Health Technology Assessment (HTA) Support for Global and UK Market Access
In many key markets, gaining approval from national reimbursement or HTA agencies is critical to the commercial success of a new product launch.
With a foundation built on deep UK HTA expertise, particularly with the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC), our experts also work across global assessment systems where similar evidentiary standards apply.
Our interdisciplinary team brings strengths in evidence strategy, evidence synthesis, statistics, health economics, and submission development.
We work collaboratively with clients to anticipate HTA body requirements, prepare rigorous evidence packages, and deliver high quality submissions for pharmaceuticals, medical devices, diagnostics, and digital health technologies.
Why partner with Petauri for HTA?
Deep expertise across UK and Ireland HTA bodies
Our experience spans the major UK HTA systems:
- NICE in England
- SMC in Scotland
- All Wales Medicines Strategy Group (AWMSG) in Wales
- National Centre for Pharmacoeconomics (NCPE) in Ireland
We understand the procedural, evidentiary, and strategic considerations unique to each pathway.
International reach
Beyond the UK, we support submissions across selected international markets where HTA processes operate with similar evidence expectations. This includes national review pathways such as Canada’s Drug Agency (CDA-AMC), Pharmaceutical Benefits Advisory Committee (PBAC) in Australia, and the EU Joint Clinical Assessment (JCA). We also support dossier and model development for Academy of Managed Care Pharmacy (AMCP) and Pre-approval Information Exchange (PIE) decks in the US.
Expertise in complex and challenging HTA submissions
Our team includes experts who have previously worked within NICE external assessment groups and the SMC, providing unique insight into how evidence is reviewed and where common challenges arise. As a result, many clients choose our team to address the most complex or specialist challenges, including:
- Complex treatment pathways
- Use of real-world evidence (RWE) or proxy-disease data to inform evidence generation, including indirect treatment comparisons (ITCs) and models
- Single-arm trials and lack of comparative data
- Immature datasets
- Early HTA submissions due to accelerated regulatory timelines (e.g., Orbis Type A, Innovative Licensing and Access Pathway (ILAP))
- Tight HTA timelines requiring efficient, high quality delivery
Our HTA services
We offer a full service across the HTA lifecycle, from early strategy and evidence planning through to submission development and post submission support.
Our support includes:
Strategic and technical evidence review
Assessment of the existing clinical and economic evidence base to identify strengths, gaps, risks, and feasibility
HTA strategy development
Structured, evidence driven strategies aligned with national templates, procedural expectations, and anticipated challenges
Applications for scientific advice
Support for early engagement with NICE, SMC, NCPE, and relevant international bodies to align evidence generation with future submission needs
Expert elicitation
Structured input from clinicians, payers, and health economists to ensure assumptions and evidence reflect real-world decision contexts
Pre-submission support
Refinement of value arguments, evidence readiness checks, and preparation for procedural requirements, including the scoping and decision problem stages for NICE, and the ultra-orphan form for SMC
HTA standard evidence package generation
High quality evidence including systematic literature reviews, targeted reviews, feasibility assessments, ITCs, network meta-analyses, and statistical analyses
HTA submission development
Full preparation of HTA dossiers tailored to NICE, SMC, AWMSG, NCPE, CDA-AMC, and other assessment bodies
Early access pathway applications
Guidance and evidence development for accelerated or interim access pathways where applicable
Post-submission support
Support for clarification questions, updates to evidence, and iterative revisions
HTA Committee meeting support
Preparation for HTA committee meetings, including message development, issue management, mock meetings, and rehearsal support
Connect with our HTA experts today
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