Critical New HTA Developments in Europe: Challenges & Solutions

With Prof. Dr Lieven Annemans

Course Details

THE CONTENT

European HTA systems are undergoing significant change. While national differences in methodology and decision-making processes and criteria remain, increasing EU-level coordination is reshaping how companies must approach market and patient access strategies.

To succeed, pharma and biotech professionals involved in market and patient access planning need a solid grasp of the HTA landscape and how it is evolving. This course provides a practical introduction to current HTA dynamics in Europe, helping you make sense of both the fundamentals and the latest developments.

Over the course of one day, you will gain a better understanding of the variety in HTA processes and criteria across Europe and how these interact with EU-level developments.

If you are looking for a concise, expert-led overview of the latest HTA trends in Europe, with recommendations for access planning, this course is a must-attend.
 

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024


THE EXPERT

Prof. Dr Lieven Annemans is one of Europe’s most respected voices in health economics and HTA.

  • He has experience in health economic evaluations across 20+ countries and numerous therapeutic areas.

  • He is a long-standing expert advisor in national and EU-level HTA initiatives, with deep insight into methodology, implementation, and policy. 

  • He is an academic professor, past president of ISPOR, author of "Health Economics for Non-Economists", and has published more than 350 peer-reviewed papers. He's also a widely recognised speaker and trainer.

  • A CELforPharma faculty member since 2009, he is consistently praised for his engaging, pragmatic, and entertaining teaching style.
     

To get a flavour of Lieven’s expertise and teaching style, watch this recent educational webinar: 


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for pharma and biotech professionals who need a clear understanding of how HTA principles, policies, and practices affect market and patient access in Europe. It is especially valuable for executives working in:

  • Market Access

  • Pricing & Reimbursement

  • Clinical Development

  • Regulatory Affairs

  • Medical Affairs

  • Governmental Affairs

  • Health Economics

  • Marketing

The interactive format includes expert-led teaching, peer discussions, practical recommendations, and in-depth Q&A. You will learn directly from Prof. Dr Lieven Annemans and benefit from exchanging experiences with peers facing similar access challenges across Europe.
 

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

  1. The different types of HTA processes in Europe and how they inform decision-making.

  2. How HTA bodies combine a variety of evaluation criteria, and what this means for value assessment.

  3. Key principles and common pitfalls in clinical evidence generation from an HTA perspective.

  4. The role of Real-World Data in HTA, including its strengths, limitations, and appropriate use across the lifecycle.

  5. What the Joint Clinical Assessment (JCA) will change, how to anticipate its implications, and how to prepare at a strategic level.

Course agenda

 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

 

Definitions and Taxonomy of HTA: What HTA Is – and Is Not – and How It Functions in Decision-Making Contexts (~1 h)
  • Definitions of HTA and its role in healthcare systems
  • Relationship and differences between HTA, health economic evaluations, and outcomes research
  • Different types of HTA across health technologies and countries
  • Different types of HTA used for health technologies (such as medicines, medtech solutions, and others) and the wide variety across countries
  • Governance, transparency, accountability, and transferability of HTA outcomes
Optimising the Mix of Criteria: Moving Beyond Cost-Effectiveness to Reflect Value, Need, and Societal Priorities (~1 h 30 min)
  • The ten possible criteria in the assessment of new health technologies and their relative weight
  • Challenging the QALY and going beyond the QALY
  • Medical need, disease severity, proportional shortfall, and societal value
  • Evolution of the key criteria and thresholds used by different HTA bodies
  • Practical dos and don’ts for addressing multiple criteria coherently
Generating Clinical Evidence: Designing Evidence That Stands Up to HTA Scrutiny (~45 min)
  • Evidence requirements of HTA bodies and payers: a moving target
  • Efficacy versus effectiveness and the changing nature of clinical trials
  • Comparator choice, PICO framing, and relevance to real-world practice
  • Relative versus absolute effects, adherence, and sustainability of effect
  • Early dialogue and advice as levers to improve HTA success rates
Lunch Break
The Increasing Need for Real-World Data (RWD): Managing Uncertainty and Evidence Gaps Across the Lifecycle (~1 h 15 min)
  • Why RWD is increasingly used in HTA
  • Strengths and limitations of different RWD sources
  • The role of RWD across the lifecycle in economic modelling, effectiveness assessment, and uncertainty reduction
  • Managed entry agreements and outcomes-based reimbursement
  • Practical dos and don’ts for generating and using RWD
Towards a Joint Clinical Assessment (JCA) in the EU: What JCA Will Change — and What It Will Not (~1 h 30 min)
  • Evolution from EU cooperation to JCA and what lies ahead
  • Scope and limitations of JCA (clinical assessment versus national appraisal)
  • Process, timelines, and operational implications
  • Pros and cons from different stakeholders’ perspectives
  • Discussion of early experiences and emerging lessons from initial JCA assessments
  • Early dialogue, preparation strategies, and key pitfalls to anticipate
  • Practical dos and don’ts in the preparation for JCA
Summary & Final Discussion (~15 min)

