HTA dossier preparation

01Overview and value chain#

Markers EC: EU Joint Clinical Assessment (Regulation (EU) 2021/2282) | OECD: Biotech and health | Regulator: FDA (USA), EMA (EU), NMPA (China)

HTA dossier preparation assembles the health-economic evidence package a biopharma manufacturer must submit to a national health technology assessment body — NICE in the UK, G-BA in Germany, CADTH in Canada — to win a pricing and reimbursement decision after a drug or device already has regulatory marketing authorization. A NICE Single Technology Appraisal gives manufacturers a hard 56-calendar-day deadline to submit a full evidence dossier once scoping is complete, and Germany’s AMNOG dossier for the G-BA carries similarly compressed timelines. One specialty consultancy has prepared over 370 HTA submission dossiers, more than 135 to NICE alone; another has built an in-house AI tool that compressed a full German AMNOG dossier’s production time to three months. This is a distinct advisory service from the CMC regulatory filing and market-access manufacturing services already covered on this site — HTA dossier work happens after regulatory approval, building the separate economic case a payer needs to agree to reimburse the product, not the safety/efficacy case a regulator needs to approve it.

Key directions of HTA dossier preparation:

1. Systematic evidence review (Systematic Evidence Review): structured literature reviews and network meta-analyses building the clinical comparator evidence base an HTA submission requires.
2. Cost-effectiveness and budget-impact modeling (Cost-Effectiveness Modeling): health-economic models calculating a therapy’s cost-per-outcome and budget impact against national HTA methodology standards.
3. AI-assisted dossier generation (AI-Assisted Dossier Generation): AI tools that convert structured clinical trial data into the narrative sections an HTA dossier requires, compressing production timelines.
4. Payer and HTA stakeholder engagement (Stakeholder Engagement): structured advisory support for the negotiation and scientific-advice stages of an HTA submission process.

Sectoral value chain#

[regulatory marketing authorization] ──> [evidence synthesis] ──> [economic modeling] ──> [dossier assembly]
                                                                          │
                                                              (HTA body statutory deadline)
                                                                          │
                                                                          ▼
[pricing/reimbursement decision] <─── [HTA body submission] <──┘

Value chain levels#

Cross-cutting technologies:

• AI-assisted dossier generation (AI-Assisted Dossier Generation): software converting structured clinical data into HTA-required narrative documentation.
• Cost-effectiveness modeling (Health-Economic Modeling): statistical and economic models calculating cost-per-outcome against HTA methodology standards.
• AMNOG/NICE submission workflow (Statutory-Deadline Submission Workflow): structured project-management processes built around each HTA body’s specific statutory submission deadlines.

02US#

The US HTA landscape is shaped by a non-mandated but increasingly influential nonprofit assessor, with specialty consultancies built specifically around navigating its evidence expectations alongside private payer requirements.

ICER’s non-mandatory but influential role, AI-native and established consultancy models, private-payer evidence requirements#

• Lumanity (Bethesda, founded 2020): formed through the merger of several established health-economics and market-access firms including Cello Health and BresMed, with 1,200+ employees across the US, UK, Europe and India providing health-economics-and-outcomes-research services.
• VantEdge Access (Illinois, hubs in Chicago/Oak Brook and Paris): combines AI-enabled HTA intelligence with consulting expertise across the US, Canada and EU-5 markets, supporting biopharma teams through development, launch and lifecycle market-access strategy.
• ICER’s non-mandatory influence: unlike NICE or other statutory HTA bodies, ICER’s cost-effectiveness assessments are not mandated in the US, but its value-based price estimates increasingly shape payer negotiations and coverage decisions.

03CN#

No confirmed China-domiciled HTA-specialist consultancy was found operating independently; international consultancies with China offices serve manufacturers navigating the National Reimbursement Drug List process instead.

NRDL as the reimbursement gateway, international-firm China offices, no confirmed domestic specialist#

• NRDL as the reimbursement gateway: inclusion on China’s National Reimbursement Drug List, administered by the National Healthcare Security Administration, determines whether a product is reimbursed nationally and is often the only path to prescription within public hospitals.
• NHDRC evaluation role: China’s National Health Development Research Center provides technical HTA consultancy to health policy-makers, with a panel of health-economic experts scoring each eligible drug — a government research-institution role rather than a private-vendor service.
• International firms’ China presence: established international HTA consultancies maintain Shanghai offices to serve manufacturers navigating NRDL submissions, but no independently confirmed China-domiciled specialist firm was found — left qualitative pending a real candidate.

