Drug reviews

In Canada, the drug review process has three stages.

Stage 1

All patented and generic drugs sold in Canada require a Notice of Compliance (NOC). The NOC is issued by Health Canada after a review of the drug’s safety, effectiveness and manufacturing quality. Health Canada’s review can take between one and two years.

Stage 2

Stage 2 is a review by the Canada's Drug Agency (CDA). Drug manufacturers must submit applications for

• New chemical and biologic entities
• New combination drugs
• New indications
• Biosimilars

Generic drugs are not reviewed by Canada's Drug Agency since they are copies of patented drugs, which have already been reviewed.

CDA reviews patient input and prepares clinical and pharmacoeconomic evidence reports. The reviews, related input and reports are sent to the Canadian Drug Expert Committee (CDEC), an advisory body to CDA.

CDEC makes a recommendation to CDA based on how well the drug works compared to similar drugs used to treat the same condition, and whether the drug provides value for money. CDEC advises provincial plans to do one of the following:

• Provide coverage
• Provide coverage with clinical criteria
• Not provide coverage

The pan-Canadian Pharmaceutical Alliance Process

Once CDA releases its final recommendation based on the advice of CDEC, the pan-Canadian Pharmaceutical Alliance (pCPA) begins negotiations with the drug manufacturer. Provinces and territories participating in negotiations collaborate to achieve better value for brand-name and generic products.

Stage 3

PharmaCare conducts its own drug review before making a final coverage decision. Drugs are submitted to CDA and PharmaCare at the same time. Only drugs submitted to PharmaCare can be covered by PharmaCare.

CDA begins its review and the Drug Benefit Council (DBC) – an independent drug coverage advisory committee working on behalf of PharmaCare – conducts an initial screening. If the drug is similar to drugs that have already gone through a PharmaCare review,  PharmaCare will review the drug without CDA.

The DBC conducts a full review if any of the following applies:

• The drug is a new chemical entity
• The submission is a new combination of approved drugs
• The submission is an approved drug being used for a new indication
• The submission is a subsequent entry biologic (biosimilar)
• The DBC deems a full review would be beneficial

A full review only begins after the CDA review is complete.

Once the DBC has completed its review, it makes a coverage recommendation to PharmaCare. PharmaCare makes a coverage decision after considering the following:

• PharmaCare policy
• If the drug could be covered by other Ministry of Health programs
• Which PharmaCare plans would cover the drug
• Whether PharmaCare has the available budget resources to cover the drug
• The outcome of pCPA negotiations (where applicable)

Resources

• Drug Review Process in B.C. – Detailed (PDF, 343KB)
• Drug Review Process Swim Lane Diagram (PDF, 138 KB)
• Quarterly Report on Completed Drug Submission Reviews (PDF, 466KB)
• Quarterly Report on Completed Drug Submission Reviews, January 2023 (PDF, 1.1MB)
• Drug Review Decisions

Drug manufacturers submitting drugs may provide input at four points along the review process:

1. After the CDA review

CDEC, the advisory body that reviews findings and makes a recommendation to CDA, shares an embargoed drug coverage recommendation and reasons for the recommendation with provincial drug plans and the drug manufacturer.

The drug manufacturer can then provide PharmaCare with objective feedback on the CDEC recommendation. Feedback must be evidence-based and referenced, indicate whether the manufacturer agrees or disagrees with the CDEC recommendation and cannot introduce new clinical evidence. This feedback is considered during the PharmaCare review.

2. After review by the DBC

The DBC releases their embargoed recommendation and clinician reviewer reports (made anonymous) to the drug manufacturer. The manufacturer can request reconsideration of the DBC decision only if

• PharmaCare or the DBC did not follow the proper process, or
• The DBC recommendation is not supported by the evidence or input reviewed

New information, including new clinical evidence, does not permit reconsideration. It may, however, be grounds for resubmission.

Requests for reconsideration can be submitted to DrugReviewProcess@gov.bc.ca. The request must be made within 10 business days of the drug manufacturer receiving the DBC’s embargoed information.

If a request for reconsideration is not received, the DBC finalizes its recommendation.

3. Before PharmaCare makes a coverage decision

PharmaCare makes a coverage decision within 10 days of the DBC finalizing its recommendation. Drug manufacturers can request a meeting with PharmaCare to discuss the DBC recommendation and related issues during this time by submitting a written statement to pharma@gov.bc.ca 

PharmaCare can also initiate discussions with the drug manufacturer during this period.

4. After PharmaCare makes a coverage decision

Drug manufacturers can file a resubmission if new information becomes available that addresses the reasons for PharmaCare’s coverage decision.

Drug manufacturers also review reports created during the review process before PharmaCare makes them public. Drug manufacturers have 15 days to request the non-disclosure of specific information they consider confidential or proprietary. The information will be redacted before the documents are made public. The 15-day period can be adjusted upon mutual agreement between PharmaCare and the drug manufacturer.

Clinicians can contribute their expertise to the drug review process in the form of clinical reviewer reports.

