Why Market Access Now Starts Years Before Approval
Life sciences companies have long balanced scientific opportunity with commercial potential. Regulatory approval, payer strategy, market access, physician adoption, pricing, and patient demand have historically shaped commercial success. What has changed is when the decisions behind these outcomes must be made and how closely those decisions are connected. Choices made years before a therapy’s approval can affect how quickly it reaches patients and how much value it creates.
That shift is redefining launch and market access readiness. Regulatory approval alone no longer signals commercial readiness. Evidence expectations, reimbursement pressures, access requirements, and increasingly complex treatment pathways can influence a therapy’s path to patient access and commercial success well before and after market entry.
For life sciences leaders, the healthcare strategy implications reach beyond improving launch execution. Decisions across the therapy lifecycle can determine which patients gain access, how a therapy is valued, and how much of its commercial potential is realized. That requires leadership to manage launch readiness across five interconnected dimensions: regulatory, evidence, access, delivery, and value readiness. Together, they provide a framework for identifying where decisions made today could strengthen or constrain a therapy’s future patient reach and value.
Launch Has Moved Upstream
Therapy launch planning has long preceded regulatory approval, but the decisions that determine success are moving earlier in the product lifecycle. Choices made during clinical development can affect both the regulatory pathway and whether the evidence supports reimbursement, market access, and adoption.
Europe’s Health Technology Assessment (HTA) framework is bringing market-access evidence requirements closer to regulatory development. Since January 2025, new cancer medicines and advanced therapy medicinal products (ATMPs) entering the EU’s centralized authorization process have been subject to Joint Clinical Assessments. Medicines for rare diseases enter the framework in 2028, followed by all new medicines in 2030.
For eligible medicines, the Joint Clinical Assessment begins alongside the European regulatory process, leaving little room to treat HTA evidence strategy as a post-approval activity. Regulatory review may not address every question relevant to a therapy’s value across European markets. Companies therefore need to anticipate the populations, comparators, and outcomes likely to shape the assessment while there is still time to address them in the development program.
U.S. regulatory expectations are also bringing critical decisions forward. Through Project Optimus and its oncology dosage guidance, FDA expects drug developers to optimize dosage during development by balancing efficacy, safety, and tolerability. FDA encourages sponsors to address dose optimization early, before trials intended to support registration.
Accelerated approval of drugs and biologics can pull post-approval evidence planning forward as well. Drugs approved through this pathway require confirmatory trials to verify anticipated clinical benefit, and FDA has authority to require those trials to be underway before accelerated approval or within a specified period afterward. These studies therefore need to be planned early enough to support both the initial approval strategy and subsequent requirements.
These developments reinforce a broader shift: evidence planning for approval, reimbursement, and access can no longer be treated as a sequence of separate activities. Not every decision needs to move earlier, but leadership needs to identify those that can constrain future options if deferred. Choices involving comparators, endpoints, dosage, diagnostics, indications, and evidence strategy can shape whether a development program ultimately supports regulatory approval, reimbursement, and patient access. Once pivotal studies are underway or complete, addressing gaps in those areas can become difficult, costly, or impossible without additional development.
Key Takeaway
Identify the option-constraining decisions that can limit future regulatory, access, or value options, and address them before they become difficult or costly to reverse.
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When Evidence Shapes Market Access Economics
Evidence generated across a therapy’s lifecycle does more than support regulatory approval. It also informs the coverage, reimbursement, and pricing decisions that shape its economics.
Pivotal trials are only part of the broader evidence base. FDA’s real-world evidence (RWE) framework recognizes the use of routinely collected data from sources including electronic health records, claims, registries, and digital health technologies.
The implications are visible in Medicare drug price negotiation. Under the Medicare Drug Price Negotiation Program, the Centers for Medicare & Medicaid Services (CMS) considers how a selected drug compares with available treatments, whether it provides a meaningful clinical improvement, and whether it addresses an unmet medical need when negotiating its Medicare price. The financial stakes are substantial: CMS estimated that if the negotiated prices had been in effect in 2023, aggregate net spending on the selected drugs would have been 22% lower, representing approximately $6 billion in savings.
