The market access, HEOR & evidence glossary.

Accelerated approval is a regulatory route that permits earlier product availability for treatments targeting serious diseases and meeting an unmet medical need by relying on surrogate measures.

The addressable population is the group of patients within a larger disease setting who satisfy defined criteria for receiving a particular product or intervention.

An advisory board is an organized session in which external experts share insights to guide strategic, clinical, or scientific decisions in pharmaceutical development.

Germany's Arzneimittelmarkt-Neuordnungsgesetz — the post-launch benefit assessment that decides the price your asset can defend in Europe's largest market.

Artificial intelligence (AI) refers to computer systems built to carry out tasks that normally require human intelligence, including learning, reasoning, and making decisions.

An asset evaluation determines the appeal, market potential, and probability of success for either an internal or external asset.

Attribution refers to the act of connecting a scientific, clinical, or strategic outcome to a defined source, action, or stakeholder, supporting transparency and traceability.

Benefit-risk assessment is the structured review of a treatment's therapeutic benefits compared with its potential risks, helping guide regulatory and clinical decisions.

Bibliometric analysis is the use of statistical methods to examine and interpret publication data.

Bibliometrics refers to the quantitative study of academic publications used to assess research performance and impact.

A biosimilar is a biological medicine that is highly comparable to an approved reference biologic, showing no clinically meaningful differences in safety, purity, or efficacy.

In market access and regulatory settings, burden of proof refers to the requirement for pharmaceutical companies to show the value, efficacy, and safety of their products to key stakeholders.

Channel strategy refers to how pharmaceutical companies use distinct communication and access routes to engage key stakeholders across medical, payer, and patient channels.

Clinical benefit refers to the positive effect a treatment has on patient health, including symptom relief, disease alteration, or improved survival.

Clinical development is the systematic process of evaluating a new medical intervention in humans to determine its safety and efficacy.

Clinical differentiation is the extent to which a product distinguishes itself from alternatives based on its therapeutic profile, safety, or usability.

The clinical landscape refers to the current state of clinical development within a specific disease area, covering ongoing and completed trials, treatment practices, and emerging standards of care.

Clinical meaningfulness describes the real-world importance of a treatment's effects on outcomes that matter to patients, providers, and payers.

Co-author impact factor is a calculated metric that measures the influence of an author's collaborators by examining their publication activity and citation records.

A collaboration network is a visual or analytical depiction of co-authorship and institutional connections within scientific research communities.

The processes through which a drug transitions from approval to real-world use. This includes launch, distribution, pricing and reimbursement, stakeholder engagement, and lifecycle management.

Comparative effectiveness assesses how a treatment performs compared with other available options in terms of efficacy, safety, and real-world outcomes.

The competitive landscape refers to the current mix of products, companies, and strategies competing within a defined therapeutic area, market, or indication.

Conference planning is the strategic organisation of a pharmaceutical company's activities before, during, and after a scientific or medical meeting to enhance scientific impact and stakeholder engagement.

Consultative bodies are advisory organisations that an HTA body is required by law or policy to consult or consider recommendations from. They may operate as a subgroup within the HTA body or as an independent organisation. They are not payers, as they do not make final reimbursement decisions.

A decentralized clinical trial (DCT) is a study that employs digital tools and remote methods to lessen or remove the need for in-person site visits.

A development pipeline is the collection of drug candidates that a pharmaceutical company (or the broader industry) has in discovery or development at any given time.

Digital activity refers to the online engagement of stakeholders across channels such as social media, webinars, and virtual conferences, offering insights into their interests, influence, and networks.

The digital landscape refers to the mix of online platforms, behaviours, and content that shape scientific dialogue, stakeholder engagement, and perception within a therapeutic area.

Digital landscaping is the structured review of online activity used to identify key stakeholders, emerging trends, and scientific discussions within a therapeutic area.

