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This article discusses three key considerations a manufacturer should either understand or seek a consulting partner to guide them through a commercialization plan.
With pharmaceutical spending forecasted to be $39.8 billion CAD ($30.2B USD) for 2018 the Canadian market can offer significant opportunity for pharmaceutical manufacturers, but only if they are able to understand the nuances of the country’s unique regulatory, market access, and customer needs. There is a perception that the majority of Canada’s healthcare policies-and coverage-exist at the national level. But Canada is a mixed market. There are public (e.g. provincial), and private reimbursement requirements that must also be considered as part of a manufacturer’s commercialization plan. If a manufacturer is able to appropriately balance the needs, timelines, and concerns of all stakeholders, they will be in a better position to proactively plan for optimal patient access.
To start, there are three key considerations a manufacturer should either understand or seek a consulting partner to guide them through: (1) planning early to secure regulatory and reimbursement for their products; (2) preparing for and responding to policy and marketplace changes; and (3) developing appropriate data presentation and collection and economic models.
Securing regulatory and reimbursement approval
When designing commercialization plans and considering payer coverage for their products, many manufacturers focus on meeting the regulatory requirements of Health Canada, the national government body responsible for the country’s public health. Regulatory approval is essential, but it is also now part of an aligned process with the Canadian Agency for Drugs and Technologies in Health (CADTH), which looks at drugs from a value perspective through a Health Technology Assessment (HTA) process on the public side. This aligned process is designed to speed up overall market approval and public reimbursement recommendations. In addition, the public drug plans rely on the pan-Canadian Pharmaceutical Alliance (pCPA) to negotiate arrangements with pharmaceutical companies similar to what happens with managed care organizations in the U.S. or Patient Access Schemes in the UK. Layer in specific requirements from each public payer, and one can see the complexity.
As noted, Canada is a mixed market with more than half of the Canadian population having access to private drug insurance through their employer, so individual private payers, again each with their own needs, must also be engaged to maximize product access.
Successful market access in Canada means balancing all of these needs, which is why manufacturers often find it helpful to consult with in-market experts who are familiar with each of the relevant stakeholders and their specifications. There are also more than 20 private insurance companies in Canada. It is important for manufacturers to submit to these payers to access their employer’s plans and coverage. These payers have a different submission process, again customized to their plan members lives. Manufacturers need to understand these requirements, timelines, and priorities in order to maximize access.
Consulting partners can also help manage the differing application cycles and timelines for each payer-which can range from six months to two years. Thankfully, several of these applications can run concurrently, but they must be thoughtfully planned well in advance of a desired launch date. Manufacturers or their partners will need to develop detailed plans for how, when, and with what data they must approach each payer to ensure success.
Understanding health policy and marketplace dynamics is critical
In addition to engaging regulators and multiple payers, manufacturers must also navigate evolving government policies; the most recent of which is an update to the guidelines by which Canada’s Patented Medicine Prices Review Board (PMPRB) evaluates proposed pharmaceutical prices in order to ensure that pricing for pharmaceuticals in Canada is not excessive.
To best maximize Canada’s market access opportunities, manufacturers must learn how to demonstrate value in innovation. Products that are able to show their unique, demonstrable value will find more success in this endeavor, such as products that are the result of a scientific breakthrough or that help a small patient population. With this information, manufacturers can make the argument to bodies like the PMPRB that their product’s valuation is accurate and necessary to support future innovation.
At the same time, the private marketplace in Canada is moving toward preferred pharmacy networks (PPN) as a potential way to control costs for specialty medications. PPNs are networks of pharmacies that agree to certain terms and mark up caps with a particular private payer to dispense prescriptions. Payers can incentivize patients to use an in-network pharmacy by reducing the amount the patient pays for the prescription at those locations. If manufacturers want to deliver their therapy to every patient, they need to understand the relationship between desired payers and their associated PPNs. This is just one example of how Canada’s payer market is evolving, and market access strategies that are forward-looking will find success.
Developing data strategies and economic modeling assessments
The foundation for both securing payer coverage and navigating regulatory requirements is, like in many markets, to prove that your product provides value to patients by collecting relevant data and telling a story that is customized to payer priorities. Manufacturers entering the Canadian marketplace will need to develop plans to collect, interpret, and distribute data constantly throughout a product’s life-cycle. For example, payers are increasingly seeking information that showcases a product’s outcomes and cost-effectiveness outside the controlled environment of a clinical trial. Meaning, manufacturers will now need to develop data sets that go beyond Phase 2 and Phase 3 investigations and include ongoing, real-world evidence (RWE).
It is often more efficient for manufacturers to work with partners who can proactively develop plans that tell a credible story. Plans should include economic modeling assessments that illustrate realistic pricing and reimbursement for products. These assessments need to be informed by Canada’s specific market conditions and healthcare ecosystem. Partners with an end-to-end commercialization service offering are well positioned to distill information that can help justify product coverage, offer data sets that follow the patient journey, and give insights into the true cost of commercializing a therapy in a particular market. These data solutions can mean the difference between a good market access strategy and a great one and help support speed to therapy for many patients throughout the drug lifecycle. It is important to remember: you need to secure reimbursement but you also need to work hard to maintain and continue it as well as this is a continuous process throughout the drug’s lifecycle.
For some manufacturers, there can be many misconceptions about the Canadian market. A manufacturer’s desire to bring new, innovative therapies to Canadians needs to be balanced with a deep understanding about the market. Ultimately, manufacturers that invest in understanding the intricacies of the Canadian landscape, with an experienced commercialization partner, and then tailor their plans accordingly, will be most successful in this growing market and bringing their innovative therapies to Canadian patients.
Sandra Anderson is Vice President, Consulting and Business Development, Innomar Strategies (a part of AmerisourceBergen)
 Canadian Institute for Health Information, National Health Expenditure Trends, 1975-2018 Data Tables – Series G, November 20, 2018.