While COVID-19 has left no industry untouched, it’s safe to say that healthcare has been hit the hardest. Yet despite this reality, there are plenty of exciting advancements happening within the industry, even amid the lingering effects of the global pandemic.
To get an idea of what’s to come in market access, I asked four of my colleagues to weigh in on upcoming challenges and opportunities within healthcare. Their answers—which cover topics from evolving payer strategies to gene therapies to digital therapeutics—are full of insights for the year ahead.
Q: What’s the biggest challenge facing market access in 2022?
Carolyn Zele, Senior Manager of Solution Enablement: Health plans already hurting financially are cutting treatment options, so while medicines are being developed and launched, fewer patients will have access to them without a fight, and payers will expect to get heavy rebates from manufacturers for therapies that never had rebate competition before.
Also, Medicare coverage is no longer a guarantee, even if the drug is the second launch in the class because the “two of class” rule seems to be relaxing. Off-label generic or end-of-life brand use in Medicare may even become common and expected practice.
Seamus Cole, Associate Consultant: While co-pay accumulators and maximizers have been out for a few years, they’re continuing to grow and can impact a manufacturer’s bottom line. A few manufacturers are implementing ways to get around these programs, such as Amgen mailing a check directly to some patients.
Many manufacturers have been taking a wait-and-see approach with addressing these programs. With the continued increase in prevalence, manufacturers may have to consider putting a plan in place in 2022 to circumvent the programs.
With COVID, a lot of meetings have been virtual, and many payers will prefer this going forward. Many manufacturers may continue to struggle to get in-person meetings with payers in 2022, especially because payers are now used to virtual meetings.
John Griggs, Senior Solution Consultant: Digital therapeutics is an area where payers have only begun management, but we can expect to see major changes over the coming year. Payers no longer limit access to therapies through restrictions within drug-specific prior authorizations. Digital therapeutic policies will be joining multiple other payer policies that can severely hinder access to therapies, which includes genetic testing, site of care, and approved billing and coding for things such as patient monitoring. A clear understanding of all access hurdles pre- and post-administration will be key to brands launching in 2022 and beyond.
Q: What industry innovations or milestones are you most excited for?
Saket Patel, Associate Consultant: In the diabetes therapy area, Eli Lilly is expected to launch tirzeptide in 2022 that could be a blockbuster due to its innovative dual GIP/GLP-1 mechanism of action. Data from Evaluate suggests that this agent’s sales in diabetes could generate $3.8 billion dollars by 2026.
Additionally, Eli Lilly is exploring the agent’s utility in obesity and will publish the results of the SURMOUNT-1 clinical trials this year. It could compete with Wegovy, making things interesting in the obesity market.
Carolyn Zele: Pharma’s focus on curative therapies, specifically stem cell therapies, outside of oncology is an exciting development. Novo Nordisk is working on a cure for diabetes with stem cells, and we already have Zolgensma, which uses a single infusion of stem cells to help spinal muscular dystrophy in toddlers (which means that toddlers with SMA won’t have to take drugs for the rest of their lives).
I’m also looking forward to genetic targeting to cure cardiac diseases without transplants, and the ability to cure liver diseases without transplants. There are advancements on the horizon that are designed to replace surgical procedures, such as Jelmyto, which targets and destroys kidney tumors.
Seamus Cole: BioMarin Pharmaceutical might have the data it needs to win approval for its hemophilia A gene therapy, which is very exciting.
Gene therapies are a relatively new space with only a few currently approved. Companies have hit roadblocks in the past, including this product specifically. This approval would be a step in the right direction. There are increasingly more gene therapies in the pipeline, and it’s encouraging that more lifesaving gene therapies could be approved.
Q: What’s the most important thing that healthcare organizations should focus on in the year ahead?
Seamus Cole: Manufacturers should prioritize being adaptable and staying on top of trends. Last year, payer market access teams had to deal with the unforeseen impacts of COVID. They had to worry about delays in launch, a decrease in in-person clinical trial participation, and very few in-person meetings with key decision-makers. Now, manufacturers need to be prepared if payers get more aggressive with management. There are a lot of upcoming rare disease medicines and gene therapies, which will increase the cost of healthcare. Payers will likely look to manage these agents strictly, and they may feel the pressure to manage other classes more aggressively in order to keep overall healthcare costs down. More advancements in therapeutic areas that already have agents approved will give payers more leverage.
John Griggs: The relationships and management dynamics between payers and IDNs/health systems is a key area of focus. IDNs and health systems have continued to rapidly consolidate throughout the pandemic. As a result, contracting power is no longer a payer-only issue for pharma: Direct contracting with both IDNs and payers is critical to both launch brands and existing brands on the market.
Saket Patel: As COVID restrictions continue to persist, manufacturers have to market products virtually due to limited access to payer teams. These constraints could have unforeseen implications on market access. Only time will tell.