 

Download Brochure

 

Complete the form below to download the course brochure and discover the full agenda, what you will learn, who you will learn from, and what past participants have to say.

 

UPCOMING DATES & FORMATS - FEES

29 May 2026

Live online

Early bird € 1 570

(until 24/04/2026)

(Full fee € 1 770)

18 November 2026

Live online

Early bird € 1 570

(until 16/10/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

The course and instructor were great. Lieven is clearly an expert in the field, with clear and articulate presentations. The interactions between attendees added to the experience, and I have gained valuable insights into the upcoming EU HTA changes. Highly recommended!

Novartis

Nick Riley, Senior Market Access Manager - Australia - June 2024

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

I got relevant information, it was refreshing also. The comparison of different countries' approaches and the excellent description of crucial parts of HTA were particularly useful. The experience from practice shared during the course enriched my understanding significantly.

Pharm-In

Dominik Grega, MA & HTA Manager - Slovakia - June 2024

People attending this course are typically also interested in the below courses. 

Need help to find the right course? Email Inge Cornelis or call +32 473 65 15 77.

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Course Details

Dates & Locations

29 May 2026

Live online

Register

18 November 2026

Live online

Register

Upcoming Session

29 May 2026, Live online

Early bird € 1 570

(until 24/04/2026)

 (Full fee € 1 770)

Prices are excl. VAT

THE CONTENT

European HTA systems are undergoing significant change. While national differences in methodology and decision-making processes and criteria remain, increasing EU-level coordination is reshaping how companies must approach market and patient access strategies.

To succeed, pharma and biotech professionals involved in market and patient access planning need a solid grasp of the HTA landscape and how it is evolving. This course provides a practical introduction to current HTA dynamics in Europe, helping you make sense of both the fundamentals and the latest developments.

Over the course of one day, you will gain a better understanding of the variety in HTA processes and criteria across Europe and how these interact with EU-level developments.

If you are looking for a concise, expert-led overview of the latest HTA trends in Europe, with recommendations for access planning, this course is a must-attend.
 

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024


THE EXPERT

Prof. Dr Lieven Annemans is one of Europe’s most respected voices in health economics and HTA.

  • He has experience in health economic evaluations across 20+ countries and numerous therapeutic areas.

  • He is a long-standing expert advisor in national and EU-level HTA initiatives, with deep insight into methodology, implementation, and policy. 

  • He is an academic professor, past president of ISPOR, author of "Health Economics for Non-Economists", and has published more than 350 peer-reviewed papers. He's also a widely recognised speaker and trainer.

  • A CELforPharma faculty member since 2009, he is consistently praised for his engaging, pragmatic, and entertaining teaching style.
     

