The Future of Patient Assistance Programs in Canada
By Sandra Anderson |
As global manufacturers of specialty pharmaceuticals look to enter the Canadian market, it is important to understand the Canadian healthcare landscape. Our previous article, "Healthcare Delivery in Canada," outlines the key regulatory agencies and considerations when navigating market access and reimbursement. The provision of patient support services is another important consideration for entry into the Canadian specialty pharmaceutical market.
Generally called Patient Support Programs or Patient Assistance Programs (Programs) in Canada and built roughly on a hub services business model, Programs initially focused on providing patient access. Today, these programs focus on enhancing care for patients who are managing complex medical conditions that are treated with high-cost specialty drugs, including: reimbursement navigation; clinic and nursing and support (including infusion and injection administration/training); patient education and counseling; risk management and compliance; and specialty pharmacy and logistics services.
The complexity, role and importance of Programs continue to change due in large part to four trends in the Canadian market:
Changes in the Payer Environment
Significant changes in the Canadian payer landscape are primarily due to the growth in the specialty drug segment. While specialty drug products in Canada contributed to 26.5% of overall drug spend from 2013-2014, this share is forecasted to significantly increase in the future.1 As such, Canadian private payers have adopted cost-containment strategies such as Preferred Pharmacy Networks, Health Case Management, plan re-design, and capping in an effort to manage these rising costs while continuing to provide patient access to critical specialty medications.
It is important for manufacturers to understand the needs and requirements of Canadian payers in order to build a successful Program that ensures continuity of care. When designing a Program, manufacturers must consider:
- the priorities of the payer to manage their drug spend while also balancing the needs of plan members and sponsors;
- the variety of programs and approaches introduced by payers focused on cost containment; and
- meaningful data, processes and services to address payers' needs to optimize outcomes and cost savings.
Need for Meaningful Data
Driven by global and local compliance, patient safety monitoring requirements and a changing payer landscape, a need for meaningful data that can be generated from a Program is key.
In 2014, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)2 resulted in the requirement of stronger surveillance and mandatory reporting of adverse events. This has placed an increased importance on pharmacovigilance (PV) and risk mitigation in Programs as patients self-report adverse events. Employing a PV strategy in a Program that strongly adheres to adverse event reporting protocols, gives manufacturers confidence that accurate and complete reporting of adverse events is occurring. As a result, there is a heightened requirement that Programs employ experienced and highly trained PV professionals that understand Health Canada requirements, to ensure regulatory compliance and that quality systems are in place.
Canadian payers are looking to manufacturers to present real-world clinical data to demonstrate the effectiveness of their products and ensure the right patient is on the right product at the right time. An opportunity exists to integrate Health Economic Outcomes Research into Programs to meet these needs and support the overall Market Access strategy. To gather relevant and useful data, building a data strategy and incorporating it into a Program at the outset is important. A variety of patient-reported health outcome studies can be performed, including: Quality of Life, product effectiveness, treatment adherence, safety, health resource utilization, and indirect costs (eg, productivity loss, out-of-pocket costs and the cost of informal care). These outcomes studies can align to a manufacturer's global strategy and be leveraged to support reimbursement and listing, while also considering cost effectiveness.
Focused Partnerships and Alliances
In addition to the manufacturer, Program provider and payer, an increasing number of partnerships and alliances among stakeholders are involved in the patient journey. The needs of the patient, along with each partner in their "circle of care" (including physicians, nurses and family members), should be considered when designing a Program. There is an opportunity to integrate customer satisfaction surveys into these Programs to inform the impact of a program and understand how to evolve program offerings. It is also important to foster partnerships with patient advocacy groups and professional healthcare associations to facilitate Program customization and gain proper support for patients and families. With these relationships, manufacturers have an opportunity to better understand the landscape and identify gaps in patient care, to perform patient journey mapping to determine what motivates patients, and to build their Program tactics accordingly.
Establishing an integrated Program is the price of entry for most specialty drugs, but more efficient program management is increasingly required throughout the lifecycle of the brand. It is important to build a sustainable Program model that can be adapted to shift and adjust as the market evolves. Manufacturers need to challenge Program providers to be proactive in identifying efficiencies throughout the product lifecycle. Opportunities to build a more sustainable model may include:
- using a portfolio approach for manufacturers with more than one specialty product. Leveraging the experience from existing Programs within the same company can help to avoid redundant systems and duplication of resources or services;
- building human resourcing of the Program at each phase of a brand's lifecycle to support optimal patient management while considering cost efficiencies; and
- employing technology to communicate with different patient and health care professional segments. This strategy provides the opportunity to be high touch but more cost effective. The type of technology could vary depending on the stakeholder requirements.
Creating an Optimal Patient Experience
The overarching goal for manufacturers when launching a specialty drug is to ensure patients can access their therapy quickly and easily. Equally important is the need to create an optimal patient experience; however, manufacturers need to take into consideration all aspects of the changing market space. Program strategies need to reflect market dynamics, brand lifecycle, the manufacturer's specialty portfolio, changes in the Canadian regulatory environment, sustainability and all impacted stakeholders. Most importantly, all of these strategies should be built into the Program up front and developed with the lens of the patient first.
Innomar Strategies Inc., a Canadian subsidiary of AmerisourceBergen Corporation, is the leading Canadian service provider for specialty pharmaceutical and biotech products, administering over 120 Patient Assistance Programs. Through our Integrated Service Model, Innomar Strategies delivers customized, scalable solutions to specialty manufacturers. Strategic consulting, Patient Assistance Programs, clinics and nursing services, specialty pharmacy distribution and 3PL services are just a few of our key areas of specialization.