Making Meaning from Numbers
July 18, 2022
A data-driven leader and communicator, Mark Omoto sees a bright future for Canada’s specialty medicine sector
As General Manager at IQVIA Canada, the country’s leading provider of healthcare data analytics, Mark Omoto oversees IQVIA’s thought leadership, marketing and communications strategy and provides consulting expertise to companies in the healthcare and other sectors. Mark’s deep experience in the pharmaceutical industry has seen him involved in product launches, market access, and global marketing. A popular keynote presenter at industry conferences, Mark pressed pause on his busy schedule to share his insights about the specialty medicine pipeline.
In a nutshell, what does IQVIA do?
We’re the largest global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. You can think of us as a mirror to the pharmaceutical industry: we provide products and services throughout the drug life cycle, with a focus on advanced data and analytics.
How do you define a specialty pharmaceutical product?
The term doesn’t have an official definition, though a lot has to do with complexity and cost. Generally speaking, specialty pharmaceuticals treat chronic, complex, or rare conditions. They may require special handling in the supply chain, have highly specific distribution pathways, or require extensive monitoring. We sometimes use $7,500 per year as a loose lower cost threshold. Within specialty, we often divide medications into biologics and non-biologics.
How would you describe the specialty innovation we’ve seen in Canada over the past decade?
We’re in the midst of a shift from infused and injected products toward oral medications, notably in oncology and auto-immune diseases. We’re also seeing an expansion in the therapeutic areas covered by specialty medications, including the addition of new indications for established products. For example, Dupixent, initially indicated for atopic dermatitis, now has an indication for asthma. Diabetes medications are now receiving indications for obesity. In essence, specialty drugs are moving into the primary-care sphere. They’re also being initiated earlier in treatment algorithms.
How is Canada doing in terms of specialty medication innovation and adoption?
I think we’re in a golden age. The medications available today give Canadians more options than ever for managing both chronic and acute conditions. In both 2020 and 2021, specialty pharmaceuticals accounted for over 33% of all new active substances commercialized in Canada. And thanks to our public and private coverage ecosystem, we’re seeing very robust uptake of biologics across many therapeutic areas.
How has the COVID-19 pandemic impacted the evolution of specialty medicine in Canada over the past couple of years?
Average sales performance for new active substance product launches across the globe during the pandemic are down by 19% from the pre-COVID benchmarks. This is to be expected, as the pandemic had affected every corner of medicine. At the same time, our recent experience with the COVID-19 vaccines speaks to how well and how fast the pharmaceutical industry can innovate when all stakeholders are aligned.
The pandemic has also raised our collective awareness of mental health and the challenges facing long-term care homes. So we’re now seeing a renewed interest in treatments for neurologic conditions, especially Alzheimer’s disease. During the course of the pandemic, the neurology market has doubled its rate of growth, which means more patients than ever will have access to effective mental health treatments —one of the few positive things to come out of the pandemic.
Where do you see the specialty pipeline going?
What we’ve seen so far is just the beginning. Innovation is going to come faster and faster, and new products will keep getting more complex. The big question going forward will be: how much improvement does the innovation provide, and will it be worth it? Like everything in life, specialty drug development requires us to consider tradeoffs.
“Innovation is going to come faster and faster, and new products will keep getting more complex.”
What are the key specialty areas to watch for?
Given the phenomenal rate of innovation in oncology, diabetes and immunology, we’re keeping a particularly close eye on those areas. The oncology pipeline alone is full of new medications for increasingly specific indications. It’s telling that rare cancers account for 40% of the oncology pipeline. We’re seeing a lot of immune checkpoint inhibitors and antibody drug conjugates coming through, and the success of biotherapies such as CAR-T bodes well for this category. The increasingly personalized approach to cancer treatment has also fuelled an interest in combining medications to optimize outcomes in different subgroups.
Neurology represents another area of high need. Right now, 154 molecules are being investigated for Alzheimer’s—some biologics, some cell therapies, some small molecules. It’s a complex area of investigation, with a high probability of failure, so the high research interest speaks to the urgency of the public need. R&D for Parkinson’s disease, depression, multiple sclerosis, migraine, and epilepsy is also thriving.
How will the Canadian specialty infrastructure need to adapt to support all the innovation?
By and large, our specialty infrastructure has been able to support the needs of patients on injected and infused drugs. We now have to integrate biotherapeutics, like CAR-T therapies, and other next-generation treatments into the system. Many of these therapeutics don’t fit into the traditional clinical and pharmacy distribution pathways. To build the required infrastructure, the private market will need to form partnerships with the public sector.
“To build the infrastructure to support biotherapeutics and other next-generation treatments, the private market will need to form partnerships with the public sector.”
Has IQVIA had to evolve to meet the new needs associated with these therapies?
Yes. In addition to tracking market segments for brands, generics, and biologics, we have added a speciality classification to our insights. We also track distribution channels beyond hospitals and pharmacy to reflect the increase in non-traditional distribution channels. For example, mail order pharmacies offer home delivery to patients, so we monitor this channel.
Do you expect some of the pipeline drugs to present challenges from a data perspective? How do you see the role of real-world evidence (RWE) in filling data gaps?
RWE has evolved by leaps and bounds, to the point that regulatory bodies are routinely incorporating it into their decisions. There’s still room for improvement in capturing data across multiple therapeutic areas and jurisdictions. Perhaps the biggest challenge lies in achieving consensus on which data matters most, especially for a pipeline drug that doesn’t have a precedent. I’m confident we can get there.
What are you most excited about in today’s specialty drug market?
Whether you’re a patient, healthcare professional or industry stakeholder, there’s a lot to be excited about. Innovations are reaching the marketplace at an incredible pace. It’s especially exciting to see specialty medicine confront the many chronic diseases that impact our aging Canadian population. Of course, benefits don’t come without costs. It’s all about striking the right balance. I hold onto the thought that innovation will continue to improve Canadian lives.