Market access & HEOR consultancy · Europe-based, working globally

Evidence that gets to the point.

We turn clinical and economic evidence into decisions payers can act on: value dossiers, HTA and cost-effectiveness submissions, outcomes research, real-world data and the digital tools that carry them into every market. AI-augmented workflows, and a team assembled for your question rather than an org chart.

See the work

Where we plug in

From insight to access, one partner

Market access is a sequence, not a department. We work across all four stages, so nothing is lost in the hand-off between the people who generate evidence and the people who negotiate with it.

Insight

Understand the payer

Payer, HTA-assessor and KOL interviews and surveys through our on-demand expert network, landscape and competitor analysis, pricing corridors and willingness-to-pay in emerging markets, evidence-gap assessment.

Evidence

Build the case

Cost-effectiveness, cost-consequence and budget-impact models, network meta-analysis and indirect comparisons, systematic and targeted reviews, PRO validation, real-world and patient-level data.

Communication

Make it land

Global value dossiers, country adaptations, objection handlers, value decks and payer brochures, abstracts, posters and manuscripts.

Access

Carry it into every market

HTA submissions and post-submission support, outcomes-based agreement input, interactive economic tools, affiliate training and launch tracking.

Capabilities

Six service lines, one team

Global pricing & market access strategy

  • Payer, HTA-assessor and KOL research via an on-demand expert network
  • Launch sequencing and pricing corridors
  • Global value dossier and core value story
  • Biosimilar launch and originator defence strategy
  • Outcomes-based and risk-sharing agreement input

Local access & HTA

  • Country-adaptable submission templates
  • HTA dossiers and local model adaptations
  • Evidence selection and consistency checks
  • Post-submission Q&A support

Health economics & statistics

  • Cost-effectiveness and cost-consequence models
  • Budget-impact models with local epidemiology
  • Network meta-analysis and indirect comparisons
  • Psychometrics and patient-level analysis

Evidence strategy & synthesis

  • Evidence-gap and payer evidence planning workshops
  • Systematic, rapid and targeted literature reviews
  • AI-assisted screening and extraction, human-verified
  • Regulatory and HTA label-claim analyses

Outcomes research & real-world data

  • COA measurement strategy and gap analysis (regulatory and payer fit)
  • PRO development: concept elicitation, content validity, psychometrics
  • Meaningful-change thresholds and clinical-trial exit interviews
  • COA evidence dossiers and label-claim support for FDA and EMA
  • Patient-level data design and extraction from source documents
  • Outcomes analytics for HTA; abstracts, posters and manuscripts

Digital tools & enablement

  • Interactive economic-impact calculators
  • Launch-tracking and knowledge platforms
  • Affiliate training and HEOR-for-commercial workshops
  • Ongoing rollout and update support

Regions where we have submitted, adapted or analysed HTA evidence

Latin America · Middle East & North Africa · Asia-Pacific · Europe · North America

Selected work

Our clients include top-ten global healthcare companies and leading immunology biotechs. We keep them anonymous here; references are available on request.

Outcomes researchClient: global immunology biotech, HEOR team
Scope: FDA and EMA approvals 2014–2024 · NICE, HAS and G-BA opinions 2019–2024
Regulatory label review · COA and PRO classification · HTA opinion analysis · Endpoint database10 years of approvals
2 regulators, 3 HTA bodies
4 COA types classified
1 reusable endpoint database

Optimizing Clinical Outcome Strategies for Regulatory Approvals in Autoimmune Diseases: A Decade of Insights

Challenge
Clinical outcome assessments decide what a label can say, yet FDA and EMA accept them differently and HTA bodies value them differently again. The client needed to know, across a decade of autoimmune approvals, which COAs earned label claims, which were sought and refused, and how NICE, HAS and G-BA later judged the PROs the EMA accepted, so that future trial designs satisfy regulators and payers at once.
What we did
Identified every new autoimmune therapy approved by FDA and EMA from January 2014 to October 2024, excluding immuno-oncology and reformulations. Reviewed drug approval packages, EPARs and product labels, and the NICE, HAS and G-BA reports on EMA-approved PROs. Built an endpoint database capturing COA type (PRO, ObsRO, ClinRO, PerfO), concept of interest, endpoint hierarchy, disease-specific versus generic instruments, reviewer and SEALD comments, and claims sought but not granted. Analysed frequencies, positioning and trends over time, compared them against published FDA and EMA guidance, and reported where regulatory and HTA expectations align and where they diverge.
Different
Regulatory and HTA evidence read together, not in separate reports: the same instrument tracked from trial protocol to label to reimbursement opinion. AI-assisted screening and extraction of approval documents, with every coded field verified by an analyst.
Outcome
A ten-year evidence base and a set of design rules for choosing COAs that survive both regulatory review and HTA appraisal.
Evidence strategyClient: global immunology biotech, late-stage asset in a rare autoimmune disease
Scope: protocol gap analysis and comparator review ahead of HTA
ITC feasibility · Protocol gap analysis · Comparator landscape · HTA anticipation3 pipeline comparators
9 studies reviewed (5 Phase II, 4 Phase III)
2 endpoints flagged as HTA focal points
1 comparator judged ITC-feasible

