Market Access and HEOR Services
Pubrica provides market access and health economics and outcomes research (HEOR) services for life-science companies preparing evidence for payers and health technology assessment (HTA) bodies. Regulators assess whether a product works and is safe, while payers assess whether it offers value and whether they can afford it. These questions require different evidence and documents written for different readers. Our health economists and market access writers provide seven services, from the systematic review that underpins the evidence to the dossier a national committee assesses, as a single engagement or one service at a time.
- Written for each assessing body: a NICE reference case, a G-BA comparator rule and a CDA-AMC reimbursement review have different requirements
- Current agency names and methods: CADTH became Canada’s Drug Agency on 1 May 2024, and the EU Joint Clinical Assessment has applied since 12 January 2025
- One evidence core, many submissions, because separate reviews for each market produce versions that disagree with each other
- Models you own: you receive the working file and the technical report, so you can update the model without returning to us
- Regulatory documents from the same team: our team also writes the CTD summaries and clinical study reports from which the payer evidence is drawn
Clinical assessment for the EUIncluded
National HTA dossiersIncluded
Economic and budget impact modelsIncluded
Evidence review and indirect comparisonIncluded
Price negotiation on your behalfNot a service we offer
Evidence → economics → dossier → assessment → reimbursement
- Built to the named agency
- Current agency names and methods
- One evidence core, reused
- Models delivered working
- Assumptions written down
Our Services
Seven Market Access and HEOR Services
The evidence review comes first, and most other services build on it. Following this order keeps figures consistent across all of your documents.
Completed firstA review written for a journal is read, whereas a review written for a submission is audited, so the two require different reporting.
In force since 12 January 2025New oncology active substances and ATMPs now; orphan medicinal products from January 2028; all centrally authorised medicines from January 2030.
From the reviewSome dossiers are still addressed to CADTH, which has been Canada’s Drug Agency since 1 May 2024. Current agency names and methods show reviewers that a submission is up to date.
To ISPOR–SMDM good practiceThe choice of extrapolation curve is often the largest driver of the result. Presenting only the selected curve leads the committee to assume that the alternatives performed worse.
The affordability questionCost-effectiveness analysis shows whether a product offers value, and budget impact analysis shows whether the payer can afford it, which often determines formulary decisions.
Across the life cycleHealth economics and outcomes research supports market access work at every stage, from study design to real-world evidence.
Format 6.0 expected October 2026Public comment on version 6.0 closed on 22 April 2026. A dossier structured now can incorporate it without being rewritten.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Market Access and HTA Methods References
Each agency publishes its own methods guide. The references below apply across agencies.
EU HTA Regulation (Joint Clinical Assessment)
In force since 12 January 2025 for new oncology active substances and ATMPs, extending to orphan medicinal products in January 2028 and to all centrally authorised medicines in January 2030. It sets the consolidated PICOs, the 100-day dossier window and the single clinical assessment every Member State must give due consideration to.
NICE evaluations manual (the reference case)
A 3.5% annual discount on costs and health effects, an NHS and personal social services cost perspective, results at GBP 20,000 and GBP 30,000 per QALY, and the severity modifier that replaced the end-of-life criteria.
ISPOR–SMDM good practices (modelling)
The seven-report series on model conceptualisation, state-transition and discrete event structures, parameter estimation, and the validation and transparency expectations that decide whether an HTA committee trusts a model it did not build.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our certified quality system governs how work is run, recorded and released.
Responsible Use of AI
Our Approach to AI Use in Market Access Submissions
HTA reviewers examine every part of a submission, so each structural assumption, input and source must be attributable. NICE has published a position on AI use in submissions, and traceability, rather than speed, governs how we use AI tools.
Why We Do Not Publish AI Accuracy Figures
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote its own accuracy figures, as they would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Our Process
How Our Market Access Process Works
We follow this sequence so that the same figures remain consistent across every document.
Evidence Review
We conduct the systematic review and any indirect comparisons once, to submission standard, so that every later document draws on the same figures.
Economic Modelling
We build cost-effectiveness and budget impact models together from shared inputs, so that they remain consistent within a submission.
Central Evidence Record
We assemble the value dossier as the single maintained source, with every claim linked to its evidence and the strength of that evidence.
Submission to Each HTA Body
We prepare the JCA dossier for the EU clinical assessment, followed by each national submission written to its own agency’s requirements.
Our Experts
Your Market Access Team
A named team of subject specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Determines what the work can claim on the basis of the evidence. The subject expert is matched to your topic and tells you clearly when the evidence does not support the intended conclusion.
Responsible for every decision that depends on the numbers. Confirms before analysis begins whether the data can answer the question, and hands over the code so the analysis can be re-run independently.
Identifies the evidence on which the work is based and documents the search so that it can be reproduced. Writes the search strategy line by line for each platform and delivers it dated and reproducible.
Reviews the work independently of the first pass and reconciles the two, because most errors in this work are transcription errors rather than errors of reasoning. All disagreements are logged and adjudicated.
FAQs
Market Access and HEOR FAQs
If your question is not answered here, please ask an expert. No quote is required.
Ideally before the pivotal trial fixes its comparator and outcome measures, if these are still open. Regulatory and HTA requirements differ, and the gap between them cannot be closed afterwards.
Where the trial has already been completed, the earliest useful point is before the economic model is built, so that it follows the correct reference case from the start.
No. It replaces the duplicated clinical assessment. Pricing and reimbursement remain national competences, and every Member State still runs its own process.
Your national economic argument now builds on a clinical assessment you did not write alone, and it must remain consistent with it.
Usually, yes. We first check whether your existing evidence is in a form the target agency accepts. Often a review or model built for a different purpose needs rework rather than replacement.
We will tell you clearly which parts transfer, which need rebuilding and which cannot be changed at this stage.
No. We prepare the evidence and documents that support the negotiation. Price negotiation remains your commercial function.
We can show what the analysis supports at different price points, so that your negotiation is based on evidence.
Related Services
Related Regulatory and Evidence Services
Payer and regulatory documents draw on the same clinical studies.
1REGULATORY DOCUMENTSsame evidence, regulatory audience
CTD module summariesModules 2.4, 2.5 and 2.7. Clinical study reportPrepared to ICH E3, where the trial data are reported.2STATISTICS AND DATAunderneath
BiostatisticsSurvival analysis and synthesis. Medical data collectionReal-world and registry data.3EVIDENCE SYNTHESISrelated
Systematic reviewSystematic reviews for publication. Meta-analysisPooled effects where trials are comparable.Request a Free Evidence Gap Assessment for Your Target Markets
You will receive a clear list of what transfers, what must be rebuilt, and what needs to be decided before the trial design is fixed.