Until recently, pharma’s biggest market access challenge in the US has been learning to navigate “known unknowns.” Suddenly, however, long-standing unknowns—like the future of the Affordable Care Act, the nature of pricing reforms, or the influence of the Institute for Clinical and Economic Review (ICER)—are being set in a whole new context. COVID-19 has reshaped the narrative, adding another tier of uncertainty to an already complex marketplace
As the economic implications of the pandemic redefine the parameters of payer decision-making, the need for agile strategic insight—and greater collaboration—has only intensified. Pharma finds itself at the brink of great change. But in a US market increasingly driven by extreme unknowns, one thing has become crystal clear: deep understanding of diverse payer archetypes has never been more important.
The US healthcare system is known for its fragmentation and market orientation. The inherent complexities mean that the world’s largest market is also one of the hardest to navigate—posing unique market access challenges that demand detailed customer insight and robust processes for sharing information. Market access teams are working diligently to find their way through, but opportunities to transform the process—and enhance customer engagement—are there for the taking.
But first, let’s examine the environment. At the macro level, securing patient access to life-changing treatments is becoming ever more complex. As the cost of healthcare increases, payers are squeezing their drug budgets in search of savings—and pharma companies need to align and fine-tune their value stories if their medicines are to avoid the cull. Meanwhile, the continued absence of a formal health technology assessment (HTA) process has led to calls for greater control over the cost of medicines and renewed pressure to overhaul pricing systems. Most intriguingly of all, payers are starting to re-evaluate the evidence they require when they review new medicines, with cost-effectiveness—a major focus in European markets but rarely a factor in the US—quietly emerging as a potential consideration. The future promises to be fascinating.
To help pharma companies navigate the diverse US landscape, we’ve developed systematic asset evaluation frameworks.
Senior Director and US Practice Lead
The payer landscape is already shifting. ICER—an independent body that assesses the comparative effectiveness of treatments and calculates a value-based price benchmark to guide negotiations between payers and manufacturers—is becoming a critical player in the market access continuum. You can find out more about its role in our on-demand webinar. However, ICER is far from being the only game in town, with significant influence on payers also stemming from value assessment frameworks published by the American Society of Clinical Oncology (ASCO), the National Comprehensive Care Network (NCCN), Memorial Sloan Kettering, and others. The market remains dominated by well-established but diverse payer archetypes, with some sub-archetypes, including:
- Managed care organizations (MCOs)
- Regional and national orgs
- Commercial plans
- Organizational funded plans
- Government plans
- Medicare Advantage
- Managed Medicaid
- Federal departments and agencies (eg, Tricare)
- Integrated delivery networks (IDNs)
- Commercial, regional, and national
- Financial risk-bearing and non-risk-bearing
- Academic systems and non-profits
- Pharmacy benefit managers (PBMs)
- MCO owned/aligned
- Federal and state governments
- Centers for Medicare and Medicaid Services (CMS)
- Veterans Health Administration
- Federal employees.
Each payer archetype has different requirements; while many payers reference ICER assessments, few have codified ICER’s value assessments into their day-to-day operations. Yet.
An archetypal approach
So what does all this mean for pharma? Well, as is the case in every major market, unlocking patient access to innovative treatments is fundamentally about aligning value messaging with local payer requirements. In the US, this is contingent on understanding distinct payer archetypes and developing the evidence that meets individual requirements. The considerations are wide-ranging. Teams must understand:
- The nuances, needs, and priorities of each payer archetype; for example, an IDN will have very different priorities to a large MCO.
- What additional evidence needs to be provided to support those needs?
- The “acceptability” of evidence for each archetype; for example, which endpoints have the biggest impact on formulary assessments and decision-making in differing populations and geographies?
- Which types of value evidence do individual payer archetypes most trust? For example, budget impact models, cost-effectiveness analyses, network meta-analyses, or indirect treatment comparisons inherently have more bias, compared with randomized controlled trials.
- How do payer archetypes search for information? Where do they go? What processes do they adopt?
- Who else has influence over payer archetypes’ decision-making processes? How much weight do they place on ICER value assessments? Are they even considering them? Do they take the ex-US HTA decisions into account, or decisions from other key payer types within the health system?
- How do decision-making processes within individual pharmacy and therapeutic (P&T) committees work?
Understanding each payer archetype, with deep granularity, is essential to developing a robust global strategy that can be successfully executed at the local level.
Although US affiliates have a deep and granular understanding of payer archetypes, many struggle to funnel that insight and efficiently communicate their needs up to market access and value leads at the global level. This knowledge gap can have a significant impact on shaping global strategy. Value communications need to reflect known commonality in payer needs—but local affiliates must also have the latitude (and materials) to flexibly meet the specificities of individual payer archetypes. Developing (and delivering) the strategy isn’t easy. It requires efficient systems for accessing and sharing insight in real time, and the agility to reorient strategy as payer requirements evolve.
That’s why, at Avalere Health, we’ve developed systematic asset evaluation frameworks to help pharma companies navigate the diverse US landscape. The frameworks are integrated into the PRMA Healthcheck® digital application, enabling collaboration between global and local teams—and helping them design customer-focused market access strategies. The PRMA Healthcheck® assessment frameworks are based on in-depth knowledge of the payer landscape—including the top IDNs, regional and national MCOs, and PBMs—built through early and ongoing engagement with payers and policymakers across the US market. The approach helps us create archetype-level gap analyses, evidence generation, and account management strategies—based on robust research and real-time, real-world insight.
The US payer landscape is changing. Significant overhauls of pricing systems and the Medicare prescription drug program (Part D) are imminent, while the role of ICER will only grow. Alongside it, an undercurrent of extreme unknowns will continue to drive the market—not least political uncertainty as we move to (and beyond) the presidential election and, of course, the long-term ramifications of COVID 19. These ever-shifting currents underline the importance of agile strategic insight and the need to understand the evolving requirements of distinct payer archetypes. In a world of extreme unknowns, it’s the only way to navigate the route to optimal reimbursement and patient access.