Market Access & HEOR
Approval Is
Only Half the Battle.
HTA dossiers for NICE, HAS, IQWiG and PBAC. HEOR study design, value dossiers, payer engagement and RWE strategy — embedded into your evidence plan from Phase II, not bolted on at launch.
4 HTAsNICE · HAS · IQWiG · PBAC
Overview
Reimbursement Built In From Phase II
Approval gets you a label. Reimbursement gets you patients. The teams that recognise the difference design their Phase II SAPs with payer requirements already in mind — not as a downstream activity, but as a design constraint.
Vigilare's Evidence-to-Reimbursement™ approach embeds HEOR, value-story development and payer engagement into clinical and regulatory planning from the start. By the time the dossier lands at HTA, the evidence already speaks the payer's language.
- HTA dossiers delivered into NICE, HAS, IQWiG, PBAC and CADTH
- HEOR and economic-modelling expertise embedded from Phase II
- Value dossiers and global value propositions co-authored with medical
- RWE strategy spanning protocol to post-launch evidence generation
Offerings
Every Access Function. Designed In From Day One.
Six integrated market-access capabilities, delivered by named senior strategists — designed to win reimbursement, not just approval.
HTA Dossiers
NICE, HAS, IQWiG (G-BA), PBAC, CADTH, AOTMiT submissions. Country-specific reference cases, comparator selection, evidence requirements.
HEOR Study Design
Cost-effectiveness models, budget-impact analyses, indirect treatment comparisons, network meta-analyses, MAIC and STC studies.
Value Dossiers
Global value dossiers (GVDs), country adaptations, AMCP-formatted US payer dossiers, value-message frameworks aligned to PICOS.
Payer Engagement
Advisory boards, payer interviews, mock HTA committee panels, early scientific advice and pre-submission stakeholder mapping.
RWE Strategy & Generation
RWE design, retrospective database studies, prospective registries, post-launch evidence generation, claims-data analytics.
Early Access Programs
Named-patient supply, compassionate use, ATU (France), expanded access (US), early access scheme (UK), conditional reimbursement.
4HTA Bodies Covered
30+Markets Served
50+HEOR Models Built
10+Years HEOR Mastery
Our Process
From Landscape to Optimised Access
A five-stage market-access framework that turns evidence into reimbursement — and reimbursement into patient reach.
01
Landscape
Stakeholder mapping, comparator analysis, HTA-body requirements, pricing benchmarks.
02
Evidence Plan
Gap analysis vs payer requirements, evidence generation roadmap, HEOR design.
03
Dossier
GVD, country dossiers, economic models, ITC/NMA, AMCP formats.
04
Engage
Mock HTA panels, early scientific advice, payer ad-boards, agency liaison.
05
Optimise
Post-launch RWE, conditional reimbursement reviews, label-extension support.
Why Vigilare
Integrated, Not Bolted On at Launch.
Four reasons biopharma sponsors choose Vigilare for global market access.
Designed In From Phase II
Our MA team sits at the protocol-design table — comparator and endpoint choices reflect payer requirements, not just regulatory ones.
Direct HTA Submission Experience
Dossiers submitted directly into NICE, HAS, G-BA (IQWiG), PBAC and CADTH — including STA, MTA and rapid-access pathways.
In-House Economic Modelling
CEA, BIA, MAIC and NMA built by senior health economists on our team — not outsourced and reformatted at the end.
Connected to Reg + Clinical
Same team as your reg and clinical workstreams — value story, clinical evidence and regulatory positioning stay in lockstep.
FAQs
Market Access, Answered.
01
When should we start market-access planning?
The latest you should start is end-of-Phase-I; the optimal time is during Phase I planning. Comparator selection and endpoint design choices made in Phase II are nearly impossible to fix retrospectively at HTA — and they are the things that most often kill reimbursement.
02
Which HTA agencies have you submitted to directly?
Direct submission experience with NICE (UK), HAS (France), IQWiG / G-BA (Germany), PBAC (Australia) and CADTH / pCODR (Canada), plus AOTMiT (Poland), TLV (Sweden), AIFA (Italy) and SMC (Scotland) for select indications.
03
Do you build economic models in-house?
Yes — CEA, BIA, partitioned survival, Markov, semi-Markov, MAIC and NMA all built by senior health economists on our team, in Excel or R as required by the target HTA body. We retain full IP and model documentation under client ownership.
04
Can you support pre-submission payer interactions?
Yes — we run mock HTA committee panels, payer ad-boards (US managed care, EU national payers, regional sick funds), early scientific advice with NICE / HAS / G-BA, and full pre-submission stakeholder mapping.
05
Do you handle US AMCP-format dossiers?
Yes. AMCP-format dossiers, US payer value tools, IDN-specific budget impact, and post-launch managed-entry agreements all delivered in-house. We also support 340B and Medicaid coverage strategy.
Related Services
Pair MA with the Full Lifecycle
Bundle market access with safety, regulatory, clinical and quality — one team, one quality system.
Ready to design for reimbursement, not just approval?
Speak to a senior market-access lead — not a sales rep. We'll map your payer pathway and propose an evidence plan in one focused call.