To get a flavour of Lieven’s expertise and teaching style, watch this recent educational webinar: 


THE AUDIENCE & INTERACTIVE LEARNING FORMAT

This course is designed for pharma and biotech professionals who need a clear understanding of how HTA principles, policies, and practices affect market and patient access in Europe. It is especially valuable for executives working in:

  • Market Access

  • Pricing & Reimbursement

  • Clinical Development

  • Regulatory Affairs

  • Medical Affairs

  • Governmental Affairs

  • Health Economics

  • Marketing

The interactive format includes expert-led teaching, peer discussions, practical recommendations, and in-depth Q&A. You will learn directly from Prof. Dr Lieven Annemans and benefit from exchanging experiences with peers facing similar access challenges across Europe.
 

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

  1. The different types of HTA processes in Europe and how they inform decision-making.

  2. How HTA bodies combine a variety of evaluation criteria, and what this means for value assessment.

  3. Key principles and common pitfalls in clinical evidence generation from an HTA perspective.

  4. The role of Real-World Data in HTA, including its strengths, limitations, and appropriate use across the lifecycle.

  5. What the Joint Clinical Assessment (JCA) will change, how to anticipate its implications, and how to prepare at a strategic level.

Course agenda

 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

 

Definitions and Taxonomy of HTA: What HTA Is – and Is Not – and How It Functions in Decision-Making Contexts (~1 h)
  • Definitions of HTA and its role in healthcare systems
  • Relationship and differences between HTA, health economic evaluations, and outcomes research
  • Different types of HTA across health technologies and countries
  • Different types of HTA used for health technologies (such as medicines, medtech solutions, and others) and the wide variety across countries
  • Governance, transparency, accountability, and transferability of HTA outcomes
Optimising the Mix of Criteria: Moving Beyond Cost-Effectiveness to Reflect Value, Need, and Societal Priorities (~1 h 30 min)
  • The ten possible criteria in the assessment of new health technologies and their relative weight
  • Challenging the QALY and going beyond the QALY
  • Medical need, disease severity, proportional shortfall, and societal value
  • Evolution of the key criteria and thresholds used by different HTA bodies
  • Practical dos and don’ts for addressing multiple criteria coherently
Generating Clinical Evidence: Designing Evidence That Stands Up to HTA Scrutiny (~45 min)
  • Evidence requirements of HTA bodies and payers: a moving target
  • Efficacy versus effectiveness and the changing nature of clinical trials
  • Comparator choice, PICO framing, and relevance to real-world practice
  • Relative versus absolute effects, adherence, and sustainability of effect
  • Early dialogue and advice as levers to improve HTA success rates
Lunch Break
The Increasing Need for Real-World Data (RWD): Managing Uncertainty and Evidence Gaps Across the Lifecycle (~1 h 15 min)
  • Why RWD is increasingly used in HTA
  • Strengths and limitations of different RWD sources
  • The role of RWD across the lifecycle in economic modelling, effectiveness assessment, and uncertainty reduction
  • Managed entry agreements and outcomes-based reimbursement
  • Practical dos and don’ts for generating and using RWD
Towards a Joint Clinical Assessment (JCA) in the EU: What JCA Will Change — and What It Will Not (~1 h 30 min)
  • Evolution from EU cooperation to JCA and what lies ahead
  • Scope and limitations of JCA (clinical assessment versus national appraisal)
  • Process, timelines, and operational implications
  • Pros and cons from different stakeholders’ perspectives
  • Discussion of early experiences and emerging lessons from initial JCA assessments
  • Early dialogue, preparation strategies, and key pitfalls to anticipate
  • Practical dos and don’ts in the preparation for JCA
Summary & Final Discussion (~15 min)

 

Download Brochure

 

Complete the form below to download the course brochure and discover the full agenda, what you will learn, who you will learn from, and what past participants have to say.

 

UPCOMING DATES & FORMATS - FEES

29 May 2026

Live online

Early bird € 1 570

(until 24/04/2026)

(Full fee € 1 770)

18 November 2026

Live online

Early bird € 1 570

(until 16/10/2026)

(Full fee € 1 770)

 


TIMING & LOCATION

Live Online: Zoom sessions between 9 AM and 5 PM CET (Brussels, Amsterdam, Paris time).

