The Canadian pharmaceutical market, which is among the 10 largest worldwide, has long been viewed as a top-tier launch destination.
From 2000 to 2019, Canada ranked fourth in median time to launch a new product—trailing only the United States, Germany and United Kingdom. Total pharmaceutical sales that include non-patented over-the-counter drugs doubled from 2002 to reach $27 billion in 2017, according to the country’s Patented Medicines Prices Review Board (PMPRB). The growth in sales was mirrored by an increase in the number of new drug launches in Canada, which climbed from an average of about 18 a year during a three-year span stretching from 2005 to 2007 to an average of 25 a year from 2016 to 2018, according to IQVIA.
However, the path to product commercialization in Canada is complex and can be challenging—particularly for those who have not launched before in this market. Bringing a pharmaceutical product to market requires an understanding of and adept ability to navigate the federal regulatory route and multifaceted reimbursement processes that involve the Health Technology Assessment (HTA), negotiations and listings with public and private payers.
To successfully navigate the Canadian healthcare system, pharmaceutical manufacturers should seek a partner with in-depth knowledge of the market that can help them design a commercialization strategy to drive product acceptance and success as quickly as possible. Without proactive planning, and the right partner to prepare them for the complex processes, manufacturers can expect delays and disappointments.
“You can’t stress enough how important it is for manufacturers to start their planning early,” said Sandra Anderson, Senior Vice President of Commercialization and Strategy at Innomar Strategies, Canada’s leading specialty pharmaceuticals service provider and a part of AmerisourceBergen. “It allows you to plan for various launch scenarios, anticipate payer or regulatory challenges, and the need to build a strong real-world evidence strategy to support your market access strategy.”
Given the unique market dynamics, manufacturers should seek an experienced partner that can provide support at each stage of the commercialization journey—eliminating the potential for any gaps in handoffs between multiple partners. An integrated partner, like Innomar Strategies, offers end-to-end commercialization services, from strategic launch planning and regulatory submission support to third-party logistics (3PL) and importation services.
Planning should start as much as two years prior to the projected launch date. During that initial phase, manufacturers need to determine whether they will apply for their own Drug Establishment License (DEL) or partner with a company, like Innomar, that can serve as the Importer of Record. Generally, it takes a year to receive market authorization from Health Canada. To save time and efficiently gain market entry, manufacturers should manage regulatory and market access submissions simultaneously, said Anderson.
Before progressing too far, manufacturers should work with their partners to gain a better understanding of the potential pricing scenarios and their product’s value story, explained George Wyatt, Executive Senior Consultant of Market Access at Innomar Strategies. The pricing analysis needs to account for rules set by PMPRB, which sets the maximum list price for products in Canada. Manufacturers also need to communicate the value of the therapy to a payer audience. Innomar’s Forecaster tool—which collects and analyzes Health Technology Assessment (HTA) data and recommendations dating back to 2004—enables the team to understand the real value and place in therapy from a payer perspective.
A required HTA submission process is about a year-long experience but can be initiated in most cases up to 180 days before market authorization. Because each of the 10 provinces and private insurers make their own decisions on reimbursing new drugs, manufacturers have to submit documents to each relevant public payer. Private insurers have their own individualized requirements.
The HTA evaluation is managed by two organizations: the Canadian Agency for Drugs and Technology (CADTH), which conducts work on behalf of all public payers except Quebec, and the Institut national d’excellence en santé et en services sociaux (INESS), which does the same for the province of Quebec. Both agencies review drugs that deal with general medicine (Common Drug Review—CDR), oncology (pan-Canadian Oncology Drug Review—pCODR), rare disease and blood products (as part of the process for Canadian Blood Services). CADTH reviews drugs from a health system perspective. INESS also includes a societal perspective. Along with the required administrative documents, the agencies review clinical and economic data before making recommendations to help guide funding and pricing decisions.
At that point the negotiations for the net price of a drug begins. This process is not dissimilar to that used by managed care organizations. The public drug plan side is administered by the pan-Canadian Pharmaceutical Alliance (pCPA) that negotiates pricing, usually over an initial three-year timeline. Private payers handle their own negotiations. In both cases, negotiations can run from two to six months. Talks can begin before market authorization is given and, in some cases, coverage can start as soon as a regulatory approval is issued by Health Canada.
“You first have to see how the manufacturer fits into the three-tier system, so we work with customers from the start to make the right decisions,” Wyatt said.
Wyatt said the earlier talks and planning begins the better the chances for a successful launch. That is becoming even more evident as government health agencies across the globe as well as private payers zero their focus in on patient health outcomes as a measurement for success and establishing price points for treatments.
“Those outcomes are driving the bus,” Wyatt added. “We are doing a lot more in investing in tracking outcomes and real-world evidence. That’s the direction reimbursement is moving across in Canada and around the world.”
Even after achieving a successful entry into the Canadian market, manufacturers that successfully navigate the process with Innomar Strategies acting as importer in the early stages can move to get their own DEL.
“And having a partner that knows all the ins and outs of Canada, it’s provinces and the myriad bodies gives manufacturers a jumpstart toward success,” Anderson said.
To learn more about how Innomar Strategies and AmerisourceBergen navigates entry into the Canadian drug market and the role distributors play in the supply chain check out: www.amerisourcebergen.com.