Health Economics & Outcomes Research

HEOR Solutions That Deliver Clinical and Economic Value

Navigate the most complex HEOR challenges with confidence

Working in partnership with our clients and leveraging our deep-rooted expertise originating from one of the world’s leading centers for health economics, we strive to consistently achieve the highest standards in demonstrating the breakthrough value of health technologies. Our trailblazing ethos has seen us achieve a number of ‘firsts’, including supporting the first ever NICE submissions in chimeric antigen receptor (CAR) T-cell therapy, immuno-oncology (I-O), and antimicrobial resistance (AMR), and supporting products through the first waves of the Inflation Reduction Act (IRA) and EU Joint Clinical Assessments (JCA). Driven by our mission to accelerate patient access, we prioritize thought leadership and scientific innovation to develop and apply novel approaches to the most challenging global health technology value assessments.

Our Offerings

A robust early HEOR strategy is critical to meeting the increasing number of challenges associated with bringing new drugs to market, from demonstrating value beyond efficacy and safety, navigating complex pricing and reimbursement landscapes, and ensuring broad market access, to supporting regulatory approvals, differentiating products in a crowded market, and meeting the expectations of patients and providers.

Partnering with our HEOR experts can help you anticipate and prepare for challenges on the path to reimbursement.
Landscape reviews, gap analysis, competitive analysis, and reimbursement road mapping
Portfolio planning, early product value assessment, and prioritization
Clinical trial design for market access and HTA requirements
Review, critique and development of evidence generation plans
In a time where drug costs are increasingly under the microscope and reimbursement decisions are based on complex value models, drug developers need to source, generate and synthesize large bodies of evidence to support value dossiers, HTA/reimbursement dossiers, and demonstrate comparative effectiveness.

We combine the expertise of our researchers and statisticians with the latest technologies to help you uncover and assess evidence of value at all stages of drug development.
Systematic and targeted literature reviews
Indirect treatment comparisons (ITCs)
Structured expert elicitation (SEE)
Structured and quantitative frameworks for evaluating cost-effectiveness and clinical outcomes are central pillars in modern day HTA. As global healthcare systems are increasingly being asked to do more with less, being able to demonstrate long-term projections on budget impact, comparative effectiveness, and patient impact are critical to support reimbursement decision-making.

We provide health economic modeling at every stage of the drug development process. From early models to inform clinical trials, evidence generation and pricing decisions, to core global modeling and local adaptations to support HTA submissions.
Cost-effectiveness models
Budget impact models
Early modeling
Global modeling and local adaptations
Communicating evidence of value to payers across global colleagues and local affiliates can be a challenge, and ensuring payers receive a clear, compelling and consistent product value proposition is key to securing a favorable reimbursement decision.

We can help you create impactful value propositions that resonate, and equip you with the tools you need to demonstrate existing unmet needs and the value of your product.
Value propositions and value dossiers, including internal and external engagement, value messages testing and roll-out trainings
Objection handlers
Value slide decks and value enhancers
Academy of Managed Care Pharmacy (AMCP) dossiers, pre-approval information exchange decks, disease state decks and other payer-facing tools
Drug developers find themselves constantly adapting to new evidence standards, and navigating the myriad and complex global HTA processes. Gaining broad market access for your product in this context can be a challenge, and a clear understanding of the HTA landscape is critical to optimize the chance of a positive recommendation.

With a proven track record of success in HTA, including to bodies such as the National Institute for Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), Canada’s Drug Agency (CDA-AMC) (previously CADTH), and the Scottish Medicines Consortium (SMC) among others, we can clarify understanding of current and likely future evidence requirements, appraisal processes, and committee preferences to secure a favorable outcome.
HTA strategy development
Advisory boards
Dossier writing
Appraisal meeting preparation and representation
Post-dossier submission support
A robust early HEOR strategy is critical to meeting the increasing number of challenges associated with bringing new drugs to market, from demonstrating value beyond efficacy and safety, navigating complex pricing and reimbursement landscapes, and ensuring broad market access, to supporting regulatory approvals, differentiating products in a crowded market, and meeting the expectations of patients and providers.

Partnering with our HEOR experts can help you anticipate and prepare for challenges on the path to reimbursement.
Landscape reviews, gap analysis, competitive analysis, and reimbursement road mapping
Portfolio planning, early product value assessment, and prioritization
Clinical trial design for market access and HTA requirements
Review, critique and development of evidence generation plans
In a time where drug costs are increasingly under the microscope and reimbursement decisions are based on complex value models, drug developers need to source, generate and synthesize large bodies of evidence to support value dossiers, HTA/reimbursement dossiers, and demonstrate comparative effectiveness.

We combine the expertise of our researchers and statisticians with the latest technologies to help you uncover and assess evidence of value at all stages of drug development.
Systematic and targeted literature reviews
Indirect treatment comparisons (ITCs)
Structured expert elicitation (SEE)
Structured and quantitative frameworks for evaluating cost-effectiveness and clinical outcomes are central pillars in modern day HTA. As global healthcare systems are increasingly being asked to do more with less, being able to demonstrate long-term projections on budget impact, comparative effectiveness, and patient impact are critical to support reimbursement decision-making.

We provide health economic modeling at every stage of the drug development process. From early models to inform clinical trials, evidence generation and pricing decisions, to core global modeling and local adaptations to support HTA submissions.
Cost-effectiveness models
Budget impact models
Early modeling
Global modeling and local adaptations
Communicating evidence of value to payers across global colleagues and local affiliates can be a challenge, and ensuring payers receive a clear, compelling and consistent product value proposition is key to securing a favorable reimbursement decision.

