Rethinking HEOR Market Access Integration: A Call for Early Engagement Before Phase 3

Early HEOR Market Access Integration

In this brief interview on ISPOR, Indranil Bagchi asserts that HEOR market access integration must occur earlier in drug development—ideally before Phase 3—to generate payer-specific evidence, such as comparative effectiveness data, alongside regulatory benefit-risk profiles. This is essential for securing formulary access amid restrictive reimbursement. He attributes the shift to evolving payer and health technology assessment (HTA) demands over the past 10–20 years, exemplified by the EU HTA joint scientific consultations (JSC), and positions it as key to bridging the “last mile” to patients.

However, the discussion lacks examples of successful implementations and overlooks how such proactive strategies might inflate development costs without guaranteeing access.

Pre-Phase 3 Payer Dialogues

Bagchi’s most impactful argument is that payer conversations must precede Phase 3 to align endpoints with HTA needs—”the conversation needs to start much earlier, way before Phase 3.” He assumes this will expedite patient access. Yet persistent global delays in reimbursement post-approval—such as in the UK’s NICE appraisals or US ICER reviews, even with tailored evidence—stem in part from budget limitations.

Payers often view early industry engagement as market shaping rather than collaborative value demonstration, potentially leading to comparator selection biases that favor the sponsor’s asset. More often than not, active comparators in trials rarely reflect true clinical practice, undermining claims of competitive efficacy. Bagchi’s optimism overlooks manufacturer-generated data, which may invite skepticism, and the paucity of pragmatic, clinically relevant head-to-head trials.

Pharma-Driven Risks

From a health economics and outcomes research perspective, this approach risks entrenching a siloed, pharma-driven paradigm that prioritizes innovator reimbursement. It could distort market access by incentivizing ever more complex pricing models, like outcomes-based agreements. It also overlooks escalating R&D costs from dual regulatory-HTA data generation, which are passed on to prices and exacerbate affordability crises in low-resource settings.

Unintended consequences might include “evidence fatigue” among HTAs, delaying approvals for truly breakthrough therapies, or ethical lapses in comparator trials that expose patients to inferior treatments. A more nuanced view would consider that early payer alignment may result in higher launch prices without proportional clinical gains, urging HTA agencies to balance innovation rewards with equitable access.