Reimbursement decisions can also evolve well beyond market entry. WHO Europe’s 2026 framework for managed entry agreements provides guidance for agreements designed to manage uncertainty about the financial impact and performance of new medicines, including principles specific to outcome-based agreements. In these arrangements, evidence generated after launch can inform ongoing reimbursement decisions.
Life sciences companies need to plan evidence generation around the decisions a therapy will face across its lifecycle. Questions about comparative performance, routine care, and reimbursement may require additional studies or real-world evidence, or other data beyond the original clinical development program.
The economic consequences of evidence uncertainty can be direct. In 2026, NICE found that amivantamab with chemotherapy improved progression-free survival for certain patients with advanced non-small-cell lung cancer, but uncertainty about overall survival contributed to questions about cost effectiveness. The combination was not recommended for routine NHS use and instead entered managed access while additional long-term evidence is collected. A well-designed life sciences evidence strategy can anticipate the evidence needed for decisions across markets, including reimbursement, contracting, clinical adoption, and future indications.
Key Takeaway
Build evidence strategy around the decisions that shape access and value across the therapy lifecycle, not regulatory approval alone.
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Market Access Must Be Designed, Not Assumed
Regulatory approval has never guaranteed patient access. Coverage restrictions, referral pathways, treatment capacity, and other barriers can determine whether an eligible patient ultimately receives a therapy. For therapies that require specialized diagnostics, treatment centers, patient support, and coordination across the healthcare system, access depends on more than generating physician and patient demand.
Coverage itself can introduce significant friction. MedPAC reported that in 2025 some form of utilization management applied to 53% of covered products in stand-alone prescription drug plans and 51% in conventional Medicare Advantage prescription drug plans. Prior authorization alone applied to roughly one-quarter of covered products in both plan types. Physician willingness to prescribe therefore does not ensure that a patient can readily obtain treatment.
Advanced therapies expose a different constraint: even when coverage exists, the healthcare system must be able to deliver the treatment. The Centers for Medicare & Medicaid Services’ Cell and Gene Therapy Access Model illustrates the challenge. Sickle cell gene therapy requires an extended inpatient hospital stay and potentially multiple visits to a gene therapy center, making access dependent on specialized providers and treatment capacity in addition to coverage.
The model is designed to address several of these barriers. It includes 32 states, the District of Columbia, and Puerto Rico, representing 84% of Medicaid beneficiaries with sickle cell disease, and uses outcomes-based agreements that tie manufacturer payment to patient outcomes. Participating manufacturers must support defined fertility preservation services, including certain related travel and lodging expenses, while participating states must ensure access to qualified treatment providers, including out-of-state care where necessary. A therapy can therefore be effective, approved, and covered while the infrastructure and services required to deliver it remain critical determinants of patient access.
For life sciences leaders, this changes the commercial question from “How much demand can we generate?” to “What will it take to convert demand into treatment?”
Leaders therefore need visibility across the path to treatment: whether eligible patients are identified and diagnosed, reach the right specialists, secure authorization, and have access to sufficient treatment capacity. Prescriptions and market share show commercial performance, but they may not reveal what is preventing eligible patients from receiving treatment. Diagnostic rates, referral conversion, authorization times, site capacity, treatment conversion, and patient abandonment can help identify where access is breaking down.
Not every access problem is a demand problem. A diagnostic gap, payer restriction, capacity constraint, or adoption problem requires a different response. Identifying the constraint allows leaders to target investment where it can have the greatest effect on treatment access.
Key Takeaway
Manage access across the full patient-to-treatment pathway. Identify where access breaks down and direct investment toward the underlying constraint.
Launch Strategy Is Now Portfolio Strategy
The path to market access varies significantly across countries. Reimbursement timelines, evidence requirements, and treatment infrastructure can materially affect when patients gain access and when a therapy begins generating revenue. Market sequencing is therefore a capital-allocation decision: where to invest, in what order, and against what expected return.
Europe illustrates why. The EU Health Technology Assessment (HTA) framework creates a common process for assessing clinical evidence, but pricing and reimbursement remain national decisions. A common clinical assessment does not create a common path to patient access.
The differences can be measured in years. An OECD analysis of high-clinical-benefit breast and lung cancer indications found that the time from European Medicines Agency authorization to national reimbursement or coverage was around 100 days or less in Germany and Sweden, but exceeded 1,100 days in Cyprus, Latvia, and Lithuania. Coverage also varied substantially across countries.