Reading a Phase III protocol the way an HTA assessor will

Challenge
With no head-to-head trials in the indication, future reimbursement would rest on indirect treatment comparisons against agents still in development. The client wanted to know, before the Phase III programme locked, whether an ITC would be feasible, against whom, on which endpoints, and what the protocol was missing.
What we did
Mapped the comparator landscape and every active or completed study. Compared the client's Phase III protocol with each comparator on population and severity criteria, exclusion rules, prior and concomitant treatment, study design, dosing and assessment timepoints. Cross-tabulated composite disease-activity and patient-reported indices, symptom scales, organ-function outcomes and quality-of-life instruments by endpoint hierarchy (primary, secondary, exploratory, post hoc), then rated ITC feasibility endpoint by endpoint and summarised published comparator results.
Different
The analysis was done from the appraiser's chair: which treatment-effect modifiers an HTA body would object to, and which exploratory endpoints would carry too much uncertainty to anchor a comparison. Recommendations went straight into the protocol, including instruments to add so the asset would not be missing endpoints its competitors report.
Outcome
A clear feasibility verdict per comparator and endpoint, and concrete protocol additions delivered while the clinical development plan could still change.
Digital toolsClient: global health-economics function of a top-ten healthcare company
Scope: interactive vaccine economic models · hosting, maintenance, country rollout
Model digitisation · Web application · Country adaptation · Publication2 interactive tools
5 country adaptations
12–16 weeks from kick-off to release
Hosted on the client's own infrastructure

Turning an influenza vaccination cost model into a tool affiliates use every week

Challenge
The economic case for seasonal influenza vaccination lived in an Excel model that only the global team could run. Affiliates needed to show local payers the cost and outcome impact of vaccinating adults and children, in their language, with their data, and with content that had passed medical and legal review.
What we did
Digitised the model into an interactive web application with scenario selection (adult, paediatric, risk groups), local-data inputs and a one-page business-case export, built to the client's brand guidelines. Updated the underlying evidence review to add cardiovascular and diabetes-related outcomes and costs, and refreshed the Excel engine so the digital tool and the source model never disagree. Delivered every screen as PDFs for MLR approval, integrated the comments, adapted the tool for five countries, deployed it to the client's own servers under its IT requirements, and provide annual maintenance with uptime monitoring. Drafted a single-country publication on adoption and usability.
Different
One team owning the evidence, the Excel engine and the software: no hand-off between the modellers and the developers. The tool is treated as a product with releases, an SLA and a change log rather than a one-off deliverable.
Outcome
A second, trivalent-vaccine tool commissioned on the strength of the first; affiliates run payer conversations without waiting for the global team.
Real-world dataClient: global immunology biotech, clinical development
Scope: adjudication-committee records from a Phase III trial
Structured extraction · Patient-level dataset · Descriptive analysis · Documentation gap assessment~240 anonymised patient records
~40 scanned pages per record
7 variable domains extracted
Dual-pass verification of every value

Why did the diagnostic adjudication committee say no? Reading 240 patient records to find out

Challenge
In a Phase III trial, an independent adjudication committee had to confirm each participant's diagnosis before enrolment. Many were rejected, most often for insufficient documentation of clinical features, treatment response or supportive testing. The insight into why sat in roughly 240 scanned case files of about 40 pages each.
What we did
Designed a structured extraction framework and data dictionary covering the evidence a diagnostic committee weighs: laboratory and antibody test history (including assay type and result), genetic and electrophysiological testing (including whether raw outputs were provided rather than summary statements), documented response to standard and advanced therapies, core clinical features, relevant treatment exposures and family history. Extracted and coded every record with dual-pass verification and a query log for ambiguous cases. Analysed documentation availability stratified by committee outcome and by concordant versus tie-break review, quantified the deficiencies most associated with rejection, and synthesised recurring documentation failure modes into a final presentation.
Different
A clinical-trial question answered with real-world-data methods: a reusable patient-level dataset rather than a one-off read-through, built under a signed data-processing agreement and our data-security SOP, with every value traceable to its source page.
Outcome
Evidence on which missing elements drive screen failure, ready to inform site guidance and future protocol design; the dataset remains available for further analyses.
Payer & expert insightClient: commercial-stage pharmaceutical company preparing a high-cost specialty launch in Europe
Scope: mixed-method payer and HTA research · EU5
Payer research · HTA assessor interviews · Mixed methods · On-demand expert network15 payers, HTA assessors and patient-advocacy leaders
48 h to identify experts
4 days to complete recruitment
1.5 weeks brief to final report

