The BC Ministry of Health recently wrote to manufacturers to communicate updates to its drug review process and reimbursement submission requirements.
Updates to the Drug Review Process include:
- The Drug Benefit Council (DBC) will now screen drug submissions under review by CDR to determine if a full DBC review is necessary. If a full DBC review is determined not to be required, the Ministry’s drug coverage decision will be based on the CDEC recommendation and internal review only.
Updates to Submission Requirements for Patented Drug Products Reviewed by CDR include:
- BC Ministry of Health is to be sent its Category 1 and Category 2 submissions at the same time they are sent to CDR.
- In addition to the documents provided to CADTH as part of Categories 1 and 2;
- All of the Ministry-specific reimbursement submission requirements previously required by the Ministry are to be submitted with the Category 1 submission
- A cover letter, written notification, a letter confirming availability of the drug (pre-NOC), an ability to supply letter, a letter of consent to release Periodic Safety Update Reports as submitted to Health Canada, a consent letter and all Pharmaceutical Advertising Advisory Board (PAAB) – approved promotional materials are to be submitted with Category 1
- An ability to supply letter, budget impact analysis information and a summary list of the product’s patents and expiry dates as per the Health Canada Patent Register (NEW requirement) are to be submitted with Category 2
- Note also that cover letters should now also list any associate companies or vendors who contributed to the submission for all submission types
Updates to Submission Requirements for Line Extensions* include the addition of the following documents:
- A cover letter (additional information required)
- Executive summary
- Letter confirming availability of the drug (pre-NOC)
- Letter of commitment to honour the submitted price
- Letter of consent to release Periodic Safety Update Reports as submitted to Health Canada
- Pricing and Distribution Information
- Efficacy, Effectiveness, and Safety Documentation (including supplementary appendixes)
- Clinical Evidence, Pharmacoecomonic evidence, etc.
*Note that manufacturers should contact the BC Ministry of Health as exceptions may be made if original submissions were made recently.
Updates to Submission Requirements for Modifications of Current Coverage Status include the addition of the following documents:
- A cover letter (additional information required)
- Letter of consent to release Periodic Safety Update Reports as submitted to Health Canada
- Product monograph
- Letters confirming:
- Written notification of any future changes
- Availability of the drug (pre-NOC)
- Ability to supply for anticipated demand
- Health Canada Documentation (Notice of Compliance, NOC and Drug Identification Number(s), DIN)
- Additional requirements for Efficacy, Effectiveness, and Safety Documentation (including supplementary appendixes)
- Pricing and Distribution Information
- Letter of commitment to honour the submitted price
For more information, please see the Drug Submissions for Patented Drug Products page on the BC PharmaCare website to access checklists documenting all necessary requirements for reimbursement submissions to the BC Ministry of Health.