For global manufacturers, those differences change the investment case by market. Markets with faster reimbursement and established delivery infrastructure may warrant earlier investment, while others may require additional evidence, contracting, or market development before broader access is achievable. The strategic decision is not simply where to launch next, but where additional investment can materially improve patient reach and economic value.
The same portfolio logic applies to indication sequencing. A therapy may have opportunities across different patient populations, each with its own competitors, clinical requirements, access conditions, and economic potential. A study of multi-indication oncology medicines across seven countries found that sequencing decisions are shaped in part by the expected value of each indication and its potential contribution to return on investment. The order in which those opportunities are pursued can influence subsequent evidence needs, investment priorities, and commercial potential.
These capital-allocation choices continue throughout the therapy lifecycle. Additional studies, new indications, companion diagnostics, treatment capacity, and market-specific data all compete for finite resources. Leaders need to assess where investment can materially improve patient access and economic value, and how reimbursement delays, additional requirements, or patient-identification barriers could affect the expected return.
Key Takeaway
Optimize for portfolio value, not maximum launch speed or breadth.
Synchronize the Decisions That Determine Value
Capabilities across development, life sciences market access, commercialization, and investment are generally well established. The greater challenge is aligning decisions across those areas before choices made in one constrain options elsewhere in the therapy lifecycle. A clinical trial, for example, may provide enough evidence for regulatory approval without answering the questions that later influence reimbursement and patient access.
Leadership teams should test each therapy against five interconnected dimensions of readiness:
- Regulatory readiness: Does the evidence support the intended approval pathway, dosage, safety profile, and benefit-risk case?
- Evidence readiness: Can the organization answer the comparative, economic, and outcomes-related questions that will influence downstream decisions?
- Access readiness: Are coverage, reimbursement, contracting, diagnostics, and clinical pathways sufficiently developed for eligible patients to obtain treatment?
- Delivery readiness: Can providers, treatment centers, specialty partners, supply networks, and patient-support systems reliably deliver the therapy?
- Value readiness: Do obtainable price and access, required investment, and remaining lifecycle opportunity support an attractive risk-adjusted value case?
These dimensions should not be assessed independently. Leadership needs visibility into the dependencies among them: which assumptions remain uncertain, which upcoming decisions rely on those assumptions, and how a choice in one area could affect decisions in another.
That requires a different management cadence. Rather than reviewing readiness primarily by function or milestone, leadership should focus on critical decisions across the therapy lifecycle: where unresolved evidence could affect access, where access constraints could change the investment case, and where targeted investment could materially improve the outcome. Particular attention should go to option-constraining decisions: choices that become difficult or costly to reverse and can narrow future regulatory, access, delivery, or value pathways.
The relative importance of these dimensions will also vary by therapy archetype. A conventional medicine may place greater emphasis on evidence, access, and value readiness, while a biomarker-dependent oncology therapy adds diagnostic and patient-identification dependencies, and a cell or gene therapy can make delivery capacity and treatment infrastructure central to the value case.
Integration creates value when it improves those decisions. The goal is not more governance forums or broader participation in launch meetings. It is to surface critical dependencies and choices while leadership still has meaningful alternatives and direct investment toward the interventions most likely to improve patient reach and economic value.
Key Takeaway
Manage readiness around dependencies and option-constraining decisions, not organizational boundaries. Prioritize the choices that can narrow future options, calibrating leadership attention to the therapy’s specific readiness profile.
From Launch Excellence to Lifecycle Value
The traditional launch model is not disappearing. Life sciences regulatory excellence, physician engagement, payer strategy, pricing, market development, and commercial execution remain fundamental.
Life sciences leaders need to understand where value can be lost, which questions must be answered earlier, and what is constraining patient access. Evidence gaps, access barriers, delivery constraints, and weak demand require different responses and different investments.
Launch is no longer a handoff from development to commercial. It is a series of interconnected decisions that determine how effectively scientific innovation becomes patient access, impact, and enterprise value. The advantage will belong to companies that recognize which decisions can change a therapy’s trajectory before critical options disappear.
