HTA Submission Dossier
Pubrica prepares HTA submission dossiers for manufacturers preparing national reimbursement submissions, written to the requirements of each agency. Each agency sets its own requirements: NICE submissions follow a reference case, CDA-AMC conducts reimbursement reviews, the G-BA assesses dossiers against a comparator it sets, HAS transparency dossiers turn on SMR and ASMR, and PBAC applies its own guidelines. These submissions share a trial but differ in almost every other respect. Pubrica’s HTA submission writers prepare each dossier for the agency that will assess it, together with clarification responses and checks against the economic model.
- Written for each agency: the reference case, comparator rule and accepted methods differ in every market
- Current agency names and methods: CADTH has been Canada’s Drug Agency (CDA-AMC) since 1 May 2024, and our dossiers reflect the change
- The appropriate comparator applied correctly, because in Germany a dossier assessed against the wrong comparator is judged to show no additional benefit
- Model and dossier written together, so the numbers in the text are the numbers in the model
- Clarification questions anticipated, because clarification rounds are where submission timelines are most often lost
Dossier built to the named agencyIncluded
Reference case and methods appliedIncluded
Clarification responses draftedIncluded
Consistency with the model checkedIncluded
A guaranteed recommendationNot something any provider can offer
Agency → reference case → evidence → dossier → clarification
- Built to the named agency
- Current agency names and methods
- Comparator rule applied correctly
- Numbers consistent with the model
- Clarification questions anticipated
Deliverables
Four Components of Every HTA Submission Dossier
Each agency requires a different argument for the same product, so we prepare each dossier for the agency that will read it.
From the reference caseA model built to a different discount rate or a societal perspective does not meet the NICE reference case and must be rebuilt, which duplicates work.
From the German fileThe comparator is settled in advance through consultation. Companies that engage in that process are better prepared than those that learn of the choice when they receive the assessment.
From the reviewThis detail affects how a submission is read. The same applies to a NICE submission that cites end-of-life criteria, which the severity modifier has replaced.
From the processClarification rounds are where submission timelines are most often lost, and where any inconsistency between the dossier text and the model is raised in committee discussion.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
HTA Submission Standards and Methods Guidance
Each agency publishes its own methods guide. The standards below apply across agencies.
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.
CHEERS 2022 (reporting economic evaluations)
The consolidated health economic evaluation reporting standard. Twenty-eight items covering model structure, inputs, assumptions, uncertainty and conflicts — and the checklist reviewers and HTA bodies increasingly ask to see completed.
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 HTA Submission Dossiers
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 HTA Dossier Development Process Works
We confirm the target agency first, because it determines the perspective, comparator, discount rate and outcome measures used throughout.
Agency and Reference Case
We confirm the target agency and establish its reference case, comparator rule and accepted methods before any analysis is run.
Evidence and Model Alignment
We check the systematic review, indirect comparisons and economic model against the methods this agency accepts, and rebuild any element developed for a different agency.
Dossier Drafting
We write the dossier to the agency template and terminology, with every figure traced to the model that produced it.
Submission and Clarification
After submission, we answer clarification questions using the same evidence base.
Our Experts
Your HTA Submission Dossier 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.
Packages
HTA Dossier Packages
Pricing depends on the agency, the indication and whether the evidence already exists in a form the agency accepts.
One agency
For a single national submission
Quoted per projectOn agency and indication
Delivery By agency timetable
- ✓Reference case and comparator rule applied
- ✓Evidence checked against agency methods
- ✓Dossier written to the template
- ✓Numbers traced to the model
- ✓Clarification responses drafted
Please tell us the target agency first, as it determines the perspective, the discount rate and sometimes the outcome measure.
Deliverables Request a quoteMulti-market sequence
For launches across several HTA markets
Quoted per projectOn markets and sequencing
Delivery By market
- ✓Shared evidence core built once
- ✓Each dossier built to its own agency
- ✓Sequencing advised against reference pricing
- ✓Consistency maintained across markets
- ✓Clarification handled per agency
The order of submission matters, because an early low price in a reference market affects pricing in later markets.
Deliverables Request a quoteResubmission and appeal
For products with a negative or restricted recommendation
Quoted per projectOn the finding to be addressed
Delivery By scope
- ✓Detailed review of the committee finding
- ✓Answerable and unanswerable issues identified
- ✓Evidence or analysis rebuilt where it can be
- ✓Resubmission or appeal drafted
- ✓Clear advice where a finding cannot be addressed
Some committee findings can be addressed with further analysis and some cannot. We tell you which is which before any resubmission work begins.
Deliverables Request a quoteSend us the agency and the indication, and we will check your evidence base against that agency’s reference case at no cost and tell you what would need to be rebuilt.
FAQs
HTA Submission Dossier FAQs
If your question is not answered here, please ask an expert. No quote is required.
A single evidence core can serve several agencies, but a single dossier cannot. The reference case, comparator rule and accepted methods differ enough that a document written for one agency does not meet the requirements of another.
The most economical approach is a global value dossier as the single evidence source, with each national submission built from it rather than adapted from another submission.
No. It removes the duplicated clinical assessment. Pricing and reimbursement remain national, and every Member State still runs its own process and asks its own questions.
Your national economic argument now builds on a clinical assessment you did not write alone, and it must remain consistent with it.
The dossier is assessed against the appropriate comparator therapy the G-BA set, not the one you argued against. Evidence against a different comparator generally cannot demonstrate additional benefit.
The comparator is settled in advance through consultation, and that is the stage at which to engage with it.
Ideally before the pivotal trial fixes its comparator and outcome measures, if these are still open. HTA requirements differ from regulatory requirements, 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.
Related Services
Related Market Access Services
Each dossier draws on underlying analysis, evidence review and value dossier work.
1ECONOMIC ANALYSISbuilt first
Cost-effectiveness modelTo the agency’s reference case. Budget impact modelThe cost to the payer’s budget.2EVIDENCE SYNTHESIScompleted earlier
Payer evidence reviewSystematic review and indirect comparison. Global value dossierA single evidence source for every market.3EU CLINICAL ASSESSMENTin parallel
EU Joint Clinical AssessmentThe joint EU clinical assessment. Health economicsThe health economics discipline behind all market access work.Request a Free Reference Case Check of Your HTA Evidence
You will receive a clear list of what transfers, what must be rebuilt, and what cannot be changed at this stage.