6.5 Drug Review Process

General Policy Description

Under the PharmaCare program, the Ministry of Health seeks to provide coverage for drugs that support the health and well-being of British Columbians and provide value for money.

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 that the PharmaCare program remains fair, effective, and sustainable.

Policy Details

National and provincial drug review processes

In Canada, drug review processes take place in three stages.

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 manufacturing process used to make the drug

>> For more information on Health Canada’s drug review process, visit www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php.

To have their patented drugs (including new drugs, new combination drugs, subsequent entry biologics (SEBs) and new uses for existing drugs) covered by public sector drug plans, drug sponsors must send a submission to the Common Drug Review (CDR), a process administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).

Drug submissions reviewed by the CDR include new drugs introduced in Canada or new Health Canada-approved uses of existing drugs.

The CDR process reviews

  • 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; based on their findings, a recommendation on whether or not drug plans should cover the drug is issued.

>> Learn more about CADTH and the CDR on their website at www.cadth.ca/en/products/cdr/cdr-overview

The Ministry of Health (the Ministry) conducts its own review before making its coverage decision. This review builds on the work done by Health Canada and the CDR process. The Ministry does not duplicate the work of the CDR.

>> See the PharmaCare website for more information on patented drug submission requirements

 

Review process in British Columbia

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.

British Columbian drug review process

When the patented drug has gone through the necessary Health Canada and CDR reviews, the Ministry starts its review process. 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.

Each DRRT produces written reports on their assigned drug and forwards them to the drug sponsor for review. The drug sponsor can submit written comments for the DBC to consider during their review.

This is one of the four points at which stakeholders can become engaged in the review process; see Health Industry Professionals for details.

The Ministry has implemented a process that lets British Columbian patients, caregivers and patient advocacy groups submit input on specific drug reviews.

>> Learn more at the Your Voice webpage.

All DRRT reports, drug sponsor written comments, patient input and other review documents are forwarded to DBC members for review at their meetings.

The DBC reviews all the documents and makes a recommendation to the Ministry about covering the drug under the PharmaCare program. The DBC recommendation includes

  • Whether or not to cover the drug
  • How to cover the drug (i.e., a regular benefit for everyone or covered only under certain circumstances as a Limited Coverage benefit)

The DBC considers the following when making a recommendation:

  • Available information on the clinical effect of the drug and health outcomes
  • Whether it is good value for the people of British Columbia
  • Whether PharmaCare already covers a drug or drugs that work as well as this one
  • Clinical practice and ethical considerations
  • Patient input
  • The sponsor’s written comments on the DRRT review reports
  • The recommendations of the national Common Drug Review, when applicable

In making its drug listing decision, the Ministry considers

  • The DBC’s recommendation
  • PharmaCare policy for this type of drug and other programs that exist in the Ministry
  • Which PharmaCare plans 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.

Ministry guidelines for the drug 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 see the Ministry’s Conflict of Interest Guidelines and forms (PDF, 32.6KB)

Ministry drug review timelines

When a drug needs a CDR review, the Ministry starts its own review process when the CDR process is complete (i.e., on the date when the CDR issues its final 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 (time-to-decision) is defined as the time from which the Ministry begins its review to the time that the Ministry publicly communicates its decision and usually includes completing all implementation steps.

The target timeline to a decision for a standard review is nine (9) months. The timeline for a complex review is twelve (12) months. A complex review usually includes extra requirements, such as having to develop clinical coverage criteria, develop a Special Authority form, complete discussions with a pharmaceutical manufacturer, and/or complete other implementation steps as required.

Priority reviews

A drug submission may be given priority status if it

  • Was granted priority review status by CDR, or
  • Meets a significant clinical need and shows major therapeutic benefit, or
  • Shows substantial economic benefit

Priority drug reviews will be completed within six (6) months for standard submissions or nine (9) months for complex submissions.

Sponsor engagement in the drug review process

Upon receipt of a drug submission, the Ministry provides the sponsor with the following four points of engagement during the drug review process:

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 will need to resubmit the drug submission to the Common Drug Review (CDR) for a CDR submission or to the Ministry for a non-CDR 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.

Once a DBC Recommendation and Reasons for Recommendation document is made final, a sponsor may engage the Ministry within ten (10) business days of this final document being issued by submitting a written statement to pharma@gov.bc.ca requesting a meeting with the Ministry before the listing decision and its implementation occurs.

The Ministry, at its discretion, may also initiate discussions with the sponsor.

If and when discussions are initiated, the target time frame to complete discussions is within 25 business days after the final DBC recommendation is released. The target timeline may be adjusted upon mutual agreement.

The sponsor may file a resubmission if new information becomes available that addresses the reasons for the decision. The resubmission should be made to the Common Drug Review (CDR) process for CDR drug submissions.

For non-CDR drug submissions, the Ministry has the discretion to determine whether the drug review reports will be made publicly available (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 time frame 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 the Your Voice website, patients, caregivers, and patient groups can add their voice to the B.C. PharmaCare drug review process (PDF, 666 KB).

Who is eligible to give input?

B.C. residents who can answer "yes" to any of the following questions for a drug available for input through the Your Voice website can give their input: 

  • Do you have the medical condition for which the drug would be used?
  • Are you a caregiver to 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 (sponsors) are required to apply to the Ministry of Health (the Ministry) to have their drug product 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 an independent advisory body called the Drug Benefit Council (DBC). The DBC's advice to the Ministry is based upon a review of many considerations, as well as available clinical and pharmacoeconomic evidence, clinical practice, patient and ethical consideration, and the recommendations of the national Common Drug Review (the CDR), 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 the CDR. Drug products that are designated as Subsequent Entry Biologics (SEBs) are also required to go through the national CDR 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, please see

General products

>> For information, see the 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 nine (9) months and for a complex review is twelve (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 the CDR, 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 Drug Review Timelines (PDF, 852KB).

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 e-mailed 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.

Tools and Resources