HEOR in Pharma: Definition and Real-World Use Cases

HEOR (Health Economics and Outcomes Research) helps pharmaceutical companies understand the value of a therapy beyond clinical efficacy, including its economic impact, real-world performance, and effect on patients’ quality of life.

In practice, HEOR leverages data from medical software ecosystems (e.g., EHR systems, clinical trial platforms, patient engagement apps, evidence analytics tools, etc.) that continuously collect and analyze outcomes data. The HEOR pharma turns medical software data into evidence that supports smarter development decisions and pricing strategies throughout a drug’s lifecycle.

To understand what does HEOR stand for in pharma in practice, you should know that it relies on diverse data that reflects both controlled research and real-world care. These inputs allow pharmaceutical HEOR teams to assess outcomes across different patient populations and healthcare systems.

Here are key HEOR data sources:

• Clinical trial data (efficacy, safety, comparators)
• Real-world evidence (EHRs, claims databases, registries)
• Patient-reported outcomes (quality of life, symptom burden, satisfaction)
• Health economics data (costs, resource utilization, budget impact)
• Epidemiological and population health data
• Payer and reimbursement datasets

Traditional clinical research evaluates treatment outcomes under controlled conditions to establish safety and efficacy. However, these trials are not designed to fully assess cost-effectiveness, real-world access, or how therapies perform across diverse patient populations and healthcare settings.

HEOR evaluates how well it works in real-world settings and whether it delivers value to patients. The HEOR approach allows pharma companies to move beyond regulatory approval and build a compelling, evidence-based case for real-world adoption and reimbursement.

To make it clearer for you, feel free to examine a detailed comparison of HEOR and traditional research below:

HEOR connects clinical, economic, and patient-centered evidence to real-world healthcare decisions. It helps pharma teams demonstrate value, control costs, improve outcomes, and secure market access in increasingly data-driven and payer-focused environments.

Below, we’ll review key pharma HEOR application methods and recognize the most vibrant HEOR use cases across the healthcare industry.

HEOR frameworks support treatment value by combining clinical outcomes with economic and humanistic data. It looks beyond efficacy to assess quality of life, long-term outcomes, and healthcare resource utilization. This holistic view can help you clearly demonstrate how a therapy delivers value to patients, providers, and healthcare systems under real-world conditions.

Real-world use case: Novartis uses HEOR frameworks to measure the long-term value of cardiovascular therapies, integrating clinical trial data with real-world evidence to demonstrate reductions in hospitalizations and improved patient outcomes for payer submissions.

Budget impact analysis estimates how a new therapy will affect healthcare budgets over time. HEOR teams model costs related to treatment adoption, patient populations, and resource use, enabling payers and providers to understand financial implications before reimbursement decisions are made.

Real-world use case: Pfizer applies budget impact models to support payer discussions for oncology drugs, helping healthcare systems forecast short- and long-term spending when introducing innovative but high-cost therapies.

HEOR uses patient-reported outcomes to measure quality of life, symptom burden, treatment adherence, and satisfaction. These insights help pharma companies refine therapies, support value-based care models, and demonstrate patient-centered benefits that matter to regulators and payers, which is the core of HEOR pharma meaning in drug evaluation.

Real-world use case: Roche uses HEOR-driven patient outcome data in chronic disease programs to track real-world adherence and quality-of-life improvements, strengthening value-based care initiatives.

HEOR provides evidence needed to justify pricing by linking treatment outcomes to economic value. HEOR can directly help healthcare professionals conduct cost-effectiveness analysis and comparative value assessments that support negotiations with payers, insurers, and HTA (Health Technology Assessment) bodies.

Real-world use case: Sanofi leverages HEOR evidence to support reimbursement submissions in European markets, aligning pricing strategies with demonstrated long-term value and health system savings.

HEOR insights are increasingly applied early in drug development to design trials that capture outcomes relevant to payers and regulators. This includes selecting endpoints tied to quality of life, real-world effectiveness, and economic value, not just clinical efficacy, an approach central to pharmaceutical HEOR strategies.

Real-world use case: AstraZeneca integrates HEOR teams into early trial planning to ensure oncology and respiratory studies generate evidence aligned with payer and HTA requirements.

After launch, HEOR supports continuous monitoring of real-world performance across diverse populations. Using real-world evidence, pharma companies can validate effectiveness, identify gaps in care, and refine market access or clinical strategies over time.

Real-world use case: Johnson & Johnson applies post-launch HEOR monitoring to assess treatment performance across global markets, using real-world data to support lifecycle management and label expansion.