We can help you create impactful value propositions that resonate, and equip you with the tools you need to demonstrate existing unmet needs and the value of your product.
Value propositions and value dossiers, including internal and external engagement, value messages testing and roll-out trainings
Objection handlers
Value slide decks and value enhancers
Academy of Managed Care Pharmacy (AMCP) dossiers, pre-approval information exchange decks, disease state decks and other payer-facing tools
Drug developers find themselves constantly adapting to new evidence standards, and navigating the myriad and complex global HTA processes. Gaining broad market access for your product in this context can be a challenge, and a clear understanding of the HTA landscape is critical to optimize the chance of a positive recommendation.

With a proven track record of success in HTA, including to bodies such as the National Institute for Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), Canada’s Drug Agency (CDA-AMC) (previously CADTH), and the Scottish Medicines Consortium (SMC) among others, we can clarify understanding of current and likely future evidence requirements, appraisal processes, and committee preferences to secure a favorable outcome.
HTA strategy development
Advisory boards
Dossier writing
Appraisal meeting preparation and representation
Post-dossier submission support
Adapting to the evolving landscape

EU HTA Regulation

The European Union Regulation on Health Technology Assessment is the biggest shake-up in a generation. Lumanity has been at the forefront of this evolving context since 2022, and is uniquely positioned to assist drug developers plan for and undergo joint clinical assessment.

IRA

The IRA brings significant changes to healthcare in the United States, including allowing Medicare to negotiate drug prices with manufacturers. Lumanity has supported a number of products through the first cycles of price negotiations and utilizes proprietary pricing models to support our clients in securing favorable outcomes.
HEOR Scientific Development

Our HEOR Scientific Development Group comprises seven colleagues with deep subject matter expertise, including a combined 120+ years of experience in HEOR-focused roles, and diverse backgrounds spanning consulting, pharma, academia, and public health. We aim to ensure Lumanity HEOR is the leading adopter of cutting-edge technologies and creative methodologies – our focus is on ensuring we can apply the emerging, novel approaches to demonstrate the value of our clients’ most innovative therapies. We do this through:

Identifying new trends
We identify new trends through regular participation in industry events and conferences, horizon scanning, our own research activities, engaging and listening to our clients. We are continuously exploring how innovations in technology and methodologies map to the evolving HEOR context, focusing on the technological and methodological innovations which have the highest potential to meet our clients’ future challenges.
Driving transformation
Our HEOR Scientific Development Group, often in collaboration with Lumanity’s technology teams, then identifies opportunities to implement innovative technologies and scientific methods that enhance and evolve our current offerings, while also developing entirely new service lines to meet emerging client needs — all while maintaining our unwavering commitment to quality.
Sharing best practices
We aim to embed learning across our teams, share insights with our clients, and contribute to the broader scientific community. We strive to disseminate learnings and best practices through external forums — such as peer‑reviewed publications, conference presentations, thought leadership pieces and through internal channels — including team training and procedure updates.

Our Impact

1st ever
NICE submission in I-O, CAR-T and AMR; Supported products in the first wave of IRA and EU JCA
30+
HTA submissions supported per year
One & only
The only global HEOR team involved in all EU Health Technology Assessment Regulation (HTAR) public consultations to date
40+
Years leadership at NICE, CMS/FDA, and AMCP
Let's Talk

We would love to hear your challenges and discuss how our HEOR experts can help. Our team brings over 100 years of combined leadership experience in pharmaceutical organizations and in key sector stakeholders such as NICE, Centers for Medicare and Medicaid Services (CMS), US Food and Drug Administration (FDA) and the Academy of Managed Care Pharmacy (AMCP). This broad experience means we have a deep understanding of the requirements of drug developers, as well as the drivers and priorities of payers, regulators, and HTA bodies, allowing us to deliver for our clients more effectively and advance patient access.

Julie Munakata MS Global President, HEOR
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Amit Ahuja MPharm, LLB Senior Director, Research, HEOR
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Ron Akehurst BSc, DSc, MFPH Chairman, HEOR
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Richard Birnie PhD Vice President, Research, HEOR
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Ann-Marie Chapman Vice President, Consulting, HEOR
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Dan Gladwell PhD Senior Vice President & Chief Scientific Officer, HEOR
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Andrea Khan LLB, PgDip Senior Director of HEOR Global Commercial Partnerships
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Jonathan Kowalski Executive Vice President & Global Head of Strategic Advisory Services, HEOR
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Alexis Kuchins MBA HEOR Global Commercial Partnerships Lead
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Sallie Latimer Vice President & Global Head of Research, HEOR
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Jeff Lee PharmD, FCCP Vice President, Consulting, HEOR
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Chrissy Lowry Vice President, Consulting, HEOR
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Matthew Madin-Warburton MSc Vice President, Research, HEOR
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Suzette Matthijsse MSc, PhD Senior Director, Strategic Advisory Services, HEOR
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Yang Meng PhD Senior Director, Consulting, HEOR
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Linda Murphy PhD Senior Director, Research, HEOR
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Julia Patterson LLB Director & Global Head of Project Management & Editorial, HEOR
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Julie Roiz Senior Vice President & Global Head of Consulting, HEOR
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Neil Roskell MS Vice President, Consulting, HEOR
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Catherine Rycroft PhD Vice President, Research, HEOR
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Paranjoy Saharia MSc Senior Director, Consulting, HEOR
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Ankush Taneja MPharm Senior Director, Research, HEOR
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Kabir Toor Senior Director, Consulting, HEOR
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