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HEOR Studies: Proving Value and Winning Market Access

Written by Randy McGonigal, MBA | Apr 28, 2025 7:50:11 PM

As healthcare systems face growing pressure to allocate limited resources, payers are demanding clear evidence that treatments deliver measurable value. 

For pharmaceutical manufacturers, Health Economics and Outcomes Research (HEOR) provides critical, data-backed insights into how treatments drive value in the real world. This research is instrumental in shaping stronger market access cases, enabling evidence-based payer negotiations, and accelerating adoption.

In this article, we explain the fundamentals of HEOR research, break down some representative methodologies, and explore why HEOR is an increasingly indispensable pillar for pharmaceutical market access strategies.

What is HEOR?

HEOR is a discipline within life sciences organizations that develops structured evidence to demonstrate the value of medical interventions. For pharmaceutical companies, HEOR plays a critical role in connecting treatments to real-world outcomes, offering payers and other stakeholders a clearer view of how therapies perform beyond the clinical trial setting.

In an article advocating for more integrated approaches to evidence generation in biopharma, McKinsey notes a few key trends fueling an increasingly central place for HEOR research:

  1. In the context of rising spending, aging populations, and an ever-expanding range of treatment innovations, payers face incredibly complex considerations for coverage and reimbursement.
  2. The proliferation of new therapies means that clinicians need more support in understanding the benefits of alternative therapies.
  3. Growing patient centricity means that benefits to patient engagement are an increasingly influential factor in coverage decisions.

How is HEOR Used in Pharmaceutical Commercialization?

HEOR research supports a wide range of use cases that directly shape pharmaceutical commercialization campaigns:

  • Informing reimbursement frameworks and coverage decisions by regulatory and payer bodies. HEOR provides structured evidence that supports pricing, formulary inclusion, and reimbursement negotiations, often in the form of cost-effectiveness models, budget impact analyses, and economic dossiers used in payer submissions.
  • Helping payers evaluate the effectiveness of therapies across real-world populations. HEOR supports targeted analyses that account for variables like treatment patterns, adherence rates, and patient demographics, all valuable evidence for population-specific coverage decisions.
  • Closing the gap between trial performance and real-world impact. Post hoc trial analytics and real-world outcomes research help connect clinical efficacy to actual value delivery to make a case for a product’s relevance in practical care settings.
  • Identifying which treatments work best for specific subgroups. Subgroup analysis through HEOR helps refine positioning and payer targeting by showing where treatment benefits are most pronounced (whether by demographic, comorbidity, or treatment history).
  • Empowering pharmaceutical teams to articulate deeper product value to clinicians, payers, and patients. HEOR findings can be used to develop practical tools, like value proposition decks, cost calculators, and scenario-based budget models. These resources can directly help shape critical moments of engagement with consistent, evidence-backed messaging. Patient-centered research, including quality-of-life measures and treatment burden data, adds meaningful context to these tools by helping stakeholders assess how a therapy affects daily life and long-term adherence.

HEOR Studies vs. Clinical Data

Unlike traditional efficacy data, HEOR takes a broader perspective on value. It considers not only clinical effectiveness but also economic impact and patient-reported outcomes. To do so, it draws on sources like health records, patient surveys, and observational studies. 

At a high level, HEOR analyzes two fundamental aspects of a given therapy’s economics:

  • Resources needed to deliver care, including drugs, devices, labor, and infrastructure. In the healthcare system, all resources are scarce, and understanding the overall operational impact of a therapy is essential for thinking beyond its first-order costs to develop a more holistic account of its value.
  • Opportunity cost compared to alternative therapies. Investing in one intervention means potentially forgoing another that may offer greater value given the same constraints.

As we explore below, a variety of different methodologies can contribute to this foundational understanding.

Core Methodologies for Health Economics and Outcomes Research

HEOR encompasses a wide range of analytic tools and study designs; the following methodologies form the foundation of typical value assessments.

Real-World Evidence Generation

While clinical trials provide controlled efficacy data, real-world evidence (RWE) captures how therapies actually perform across diverse populations and practice settings. RWE draws on sources like electronic health records and patient registries to provide a more complete view of efficacy in practice.

RWE can also highlight access gaps and help identify patient populations that benefit most from a therapy. For pharmaceutical companies, this can translate directly to stronger arguments for formulary placement, better-informed payer segmentation strategies, and more adaptive lifecycle planning.

Cost-Effectiveness Analysis

Cost-effectiveness analysis (CEA) compares the economic and health outcomes of two or more interventions to determine which offers the best value. CEA does not seek to simply identify the lowest-cost option but to understand which therapies deliver the most benefit per dollar spent.

