The foundations of successful market access strategies are typically laid in Phase 3 studies. It’s therefore essential that trial designs are shaped by early understanding of the HTA and P&R decision-making landscape to ensure evidence generation strategies are aligned with payer expectations. However, with those expectations always evolving, pharma companies need good intelligence systems to help them track trends, anticipate needs, and adapt accordingly when thinking shifts. Foresight and flexibility are critical—but expert insight is everything.

Fortunately, we’ve developed a solution that gives clients all three.

Tracking the market access environment

But first let’s examine the context. From the earliest possible opportunity, global market access teams need to constantly monitor the pulse of the regulatory and HTA environment for competitor products to understand what’s driving decision-making in all markets.

Keeping track of thinking in areas such as appropriate comparators, endpoints, and target populations can help organizations anticipate needs and prioritize evidence generation activity in line with payer expectations. While intelligence of this kind is a prerequisite for all products, it’s particularly important for manufacturers who are moving into new disease areas or where treatment paradigms are being transformed by breakthrough therapeutic innovation.

By assessing HTA and P&R decisions—and learning from competitors’ experiences—organizations are better-placed to design trials that focus on developing the most resonant evidence. Reliable intelligence is critical.

It’s no surprise that companies are turning to technology to track the competitive environment and build an informed view of the decision-making landscape. The approach makes good sense. Modern technology makes it easier than ever before to monitor markets, with digital innovation like AI and machine learning helping organizations detect change and trigger alerts as disease areas evolve.

However, some organizations make the mistake of thinking that AI alone will answer all their questions. It won’t. Sure, it can automate useful information, but it only tells you part of the story. Basic notification systems may alert you when something pertinent has happened, but they rarely tell you what it means for your brand. In isolation, that’s not enough.

The best intelligence isn’t about the “what”, it’s about the “so what?”

It’s the difference between information and insight. And in nuanced areas like market access, it’s the magic ingredient that inspires joined-up strategy. Deep insight–the kind that helps you understand diverse payer archetypes and anticipate evidence needs–requires expertise, knowledge, and experience that cannot be captured by an algorithm alone.

A hybrid solution for market access

The most effective intelligence systems combine information and expert insight to empower evidence-based decision-making.

A great example is the PRMA Tracker^®—a digital application that informs payer evaluation and HTA strategy—where technology and specialist market access insight work together in concert.

The PRMA Tracker^® helps pharmaceutical organizations understand the competitor environment, HTA trends, and evidence needs—to identify gaps and inform product strategy.

At its core, the application tracks the P&R and HTA decision landscape, providing timely updates as new decisions are published, and information on what drove them. However, monitoring the environment is just one element. The sophisticated process builds on our specialist consulting expertise to critically evaluate baseline information and provide value-added strategic recommendations for clients.

Evidence domains

Once they’ve been identified, P&R and HTA decisions are reviewed in detail by our consulting team to understand the evidence presented to payers and the influence it had on decision-making.

The application provides a systematic framework for analyzing and comparing decisions—extracting evidence and narrative from published decisions and grouping it into clearly defined domains:

• Unmet need
• Patient population
• Competitors
• Efficacy
• Safety
• Health-related quality of life (HRQL)
• Network meta-analysis (NMA) or indirect treatment comparison (ITC)
• Cost-effectiveness
• Budget impact
• Price information/risk-sharing agreements
• Implementation considerations

Clearly, not every domain will be relevant to each decision, with the type of submission will be dictated by product, disease area, and national HTA expectations and requirements. However, where information is available, the PRMA Tracker^® captures, organizes, and visualizes it.

The application also allows global teams (and local affiliates) to view the clinical and economic data and associated critique from review committees—all in one place, and in an easy-to-navigate format. This bolsters collaboration between global and local teams, providing a single version of value that supports joined-up thinking.

Combining digital innovation and expert market access insight

The powerful combination of intuitive technology and expert insight helps clients unlock the answers to crucial “so what” questions, like:

• What comparators are HTA agencies accepting? Are we using the right ones?
• Are we focusing on the right endpoints? Which endpoints have the biggest impact on decisions?
• Is our trial duration or size optimal?
• How much weight do payers place on specific evidence models?
• What additional evidence may we need to provide?

The hybrid approach, underpinned by synthesized intelligence from the PRMA Tracker^®, allows organizations to anticipate evidence needs and base strategic market access decisions on an informed understanding of payer expectations.

As demonstrated in our free eBook, which shows how a leading pharmaceutical organization used expert insight to inform the launch of a new immunotherapy asset, the PRMA Tracker^® can help:

• Reduce the risk of unforeseen HTA/P&R objections
• Anticipate evidence needs early, creating time and cost efficiencies
• Focus evidence generation on payers’ priorities and expectations
• Provide a single view of the HTA and P&R decision landscape that strengthens cross-team engagement and collaboration between global/local affiliates

Mastering the art of foresight

The environment for your product is always changing; as medical science evolves, payer thinking shifts with it. Global teams therefore need good, agile, and trusted information to ensure their strategies respond to market fluctuations.

However, where others react, leaders anticipate.

Avalere Health gives pharmaceutical organizations all the market access tools they need to anticipate evidence requirements and design optimal insight-based strategies. Digital innovation is at the core of the offering and will undoubtedly shape the future of market access. But, despite the growth of AI and automated technologies, expert insight will always have a human heartbeat.