Digital listening is the ongoing monitoring and analysis of online conversations to capture insights on stakeholder views, emerging topics, and perceptions of scientific data.

A DOL is an influential individual or organisation with a substantial online presence, often on social media, within the healthcare or pharmaceutical industry.

Digital transformation is the integration of digital technologies into core pharmaceutical operations to improve scientific, clinical, and commercial performance.

Disease burden refers to the overall impact of a health condition on individuals, healthcare systems, and society, spanning clinical, economic, and quality of life effects.

Disease severity refers to the degree or intensity of a condition's effect on a patient's health, daily functioning, and quality of life.

The digital opinion leader (DOL) impact factor is a proprietary bibliometric-based metric used to identify and rank DOLs.

Dose optimization is the process of determining the most effective and safe drug dose for a defined patient population.

An early access program (EAP) enables patients with serious or life threatening conditions to obtain investigational therapies before full regulatory approval.

Economic modeling involves applying mathematical frameworks to estimate the cost effectiveness, budget impact, or overall value of healthcare interventions.

Eligibility criteria are the inclusion and exclusion rules that specify which participants may enroll in a clinical trial.

Engagement planning is the strategic design of how and when to engage external stakeholders to support scientific, clinical, and commercial goals.

Epidemiology is the study of the distribution, patterns, and determinants of health within defined populations.

An evidence hierarchy is a tiered framework that ranks types of evidence according to their methodological strength and reliability.

An evidence generation program is a coordinated plan for producing clinical, real world, and economic data to support the value and positioning of a pharmaceutical product.

An external control arm uses data from outside a clinical trial to act as a comparator for assessing a treatment's effectiveness.

Feasibility planning is the process of assessing whether a clinical trial or development strategy can be successfully carried out based on operational, scientific, and market factors.

First author refers to the individual credited with leading the design, execution, and writing of a scientific publication.

Formulary inclusion is the decision by a healthcare payer or institution to list a pharmaceutical product as an approved treatment option.

Gap analysis is the process of identifying missing evidence, insights, or capabilities required to meet strategic, regulatory, or stakeholder expectations.

A generic is a medication that is chemically equivalent to an approved brand name drug and intended to provide the same clinical benefit at a lower cost.

A global value dossier (GVD) is a comprehensive document that compiles all supporting evidence for a product's value, created for use in payer and HTA submissions across global markets.

A health economic model is a structured tool used to estimate the costs and outcomes linked to a healthcare intervention over time.

HEOR is the field dedicated to assessing the economic value, clinical outcomes, and humanistic effects of healthcare interventions to support decision making.

A health technology assessment (HTA) is a systematic evaluation of the clinical, social, economic, and ethical implications of a new medical intervention or technology.

The discipline that translates clinical evidence into the cost-effectiveness, budget impact and value arguments HTA bodies and payers actually buy.

An HEOR stakeholder is an individual or organisation that relies on health economics and outcomes research to inform decisions in healthcare policy, reimbursement, or treatment adoption.

An HTA submission is a formal package of clinical and economic evidence submitted to a health technology assessment body to support product reimbursement or funding.

The headline number every HTA submission revolves around — the extra cost per QALY of your therapy versus the comparator. It's the price of the question every payer asks first.

Implementation science is the study of how to support the adoption and integration of evidence based practices within real world healthcare settings.

In epidemiology, incidence is the rate at which new cases of a disease arise in a population over a defined time period.

Inclusion and exclusion criteria specify who may or may not participate in a clinical trial, based on factors such as disease state, age, comorbidities, or prior treatment.

Indications are the specific medical conditions or diseases for which a treatment or intervention is authorised.

An indication assessment is the strategic evaluation of market opportunities across multiple potential indications to determine which to prioritise for development and launch, aiming to maximise the commercial success of a new product or medical device.

An insight is understanding drawn from data or lived experience that highlights a trend, need, or opportunity.

