CEO Executive AssistantHealth economics and outcomes research has become one of the most strategically important functions in the pharmaceutical organization. As payers in the United States and globally increasingly require economic evidence to support formulary decisions, and as health technology assessment bodies in Europe and other markets use cost-effectiveness analyses to inform reimbursement, HEOR has moved from a niche analytical function to a core commercial asset.
For pharmaceutical CEOs, HEOR presents a specific delegation challenge: the function requires deep technical expertise that most CEOs do not possess, yet the strategic decisions about evidence generation priorities and market access strategy require CEO-level judgment about where organizational resources are invested.
This guide gives pharmaceutical CEOs a practical framework for delegating HEOR operations while maintaining the strategic oversight of evidence strategy that determines market access success.
Why HEOR Deserves CEO Strategic Attention
Understanding why HEOR warrants CEO-level strategic attention helps calibrate the appropriate delegation model.
Market access is the commercial gateway. In most markets, achieving appropriate reimbursement and formulary placement is the most critical determinant of commercial performance. HEOR generates the evidence that supports these access decisions. Underinvestment in HEOR evidence generation directly translates into market access failures.
Evidence takes time to generate. Real-world evidence studies, health technology assessment submissions, and pharmacoeconomic models require years to develop and validate. HEOR strategy decisions must anticipate market access needs well in advance of approval and launch.
Value story differentiation. In increasingly competitive therapeutic landscapes, the economic value story, what the drug costs, what it replaces, and what outcomes it achieves relative to alternatives, is a key commercial differentiator.
HTA requirements are increasing. Health technology assessment requirements in Europe, Canada, and other markets are becoming more demanding, with the EU’s Joint Clinical Assessment creating new requirements for companies seeking market access across member states.
The CEO’s HEOR Strategic Role
The CEO’s involvement in HEOR is strategic: defining the evidence investment priorities and ensuring organizational alignment between HEOR, commercial, and regulatory strategies.
Evidence investment prioritization. Decisions about which evidence gaps to close, which real-world evidence studies to invest in, and how to sequence HEOR activities across a product portfolio require CEO-level resource allocation judgment.
Market access strategy alignment. When HEOR evidence strategy is not aligned with the commercial and regulatory strategy, the organization faces fragmented external messaging and missed access opportunities. The CEO should ensure strategic alignment across these functions.
HTA engagement strategy. For companies with products subject to significant HTA review, particularly in Europe, the CEO should understand the HTA landscape and be engaged in major strategic decisions about how to approach HTA processes.
Investor communication on evidence strategy. Investors and analysts increasingly ask pharma CEOs about real-world evidence and HEOR strategy as proxies for market access confidence. The CEO must be able to discuss the company’s evidence strategy fluently in investor settings.
Delegating HEOR Operations
A strong HEOR leadership team should own all operational dimensions of the function.
VP of HEOR or Head of Outcomes Research. This leader owns the full HEOR function: pharmacoeconomic modeling, real-world evidence study design and execution, health technology assessment strategy, outcomes research publications, and HEOR support for commercial and market access teams. The CEO provides strategic direction; the HEOR leader manages the function.
Health economists and pharmacoeconomists. Specialists in cost-effectiveness analysis, budget impact modeling, and economic value communication should own the development of pharmacoeconomic models and economic evidence packages.
Real-world evidence team. Epidemiologists, data scientists, and outcomes researchers should own real-world evidence study design and execution: identifying data sources, designing study protocols, conducting analyses, and publishing results.
HTA specialists. For companies with products subject to significant HTA review, dedicated HTA specialists should own the HTA submission process: preparing value dossiers, managing interactions with HTA bodies, and coordinating responses to HTA questions.
HEOR communications function. Communicating HEOR evidence to payers, physicians, and policymakers requires specialized skills. A HEOR communications or publications team should own the translation of HEOR findings into payer-ready materials, publications, and presentation content.
For a broader framework on commercial delegation in pharma, see our resource on pharma commercial strategy.
HEOR and Market Access Integration
One of the most common HEOR organizational failures is a disconnect between the evidence that HEOR generates and the evidence that market access teams need for payer negotiations. The CEO must ensure that these functions are tightly coordinated.
A joint HEOR-market access planning process, led by the VP of HEOR and VP of market access, should define the evidence needs for each payer segment, set HEOR study priorities to address those needs, and establish a timeline for evidence generation that aligns with payer engagement milestones.
The CEO should review and approve the evidence generation plan as part of the annual strategic planning process, ensuring that HEOR investments are adequately resourced and aligned with commercial priorities. Operational coordination between HEOR and market access teams belongs with those functions’ leaders.
