Submitting Patented Drugs and Biosimilars
Drug manufacturers must apply to the Ministry of Health to have their product considered as a PharmaCare benefit.
The Ministry bases coverage decisions on PharmaCare policies, programs, therapeutic options, resources and the evidence-informed recommendations of the independent Drug Benefit Council (DBC).
To be considered for coverage, patented product submissions for new drugs, new combination products, and drugs with new indications must first undergo a review by the Common Drug Review (CDR).
All other submissions, including biosimilars, line extensions and modification of criteria, are submitted directly to the Ministry.
The review timeline starts when the Ministry begins its review and ends when the Ministry publicly communicates its decision. The target timeline for a decision for a standard review is nine months and 12 months for a complex review. A review is complex if there is a need to develop clinical coverage criteria, create a Special Authority form, complete a Product Listing Agreement (PLA), or other such steps.
For submissions reviewed by the CDR, the start date will be the issue date of the final Canadian Drug Expert Committee (CDEC) Recommendation and Reasons for the Recommendation.
For other patented drug submissions, including line extensions, coverage status, and blood glucose test strips, the review start date will be the date the complete submission is received by the Ministry.
If the CDR conducts a review, the Ministry’s review generally follows an internal nine-month timeline. For non-CDR drug submissions, the Ministry’s review generally follows a 12-month timeline.
The Quarterly Report on Drug Submission Reviews (PDF) has examples of review periods for recently reviewed patented drugs.
Criteria for specific submissions:
- patented drug products reviewed by the Common Drug Review (PDF)—Category 1 and 2 submission requirements for new drugs, drugs with new indications, and new combination products to CDR for review
- biosimilars submission requirements (PDF) and submission template (PDF)
- modification of current coverage criteria (PDF)
- line extensions (PDF)—new strengths, delivery mechanisms, and dosage forms
- blood glucose test strips (PDF)
Send the complete drug submission package to the courier address below. For all other correspondence, use the regular correspondence address.
Courier Packages to:
Director, Formulary Management
Regular Correspondence to:
Director, Formulary Management
E-mailed submissions will not be accepted for review. Incomplete submissions will not be reviewed. You will be contacted to complete the submission.
Priority drug review is reserved for drugs that meet a significant unmet clinical need and shows major therapeutic benefit, or drugs demonstrating substantial economic benefit.
BC PharmaCare grants priority drug review automatically to drugs given priority review by Common Drug Review (CDR).
Drug manufacturers can apply to BC PharmaCare for priority review if their drug meets at least one of the following criteria:
1) The drug meets an unmet clinical need and provides substantial therapeutic benefit
A drug meets an unmet clinical need if it will help patients suffering from an immediately life-threatening or severely debilitating disease for which no therapeutic alternatives are available.
A drug provides substantial therapeutic benefit if it vastly improves mortality or other clinically important outcome measures of effectiveness and safety compared to other available therapies. Therapeutic benefit must be documented with high-quality clinical trial evidence.
2) The drug provides substantial economic benefits
Drugs that can achieve a projected cost avoidance or incremental savings of more than $500,000 per year provide substantial economic benefit. The monetary figure is based on a budget impact analysis that the Ministry of Health is comfortable with in terms of methodology and input assumptions.
The Ministry may consider a drug for priority review for a lesser amount at its discretion.
Priority Drug Review Target Timelines
For drugs granted a priority review, the province commits to complete its drug review within a target timeline of six (6) months (standard submission) or nine (9) months (complex submission).
At its discretion, the Ministry may adjust the drug review process to achieve the target timeline.
Additional information on the drug review process
- Health Industry Professionals
- The Drug Review Process in B.C.—Detailed (PDF)
- Drug Submission Guidelines for Generic Drug Products
If you have any questions about specific drug submissions, or the drug submission process, send an email to the Ministry of Health Formulary Management team at: DrugReviewProcess@gov.bc.ca