Institutional affiliation refers to the academic, research, or clinical organisation with which a healthcare professional is formally associated.

An integrated evidence plan (IEP) outlines the coordinated generation of clinical, economic, and real world data to support a product's lifecycle strategy.

An intelligence board is an expert curated synthesis of evidence, data, and strategic insights created to support pharmaceutical decision making on specific questions or topics.

Internal buy in refers to securing cross functional agreement and support for a strategic decision, investment, or action plan within a pharmaceutical organisation.

An investigator initiated study (IIS) is a clinical or scientific study designed and led by an independent researcher, often supported with funding or materials from a pharmaceutical company.

When you don't have a head-to-head trial, ITCs and NMAs estimate relative effects across a network of trials connected by a common comparator.

The EU-wide clinical assessment under HTAR — one shared dossier, multiple national pricing decisions, on a clock that doesn't move.

A JCA is an EU level evaluation of the clinical effectiveness and safety of a new medicine, providing a single standardised clinical assessment usable by all EU member states. It focuses solely on clinical evidence, not pricing, reimbursement, or country specific economic evaluations, which remain the responsibility of national HTA bodies.

Journal prestige refers to the perceived authority, influence, and visibility of a scientific journal within its field, extending beyond its impact factor alone.

A key clinical investigator (KCI) impact factor is a proprietary bibliometric based metric used to identify and rank KCIs.

A key clinical investigator (KCI) is a highly experienced healthcare professional with a demonstrated track record in conducting successful clinical trials.

A key opinion leader (KOL) is a highly influential and respected expert in their field who helps shape opinions and decision making.

Key opinion leader (KOL) mapping is the process of identifying and analysing key opinion leaders based on their influence, expertise, and relevance to a specific therapeutic area or strategy.

The key opinion leader (KOL) impact factor is a proprietary bibliometric based metric used to identify and rank KOLs.

Launch sequence optimization is a strategic process that defines the optimal order and timing for introducing a new drug across different markets.

Lifecycle evidence generation is the strategic planning and execution of data generation activities across a product's development, launch, and post-market phases.

Line of therapy refers to the sequence in which treatments are administered to a patient, typically classified as first line, second line, or third line based on clinical guidelines or prior treatment history.

A literature library is a curated collection of publications relevant to a specific individual, topic, or strategy, used to support insight generation and engagement planning.

Market access is a function within pharmaceutical and biotechnology companies that ensures patients who are most likely to benefit from a new drug can obtain it, and that the drug remains cost effective for healthcare systems and commercially viable for the manufacturer.

Marketing authorization is the regulatory status granted by agencies such as the FDA, EMA, or MHRA that permits a drug to be marketed and prescribed. To receive marketing authorization, a medicine must demonstrate clinical benefit and meet required safety, efficacy, and quality standards.

Market conditioning is the strategic process of shaping stakeholder awareness, perceptions, and expectations ahead of a product launch or clinical milestone.

Market potential is the estimated maximum revenue opportunity for a pharmaceutical product within a defined population, therapeutic area, or geographic region.

Market shaping is the deliberate effort to redefine or broaden a therapeutic space by influencing standards of care, stakeholder behaviour, or access pathways.

Market value refers to the current or projected financial worth of a pharmaceutical product or therapeutic area based on real world sales, pricing, and market dynamics.

Medical affairs is a strategic function within the pharmaceutical, biotechnology, and consumer healthcare industries that communicates scientific data to healthcare professionals, payers, and policymakers.

Medical insight capture is the process of gathering, analysing, and synthesising insights from healthcare professionals to guide strategy and decision making.

A Medical Science Liaison (MSL) is a scientific expert who engages with healthcare professionals to share clinical data and gather insights that inform medical and commercial strategy.

Medical strategy is the plan that directs how scientific and clinical knowledge is generated, interpreted, and communicated across a product's lifecycle.

Modeling is the process of applying mathematical frameworks to simulate clinical, economic, or epidemiological scenarios that support pharmaceutical decision making.