HEOR compares new treatments against existing standards of care by evaluating outcomes, costs, and patient impact. These comparisons help decision-makers understand whether innovation delivers meaningful improvement over current options.

Real-world use case: Bristol Myers Squibb uses comparative HEOR analyses in immunology and oncology to demonstrate that new therapies outperform existing treatments across outcomes and long-term cost efficiency.

Embedding HEOR across the pharmaceutical lifecycle can positively impact your credibility and overall efficiency. With confident decisions across healthcare ecosystems, you can seamlessly align patient outcomes with system sustainability. Below, you’ll learn about the main improvements you’ll get by implementing pharma HEOR.

HEOR in pharma enables companies to demonstrate the real-world impact of therapies beyond controlled clinical trials by analyzing outcomes, resource use, and treatment patterns. PubMed studies show that HEOR and RWE are increasingly used by payers and providers to assess value, with 74-77% of healthcare decision-makers reporting HEOR data influences formulary or treatment decisions globally. This real-world evidence builds confidence among providers and regulators by showing how treatments perform in everyday clinical practice, helping to justify adoption and optimize care delivery.

Pharma in HEOR helps guide pricing and reimbursement strategies by quantifying cost-effectiveness and value compared with alternatives. According to Mordor Intelligence, the global HEOR services market is projected to grow from an estimated $1.75 billion in 2025 to over $3.29 billion by 2030, driven by payer demand for defensible evidence and value-based pricing models. This reflects how integral HEOR analyses (such as cost-effectiveness and budget-impact models) have become in securing coverage, reducing uncertainty in negotiations, and ensuring treatments are reimbursed appropriately.

HEOR pharma strengthens a company’s position during market access and payer negotiations by providing robust, data-driven evidence of value. Comparative effectiveness, quality-of-life measures, and cost-effectiveness analyses support stronger arguments for formulary placement, reimbursement, and pricing justification. By presenting clear, evidence-based insights, HEOR ensures therapies are recognized for their full impact, reduces access delays, and enhances strategic positioning in competitive markets.

HEOR insights help identify which interventions deliver the most meaningful improvements in patient health and daily life. By integrating real-world evidence into care pathways, HEOR allows healthcare providers to tailor treatments, optimize adherence, and monitor long-term outcomes across diverse patient populations. This approach supports more personalized care, reveals gaps between clinical efficacy and real-world effectiveness, and enables continuous refinement of treatment strategies based on actual patient experiences and resource utilization.

Below is a graph illustrating the difference between Clinical efficacy alone and Clinical + HEOR evidence, highlighting how incorporating HEOR enhances decision-making and maximizes patient benefit:

Implementing HEOR is a multi-stage process that connects strategic objectives with real-world evidence generation, digital infrastructure, and post-launch value optimization. Below is a step-by-step overview of how HEOR is implemented in practice, and how we at Cleveroad support you at every stage of this process.

Pharma HEOR implementation begins with establishing clear, outcome-driven objectives aligned with your product strategy, target markets, and stakeholder needs. This includes defining which value questions must be answered (e.g., clinical effectiveness, economic impact, quality of life), identifying target payer and regulatory requirements, and determining success metrics across the product lifecycle.

Clear goal definition ensures HEOR efforts directly support pricing, reimbursement, market access, and patient outcome strategies. Cleveroad’s healthcare domain experts support this step by collaborating with clinical, market access, and commercial teams to translate strategic priorities into actionable HEOR use cases, KPIs, and technical requirements that underpin scalable implementation.

Once you define key objectives, the focus shifts to identifying and validating the data required to support them. This typically involves combining clinical trial data with real-world data sources, including electronic health records, claims data, patient registries, patient-reported outcomes, and digital health or remote monitoring data.

Selecting the right data sources is critical to ensuring relevance, data quality, regulatory compliance, and geographic applicability. We assist by evaluating data availability, ensuring interoperability across sources, and designing secure, compliant data architectures that consolidate fragmented datasets into a unified HEOR data foundation.

Reliable HEOR depends on structured, compliant data foundations. Our experience building regulated healthcare systems illustrates how we approach data integrity and interoperability in practice.

To represent our expertise in healthcare software development, we’d like to share one of our recent cases – Quality Management System for a medical device manufacturer.

Prime Path Medtech™ relied on an outdated Quickbase-based Quality Management System (QMS) that was inefficient for its B2B model and regulatory requirements. They needed us to develop a fully automated SaaS QMS, designing the architecture and modules to comply with FDA 21 CFR 820, 21 CFR 11, and ISO 13485 standards, while integrating all quality control processes and roles.