All practical details will be shared upon registration. For any questions, please contact Margherita Mutto or call +32 472 03 11 38 .

 

GROUP DISCOUNTS

Team discounts can be offered to 2 or more delegates from the same company.

Email Annelies Swaan for more details. 

 

HOW TO REGISTER

  • Click the green “Register” button on your preferred course session.
    The registration wizard will guide you through the process.

  • Alternatively, download the offline registration form and send the completed form to Annelies Swaan.

 

PAYMENT OPTIONS

  • Credit Card: You’ll receive a secure payment link with your invoice (no immediate payment required).

  • Bank Transfer: Details provided with your invoice.

For help with registration, email Annelies Swaan or contact her by phone at +32 486 98 52 49.

 

INCLUDED IN THE REGISTRATION FEE

  • Access to a highly interactive, small-group online course (max 20 participants)

  • Course materials in both digital and hard copy format

  • Certificate of attendance signed by the experts and CELforPharma

 

VAT INFORMATION

Prices exclude VAT. VAT application depends on course format and your location:

  • Face-to-Face in Belgium: 21% Belgian VAT applies

  • Live online courses: The applicable VAT depends on your invoicing address. Contact your local VAT office for refund procedures where applicable.

 

TRANSFER & CANCELLATION POLICY

Flexible Transfer

If a registrant is unable to attend the scheduled course, they can avoid any cancellation charges by providing a suitable replacement participant.

Alternatively, the registrant may transfer once, on a 'space-available' basis and at no extra cost, to another course of the same value held within one year of the original course date, provided this is done at least three weeks prior to the event.

Registration Cancellation

  • Less than 14 days prior to the course date: The registrant is liable to pay the full invoiced registration fee.

  • Between 15 and 30 days prior to the course date: The registrant is liable to pay 50% of the invoiced registration fee.

  • More than 30 days prior to the course date: The registrant is liable to pay a cancellation fee of € 450 per registrant.

If a registrant postpones their participation to a future course and subsequently cancels again, no refund will be issued for the registration fees.
 

An excellent top-line overview of the practical application of health economics. The course covered a lot in a single day but remained digestible thanks to its clear format. I especially valued the discussion on current JCA developments. Peer input also added real value.

Kevin Veninga, Healthcare Communicator - The Netherlands - June 2025

Great overall introduction to the topic, with excellent details on the challenges to be dealt with in the new legislation. The interactive aspect and engaging presentation by Prof. Dr. Lieven Annemans, an obvious expert, were particularly valuable. The course deepened my understanding of HTA and provided a comprehensive overview of the topic.

Merck

Laura Bauer, Senior Manager, Global Policy & External Affairs - Germany - June 2024

The course and instructor were great. Lieven is clearly an expert in the field, with clear and articulate presentations. The interactions between attendees added to the experience, and I have gained valuable insights into the upcoming EU HTA changes. Highly recommended!

Novartis

Nick Riley, Senior Market Access Manager - Australia - June 2024

Great lecturer; the information covered during the training was very comprehensive, addressing both the basics and the latest developments. The overview of different models used in different EU countries was extremely valuable and the participant engagement in discussions was enriching. I highly recommend this course!

Insuvia

Monika Staniulyte, Regulatory Affairs Team Lead - Lithuania - June 2024

I got relevant information, it was refreshing also. The comparison of different countries' approaches and the excellent description of crucial parts of HTA were particularly useful. The experience from practice shared during the course enriched my understanding significantly.

Pharm-In

Dominik Grega, MA & HTA Manager - Slovakia - June 2024

Do you want to upskill your team?

We can organise this training in-company (face-to-face or live online) and customise it to your specific focus and needs.

Fill in the below form and Inge Cornelis will contact you with further information.
 

Dates & Locations

29 May 2026

Live online

Register

18 November 2026

Live online

Register