June 30, 2016
The Canadian Pharmaceutical market represents 2.2% of the global market. Canada does not have an explicit definition and regulatory pathway for rare disease drugs. At first glance this could keep companies from researching, investing and launching their rare disease products in Canada. The reality is that Canada offers a terrific opportunity for these companies.
Canada offers Intellectual Property on par with the U.S / Europe and other jurisdictions as well as eight year data protection legislation for newly launched products. The average regulatory approval time for a Notice of Compliance (NOC) post submission is generally twelve months and has been stable. Currently, there is no specific process or program for the approval of drugs for rare diseases in Canada but there are two mechanisms in place that have been used for orphan drugs: Priority Review and conditional Notice of Compliance (cNOC). Both have faster approval times and many molecules developed to treat rare diseases meet the criteria for these mechanisms. Drugs can also be made available to patients through a Special Access Program (SAP) if the sponsor has not yet obtained the product approval. The conditions for this include:
In addition to all of these options there is a significant movement by the rare diseases community to have a specific regulatory approval program implemented. This has been submitted to government.
One of the key concerns of any company is obtaining reimbursement by payers for the product in a reasonable time frame. Canada has a robust private payer market that represents 40% of the overall drug reimbursement. This segment is even is even higher in some therapeutic areas. Private payers are putting more strategies in to place to ensure funding orphan (and other) drugs remain affordable. Canada is diverse and pharmaceutical public reimbursement is determined by the ten Provinces and three Territories which may look daunting. The good news is that four Provinces represent 80% of the Canadian pharmaceutical market.
The Provinces (public payers) market will not likely list these molecules on their general benefits, however all provinces have exceptional approval status that is reviewed on a one by one basis.
It is important to understand the public and private payer landscape when entering this market to ensure new rare drugs are accessible to those suffering with the rare disorder that they are approved to treat.
Market size, prevalence and incidence for most diseases is generally 10% of the US market. Given the low incidence of rare diseases and the relatively low number of healthcare providers/ KOL's that are active in these areas, and the fact that rare disease communities are often global, disease management guidelines tend to be the same for Canada, US and EU markets. Canadian research centres, capabilities and reputation are world class and quite often are part of the industry’s Phase 2 and Phase 3 global clinical trials. Canadian Key Opinion leaders are experienced in operating at an international level and integrate well with US/ EU counterparts and either influence or participate in establishing treatment regimens for the disease areas in which they are expert.
Canada also has a national network for organizations representing people with rare disorders called Canadian Organization for Rare Disorders (CORD). “CORD provides a strong common voice to advocate for health policy and a healthcare system that works for those with rare disorders. CORD works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada. CORD is launching a “Rare Alliance Canada” initiative in an effort to harness rare disease groups’ efforts to build a strategy and collective effort to address awareness of the public health issue that rare diseases represent. CORD provides an existing network that works with all players and collaborative work with them can help facilitate entry into the market.
One additional benefit of commercializing in Canada, is the extremely small corporate footprint required to resource pre launch, launch and post launch. Most companies can use shared services internally, or outsource locally to qualified service providers. The Canadian team could be as small as GM, Medical, MSL, Marketer, and 3-6 Specialty Representatives.
In conclusion, Canada indeed represents a significant opportunity for companies with rare disease drugs as exclusivity is on par with or better than many major markets, reimbursement potential through different payer types exists and a very small investment footprint is required for successful commercialization.
Originally published in BTC Insights Spring 2016
For further information, please contact Joe Knott, Managing Director, The Pangaea Group