04EU#

Europe hosts the field’s most established specialty consultancies, built around the UK’s NICE and Germany’s AMNOG processes, both running on strict statutory deadlines.

NICE 56-day statutory deadline, AMNOG AI-compressed dossier production, B Corp-certified global consultancy model#

• Costello Medical (Cambridge, UK): a B Corp-certified consultancy with offices spanning Europe, Asia-Pacific and North America, having developed over 370 HTA submission dossiers with 135+ submitted to NICE alone, and winner of the King’s Award for Enterprise in International Trade (2025).
• Kintiga (UK, ~90 employees): a pan-European market-access consultancy whose in-house AI tool (EPRI) compressed a full German AMNOG HTA dossier’s production to three months, alongside direct AMNOG negotiation support.
• NICE’s 56-day statutory deadline: manufacturers face a hard 56-calendar-day deadline to submit a full evidence dossier for a NICE Single Technology Appraisal once scoping concludes, the timeline pressure driving demand for specialty dossier-preparation services.

05Leading companies and research institutes#

06Tech stack and innovations#

The category’s technical work spans health-economic methodology and, increasingly, AI tooling that compresses the traditionally document-heavy dossier-writing process.

1. Cost-effectiveness modeling infrastructure (Health-Economic Model Construction):
   • Modelers build cost-effectiveness and budget-impact models specific to each HTA body’s required methodology — NICE’s reference-case requirements differ from G-BA’s AMNOG framework, requiring jurisdiction-specific model construction rather than a single reusable template.
   • Network meta-analysis techniques let a dossier compare a therapy against multiple relevant comparators even when no direct head-to-head trial exists.
2. AI-assisted dossier drafting (Structured-to-Narrative AI Conversion):
   • AI tools convert structured clinical trial data directly into the narrative sections an HTA dossier’s required format demands, compressing a process that traditionally took many months of manual medical writing.
   • This is a live technical differentiator: one firm’s AI-assisted workflow completed a full AMNOG dossier in three months, a significantly compressed timeline versus traditional manual preparation.
3. Statutory-deadline project management (Multi-Jurisdiction Submission Workflow):
   • Firms operating across multiple HTA bodies manage genuinely different statutory deadlines and evidence-format requirements in parallel — a NICE STA’s 56-day window differs from AMNOG’s own compressed timeline — requiring dedicated project infrastructure rather than a single generic consulting workflow.

07Value chains and production pipelines#

Industrial pipeline of a NICE Single Technology Appraisal dossier#

┌───────────────────────────┐      ┌───────────────────────────┐
│ 1. Scoping                 │ ───> │ 2. Evidence synthesis     │
└───────────────────────────┘      └───────────────────────────┘
                                                 │
                                                 ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 4. Dossier assembly       │ <─── │ 3. Economic modeling      │
└───────────────────────────┘      └───────────────────────────┘
              │
              ▼
┌───────────────────────────┐      ┌───────────────────────────┐
│ 5. Submission             │ ───> │ 6. Decision & negotiation │
└───────────────────────────┘      └───────────────────────────┘

Stage 1: Scoping

The consultancy and manufacturer agree the submission’s target population, comparator therapies and outcome measures based on the HTA body’s published scoping document.

Stage 2: Evidence synthesis

A systematic literature review and network meta-analysis assembles the clinical evidence base, including indirect comparisons where no direct head-to-head trial against every relevant comparator exists.

Stage 3: Economic modeling

A cost-effectiveness and budget-impact model is built to the specific methodology the target HTA body requires, calculating cost-per-outcome and national budget impact.

Stage 4: Dossier assembly

Evidence synthesis and modeling outputs are compiled into the complete dossier document, in the exact format and section structure the HTA body mandates — increasingly assisted by AI tools that draft narrative sections from structured data.

Stage 5: Submission

The complete dossier is formally submitted within the HTA body’s statutory deadline — 56 calendar days for a NICE STA following scoping — and the consultancy manages responses to any evidence clarification requests.

Stage 6: Decision and negotiation

The HTA body issues its pricing/reimbursement evaluation, with the consultancy supporting the manufacturer through any negotiation or appeal stage before a final reimbursement decision and price agreement.