Skill Guide

Health Technology Assessment (HTA) methodology and submission processes (NICE, PBAC, CADTH, G-BA)

Health Technology Assessment (HTA) is the systematic evaluation of clinical effectiveness, cost-effectiveness, and broader impact of health technologies to inform government reimbursement and access decisions.

This skill is the gatekeeper for market access and pricing for pharmaceuticals, medical devices, and diagnostics, directly determining a product's commercial viability and patient reach in major markets.

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How to Learn Health Technology Assessment (HTA) methodology and submission processes (NICE, PBAC, CADTH, G-BA)

Focus on foundational terminology (ICER, QALY, incremental cost-effectiveness ratio), the core principles of evidence-based medicine (EBM), and the structure and mandate of one HTA agency (e.g., NICE's Technology Appraisal).

Deep-dive into one agency's specific submission dossier requirements (e.g., PBAC's 12-step process). Practice constructing a simple cost-effectiveness model in Excel using dummy data. Analyze real-world 'Reconsideration' or 'Re-submission' case studies to understand common reasons for failure.

Master the strategic orchestration of parallel global HTA submissions. Develop expertise in managing complex evidence generation strategies (e.g., Bayesian network meta-analyses) and navigating political/clinical stakeholder landscapes to influence committee decisions.

Practice Projects

Beginner

Case Study/Exercise

Deconstructing a NICE Technology Appraisal

Scenario

You are a junior market access analyst. Your manager has assigned you the published final appraisal document for a new oncology drug. Your task is to create a one-page summary for the commercial team.

How to Execute

Download the NICE TA document and the appraisal committee meeting minutes.,Identify the Committee's key points of discussion: clinical evidence gaps, cost-effectiveness (ICER), and the Patient Access Scheme (PAS).,Map the final decision (e.g., Recommended, Not Recommended, Optimised) to the specific evidence or economic arguments that drove it.,Draft a concise internal summary highlighting the 'why' behind the decision and key learnings for future submissions.

Intermediate

Case Study/Exercise

PBAC Pre-Submission Strategy for a 'Me-Too' Drug

Scenario

You are the Australian market access lead for a new diabetes drug entering a crowded class. The PBAC is known for demanding strong evidence of clinical differentiation and cost-effectiveness versus existing reimbursed therapies.

How to Execute

Conduct a systematic literature review to identify the comparative effectiveness data you have versus the likely PBAC comparator(s).,Develop a preliminary economic model structure that can demonstrate value-for-money, even if the price is similar to competitors.,Draft a pre-submission briefing document for PBAC that proactively addresses likely clinical and economic objections.,Outline a strategy for an 'Initial Submission' vs. a 'Major Submission' and the risk/benefit of each path.

Advanced

Project

Navigating a Negative G-BA Benefit Assessment and Price Negotiation

Scenario

Your company's flagship drug has received a 'Not Quantifiable Added Benefit' determination from Germany's G-BA. The next step is AMNOG price negotiations with the GKV-Spitzenverband, but your negotiating position is severely weakened.

How to Execute

Conduct a thorough internal debrief to diagnose the root cause: was the comparator choice wrong? Were clinical endpoints inappropriate for the IQWiG/G-BA framework?,Develop a multi-pronged counter-strategy: prepare alternative evidence submissions for the G-BA (if possible), and model the financial impact of different pricing and rebate scenarios.,Engage key opinion leaders (KOLs) and patient advocacy groups to build a dossier of real-world value arguments for the negotiation table.,Lead the negotiation team, using BATNA (Best Alternative To a Negotiated Agreement) analysis to secure the best possible price-volume or rebate contract.

Tools & Frameworks

Regulatory & Submission Frameworks

NICE Single Technology Appraisal (STA) & Evidence Review Group (ERG) processPBAC 12-Step Submission ProcessCADTH Reimbursement Review (pCODR) dossier requirementsG-BA/IQWiG Benefit Assessment (Dossier Template)

These are the mandatory procedural frameworks. Deep knowledge of each is non-negotiable for creating compliant, strategically sound submissions.

Methodological & Analytical Tools

Cost-Effectiveness Modelling (Decision Tree, Markov, Partitioned Survival)Network Meta-Analysis (NMA) & Indirect Treatment ComparisonBudget Impact Analysis (BIA)Patient-Reported Outcome (PRO) & Health-Related Quality of Life (HRQL) instruments (e.g., EQ-5D)

These are the core analytical engines of an HTA submission. Mastery involves both technical execution (running the models) and strategic presentation (framing the results for decision-makers).

Software & Databases

Excel (Advanced modelling, VBA macros)R/WinBUGS (Statistical analysis for NMA)TreeAge / @RISK (Specialized decision-analytic modelling)NHS Economic Evaluation Database (NHS EED), Cochrane Library

The practical tools for evidence synthesis, model construction, and literature retrieval. Proficiency in Excel modelling is the baseline; specialized software is for advanced applications.