The "Too Late" Test: A Framework for Evidence-Ready Launch Planning

Editor's note: Last month's blog covered how to structure value communications that influence access decisions. Our latest newsletter introduced the "Too Late" Test as a way to check readiness. Today, we're focusing on what happens in the middle of the value strategy stack: evidence planning.

(4 Min Read)

Executive Summary

Market access failures rarely stem from weak evidence. More often, they result from evidence that is misaligned with decision-makers’ needs or arrives too late.

The challenge isn't just how to generate data. It's ensuring the right evidence exists at the right moment. This requires a shift from traditional evidence planning that builds forward from capabilities to strategies that work backward from decision points.

The Gap Between Evidence and Access

Most evidence generation follows a predictable pattern. Clinical development drives the timeline. Regulatory milestones set the pace. HEOR fills in gaps with studies and models. Market access teams inherit whatever data emerges from this process. The assumption is that comprehensive evidence automatically translates to access success. Teams also treat this as a one-time decision.

This approach misses a critical reality: decision-makers don't evaluate treatments in isolation. They assess them within specific contexts, timelines, and organizational constraints. When key questions arise during these evaluations, having the "right" answer six months later provides little value.

The gap between evidence generation and decision timing creates what I call the "Too Late" problem. These are moments when otherwise strong value propositions fail because critical data isn't available when decisions get made.

The "Too Late" Test Framework

1. Map the questions: What will decision-makers ask before saying yes? This goes beyond standard evidence requirements. It includes context-specific concerns, competitive comparisons, and implementation considerations that emerge during real evaluations.
2. Audit the answers: Do we have the evidence, and is it clearly communicated? Raw data isn't sufficient. Evidence must be synthesized, validated, and formatted for decision-making contexts.
3. Assess risk and readiness: When is the last moment we can generate missing evidence? If we start now, when will this data be ready? What is the earliest time we can prove projected impact with RWE? This timeline assessment determines whether gaps can be filled or require strategic workarounds.

If that bird question can't be answered confidently, the evidence strategy isn't complete. 

Implementation: Working Backward from Decision Points

The framework requires systematic application across launch planning:

Define evidence needs and identify decision points. Map what different stakeholders require and when their decisions occur. P&T committees (pharmacy and therapeutics committees), HTA bodies (health technology assessment organizations), Guidelines Groups, and health plan medical directors operate on different timelines with distinct evidence standards.

Plan backwards from the decision. Calculate lead times for missing evidence. Complex health economic models require 12-16 weeks. Real-world evidence studies need 6-12 months. Registry analyses depend on data availability and can take 3-9 months. If peer review citations are required, add an additional 6-12 months to timelines.

Generate timely, relevant evidence. Prioritize evidence that directly addresses decision-maker concerns over academically interesting but non-essential analyses.

Sidebar: Common Evidence Timing Traps

• Real-world effectiveness data: Often requested during payer discussions but requires time in the market, sufficient adoption and months to generate from claims databases or registries. 
• Budget impact models: Health plans want models that reflect their specific populations, insights on adoption and utilization patterns, not generic industry assumptions.
• Implementation feasibility studies: Decision-makers need to understand workflow integration, training requirements, and resource implications, especially in acute care settings. 
• Comparative effectiveness research: Head-to-head comparisons with market leaders rarely exist at launch but frequently drive access decisions. 

Case Study: Specialty Drug Launch 

Specialty therapy preparing for health plan presentations:

Traditional evidence planning might focus on clinical trial results, published health economic studies, and standard budget impact models.

The "Too Late" Test reveals different priorities:

Questions health plans will ask: How does this compare to the preferred alternative on our formulary? What's the real-world adherence rate? How will this affect our specialty pharmacy costs?

Current evidence gaps: No head-to-head comparison with the preferred competitor. Limited adherence data from clinical trials. No analysis of specialty pharmacy impact.

Timeline constraints: Health plan meetings scheduled in 10 weeks. Prospective head-to-head studies would take 6 months. Real-world adherence analysis could be completed in 8 weeks using existing databases.

Strategic response: Commission the adherence analysis immediately. Develop indirect comparison methodology for the competitive question. Create specialty pharmacy cost model based on existing utilization data.

Beyond Launch: Lifecycle Applications

Formulary reviews: Annual evaluations require updated comparative effectiveness and budget impact data.

Indication expansions: New patient populations trigger different evidence requirements and decision timelines.

Competitive responses: New entrants force reassessment of value propositions and supporting evidence.

Policy changes: Regulatory updates or coverage policy modifications create new evidence needs with fixed deadlines.

Putting the Framework into Practice

1. Start with decision mapping. Before developing any evidence, map stakeholder decision processes, timelines, and evidence requirements 
2. Build evidence roadmaps. Create project plans that work backward from decision dates to ensure adequate lead times.
3. Establish early warning systems. Monitor for emerging questions or competitive threats that could create new evidence needs.
4. Test readiness regularly. Conduct quarterly assessments using the three-question framework to identify emerging gaps. 

Final Thought

Successful evidence planning means you have the right answers when decisions get made.

The "Too Late" Test shifts evidence strategy from hope-based planning to readiness-focused execution. When evidence generation aligns with decision timing, access conversations move from "we'll get back to you" to "yes."

When you're building your evidence plan, start with the decision moments and work backward. Your career depends on getting the right evidence at the right time. This applies not just for external payers and HTA bodies, but also for internal leadership teams, medical affairs, and commercial functions who need evidence to support strategic choices.

Betsy J. Lahue is the Chief Executive Officer of Alkemi, where she helps teams build strategy and evidence to get their treatments access.