The Route to Market Access in Canada
Understanding the unique considerations for access to
reimbursement for your pharmaceutical product.
Gaining expedited market access is important to every manufacturer, and to do so, timing is critical.
Initiate your product reimbursement strategy in advance of
market authorization
Begin reimbursement strategy and submission planning early to make a difference to your product's success
Consider drug delivery commercialization costs
as part of your market access strategy
MARKET AUTHORIZATION
~ 1-YEAR PROCESS
1, 2
Manufacturers who wish to market a
pharmaceutical product in Canada must
obtain authorization from Health Canada.
Dossiers for public and private drug plans should be
prepared and submitted in advance of market
authorization, even if you have received an expedited
review from Health Canada.
TICKETS
The HTA process can be initiated up to 180 days
before market authorization
for most drugs.
HEALTH TECHNOLOGY
ASSESSMENT
~ 1-YEAR PROCESS
Each of Canada's provinces and private
insurers make their own decisions about
funding new drugs.
For public reimbursement,
manufacturers must submit a dossier
to the relevant health technology
assessment (HTA) organizations
Private insurers have their own distinct
submission and evidence requIrements
ROUTE 1 - CADTH
COMMON DRUG
REVIEW
The Common Drug Review (CDR), which is governed by the Canadian Agency for Drugs and Technologies in Health (CADTH), is the pan-Canadian HTA review agency for non-active oncology pharmaceuticals. CADTH’s “customers” are the public drug plans which rely on these recommendations for their funding decisions.
TRACK B
pCODR
Also governed by CADTH, the pan-Canadian Oncology Drug Review
(pCODR) assesses clinical and economic data, and makes listing
recommendations for all new active oncology agents paid for by the
provincial cancer agencies and public drug plans.
ROUTE 2
INESSS
The province of Quebec uses its own
HTA process led by the Institut
national d'excellence en santé et en
services sociaux (INESSS) and does not
participate in the CDR or pCODR
process. INESSS reviews both oncology
and non-oncology products.
pCPA
PUBLIC PRICE NEGOTIATIONS
~ 3 TO 12- MONTH PROCESS
All provinces participate in a centralized
process for price negotiations with
manufacturers: the Pan-Canadian
Pharmaceutical Alliance (pCPA). The
strength of the HTA recommendation,
combined with other factors, determines
the strength of your initial pricing
negotiation position.
PRIVATE PAYERS
~ 2- TO 6- MONTH PROCESS
The private payer market access process
generally includes submission of a
comprehensive dossier including
clinical, economic and financial
information to all major
Canadian insurers.
PUBLIC DRUG PLANS AND
CANCER AGENCIES
~ 5- MONTH PROCESS
Upon review of the manufacturer
submission, HTA assessment, and successful pCPA negotiation, each public plan and provincial cancer agency will make a final reimbursement decision for their jurisdiction.
For private access,
communications can start
before marketing
authorization is granted,
and coverage can begin as soon as the drug
identification number (DIN) is assigned by Health Canada in some cases.
Collective negotiations generally
only occur when the HTA
process is complete.
Access to reimbursement for your pharmaceutical product
For further information on how we can help you navigate the unique
Canadian market access process, contact InnomarConsulting™ at
www.innomar-strategies.com
Sources
1) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html
2) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products.html
