through the necessary Health Canada and CADTH reviews, the Ministry starts its review. The Ministry sends the drug submission to the DRRC, a subcommittee of the DBC.
The DRRC establishes the review requirements, including requesting reports or other inputs required for each drug submission. The DRRC also assigns expert review teams, called Drug Review Resource Teams (DRRTs), to complete the required review reports for each drug submission.
Depending on what reviews have been done to date, requested reports may include clinical evidence, clinical practice and pharmacoeconomic reviews.
2. Drug Review Resource Teams (DRRT)
Each DRRT produces written reports on their assigned drugs and forwards these to the drug sponsor for review. The drug sponsor can submit written comments for the DBC to consider in its review.
This is one of the four points at which health professionals can become engaged in the review process. See Health industry professionals for details.
3. Patient input through Your Voice
The Ministry invites input from patients, caregivers and patient advocacy groups through Your Voice.
4. Drug Benefit Council (DBC)
All DRRT reports, drug sponsor written comments, patient input and other review documents are forwarded to the DBC.
The DBC reviews all the documents and makes a recommendation to the Ministry about covering the drug. The DBC recommendation includes
- Whether or not to cover the drug
- How to cover the drug (i.e., as a regular benefit or covered only under certain circumstances)
The DBC considers the following when making a recommendation:
- Available information about the clinical effect of the drug and health outcomes
- Whether it is good value for the people of B.C.
- Whether PharmaCare already covers a drug that works as well as this one
- Clinical practice and ethical implications
- Patient input
- The sponsor’s written comments on the DRRT review reports
- The recommendations of CADTH, when applicable
5. Ministry decision
In making its drug listing decision, the Ministry considers
- The DBC’s recommendation
- PharmaCare policy for this type of drug, and other Ministry programs
- Which PharmaCare plan(s) would cover the drug
- Whether PharmaCare has the resources to cover the cost of the drug
Conflict of interest guidelines
The Ministry is committed to a fair, independent, objective, and unbiased drug review process. All those who take part in the review of a drug submission, including members of the DBC, the DRRC, and the DRRTs, are held to the highest ethical standards when conducting their activities.
For this reason, all persons involved in the drug review process must declare any relationship they, or their immediate family, have that creates—or could appear to create—a conflict of interest. The need to disclose conflict of interest information is ongoing and is the responsibility of all involved in the review process.
The Ministry's Conflict of interest guidelines for the drug benefit review process (PDF, 32.6KB) state that "a conflict of interest may exist whenever a Participant or an Immediate Family Member of a Participant has a direct or indirect interest or relationship, financial or otherwise, with an Entity that may affect or reasonably appear to affect the objectivity or fairness of the Participant in the Drug Benefit Review Process."
Examples of information that need to be disclosed include: payments or research funds received from a company that may benefit from the drug review decision; financial ownership in such a company, being employed by such a company; and any arrangement or relationship through which the participant could either earn or lose money because of a Ministry drug coverage decision.
Individuals who declare possible conflict of interest information are not automatically excluded from participating in the drug review process.
Whether an individual is selected to participate or not depends upon the particular drug submission under review and is determined by the DBC and/or the DRRC. To select drug reviewers, the DRRC assesses the review requirements of the particular drug submission, the expertise of the potential reviewers, and the conflict of interest information declared by the reviewers. It is up to the DRRC to select the best reviewer without conflict of interest whenever possible. As such, the DRRC may select a reviewer with an identified conflict of interest after weighing the potential benefits and risks of including the participant in the review.
>> For full details, refer to the Ministry's Conflict of interest guidelines for the drug benefit review process (PDF, 32.6KB)
Ministry drug review timelines
When a drug needs a CADTH review, the Ministry starts its own review process when the CADTH process is complete (i.e., on the date CADTH issues its recommendation).
All other patented drug submissions start on the date the complete submission is received by the Ministry.
The Ministry's target timeline to a decision is defined as the time from when the Ministry begins its review to the time it publicly communicates its decision.
The target timeline to a decision for a standard review is 9 months. The timeline for a complex review is 12 months. A complex review involves extra requirements, such as developing clinical coverage criteria, developing a Special Authority form, discussions with the manufacturer, and/or other steps as required.
Priority reviews
A drug submission may be given priority status if it
- Was granted priority review status by CADTH, or
- Meets a significant clinical need and shows major therapeutic benefit, or
- Shows substantial economic benefit
Priority drug reviews will be completed within 6 months for standard submissions or 9 months for complex submissions.
Sponsor engagement in the drug review process
The Ministry provides the sponsor with four points of engagement during the drug review process:
A. Pre-DBC: when the Drug Review Resource Team (DRRT) reports are ready for comment
The sponsor may review the reports of the Drug Review Resource Teams (DRRT) and submit written DRRT report comments to the Ministry within ten (10) business days of receiving the reports. These comments will be included in the documentation forwarded to the DBC for review. The comments should
- Indicate whether there is agreement or disagreement with the reviewers report;
- Be evidence-based and referenced, citing material from the original drug submission; and
- Not introduce new clinical evidence
New clinical evidence included in manufacturer comments will not be considered by the DBC. If the manufacturer would like new clinical evidence considered by the DBC, the manufacturer must resubmit the drug submission to CADTH or to the Ministry for a non-CADTH submission.