Morbidity rate is a measure of how often a disease or health condition occurs within a specific population over a defined period of time.

Mortality rate is a measure of how often death occurs in a defined population over a specified period, often used to assess the severity or impact of a disease.

Multi stakeholder engagement refers to the coordinated interaction with diverse healthcare decision makers, including providers, payers, regulators, and patient advocates.

Multiplicity refers to the heightened risk of false positive findings when multiple statistical tests are conducted within a clinical trial.

Net clinical benefit refers to the overall advantage of a treatment when balancing its therapeutic effects against its risks in real world patient care.

An observational study is a non interventional research design that examines outcomes in patients receiving routine medical care.

An outcomes based agreement ties a drug's reimbursement to the real world results it delivers in a patient population.

A patient advocacy group is an organisation that represents the interests of individuals affected by a specific disease or condition, often influencing research, policy, and access.

Patient engagement is the active involvement of patients in the design, development, and evaluation of healthcare strategies, including clinical trials and evidence generation.

Patient reported outcomes (PROs) are direct reports from patients about their symptoms, functioning, or quality of life, provided without clinician interpretation.

A payer influencing key opinion leader (PIKOL) is a key influencer of healthcare policy and reimbursement decisions.

Payers are decision making organisations that determine whether a medicine will be reimbursed or funded, and under what conditions, within healthcare systems. They make these decisions based on assessments of clinical value, cost effectiveness, and the impact on healthcare budgets.

Peer to peer engagement involves direct scientific exchange between healthcare professionals, often supported by field medical teams such as medical science liaisons (MSLs).

Pharmacovigilance is the science and practice of monitoring, detecting, assessing, and preventing adverse effects or other drug related problems once a product is on the market.

A placebo controlled study is a clinical trial in which the effects of an investigational treatment are compared with an inactive substance that mimics the treatment but has no therapeutic effect.

Population health impact refers to the measurable effect of a therapy or intervention on the overall health outcomes of a defined population.

Predictive analytics uses historical and real time data to forecast future outcomes, helping guide strategic decisions in clinical development and market access.

In epidemiology, prevalence describes the proportion of a population that has a disease at a specific point in time.

Price benchmarking is the process of comparing the price of a pharmaceutical product with similar therapies across markets to inform pricing strategy and negotiation.

Price potential refers to the estimated price a pharmaceutical product could reasonably attain based on its clinical value, competitive positioning, and payer willingness to pay.

Pricing and reimbursement refers to the processes through which a pharmaceutical product is assigned a price and granted coverage or funding by healthcare payers.

Product value communication is the strategic process of conveying the unique attributes, patient benefits, and economic value of a drug or therapy.

A publication strategy is a structured plan for disseminating scientific and clinical data through peer reviewed journals and congresses to support a product's development and value story.

Publication type classifies scientific articles by format and purpose, shaping how they are perceived and weighted in bibliometric analysis.

A publishing plan is a strategic roadmap for disseminating clinical, real world, and health economic data through peer reviewed journals and scientific platforms.

Qualitative research is a method used to gather non numerical insights into stakeholder behaviours, perceptions, motivations, and decision making processes.

Quantitative research involves the collection and statistical analysis of numerical data to identify patterns, test hypotheses, or measure outcomes.

Real world data (RWD) refers to health related data collected outside traditional clinical trials, used to understand how treatments perform in routine clinical practice.

Real world effectiveness measures how well a treatment performs in routine clinical practice, outside the controlled conditions of clinical trials.

Real-world evidence (RWE) describes clinical insights obtained through analyzing real-world data (RWD) to assess how treatments function beyond the environment of controlled clinical trials in practice.

Regulatory strategy is the plan that directs how a pharmaceutical company will meet requirements for product approval, labeling, and obligations after a product reaches the market.

