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 Canada's Drug Agency (CDA). 

All other submissions, including biosimilars, line extensions and modification of criteria, are submitted directly to the Ministry.

For more information, visit Drug Review Process — Section 6.5, PharmaCare Policy Manual. 

On this page: Review timelines | How to submit documents | Submission checklists | Priority review | Resources

Review timelines

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 is 9 months for a standard review 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 additional steps.

For submissions reviewed by CDA, the start date will be the issue date of the final Canadian Drug Expert Committee (CDEC) recommendation.

For other submissions, including line extensions, coverage status and blood glucose test strips, the review begins on the date the complete submission is received by the Ministry.

If CDA conducts a review, the Ministry’s review generally follows an internal 9-month timeline. For non-CDA drug submissions, the Ministry’s review generally follows a 12-month timeline. 

The Quarterly Report on Drug Submission Reviews (PDF, 466KB) has examples of review periods for recently reviewed drugs.

How to submit documents

PharmaCare accepts submissions via Dropbox or email. Review the relevant submission checklist below to ensure you include everything required. Incomplete submissions will not be reviewed.

Dropbox

Please email us to provide access to your secure Dropbox: 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

To request an alternative submission method, please email DrugReviewProcess@gov.bc.ca

Submission checklists

Submission requirements vary depending on the drug and the purpose of the review. Submissions that do not meet the requirements and criteria on these checklists will not be reviewed.

• Patented drugs submission checklist (PDF, 131KB) 
• Biosimilar submission checklist
• Modification of current coverage criteria submission checklist (PDF, 117KB)
• Line extension checklist
• Blood glucose test strips submission checklist (PDF, 105KB) 

Priority review

Priority reviews are reserved for drugs that meet a significant unmet clinical need and show major therapeutic benefit, or drugs demonstrating substantial economic benefit.

BC PharmaCare grants priority drug review automatically to drugs given priority review by CDA.

Drug manufacturers can apply to 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 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.

Target timelines

The Province aims to complete priority drug reviews within 6 months for standard submissions or 9 months for complex submissions.

At its discretion, the Ministry may adjust the drug review process to achieve the target timeline. 

Resources

Additional information on the drug review process:

• Health Industry Professionals
• The Drug Review Process in B.C. - Detailed (PDF, 343KB)
• 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