Evidaxia
xia access · Market access and HTA

Market access, from value proposition to reimbursement.

HTA submissions, EU joint clinical assessment, pricing and reimbursement, market access strategy and value communication.

Doctor talking with a patient and family member
Medicine packs on a pharmacy counter
Doctor on a phone call at a laptop
The problem

Reimbursement is harder to secure and slower to achieve.

Evidence standards keep rising, the EU JCA adds a layer to every European launch, and international reference pricing and US MFN policy link prices across markets.

Our view

HTA assessor insight, manufacturer-side delivery.

We have worked inside NICE and on company submissions to NICE, SMC, AWMSG, NCPE, CDA-AMC and the EU JCA, including resubmissions and commercial offer preparation.

Questions we answer
  • What will NICE, SMC, AWMSG or NCPE challenge in our submission?
  • How do we prepare for PICO scoping under the JCA?
  • What price can our evidence defend?
  • How do we plan a successful resubmission?
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Health technology assessment

Submissions written by people who have assessed them, with support before, during and after the submission.

  • NICE technology appraisals and HealthTech submissions
  • SMC, AWMSG and NCPE submissions and rapid reviews
  • CDA-AMC (Canada) reimbursement submissions
  • Early value assessment so trials capture the outcomes payers need
  • A clear, consistent value story across the clinical and economic sections
  • Submission project management, timelines and review cycles
  • Model adaptation and training for local affiliates
  • Advisory boards, expert elicitation and mock appraisal committees
  • Clarification responses, technical engagement and post-submission support
  • Resubmission strategy after negative recommendations and NICE appeal support
  • Briefing books for NICE Advice, EMA–HTA parallel consultation and joint scientific consultation
  • HTA benchmarking: what drove past decisions in your therapy area
  • Likelihood-of-success assessments and plans for missing comparator or immature data
  • Patient voice reviews and support for patient organisation input
  • AMCP-format dossiers for US payers
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Value communication

A compelling, evidence-based value proposition, built early and told consistently.

  • Early aspirational payer value stories and evidence gap analysis
  • Evidence generation planning, prioritised with early economic modelling
  • Global value dossiers (GVDs)
  • Payer value stories, value propositions and payer question-and-answer guides
  • Payer-facing materials for clinicians and decision makers
  • Manuscripts on economic, statistical and burden-of-illness analyses and systematic reviews
  • Interactive global value dossiers
  • Value message testing and validation with payers
  • Publication strategy and planning
  • Advisory board materials and interview guides
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EU JCA and regulatory

Ready for the EU HTA Regulation, from PICO to national follow-on.

  • JCA dossier development for medicines and devices
  • PICO scoping and evidence gap analysis
  • Joint scientific consultation preparation
  • JCA readiness assessment across EU member states (see our index)
  • National HTA adaptation after the JCA report
  • Aligning regulatory and HTA evidence strategies
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Pricing, reimbursement and negotiations

Turning evidence into an agreed price.

  • Pricing and reimbursement strategy and launch sequencing
  • US most-favoured-nation (MFN) and international reference pricing analysis
  • Payer engagement support, including preparation for pricing meetings
  • Managed access and commercial arrangement design
  • Time-to-reimbursement and pricing landscape analysis
  • Payer negotiation materials and pricing scenarios
  • Innovative commercial models and deal structures
  • Tender and procurement support for medical technologies
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Market access strategy

Access thinking from early development onwards.

  • Market access strategy and integrated evidence plans
  • Opportunity assessment and indication sequencing
  • Launch feasibility assessments for go/no-go decisions
  • Access to an expert panel of clinicians, payers and former assessors
  • Launch readiness and market support
  • Payer landscaping and stakeholder mapping
  • Adoption and uptake: local health system engagement, business cases and field team tools
  • Multi-market launch and uptake planning
Interactive

From early advice to patient access.

Every stage of the access pathway shapes the next. Select a stage to see where we come in.

Illustrative data and models, for demonstration only.

How an engagement runs

From access strategy to reimbursement and uptake.

  1. 01

    Access strategy

    Value story, evidence plan and launch sequencing, set before key decisions are locked.

  2. 02

    Dossier and model

    Submissions, GVDs and value materials that tell one consistent story.

  3. 03

    Submission and review

    Clarification questions, mock committees and technical engagement.

  4. 04

    Price and uptake

    Pricing scenarios, commercial offers and negotiation support.

Inside the HTA process

Led by a former NICE HTA Technical Lead and Analyst, who knows how committees read a submission.

Across HTA systems

NICE, SMC, AWMSG, NCPE, CDA‑AMC and the EU JCA, plus US pricing work.

Senior-led

The person who scopes your project builds the model and joins the meeting.

In health since 2015

More than a decade across clinical practice, public health, agencies and HTA.

Markets

Country and market guides

HTA requirements compared

Bodies, perspectives, discount rates and value logic, side by side.

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NICE, SMC and AWMSG submissions

Evidence submissions, models and committee preparation for England, Scotland and Wales.

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NICE technology appraisal in England

STA and HST submissions, the 2026 threshold and managed access.

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SMC submissions in Scotland

Full, abbreviated and resubmissions, PACE and ultra-orphan routes.

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AWMSG submissions in Wales

AWTTC assessment, limited assessments and WPAS, under the 2025 process.

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NCPE submissions in Ireland

Rapid review and full HTA submissions, built to HIQA methods.

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EU JCA dossiers

PICO simulation, JCA-standard evidence and dossier writing.

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EU HTA and INAMI-RIZIV in Belgium

The EU HTA Regulation at EU level and INAMI-RIZIV in Belgium.

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AMNOG dossiers for G-BA and IQWiG

Module 1 to 5 dossiers, zVT strategy and the G-BA benefit assessment.

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HAS submissions in France

Transparency Committee, SMR and ASMR, CEESP efficiency opinions.

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Zorginstituut submissions in the Netherlands

GVS, the lock procedure and Dutch economic evaluation.

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Nordic HTA: TLV, DMP, Medicinrådet, Fimea

Sweden, Norway, Denmark and Finland compared, plus JNHB.

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TLV submissions in Sweden

TLV reimbursement, NT council assessments and three-party talks.

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DMP and Nye Metoder in Norway

DMP single technology assessments and absolute shortfall.

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Medicinrådet applications in Denmark

Medicinrådet applications, Danish methods and Amgros pricing.

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ANMDMR HTA and reimbursement in Romania

The ANMDMR scorecard, CNAS contracts and Romanian pricing.

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CDA-AMC submissions in Canada

CDA-AMC reviews, INESSS, pCPA and PMPRB.

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