Canadian Agency for Drugs and Technologies in Health Revises Biosimilar Submission Procedures

The Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian entity responsible for health technology assessments, has announced that it has revised its approach to reviewing biosimilars. CADTH says that its new process will provide for shorter timelines, fewer submission requirements, and an abbreviated biosimilar summary dossier template for manufacturers’ use.

CADTH reports that its experience in reviewing biosimilars, together with stakeholder input gathered through an open consultation in 2017—which garnered input from 25 individuals and organizations—allowed the organization to identify key areas for improvement in its internal processes.

The new procedure will reduce the number of submission requirements that manufacturers must meet when submitting a biosimilar summary dossier (a document in which manufacturers provide all relevant information for a biosimilar product for the pan-Canadian Pharmaceutical Alliance and participating Canadian jurisdictions to make decision about which products to include in their drug plans). The dossier is intended to give CADTH the information it needs to assess the cost of biosimilars, consolidate stakeholder feedback, and identify potential implementation issues.

In the biosimilar dossier, manufacturers must submit drug pricing information for the smallest dispensable unit of the biosimilar—for all packaging formats—and must not be exceeded for any of the drug plans that choose to adopt the biosimilar after the review process has been completed. The price for the drug must be reported for 4 decimal places, and will be disclosed in all CADTH reports. The price submitted is used in the pharmacoeconomic evaluation of the biosimilar, and in budget impact analyses for the models used in individual Canadian provinces’ health plans.

The department may also choose to review evidence from switching studies from the reference biologic to the biosimilar on a case-by-case basis, and says that “This determination is made in consultation with the participating public drug plans and may be influenced by the volume and quality of available evidence, as well as reimbursement and switching policies for other biosimilars for the same reference drug and/or indications.” CADTH will also collect and summarize input from patient groups, and will share that input with drug plans.

After reviewing all of the submitted information, CADTH’s reviewers will provide summary of stakeholder input comment on the manufacturer’s cost information, and forward its summary dossier to both the applicant and participating drug plans for a determination. CADTH’s biosimilar summary dossiers will also be available publicly and without redaction.

CADTH’s new submission process took effect on February 13, and is expected to reduce the overall biosimilar review timeline from 6 months to 3 months.