These reports may involve:

1. Reviewing documents for the drug. You may submit drug review summaries, a budget analysis, clinical review reports, CDA drug listing recommendations or pharmacoeconomic reviews.

2. Preparing a concise 3-5 page review responding to specific questions about your experience or the experiences of your peer group. You will not be asked to re-write or prepare clinical trials.

3. Advising on other factors, such as desired treatment outcomes, standard treatment options, treatment impact, available clinical evidence, appropriate patients to receive the drug, potential product use, or clinical trial data not included in the DBC materials.

4. Discussing whether the review documents reflect what you see or expect to see in patients in B.C. For example, do the incidence, disease prevalence, diagnosis, natural disease history, patient populations and standards of therapy reflect the B.C. population?

5. Indicating your agreement or disagreement with the CDA recommendation.

6. Sending additional information you think the DBC should take into account.

Maintenance of Certification and Mainpro credits

Clinical practice review reports can be used as credits for the Maintenance of Certification Program (MOC Program) or Maintenance of Proficiency (Mainpro®) program.

Clinicians who complete reports can claim 15 credits once per year under Section 2 – Systems Learning: Peer Review in their MAINPORT ePortfolio.

An additional two credits per hour can be claimed if you must research or review materials and gain further knowledge as part of preparing the report. Additional credits are claimed under Section 2 – Personal Learning Project. You will be asked to identify the subject of the research, the date you conducted the research, and the impact the learning had on your practice.

One credit per hour of participation can be listed in your Mainpro® portfolio under Mainpro-M2 activities.

How are reviewers selected?

The DBC selects a clinician to prepare a clinical practice review report based on the drug submission being reviewed. The DBC considers

• The requirements of the drug submission
• The expertise of the potential reviewer
• Conflicts of interest

If possible, the DBC selects a clinician without a conflict of interest. However, the DBC may select a reviewer despite a conflict of interest after weighing the potential benefits and risks.

If you are interested in becoming a clinical practice reviewer, submit your name, contact information, areas of specialization and expertise to DrugReviewProcess@gov.bc.ca

Resources

• PharmaCare drug data files
• PharmaCare Formulary Search 
• PharmaCare publications

Patented drug products and biosimilars 

Before submitting, review the appropriate checklist to make sure you are including everything required. Incomplete submissions will not be reviewed.

Dropbox

• Dropbox is a secure online file storage service. Request access to Dropbox by emailing DrugReviewProcess@gov.bc.ca

Email

• Compress: Remove non-essential graphics and compress the submission, preferably using Microsoft Windows
• Rename: Rename the compressed file to remove the .zip extension. Government email programs reject emails with a .zip attachment
• Encrypt: Encrypt the submission package using AES-128 encryption standards or better, preferably using Microsoft Windows
• Submit: Send the compressed, encrypted file to DrugReviewProcess@gov.bc.ca. Send the decryption password to the same address in a separate email. Drug Review staff will confirm they have received the submission

Submission checklists

• Submissions for patented drug products and biosimilars
• Submitting price changes

Submissions must meet the criteria on these checklists:

• Patented drugs submission checklist (PDF, 131KB) 
• Biosimilars submission checklist (PDF, 188KB) and biosimilars submission template (PDF, 1.576MB)
• Modification of current coverage criteria submission checklist (PDF, 117KB)
• Line extensions submission checklist (PDF, 117KB)
• Blood glucose test strips submission checklist (PDF, 105KB) 

Generic drug products

• Submissions for generic drug products
• Generic drug products checklist
• Submitting price changes

As of July 31, 2023, PharmaCare and the province’s health authorities are piloting a joint drug review process. Aligned formularies will help ensure that patients have timely access to high quality, appropriate, and cost-effective pharmaceutical therapies and services.

Only drugs of interest to HAs will undergo a joint drug review with PharmaCare.

Benefits of the aligned review process include:

• Pooled resources, including patient input through YourVoice and clinical input from throughout the province
• Reduced duplication of work
• Joint price negotiations
• Improved patient care at transition points

The pilot was launched on July 31, 2023, and is continually being evaluated, with improvements and adjustments made to ensure its success.

The Drug Benefit Council (DBC) is an independent advisory body that makes evidence-informed recommendations to the Ministry of Health about listing drugs in the PharmaCare formulary.

The DBC is made up of 12 members: 9 professional members with expertise in critical appraisal, medicine, ethics, pharmacy and health economics; and 3 public members. The full list of members is available at the Directory of Agencies. The Drug Review Resource Committee (DRRC), a subcommittee of the DBC, is made up of four members from the DBC. For their remuneration details, view Drug Benefit Council Fees (PDF, 72KB). 

DBC members are held to the highest ethical standards when conducting reviews and making recommendations. Their activities are governed by the DBC’s Terms of Reference (PDF, 51KB). All individuals involved in the drug benefit review process, including DBC members, are subject to the process's Conflict of Interest Guidelines (PDF, 33KB).