The QSuite platform built by Cleveroad ensures data consistency across complex organizational hierarchies, simplifies workflows, and reduces manual operations for manufacturers with multiple subsidiaries. Its intuitive UI/UX and flexible onboarding streamline adoption for diverse users.

As a result, the customer received a scalable, fully automated QMS solution that improves regulatory compliance, enhances operational efficiency, and boosts user satisfaction across its client base.

Here’s what Breanne Butler, project manager at Prime Path Medtech™, says about our collaboration on the project:

To generate sustained value, HEOR must be operationalized within existing pharma workflows rather than treated as a standalone analytical function. This step focuses on embedding HEOR insights into pharma workflows into clinical development, evidence generation, market access preparation, and post-launch operations, ensuring insights are delivered at the right time to the right stakeholders.

Cleveroad enables this integration by building digital platforms and interfaces that connect HEOR data and analytics with your internal systems, allowing clinical, regulatory, and commercial teams to access, interpret, and act on HEOR insights within their daily workflows.

With integrated data and workflows in place, HEOR insights are translated into robust analytical outputs such as cost-effectiveness models, budget impact analyses, comparative effectiveness studies, and real-world evidence models. These models support payer submissions, health technology assessments, and strategic decision-making across markets.

Cleveroad supports this phase by implementing digital platforms and analytical environments that support HEOR modeling and scenario analysis, market-specific customization, and continuous updates as new data becomes available.

Post-launch HEOR focuses on continuous evidence generation and value validation in real-world settings. This includes monitoring long-term outcomes, treatment adherence, healthcare resource utilization, and patient quality of life to refine value propositions and support lifecycle management.

Cleveroad enables ongoing post-launch HEOR through patient monitoring systems, real-time analytics, and reporting tools that help you respond to payer evidence requests, optimize market access strategies, and consistently demonstrate treatment value as healthcare conditions evolve.

Cleveroad is an experienced healthcare software development partner with strong expertise in HEOR-enabled digital platforms, real-world evidence (RWE) data systems, and data-intensive healthcare solutions. We design and build secure, compliant software products that help pharmaceutical and life sciences companies collect, integrate, and analyze clinical, economic, and patient-reported data across the product lifecycle.

For over 15 years, we have supported healthcare organizations, pharma companies, and MedTech providers in delivering data-driven solutions that enable evidence generation, support pricing and reimbursement activities, and improve patient-centric outcomes. Our focus is on building technology foundations that allow HEOR teams to work with reliable, structured, and audit-ready data.

By embedding HEOR-supporting capabilities into healthcare workflows, we help clients transform fragmented datasets into actionable insights that inform decision-making across clinical development, market access preparation, and post-launch monitoring.

By partnering with Cleveroad, you gain access to the following benefits:

• HEOR and RWE strategy workshops: We help identify priority HEOR use cases and define a technology implementation roadmap aligned with regulatory, payer, and market requirements.
• Healthcare-compliant solution architecture: We design digital platforms that support HEOR analytics and evidence workflows in compliance with HIPAA, GDPR, HL7/FHIR standards, PIPEDA, and other applicable regulations.
• End-to-end system integration: Our team integrates HEOR-supporting solutions with EHR systems, clinical trial platforms, analytics environments, and enterprise healthcare software to ensure data continuity and interoperability.
• HEOR-focused PoC and MVP development: We build proof-of-concepts and MVPs to validate real-world data capture, outcome tracking, and value-based evidence workflows before scaling across regions or portfolios.
• ISO-certified delivery processes: Our delivery is backed by ISO 9001:2015 and ISO/IEC 27001:2013 certifications, ensuring consistent quality management, data security, and trust throughout the development lifecycle.

To demonstrate our technical expertise in building regulated, data-driven healthcare systems, we can share one of our relevant projects – an IoT-based System for Monitoring EKG and Blood Oxygen Level.

Our client, a U.S.-based medical device manufacturer, approached Cleveroad to build a digital solution to complement its IoT-enabled ECG monitors and pulse oximeters. The company needed mobile software that allowed patients and clinicians to monitor heart activity and blood oxygen levels in real time, while also ensuring compliance with FDA 510(k) requirements and HIPAA regulations. In parallel, the client aimed to enable online device sales and foster a professional community around its products.

We designed and developed iOS and Android applications integrated with the client’s IoT devices via Bluetooth, enabling secure, real-time health data tracking. We implemented robust data protection measures, including AES-256 encryption and compliant PHI storage, and built an e-commerce module and a professional forum integrated with the platform.

As a result, the customer received a compliant, scalable healthcare ecosystem that supports remote monitoring, enables new B2C and B2B revenue streams, and strengthens trust among patients and medical professionals.