Health Industry Professionals
BC PharmaCare reviews patented drugs, generic drugs, biologics and biosimilars that have been submitted for coverage consideration by drug manufacturers. This review ensures that PharmaCare coverage is fair, effective and sustainable. Only drugs submitted by the manufacturer are considered for coverage.
The information presented here is for pharmaceutical professionals, physicians and other medical practitioners interested in how drugs are reviewed and approved for coverage in B.C.
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 Canadian Agency for Drugs and Technologies (CADTH) Common Drug Review (CDR). Drug manufacturers must submit applications for
- New chemical and biologic entities;
- New combination drugs;
- New indications; and
- Biosimilars.
Generic drugs are not reviewed by the CDR since they are copies of patented drugs, which have already been reviewed.
The CDR 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 CADTH.
CDEC makes a recommendation to CADTH 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 either
- Provide coverage
- Provide coverage with clinical criteria, or
- To not provide coverage.
pan-Canadian Pharmaceutical Alliance Process
Once CDR 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 and generic products.
Stage 3
PharmaCare conducts its own drug review before making a final coverage decision. Drugs are submitted to the CDR and PharmaCare at the same time. Only drugs submitted to PharmaCare can be covered by PharmaCare.
The CDR 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 the DBC.
The DBC conducts a full review if
- 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); or
- the DBC deems a full review beneficial.
A full review only begins after the CDR is complete.
Once the DBC has completed its review, it makes a recommendation to PharmaCare on coverage.
PharmaCare takes the DBC recommendation and makes a final coverage decision after considering
- PharmaCare policy;
- if the drug could be covered by other programs in the Ministry of Health;
- which PharmaCare plans would cover the drug;
- whether PharmaCare has the resources to cover the cost of the drug; and
- the outcome of pCPA negotiations (if applicable).
Resources
Submitting generic drugs, patented drugs, biologics, and biosimilars to BC PharmaCare requires different documentation.
Drug manufacturers submitting drugs may provide input at four points in the review process:
1. After the Common Drug Review (CDR)
CDEC, the advisory body that reviews findings and makes a recommendation to CADTH, 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 BC 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 BC 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 electronically to DrugReviewProcess@gov.bc.ca. The request must be submitted within ten 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 ten days of the DBC finalizing its recommendation. Drug manufacturers can request a meeting with BC PharmaCare to discuss the DBC recommendation and related issues during this time.
Submit a written statement to pharma@gov.bc.ca to request a meeting.
PharmaCare can also initiate discussions with a 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.
The report may involve:
1. Reviewing documents for the specified drug. These may be drug review summaries, a budget analysis, clinical review reports, CDR 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 you are aware of not included in the DBC materials.
4. Discussing whether the documents reflect what you see or expect to see in B.C. patients. For example, do the incidence, disease prevalence, diagnosis, natural disease history, patient populations and standards of therapy reflect the B.C. population?
5. Indicating agreement or disagreement with the CDR recommendation.
6. Sending in 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 has 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; and
- 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
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: nine professional members with expertise in critical appraisal, medicine, ethics, pharmacy and health economics; and three 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, see Drug Benefit Council fees (PDF).
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). All individuals involved in the drug benefit review process, including DBC members, are subject to the process's Conflict of Interest Guidelines (PDF).