A regulatory submission is a detailed dossier provided to health authorities to obtain approval for a new drug, indication, or formulation.

The process through which a healthcare system, insurer, or government agrees to pay part or all of a medicine's cost so that patients are not responsible for the entire out-of-pocket expense.

The reimbursement landscape refers to the policies, payer expectations, and pricing systems that shape whether and how a product will receive funding.

Research and development (R&D) is the process of identifying, creating, and evaluating new pharmaceutical products to advance medical science and enhance patient outcomes.

A risk factor is any trait, condition, or behavior that raises the chance of developing a disease or experiencing a negative health outcome.

A risk-sharing agreement is a contractual arrangement in which a pharmaceutical company and a payer share financial or clinical risk tied to treatment outcomes.

Evidence derived from real-world data — registries, claims, EHRs, chart reviews — used to complement RCTs in HTA, label expansion and post-marketing commitments.

Scientific exchange refers to non-promotional, evidence-based communication between a pharmaceutical company and healthcare professionals aimed at advancing clinical understanding.

Scientific landscaping is the structured assessment of published and emerging research to uncover trends, gaps, and strategic opportunities within a therapeutic area.

Sentiment analysis is the application of natural language processing (NLP) and machine learning to determine the tone and emotional context of written or spoken content.

Share of voice is a metric that reflects the proportion of total mentions or visibility a product, brand, or company gains within a defined competitive or thematic space.

Site ranking is the process of assessing and ordering clinical trial sites using performance metrics such as patient enrollment, data quality, and regulatory compliance.

Stakeholder mapping is the development of a comprehensive overview of key stakeholders relevant to a specific therapeutic area, indication, condition, or product.

Stakeholder segmentation is the process of grouping healthcare stakeholders according to shared attributes, interests, or behaviors to refine engagement strategies.

Stakeholder sentiment refers to the tone and attitude shown by healthcare professionals, payers, patients, or other influencers toward a product, topic, or company.

Stakeholders are the individuals, groups, or organisations involved in, affected by, or contributing to the development, regulation, evaluation, and use of medicines, including patients, healthcare professionals, industry, regulators, HTA bodies, and payers.

Strategic publication planning is the process of aligning scientific communication activities with product objectives, evidence timelines, and stakeholder needs.

A surrogate endpoint is a biomarker or intermediate measure used in clinical trials as a stand-in for a direct measure of clinical benefit.

A target product profile (TPP) outlines the desired characteristics of a pharmaceutical product to guide development and align stakeholder expectations.

Territorial lines refer to the geographic or operational boundaries used to organise stakeholder engagement and field team activities.

A thought leader is an individual widely recognised for their expertise, original ideas, and capacity to influence thinking and practice within a specific field.

Time to peak uptake is the period it takes after launch for a product to achieve its highest level of market adoption.

Top 100 KOL refers to a select group of highly influential experts in a specific therapeutic area, identified through both quantitative and qualitative analysis.

The treatment landscape describes the complete range of available therapies and treatment approaches for a particular disease or condition.

Trial site analysis is the assessment of potential clinical trial sites to optimise study performance.

Unbranded engagement involves scientific or educational communication that does not promote a specific product but increases awareness of a disease, unmet need, or treatment approach.

Unmet need refers to a gap in medical care where existing treatment options are insufficient, unavailable, or ineffective for a specific patient population or condition.

User defined data updates allow users to set how often their dashboards and datasets refresh, supporting continuous tracking of changing metrics.

A value proposition is a clear, evidence based summary of the benefits a product delivers to patients, providers, and payers.

Voice of the customer refers to insights collected from stakeholders that capture their needs, expectations, and experiences with a product or therapeutic area.

Willingness to pay refers to the maximum amount a healthcare payer, provider, or system is prepared to spend for a treatment based on its perceived value and resulting health outcomes.

Workflow integration refers to the alignment of a product or tool with the routines and systems used by healthcare professionals in everyday clinical practice.