Real-World Evidence Strategy
Real-world evidence, derived from electronic health records, claims databases, patient registries, and other non-clinical trial sources, has become essential for demonstrating product value in real clinical practice. Planning and executing a real-world evidence strategy requires significant organizational investment and long lead times.
The HEOR team should own real-world evidence strategy: identifying the most important real-world questions, designing observational studies to address them, partnering with health systems and data providers, conducting analyses, and disseminating findings through publications and payer communications.
The CEO engages with real-world evidence strategy at the level of major investment decisions: approving significant real-world evidence study investments, understanding the timeline and milestones for priority studies, and ensuring that real-world evidence results are integrated into commercial and market access messaging.
Health Technology Assessment Management
For companies seeking market access in European markets, Canada, Australia, and other jurisdictions with formal HTA processes, managing the HTA function is a significant and specialized responsibility.
An HTA director or team should own the HTA management function: preparing value dossiers for HTA submissions, managing the submission and review process, engaging with HTA bodies on questions and clarifications, and coordinating responses to HTA findings.
The CEO should be briefed on major HTA outcomes and their commercial implications. When an HTA decision significantly affects market access or creates strategic choices about how to respond, the CEO must be engaged in those strategic decisions.
Patient-Reported Outcomes and HEOR
Patient-reported outcomes data, which captures patients’ own assessments of their symptoms, functioning, and quality of life, has become an important component of HEOR evidence packages. Regulatory agencies increasingly require PRO data in labeling, and HTA bodies use PRO data in their value assessments.
A PRO specialist or team within the HEOR function should own patient-reported outcomes strategy: selecting PRO instruments, designing PRO endpoints in clinical trials, analyzing PRO data, and communicating PRO findings to payers and HTA bodies.
The CEO ensures that clinical trial designs include appropriate PRO endpoints that will support HEOR evidence needs, a decision that requires coordination between HEOR, clinical development, and regulatory affairs at the time of trial design.
HEOR Budgeting and Resource Allocation
HEOR requires sustained investment in research activities, including real-world evidence studies, pharmacoeconomic modeling, HTA submissions, and scientific publications. These investments are long-duration and not always easily justified on a year-by-year basis.
The CEO must champion sustained HEOR investment as a strategic priority, not an area to cut when budgets are tight. HEOR evidence gaps at the time of launch cannot be filled quickly, and underfunded HEOR programs create market access risks that are far more costly than the investment they would have required.
The HEOR budget and investment plan should be developed by the HEOR and market access leadership teams and reviewed and approved by the CEO and CFO as part of the annual planning process. The CEO ensures that HEOR investments are adequate relative to the commercial stakes of each product’s access challenges.
According to McKinsey and Company, pharmaceutical companies that invest in HEOR as a strategic commercial asset and integrate HEOR strategy with commercial and market access planning achieve significantly better market access outcomes than those that manage HEOR as a peripheral analytical support function.
External HEOR Partnerships
Many pharmaceutical companies supplement internal HEOR capabilities with external partnerships: academic research groups, contract research organizations with HEOR expertise, health economics consulting firms, and patient advocacy organizations with data resources.
The HEOR team should own external partnership management for HEOR: identifying and qualifying external partners, managing research contracts, overseeing study quality, and ensuring that external HEOR activities meet the company’s scientific and publication standards.
The CEO engages when external HEOR partnerships involve major strategic commitments or when academic partnerships have significant publication or IP implications.
Communicating HEOR Results
The most technically excellent HEOR evidence has limited value if it is not communicated effectively to payers, physicians, and policymakers. HEOR communication is a specialized skill that requires translation of complex economic and epidemiological findings into clear, compelling messages.
A publications and communications team within HEOR should own the dissemination of HEOR findings: managing the publication pipeline, developing payer-ready evidence summaries, and designing scientific symposia and presentations at major payer and health economics conferences.
The CEO participates in high-profile presentations of HEOR evidence at major forums, such as ISPOR or national payer meetings, when CEO-level presence strengthens the organizational credibility of the evidence.
For guidance on delegating the full product launch function where HEOR evidence is deployed, see our resource on pharma product launch.
The CEO as Evidence Champion
The pharmaceutical CEO who understands the strategic importance of HEOR and champions its investment creates a commercial organization with a genuine evidence-based competitive advantage. The CEO who treats HEOR as a technical support function rather than a strategic asset risks entering markets without the evidence needed for access, a failure that no amount of sales force effectiveness or marketing excellence can compensate for.
Delegate the technical operations to the experts. Own the strategic evidence vision. And invest consistently in the evidence generation that will determine whether your products reach the patients who need them.
Related Reading
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