Fifteen payers and HTA assessors, interviewed and reported in ten working days

Challenge
Before committing to an evidence-generation plan and launch sequence, the client needed first-hand insight on value-based pricing expectations, HTA evaluation criteria and local reimbursement dynamics in the EU5. A conventional agency quoted months, largely for recruitment and contracting.
What we did
Designed a mixed-method study: a short quantitative survey followed by in-depth interviews with 15 national and regional payers, HTA assessors and patient-advocacy leaders. Through our expert-network partnership, which gives us on-demand reach into more than 15 million verified experts and 50,000 payer profiles, we identified the right respondents within 48 hours and completed recruitment in four days. We moderated the interviews ourselves, coded the transcripts with LLM-assisted thematic analysis, and reported implications for the value dossier and launch sequencing.
Different
Access to experts at network scale, but with HEOR specialists designing the questions, moderating the calls and translating the answers into evidence and pricing decisions. Compliance, contracting and expert payment handled on the platform, so the client saw one contract and one point of contact.
Outcome
Brief to final report in a week and a half; findings fed directly into the global value dossier and market-entry sequence.

Client names withheld for confidentiality. References available on request.

Our work has been presented at

EAN · NANOS · AANEM · MGFA Scientific Session · AAN

Ways of working with us

Project-based · Embedded support (day-rate, months at a time) · Workshops and training · On-demand expert and payer research

How we work

AI-augmented, human-owned

We use large language models the way a good analyst uses a calculator: for screening, extraction, localisation and QC. Every number and every claim is owned by a named person, and the process is documented.

Where AI earns its place

Literature screening and evidence tables. Structured extraction from long documents with human confirmation. First-pass localisation of dossiers and model inputs. Thematic coding of interviews. Cross-checking models and references before QC.

Where it doesn't

Choosing the comparator. Framing the value story for a specific payer. Deciding what a meaningful change is. Signing off. These stay with a senior consultant who has sat on the payer side of the table.

Secure by design

Client data is processed only to deliver the engagement it was shared for, and never used to train shared or third-party AI models. Anonymised datasets, controlled-access environments and version-controlled workflows are the default; for sensitive data we offer EU-hosted or on-premise processing rather than public cloud.

SOP-QM Quality managementSOP-QC ReviewSOP-SEC Data securitySOP-CAPA Incident managementGDPR & DPAVendor quality & security questionnaire on fileAnti-bribery & code of conduct

Data protection in practice

Encryption in transit (TLS 1.2+) and at rest (AES-256) for files, databases and backups. Least-privilege, time-bound access to project data, multi-factor authentication for everyone on the team, and access logs kept for the life of the project. Encrypted backups with restore testing. Retention agreed per project, with deletion or hand-back of all client data on request and at close-out. A small, vetted set of sub-processors (hosting, e-mail, authentication), listed on request and bound by written data-protection terms. Incidents follow a documented runbook with defined severity levels and notification timelines.

Teams built to fit

We compile each team from the expertise the question needs, drawing on a standing group of half a dozen specialists in HEOR, health-economic modelling, outcomes research, data engineering and software. One accountable lead, no account layer: you brief the person who does the work, and the person who does the work presents it. The result is the right mix of skills at the best value, without paying for a bench you do not use.

Questions

Frequently asked

Short answers to what prospective clients ask first. Anything else, use the Contact us button.

What does id est point do?

id est point is a market access and health economics and outcomes research (HEOR) consultancy for pharmaceutical and biotech companies. We build global value dossiers, HTA and cost-effectiveness submissions, budget-impact models, outcomes research and real-world data studies, and interactive digital tools that carry the evidence into local markets.

Which regions do you cover?

We have submitted, adapted or analysed HTA evidence in Latin America, the Middle East and North Africa, Asia-Pacific, Europe and North America, with particular depth in emerging markets and private-payer systems.

How are engagements staffed?

Each team is compiled for the expertise the question needs, drawing on a standing group of half a dozen specialists in HEOR, health-economic modelling, outcomes research, data engineering and software. One senior lead is accountable from brief to sign-off.

How quickly can you run payer or expert research?

Through our expert-network partnership we typically identify the right payers, HTA assessors or clinicians within 48 hours, complete recruitment within days and deliver a mixed-method study in about two weeks.

How do you handle confidential client data?

Client data is processed only for the engagement it was shared for and never used to train shared or third-party AI models. We work under documented SOPs for quality management, QC review, data security and incident management, with GDPR-aligned data-processing agreements, encryption in transit and at rest, least-privilege access and agreed retention.

Can you provide client references?

Yes. Client names are withheld on this site for confidentiality; references from global healthcare companies and immunology biotechs are available on request.