August 8, 2017
Currently all resubmissions based in improved efficacy to CDR and pCODR requires at least one new randomized controlled trial. However, CADTH is proposing new requirements given the importance of information provided from non-randomized studies. CADTH will no longer require a new randomized controlled trial when filing a resubmission based on improved efficacy but will allow for non-randomized studies in this situation. In particular, CADTH considers non-randomized studies to be useful when:
*the evaluation of important clinical end points and rare adverse events requires longer-term follow-up
*there is uncertainty regarding the persistence of efficacy of the drug under review, due to short-term clinical trials
Acceptance of non-randomized trials is certainly welcome when there is so much to be gained from these studies in certain situations.
CADTH is requesting responses to pCODR clarifying questions and any applicable requests for additional information be provided at least one business day in advance of the scheduled Checkpoint Meeting vs the current one business hour in advance of the scheduled meeting.
This certainly sounds quite reasonable. How were they able to review information within 1 hour of these meetings??
CADTH is proposing a new simplified review process for biosimilar submissions. Manufacturers can submit to CADTH shortly after making a submission to Health Canada. CADTH review teams will provide analyses on specific sections of the Biosimilar Summary Dossier and will work in collaboration with Health Canada to complete Section 3 of the Biosimilar Summary Dossier Template which includes Health Canada’s assessment of the biosimilar for market authorization in order to reduce duplication of work and time to completion. This proposed Biosimilar Summary Dossier Template is an abbreviated version of the current submission requirements. Manufacturer will need to provide: the cost comparison of the proposed biosimilar’s price vs that of the original biologic both in Canada and internationally; clinical trials or other supportive evidence to assess the efficacy and safety of switching patients from the reference product to the biosimilar agent; as well as informing CADTH of the availability of both patient support and health care provider support programs. All information submitted on this Biosimilar Summary Dossier will be fully disclosed.
Given light of these amendments, the time for biosimilar review by CADTH will indeed be shortened. The HTA agency will be working in collaboration with Health Canada, the pCPA, participating federal, provincial and territorial public drug plans (possibly except for Quebec), and provincial cancer agencies, and as such formulary decisions and acceptance of biosimilars will occur with greater speed and efficiency. One more additional issue to handle for original biologic companies.
The CDR Update — Issue 125 contains details of these new programs and services.
For more information, please contact Marla Weingarten, Consultant, The Pangaea Group