Compare how HTA bodies assess clinical effectiveness, safety and cost-effectiveness across technologies.
Healthcare & Pharmaceutical Management
Health Technology Assessment for Medical Device and Drug Adoption
Prepares health technology assessment and market access professionals to build the clinical, economic and organisational case for adopting new drugs and medical devices.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
New drugs and medical devices reach payers and health systems with evidence packages that rarely match the reference case a health technology assessment body expects, leaving strong technologies stalled in appraisal while weaker submissions pass through on more disciplined evidence design. This course covers how national and regional HTA bodies assess clinical effectiveness, safety and cost-effectiveness, and how the evidence standards for medical devices differ from those built around randomised drug trials. It works through building decision-analytic models, deriving quality-adjusted life year estimates and calculating incremental cost-effectiveness ratios, then modelling budget impact and affordability across a multi-year horizon. Later modules cover preparing a full HTA submission, negotiating managed entry agreements and coverage-with-evidence-development arrangements, and moving from a national HTA decision to local formulary adoption. Teaching uses model templates, submission structures and appraisal committee scenarios drawn across drug and device evaluation. Participants leave able to plan evidence generation and build a submission that withstands committee scrutiny.
Expected Learning Outcomes
Build a decision-analytic model that derives quality-adjusted life year and cost-effectiveness estimates.
Test economic model assumptions through deterministic and probabilistic sensitivity analysis.
Model budget impact and affordability across the eligible population and adoption horizon.
Assemble a complete HTA submission covering clinical, economic and organisational evidence.
Design managed entry agreements and coverage-with-evidence-development arrangements.
Adapt national HTA guidance to local formulary and medical device adoption decisions.
Who Should Attend
Market access and health economics specialists preparing HTA submissions.
Medical device manufacturers planning clinical and economic evidence generation.
Pharmaceutical value and access teams negotiating reimbursement and pricing.
Hospital formulary and technology committee members assessing adoption requests.
Health economists building cost-effectiveness and budget impact models.
Payer and health system staff reviewing technology adoption submissions.
Course Modules
Select any module to see its sessions and points.
01HTA Frameworks and the Evidence Base
2 sessions · 8 points
Session 1Comparing Health Technology Assessment Systems
- Compare the core domains that HTA bodies assess, including clinical effectiveness and cost-effectiveness.
- Map how national and regional HTA processes reach adoption or reimbursement decisions.
- Identify the evidence standards that differ between drug and medical device assessment.
- Align an evidence-generation plan to the reference case a target HTA body expects.
Session 2Building and Appraising the Clinical Evidence Base
- Appraise systematic reviews and randomised trial evidence for quality and relevance to the decision.
- Assess real-world evidence and registry data where trial evidence for a device is limited.
- Address learning-curve and evolving-technology issues specific to surgical and device evaluation.
- Identify evidence gaps early enough to commission additional studies before submission.
02Economic Evaluation and Modelling
2 sessions · 8 points
Session 1Cost-Effectiveness and Cost-Utility Analysis
- Build a decision-analytic model, such as a Markov model or decision tree, for the technology.
- Derive quality-adjusted life year estimates and calculate the incremental cost-effectiveness ratio.
- Test model assumptions through deterministic and probabilistic sensitivity analysis.
- Present cost-effectiveness results against the relevant willingness-to-pay threshold.
Session 2Budget Impact and Affordability Analysis
- Model budget impact across the eligible population over a multi-year adoption horizon.
- Forecast displacement effects on existing technologies, staffing and pathway costs.
- Test affordability scenarios against health system or payer budget constraints.
- Present budget impact alongside clinical and cost-effectiveness evidence in the submission.
03Submission, Negotiation and Adoption Decisions
2 sessions · 8 points
Session 1Preparing the HTA Submission
- Assemble the clinical, economic and organisational sections of a formal HTA submission.
- Respond to clarification questions and committee critiques during the appraisal process.
- Engage patient groups and clinical experts to strengthen the submission's evidence base.
- Use early scientific advice or parallel HTA-regulatory dialogue to de-risk the submission.
Session 2Managed Entry Agreements and Coverage Decisions
- Design managed entry agreements, including outcome-based and financial risk-sharing schemes.
- Structure coverage-with-evidence-development arrangements where clinical uncertainty remains high.
- Negotiate conditional adoption terms with payers or national procurement bodies.
- Plan the data collection needed to convert conditional adoption into permanent coverage.
04Local Adoption and Lifecycle Review
2 sessions · 8 points
Session 1Moving from National HTA to Local Adoption
- Present national HTA guidance to local formulary or medical device evaluation committees.
- Adapt national cost-effectiveness findings to local casemix, pricing and pathway assumptions.
- Plan the clinical training and pathway redesign needed to adopt the technology safely.
- Track early adoption metrics against the assumptions made in the original HTA submission.
Session 2Post-Adoption Review and Disinvestment
- Monitor real-world clinical and cost outcomes against the HTA's predicted performance.
- Trigger re-assessment when new comparator technologies or evidence become available.
- Apply disinvestment criteria to technologies that no longer represent good value.
- Feed post-adoption findings back into future evidence-generation and submission strategy.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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