It’s hard to get people to believe in new and innovative products. Products that innovators (and even venture capitalists) regard as game-changers still fail to reach their most important target: the payers.
For companies that manufacture medical devices, the most important payers in the Canadian market are the governing provincial authorities, such as the Ontario Ministry of Health and Long-Term Care and hospitals. Surprisingly, a large number of medical devices try to enter the Canadian market, with millions of dollars and many years spent on research and development (R&D), and yet they still fail to gain adoption. The result is a slow death for the technology. As a consequence, patients miss out on the potential benefits of these innovations and the tremendous amount of R&D investment goes to waste.
When you consider that some medical devices can drastically change the way a disease is managed—with some being very invasive or having a high impact on how a disease is diagnosed and treated—you can appreciate that the healthcare system (the payer) has to ask a lot of questions before making the decision to roll a device out widely and make significant changes to existing practices. Payers need to be certain that a medical device demonstrates both benefits to patients and value for money.
The healthcare system demands that companies show it the evidence. However, while companies believe they have the evidence needed to convince the healthcare system to invest, the evidence is often insufficient.
The confusion may be due to the two-part process companies need to go through to get products into the market: licensing and adoption. Licensing is the better understood stage of the process. Companies know that they need to spend money on studies in order to generate evidence that will prove that their device works as described. They also need to prove that it is safe and efficacious in order to satisfy regulatory requirements (with Health Canada, for example). This is called pre-market testing.
The kind of evidence needed for adoption is typically less well understood. A license to sell is simply not enough to gain buy-in during a reimbursement review. Healthcare systems need answers to questions that extend beyond what regulatory bodies require. Such questions delve into the areas of clinical utility, cost effectiveness and comparable effectiveness, all from the perspective of the system in which it is to be implemented.
Specific questions include:
The evidence generated for regulatory licensing approval is oftentimes not enough to answer such questions; typically, innovators do not incorporate these questions into their pre-market testing. If a product fails to gain adoption due to uncertainty in the evidence, the company would need to circle back for more testing or redevelopment of the product, which can take years to complete and, in some cases, result in insurmountable costs.
If companies were to think about the adoption process during pre-market testing, an incremental investment in additional evaluations at this stage could greatly improve a device’s chance of success—and decrease the number of companies that would say, “If only we had known!”
As healthcare systems worldwide, including Canada’s, are facing fiscal constraints, they are turning to evidence-based decision-making. Moreover, medical devices that are unsuccessful at gaining adoption in their local market face skepticism when attempting to enter markets elsewhere. This makes it important for companies with global ambitions to consider the evidence requirements of all major payers (in Ontario and elsewhere), ideally in co-ordinated studies.
They can focus on early health technology assessment!
The goal of early health technology assessment (early HTA) is to answer the right questions early on, gaining the evidence needed to avoid the common pitfalls and barriers to market penetration. Through the early HTA process, medical device companies can gain feedback, from both knowledge experts and payers, early on during the development and pre-market process so that they can better prepare for both licensing and adoption.
The MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE) initiative is the world’s first evaluation platform to guide breakthrough medical technologies from small and large companies through a harmonized, cost-effective early HTA process and to successfully cross the “valley of death.”
EXCITE helps companies learn how to engage with HTA experts, clinicians and the government. Unifying Ontario’s best-in-class approach to medical technology testing, EXCITE brings together a broad spectrum of research under one harmonized platform based on relationships brokered with academic health research facilities across the province. Through EXCITE, medical devices undergo a combination of clinical testing and HTA in order to obtain the evidence needed for both federal licensing and provincial health system adoption.
On May 30, 2013, at MEDEC’s annual MedTech Conference, the Hon. Deb Matthews, the minister of health and long-term care, echoed in her keynote address the importance of early evidence gathering, saying: “Let’s get those products tested earlier, so that when you have a good idea that meets our system’s needs, you have the evidence you need to sell into an Ontario market and a global market.”
During her address, Minister Matthews made a special announcement on behalf of Reza Moridi, the minister of research and innovation, introducing the first participants of the MaRS EXCITE program: ApneaDx Inc., Rna Diagnostics Inc. and Medtronic of Canada Ltd.
These medical devices have the potential to be true game-changers and are engaging with payers early on to increase the likelihood that they will impact people and patients everywhere.