HEOR teams may use different types of economic evaluations depending on the context. For treatments with largely equivalent outcomes, cost-minimization analysis may be sufficient for selecting the most efficient treatment option. For therapies with more nuanced differentiation, however, a deeper cost-effectiveness analysis may be needed to weigh costs against concrete benefits measured by life-years gained and quality-of-life metrics (see below).

Quality-of-Life Assessments

HEOR incorporates quality-of-life (QoL) assessments to measure how patients experience their treatment. These evaluations often rely on standardized patient-reported outcomes (PROs), which provide structured insight into physical, emotional, and functional well-being.

Quantifying how a therapy affects daily life (from managing side effects to enabling routine activities) is crucial to complete an access narrative. These insights can be especially critical in competitive categories, where incremental improvements in patient experience may distinguish one therapy from another.

Key Challenges for Effectively Leveraging HEOR Analytics

While HEOR offers tremendous strategic value, pharmaceutical teams often face practical challenges when trying to apply this data across the product lifecycle.

  1. Building a clear value narrative: Teams must translate raw data into compelling, evidence-backed stories that communicate how a therapy creates value for patients, payers, and providers.
  2. Identifying and addressing evidence gaps: Early access and pricing decisions often hinge on data that may not exist yet. Teams must proactively map evidence gaps and build plans to generate the missing information through targeted HEOR studies.
  3. Informing pipeline strategy with early modeling: Without early cost-effectiveness modeling, pharmaceutical teams risk misaligning market access goals with clinical development.
  4. Extracting value from clinical trial data: Clinical trial datasets often contain under-leveraged insights. Post-hoc HEOR analyses are essential for surfacing cost, utility, or adherence trends that may not be captured in topline efficacy data.
  5. Generating RWE with purpose: Real-world evidence is increasingly expected, but not all RWE is useful. Designing meaningful RWE studies means selecting the right data sources, applying sound methodology, and targeting questions directly tied to access decisions.

HEOR Than The Sum of Its Parts: Purposefully Integrating Outcomes Research in Pharmaceutical Commercialization

As the challenges outlined above suggest, tapping into the value of HEOR for pharmaceutical commercialization requires more than just relaying the relevant data to payers and HCPs. Outcomes research carries the most weight when it is developed with purpose and communicated with precision. 

At TJP, we work with clients to ensure that outcome metrics align directly with concrete decision points (like formulary review, contracting discussions, and patient access policy development). From there, we shape our presentation of those metrics to speak to the specific criteria employed by the relevant stakeholders.

This approach is rooted in a deep understanding of how payers frame value. While clinical effectiveness and cost remain essential, the most persuasive evidence often speaks to operational impact: time to treatment, resource utilization, quality-of-life improvement, adherence support, and system-level cost offsets. We help clients identify the specific measures and outcomes that will resonate with each payer segment, then use that understanding to inform both the research approach and the communication strategy around it.

Long-term, the result is not just a static deliverable but a foundation that supports ongoing engagement. We help translate research findings into payer-facing narratives, field team resources, and tools that support real-time interactions. In our experience, this is the best way to truly embed HEOR into the broader commercialization plan.

Example: How TJP Integrated HEOR as Part of a Broader Market Access Strategy

TJP’s work supporting a novel therapy for Duchenne Muscular Dystrophy (DMD) provides a detailed example of how HEOR fits into a successful market access strategy. In this case, despite leading Medicaid coverage within its category, the therapy faced persistent barriers to prescribing due to complex payer requirements and administrative friction.

To address the challenge, we supported the manufacturer in conducting both direct and indirect cost analyses tied to treatment outcomes. Once cost offsets for payers were identified, TJP helped build an outcomes-driven value story to support strategic payer engagement. 

Next, TJP partnered with the manufacturer to identify the root causes of treatment delays and streamline the access process. Through targeted advisory boards, we surfaced specific pain points in prior authorization and documentation workflows, which were contributing to significant lags in therapy initiation. In response, we developed a suite of tailored tools, including a Letter of Medical Necessity (LMN) builder and standardized patient status forms, to support providers with faster, more complete submissions.

The impact was clear. The average delay in therapy start time dropped by 27 days. Provider feedback emphasized ease of use and reduced administrative burden, and the LMN builder quickly became the most-visited resource on the product’s website.

Weave HEOR into Your Market Access Strategy

TJP builds HEOR into the core of market access planning, linking evidence generation directly to payer strategy, patient access, provider engagement, and launch execution. Our work helps teams translate clinical and economic data into powerful narratives and actionable tools.

We collaborate with pharmaceutical teams to ensure HEOR insights are not only rigorous but also strategically deployed, ready to support everything from pricing to field training. Evidence generation that is carefully aligned with real-world decision points is the key for brands to improve access outcomes.

How can we help leverage data-driven insights to strengthen your market access strategy? Reach out to our team to discuss.