Drug Sponsor Engagement in the Drug Review Process
BC PharmaCare maintains a transparent drug review process and provides drug submission sponsors (or drug manufacturers) with opportunities to engage with PharmaCare during the drug review process and to respond to the PharmaCare coverage decision.
PharmaCare considers submissions for patented drug products—new drugs, new combination products, drugs with new indications, and biosimilars—only after an initial review by the national review body, the Common Drug Review (CDR).
All other submissions, (i.e., submissions that the CDR does not review) including those for line extensions, modifications of criteria, and blood glucose test strips should be submitted directly to PharmaCare.
Visit the drug submission requirements webpage for information on the how to make a drug submission to PharmaCare.
PharmaCare bases its drug coverage decisions on:
- existing PharmaCare policies and programs
- other therapeutic options that may be available
- Drug Review Resource Team reports (which may include clinical evidence and pharmacoeconomic evidence, clinical practice reviewer reports, input from patients, caregivers and patient groups collected through Your Voice)
- the recommendation and reasons for recommendation of the CDR, and/or
- the recommendation and reasons for recommendation of B.C.’s independent drug advisory committee, the Drug Benefit Council (DBC).
Note: Drug reviews involve a variety of inputs and the above are not available/applicable for each drug review.
To learn more about the various stages of the drug review process in B.C., see:
- Drug Review Process in B.C. – Overview (PDF, 148KB)
- Drug Review Process in B.C. – Detailed (PDF, 257KB)
Upon receipt of a drug submission, drug sponsors have the following opportunities to provide input to the drug review process:
- After the Common Drug Review (CDR)
- Before the Drug Benefit Council (DBC) review
- After the Drug Benefit Council (DBC) review
- Before the PharmaCare coverage decision
- After the PharmaCare coverage decision
The national CDR reviews drug submissions and the CDR Canadian Drug Expert Committee (CDEC) then shares its embargoed drug coverage recommendation and reasons for its recommendation with provincial drug plans and drug sponsors.
Drug sponsors are invited to provide PharmaCare with objective feedback on the CDEC embargoed recommendation. Any input provided is included as part of the drug review and, if applicable, is forwarded to the DBC. The DBC considers drug sponsor input in its drug listing recommendation to PharmaCare.
Drug sponsor feedback must:
- be evidence-based and referenced, citing material from the original drug submission;
- indicate whether the drug sponsor agrees or disagrees with the CDEC recommendation; and
- not introduce new clinical evidence.
Note: If the drug sponsor wants new clinical evidence to be considered, they will need to resubmit the drug submission to the CDR.
Once the CDR review is initiated, the Ministry forwards the drug sponsor’s submission to the DBC for an initial screening. The DBC screens all drugs reviewed by the CDR and informs PharmaCare if it will conduct a full review of the drug submission, or advise PharmaCare to accept the CDR final recommendation.
DBC reviews drug submissions and issues a drug coverage recommendation along with its reasons for the recommendation. This information, specific to B.C., is provided to PharmaCare for consideration in its coverage decision, if applicable.
After the DBC provides PharmaCare with its initial recommendation, the embargoed recommendation is shared with the drug sponsor. If available, clinician’s anonymized drug coverage advice in the form of Clinical Practice Review reports is also shared with the drug sponsor. Drug sponsors must sign a confidentiality agreement prior to receiving the information.
Requests for Reconsideration
When the DBC embargoed recommendation is released, a drug sponsor may submit a request for reconsideration. A request for reconsideration must specifically identify the reasons for the request.
A request for reconsideration must be based on either of the following:
- PharmaCare and/or the DBC did not follow the proper process; or
- the DBC recommendation is not supported by the evidence or input reviewed.
A request for reconsideration must:
- be made solely because the drug sponsor disagrees with the interpretation of the evidence or input reviewed by the DBC; or
- not contain any new information. New information can only be considered as part of a resubmission.
Note: If the drug sponsor wants new clinical evidence to be considered, they will need to resubmit the drug submission to the CDR or to PharmaCare for non-CDR submissions.
Submitting a request for reconsideration
Requests for reconsideration must be submitted within 10 business days of the drug sponsor receiving the DBC embargoed recommendation.
Submit the request electronically to DrugReviewProcess@gov.bc.ca.
PharmaCare’s DBC Secretariat, in consultation with the DBC Chair, reviews requests for reconsideration to determine whether or not the request can be accepted (based on the stated conditions) and if it is accepted, whether the issues raised can be resolved in discussion with the sponsor. If PharmaCare is unable to address the issues, the request for reconsideration is forwarded to the DBC.
If PharmaCare does not receive a request for reconsideration within 10 business days, the DBC embargoed recommendation is finalized.
Within 10 business days of the DBC final recommendation being issued, and before PharmaCare makes a drug coverage decision and implements that decision, a drug sponsor may request a meeting with PharmaCare to discuss the DBC recommendation and related issues. To request such a meeting, sponsors can submit a written statement to email@example.com.
PharmaCare may also initiate discussions with a drug sponsor. Please note that a drug sponsor may also engage with PharmaCare and other drug plans as part of the pan-Canadian Pharmaceutical Alliance (pCPA) negotiation process.
The drug sponsor may file a resubmission to CDR if new information becomes available that addresses the reasons for PharmaCare’s coverage decision.
For both CDR and non-CDR drug submissions, PharmaCare determines whether to make DRRT reports publicly available on its website. Before the online publication any final reports, the drug sponsor has 15 business days upon receipt to review the reports and, if desired, request the non-disclosure of specific information they consider confidential or of proprietary nature. The review timeframe may be adjusted on mutual agreement.
If the drug sponsor identifies confidential information in a report and requests its redaction, PharmaCare will redact (“black out”) that information before publishing the report.