B. Post-DBC: when the embargoed DBC recommendation and reasons for recommendation are ready for review
The sharing of the embargoed DBC Recommendation and Reasons for Recommendation is intended to improve the dialogue between the Ministry and the sponsor. The sponsor will be provided with an embargoed copy of the DBC Recommendation & Reasons for Recommendation after the DBC meeting subject to requirements of a confidentiality agreement.
At the time the embargoed DBC recommendation is released, the sponsor may file a Request for Reconsideration based on grounds that either
- The Ministry and/or the DBC did not follow the proper process; or
- The DBC recommendation is not supported by the evidence or input reviewed.
This written request, directed to the Director of Formulary Management, must be filed within five (5) business days of receiving the embargoed copy of the DBC Recommendation and Reasons for Recommendation.
The Request for Reconsideration will be composed of the reason and grounds for the request, the relief sought, and supporting evidence. A Request for Reconsideration cannot be made solely because the sponsor disagrees with the recommendation. The request must identify the aspect(s) of the DBC recommendation with which the sponsor disagrees.
No new information will be considered in the reconsideration as new information requires a resubmission.
Requests are examined by the Ministry DBC Secretariat in consultation with the DBC Chair to determine whether the issue(s) raised can be resolved in discussions with the sponsor. If the Ministry is unable to address the issues, the request will be forwarded to the DBC for reconsideration.
If the Ministry does not receive a request for reconsideration after five (5) business days, the embargoed Recommendation and Reasons for Recommendation will become final.
C. Pre-Ministry of Health decision: once the DBC recommendation becomes final but prior to implementation
Once a DBC Recommendation and Reasons for Recommendation document is made final, a sponsor may engage the Ministry within 10 business days by submitting a written statement to pharma@gov.bc.ca requesting a meeting with the Ministry before the listing decision is made and implemented.
The Ministry, at its discretion, may also initiate discussions with the sponsor.
If and when discussions are initiated, the target timeline to complete discussions is 25 business days from the day the final DBC recommendation is released. The target timeline may be adjusted upon mutual agreement.
D. Post-Ministry of Health decision: after the Ministry has implemented the decision
The sponsor may file a resubmission if new information becomes available that addresses the reasons for the decision. The resubmission should be made to CADTH for CADTH drug submissions.
For non-CADTH drug submissions, the Ministry has the discretion to determine whether the drug review reports will be made public (i.e., posted on the Ministry website) once a listing decision has been made. Prior to posting publicly, the submission sponsor will have 15 business days to review the final reports to request the non-disclosure of any specific portions that it deems to be of a confidential or proprietary nature. The timeframe may be adjusted on mutual agreement.
If the submission sponsor requests the confidential information be deleted, the Ministry will remove the confidential information by using “blacking out” redaction techniques.
Patient engagement in the drug review process
Through Your Voice, patients, caregivers, and patient groups can have input to the PharmaCare drug review process (PDF, 666KB).
Who can give input?
B.C. residents who can answer "yes" to any of the following questions for a drug on the Your Voice web page can give input:
- Do you have the medical condition for which the drug would be used?
- Are you a caregiver for someone who has that medical condition?
- Does your patient group represent patients who have that medical condition AND have you registered with PharmaCare to give input?
Drug submission requirements
Patented drug products
Drug submission sponsors are required to apply to the Ministry of Health to have their drug considered as a PharmaCare benefit. The following information outlines the submission requirements for patented drug products that must be submitted to the Ministry.
The Ministry makes PharmaCare coverage decisions based on a range of considerations, including existing PharmaCare policies, programs, therapeutic options, resources, and the evidence-informed recommendations of the Drug Benefit Council (DBC). The DBC's advice to the Ministry is based upon a review of many considerations, including available clinical and pharmacoeconomic evidence, clinical practice, patient and ethical considerations, and the recommendations of CADTH, when applicable.
In order for patented drug product submissions for new drugs, new combination products, and drugs with new indications to be considered by the Ministry, the submission must undergo an initial review by CADTH. Drug products that are designated as Subsequent Entry Biologics (SEBs) are also required to go through the CADTH process.
All other submissions, including those for line extensions and modification of criteria, should be submitted directly to the Ministry.
For detailed drug submission requirements for patented drug products, visit the Health industry professionals page.
General products
>> For information, see Section 5.6 to 5.12 of this manual.
Review timelines
The target timeline to a decision (time-to-decision) is defined as the time form when the Ministry begins its review to the time the Ministry publicly communicates its decision.
The time-to-decision for a standard review is 9 months and for a complex review is 12 months. Complex reviews may involve the need to develop clinical coverage criteria and/or a Special Authority form, to complete a Product Listing Agreement or other implementation steps.
For submissions reviewed by CADTH, the review start date is the issue date of the final Canadian Drug Expert Committee (CDEC) Recommendation and Reasons for Recommendation.
For other patented drug submissions (including line extensions and modification of criteria), the review start date is the date the complete submission is received by the Ministry.
For information on review periods for recently patented drugs, refer to the Quarterly Report on Completed Drug Submission Reviews (PDF, 466KB).
Submitting the documents
Sponsors are required to submit copies of their submissions to:
Director, Formulary Management
Pharmaceutical, Laboratory and Blood Services Division
Ministry of Health
PO Box 9652 Stn Prov Govt
1515 Blanshard St
Victoria BC V8W 9P4
Submissions that are emailed to the Ministry will not be accepted for review.
If a drug submission has incomplete information, PharmaCare will contact the manufacturer with a request to complete the submission. Incomplete submissions cannot be reviewed.