MODERN COMMERCIAL STRATEGY: WHY VALUE  & ACCESS MUST LEAD EARLY

For years, commercializing a treatment followed a familiar path.

First, you built the evidence.
Then you defined the value.
Next, you mapped the landscape.
Finally, you prepared for launch.

Each step followed the last. It was orderly. Predictable. Linear.

That model worked when competition was lighter, regulatory timelines were slower, and payers were willing to wait for data. Companies could afford to perfect thestory before engaging decision-makers.

That world no longer exists.

What replaced it is not a new sequence of steps, but rather a fundamentally different mindset. Today, Value & Access must drive commercialization from the very beginning.

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WHEN SEQUENTIAL THINKING BECAME A RISK

Regulatory pathways have accelerated to get treatments to patients faster. At the same time, the bar for access has risen. Payers now make decisions with incomplete evidence. HTA bodies expect comparative data before most companies can realistically generate it.

Real-world evidence is no longer a post-launch add-on. It has become a pre-launch expectation.

The old model assumed time. Today’s environment allows very few chances to shape first impressions. When companies wait too long, payer positions harden, once that happens, changing the narrative becomes expensive or impossible.

This shift forced successful organizations to rethink how they commercialize. They start by asking what decision-makers need, not what the development plan happens to produce. They build evidence to demonstrate value in ways that resonate. And they engage early enough to shape understanding before assumptions set in.

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WHY WAITING UNTIL YOUR PIVOTAL TRIAL COSTS YOU MORE THAN YOU THINKI

The companies that win today do not wait for launch to explain their value. By then, competitors often control the narrative. Payers form opinions based on what they know now, not what might arrive later.

Here’s A critical mistake I see repeatedly: by the time a company reaches its pivotal trial, it has often locked in an evidence strategy that does not align with payer expectations.

Phase II is the last real opportunity to influence what evidence gets collected. That is when teams can still adjust endpoints, incorporate resource use measures, and plan for real-world relevance.

Without this early insight, companies miss what payers care about, or worse, they fail to challenge an entrenched status quo. In well-managed categories, “good enough” is often the biggest barrier to adoption.

Market shaping means engaging decision-makers while their understanding is still forming. It means testing value propositions before committing millions of dollars to evidence that may not move decisions.

The alternative is costly. Teams burn budget on data that does not change coverage outcomes, build dossiers that answer the wrong questions, and leave patients waiting longer for access.

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VALUE & ACCESS AS THE ORGANIZING PRINCIPLE

The hope-based, wait-and-see era of market access is over. Organizations that shape the evidence landscape starting in Phase II gain a real competitive advantage.

The core elements of commercialization have not disappeared. What changed is how companies execute them. When Value & Access becomes the north star, everyworkstream serves one goal: prove value in ways that drive access.

- Evidence development starts early and evolves as payer feedback emerges.
- Stakeholder engagement runs alongside clinical development, not after it.
- Economic models guide evidence priorities by showing what truly matters.
- Value propositions get tested with the people who must believe them.
- Internal teams operate as one strategic unit, not functional silos.

This is not sequential execution. It is continuous, parallel, and iterative.

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THE TEN INTERCONNECTED WORKSTREAMS

As soon as clinical development commences high-performing organizations orchestrate these ten workstreams together:

1. A strong evidence base built on meaningful clinical outcomes, resource use data, and planned real-world evidence
2. Clear value propositions for payers, providers, patients, and policy-makers; tested early and refined continuously
3. Access landscape mapping that identifies stakeholders, pathways, and influence points in each market
4. Early payer engagement that shares emerging evidence and incorporates feedback before launch
5. Disease and health economic models that quantify population impact, scenarios, and budget implications
6. Value assessment preparation for HTA bodies and P&T committees, with answers ready for tough questions
7. Internal alignment across Commercial, Medical, HEOR, and Access teams around one value story
8. Advocate engagement that activates clinical and patient voices to open doors and build credibility
9. Post-launch monitoring to track uptake, competition, and market signals in real time
10. Continuous communication that keeps new data and differentiation front and center

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These workstreams inform one another. Stakeholder insights reshape evidence plans. Economic models focus attention on what's impactful. Evidence strengthens engagement. No activity is done in isolation. For a deeper look at how evidence, value, and access planning is operationalized, see 10 steps to commercialize a new treatment (my proven EV&A playbook).

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WHEN VALUE AND ACCESS BECOME THE STRATEGY

Companies that still rely on sequential models often scramble at launch. Coverage decisions solidify before meaningful engagement begins. Competitors define value first. And teams realize too late that their evidence doesn't resonate.

The transition from stepwise execution to Value & Access–led strategy is already underway. The market rewards companies that shape understanding early and prove value before access decisions solidfy.

The shift is happening, the question is how quickly can you make it?

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‍BetsyJ. Lahue is Chief Executive Officer of Alkemi. She partners withlife sciences leaders to transform regulatory success into appropriate market access for breakthrough treatments worldwide.