This article discusses three key considerations that a manufacturer should either understand or seek out a consulting partner to guide them through a marketing plan.
With pharmaceutical spending estimated at C $ 39.8 billion (US $ 30.2 billion) for 2018 The Canadian market can offer significant opportunities for pharmaceutical manufacturers, but only if they are able to understand the nuances of the country’s unique regulations, market access and customer needs. It is felt that the majority of health care policies and coverage in Canada exist at the national level. But Canada is a mixed market. There are public (eg provincial) and private reimbursement requirements that must also be considered as part of a manufacturer’s marketing plan. If a manufacturer is able to appropriately balance the needs, deadlines and concerns of all stakeholders, they will be in a better position to proactively plan for optimal patient access.
To begin with, there are three key considerations that a manufacturer should either understand or seek out a consulting partner to guide them: (1) plan early to ensure the regulation and reimbursement of their products; (2) prepare for and respond to policy and market changes; and (3) develop appropriate presentation and data collection and business models.
Obtaining regulatory and reimbursement approvals
When designing marketing plans and reviewing payor coverage for their products, many manufacturers focus on meeting the regulatory requirements of Health Canada, the national government agency responsible for the country’s public health. Regulatory approval is key, but it’s also now part of a process aligned with the Canadian Agency for Drugs and Technologies in Health (CADTH), which reviews drugs for value through a process. health technology assessment (HTA) on the public side. This aligned process is designed to accelerate overall market approval and public reimbursement recommendations. In addition, public drug plans rely on the Pan-Canadian Pharmaceutical Alliance (PPA) to negotiate agreements with pharmaceutical companies similar to what is happening with managed care organizations in the United States or the Patient Access Schemes in the UK. Layer in the specific requirements of each public payer, and you can see the complexity.
As noted, Canada is a mixed market with more than half of the Canadian population having access to private drug coverage through their employer, so individual private payers, again each with their own needs. , must also be engaged to maximize access to products.
Successful market access in Canada means balancing all of these needs, which is why manufacturers often find it helpful to consult with market experts who know each of the stakeholders involved and their specifications. There are also over 20 private insurance companies in Canada. It is important that manufacturers submit to these payers to access their employer’s plans and coverage. These payors have a different submission process, again tailored to the lives of their plan members. Manufacturers must understand these requirements, deadlines and priorities in order to maximize access.
Consulting partners can also help manage the different application cycles and deadlines for each payor, which can range from six months to two years. Fortunately, several of these apps can run simultaneously, but they need to be carefully planned well in advance of the 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 healthcare policies and market dynamics is essential
In addition to involving regulators and multiple payers, manufacturers must also adapt to changing government policies; the most recent of which is an update to the guidelines by which the Patented Medicine Prices Review Board (PMPRB) of Canada assesses the proposed prices of pharmaceutical products to ensure that the prices of pharmaceutical products in Canada do not. are not excessive.
To best maximize Canada’s market access opportunities, manufacturers must learn to demonstrate the value of innovation. Products capable of showing their unique and 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 case to organizations like the PMPRB that the evaluation of their product is accurate and necessary to support future innovation.
At the same time, the private market in Canada is moving towards Preferred Pharmacy Networks (RPPs) as a potential means of controlling the costs of specialty drugs. PPNs are pharmacy networks that agree to certain conditions and mark caps with a particular private payer for dispensing prescriptions. Payers can encourage patients to use a network pharmacy by reducing the amount the patient pays for the prescription at these locations. If manufacturers are to offer their treatment to every patient, they must understand the relationship between the desired payers and their associated PPNs. This is just one example of how the Canadian payers market is evolving, and forward-looking market access strategies will be successful.
Develop data strategies and economic modeling assessments
As in many markets, the basis of securing payer coverage and navigating regulatory requirements is proving that your product delivers value to patients by collecting relevant data and telling a story tailored to patient priorities. payers. Manufacturers entering the Canadian market will need to develop plans to collect, interpret and disseminate data continuously throughout a product’s lifecycle. For example, payers are increasingly looking for information that presents the results and cost-effectiveness of a product outside of the controlled environment of a clinical trial. This means that manufacturers will now need to develop datasets that go beyond Phase 2 and Phase 3 investigations and include ongoing and actual evidence (RWE).
It is often more effective 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 of products. These assessments must be informed by the specific market conditions and the Canadian healthcare ecosystem. Partners with an end-to-end marketing services offering are well positioned to distill information that can help justify product coverage, deliver data sets that follow the patient journey, and provide insight into the true cost of marketing. therapy in a particular market. These data solutions can make the difference between a good market access strategy and a good strategy and help speed up treatment for many patients throughout the drug lifecycle. It’s important to remember: you have to get reimbursement, but you also have to work hard to maintain and continue with it, as this is an ongoing process throughout the life cycle of the drug.
For some manufacturers, there can be a lot of misconceptions about the Canadian market. A manufacturer’s desire to bring innovative new therapies to Canadians must be balanced with a deep understanding of the market. Ultimately, manufacturers who invest in understanding the intricacies of the Canadian landscape, with an experienced marketing partner, and then tailor their plans accordingly, will be more successful in this growing market and bring their innovative therapies to Canadian patients.
Sandra Anderson is Vice President, Consulting and Business Development, Innomar Strategies (part of AmerisourceBergen)
 Canadian Institute for Health Information, National Health Expenditure Trends, Data Tables 1975-2018 – Series G, November 20, 2018.