Programme
EMAUD 2021/2022 is to be performed online. Each module will be repeated, with the recorded content, to all students of a particular module. That would give students the opportunity to review materials once again or to catch up missed lectures.
- The program consists of 5 mandatory modules plus one optional module on Health Economics
The program has been revised from now and module lectures expanded to 28 hours per module: - Each module will contain one case study and one workshop
- Practical applications for each main topic
- Multiple examples from the public domain and lecturers experience
- An optional module of 3 days on health economics
- The full development of a Market Access Plan including strategy, gap analysis, activity prioritization
EMAUD 2022/2023
Module 1
Module 1 – 28h: Market Access Environment
(24 – 28 October 2022)
Objective
- Set the scene: health environment, health policies, market access regulations across a broad range of countries. Country-specific policies are presented by Public Agency Representatives.
- Impact of COVID-19 pandemic on pharmaceutical industry business
model and focus on market access (NEW)
Activities
- Introduction to market access definition, concept, and principles
- National stakeholders
- Regional stakeholders
- Local stakeholders
- Why has market access emerged? Decision-making chain
- Market access strategies
- Adapting the strategy for each market access stakeholder
- Market access policies in Europe
- Market access policies outside Europe (USA, Canada, Australia, Japan and China)
- Market access perspectives and drug development
- Key activities, outputs and benefits from Phase I to LCM: what should you do and when should you do it?
- Impact
of COVID-19 pandemic on pharmaceutical industry business model and focus on
market access (NEW)
Workshop & Case study
Module 2
Module 2 – 28h: Market Access Activities in Early Preparation Phase I/II
(05 – 09 December 2022)
Objectives
- Market Access landscape, and strategy
- Gap Analysis and activity prioritization
- Market access planning, budgeting and execution
- Support to development decision making
- Drivers and barriers for access
- Incorporate market access issues in clinical development (P&R, HTA and Market Access Plan)
Activities
- Landscape analysis
- Desk Research
- Disease understanding
- Mapping
- Literature Review (PRO, competitors, disease management, policy review, Guidelines, HTA assessment)
- Desk Research
- Pricing
- Payer research
- Price anchoring studies
- Reimbursement evaluation
- Market Access Agreement
- Early HTA advices
- Value story development and Gap Analysis
Workshop & Case study
Module 3
Module 3 – 28h: Market Access Activities in Early Phase III/Pre Launch
(20 – 25 February 2023)
Objectives
- Monitor Environmental Changes
- Advocacy
- Managing uncertainty
- Pricing studies
- Market Access focus on specific products
Activities
- Pricing
- P&R environment
- Price sensitivity
- Payer research
- External reference pricing
- Pricing sequence
- Price strategy
- P&R risk evaluation
- Building an effective advocacy strategy to support market access
- Market access specificities in emerging countries
- Market access of specific products
- Orphan drugs
- Oncology products
- Regenerative
medicine (one full day) New - Mature products
- Value added medicine
- Combined products (fix combination and device drugs combination)
- Biosimilars
Workshop & Case study
Module 4
Module 4 – 28h: Market Access Activities in Launch/Post Launch/LCM
(24 – 28 April 2023)
Objectives
- Achieve P&R, HTA recommendations, and Formulary inclusion at optimal prices/restrictions
Activities
- Final Pricing Strategy
- Launch
- Negotiation guide
- Core Value Dossier
- Adaptation Core Value Dossier to Local Needs
- Strategic advice
- Negotiation Skills and Strategy
- Life Cycle
- Price database; Coordination sequence; Price Erosion
- HEOR/Epidemiology
- Launch
- FDA/EMEA PRO submission dossier
- Publication HEOR evidence (Cost-effectiveness, comparative effectiveness, clinical relevance, Phase III HEOR results)
- Standard HTA dossier
- Local Adaptation (Cost-effectiveness and local HTA Dossier)
- HE studies
- Post-hoc analyses
- Publications
- Life Cycle
- IITs; real life effectiveness
- Scientific Lobbying
- Anticipate re-evaluation and update HTA dossier
- Monitor New entrants/Environment
- Launch
- Interaction Affiliates Region and corporate functions for successful market access
Workshop & Case study14
Module 4bis
Module 4bis – 18h: Health Economics and Outcome Research
(15 – 17 May 2023)
Objectives
- Understand the concept of HEOR and realize basic exercise including:
- Develop specification of a model
- Develop a model
- Develop a utility instrument
- Develop a protocol for micro-costing
- Critical review of a model
- Morning lectures are centered around theory, while the afternoon session is dedicated to practical exercises
Activities
- Health Economics and Outcome research
- Conceptual Model
- Pro Development
- COI Studies
- Ballpark Modelling/Value Based Pricing
- Early cost-effectiveness evaluation
- Different types of models
Module 5
Module 5 – 28h: Market Access for Vaccines, Medical Device and Diagnostics
(12 – 16 June 2023)
Objectives
- Understand the specificities of Market Access for Vaccines, Medical Devices and Diagnostics.
Activities
- Overview of the market and strategy
- Mapping of the access process in Europe and outside Europe
- Definition, regulation, classification, certification
- HTA and NITAG
- Vaccines in emerging countries: a worldwide paradigm
- Specificities for health economics assessment and value demonstration
- Innovation and future challenges
- Value based pricing for diagnostics and devices