A 1-Day Training Course Delivered by
Louise Heron

Louise Heron

  • Louise Heron is Senior Director and Deputy MD at Adelphi Values, part of the Adelphi Group, a group of specialist companies that uniquely embraces all the disciplines that integrate into Market Access.
  • Louise is a health economist and leads PROVE (Payer-Reimbursement-Outcomes-Value-Evidence) projects to optimise market access for new products and treatments.

Learn

  1. How the different functions within Pharma/Medtech companies need to collaborate for successful HTA submissions.
  2. How to prepare for HTA submissions in a step by step manner, at both global and local level.
  3. The critical success factors when preparing HTA.
  4. Lessons from real-world cases.
  5. How the HTA process and considerations differ for orphan drugs and biosimilars.
  6. What the impact of the move towards EU harmonisation is on the HTA landscape.

Additional Benefits

  • This is a great opportunity to review real world examples of HTA submissions and outcomes, and explore how they have impacted market access.

 

Why You Should Attend

The Content: This programme nicely complements Prof. Dr. Lieven Annemans’ The Health Technology Assessment Course in that it focuses on the practical implications of HTA in Europe’s complex market environment with its many HTA bodies. The expert will share and discuss concrete examples of HTA processes and demonstrate best working practices to ensure that HTA is incorporated effectively into market access strategy and commercial brand plans to maximise chances of success.

The Expert: Louise Heron has broad experience across all elements of Market Access, Health Economics & Outcomes Research and HTA submissions, at both global and local levels. She brings expertise from across the whole spectrum of activities required for HTA submissions, from advising clients on HTA strategy through to the implementation of HTA development plans and conducting HTA negotiation at the local level.

The Practical Guidelines for Health Technology Assessments in Europe course is the only available public training course delivered by Louise Heron on this topic.

Agenda of Practical Guidelines for Health Technology Assessments in Europe

 

10:00

Welcome & Audience Expectations

10:15

HTA Within Pharma’s Organisational Context

 
  • Why it is important and how it fits into the drug development process
  • Global vs. local role: While the Affiliate focusses on the individual country HTA, Global’s strategic role is to ensure sequencing and outcome is beneficial to other markets and access as a whole, with a focus on major HTAs only.
  • How does HTA fit into the market access plan as a whole and how does it align with the bigger picture within Pharma?
  • Parallel activities: Value proposition development - Advocacy plans - Evidence development - Landscape analyses

10:45

Critical Success Factors for Pharma When Preparing HTA

 
  • When does it start?
  • HTA horizon scanning and developing the global value dossier to inform local HTA dossiers
  • How to engage stakeholders: Gaining HTA advice - Ongoing dialogues - Payer research to inform likely opinion – etc.
  • Evidence requirements and gap analysis – How do we know what is needed? - Payer research activities to inform HTA dossiers - etc.
  • Key activities that are needed to facilitate HTA dossier development

11:45

Coffee Break

12:00

HTA Outcomes: What Happens Next?

 

  • Examples of different outcome possibilities in key HTAs, e.g. what does ASMR 3 vs ASMR 4 mean, and what is the implication?
  • Different roles of HTA and the implications in terms of reimbursement, pricing & access
  • Timelines to reimbursement and next steps beyond HTA submissions

13:00

Lunch

13:45

Learning from HTA Decision Case Studies

 
  • Deep dive review of two case study products which have received differential outcomes from HTA bodies across Europe, what reasons were given and what the implications were

15:15

Coffee Break

15:30

HTA in Germany

 

Besides being the biggest market in Europe with a favourable environment towards innovative treatments, Germany is exemplary because the HTA process there is complex, with very strict timings and evidence requirements. Other countries often look to Germany as a first step.

  • IQWIG & GBA: a closer look at the process
  • Step-by-step walk through for preparing the HTA submission from a Global and Local level

16:30

Evolving HTA Landscape: Global Developments

 
  • Procedural differences and challenges with Orphan drugs as compared to Biosimilars
  • Emerging HTAs & move toward EU harmonisation

17:30

Wrap-up & Close

>> Click here if you wish to receive the PDF brochure of this course

Learning Methodology

This faculty is very experienced in leading interactive sessions and will actively engage participants in discussions alongside the presentations. The course includes group work and case study examples to illustrate the concepts.

One of the most valuable aspects of attending any C.E.L.forpharma course is not only being able to have your specific questions answered by leading experts, but also having the opportunity to share experiences and have in-depth discussions with your international peers.

infoThe typical audience size of our courses ranges from 6 to 24 (max) participants.

Who Should Attend?

This course is a must-attend for executives in pharma, diagnostics and medical device companies who are directly involved in preparing for HTA submissions, i.e. for the provision of and planning for clinical, economic and other required data, at both global and regional/local levels.

This course will also benefit executives responsible for developing overall HEOR plans and market access strategies because they need to understand the process and the practical challenges for HTA, and how this needs to be accounted for in the product development plans.

The audience of this course will thus typically include executives in the following functions: Market Access, Pricing & Reimbursement, Health Economics and Medical.

As this course is delivered by Louise Heron of Adelphi Values, a leading pharma consultancy company, executives from other professional service agencies should request approval prior to registering for this course. Please contact Inge Cornelis, Director Commercial Communications, for more information (inge.cornelis@celforpharma.com, tel +32 (0)2 709 01 43).

 

Past Participants

As this is the first session of the Practical Guidelines for Health Technology Assessments in Europe course, there is no past participants list available.

 

Testimonials

As this is the first session of the Practical Guidelines for Health Technology Assessments in Europe course, there are no testimonials available.

Dates & Locations

All C.E.L.forpharma courses are held in top-class four or five star hotels situated in easily accessible locations, either close to an international airport or near public transportation links in city centre locations.

 

  • 27 November 2019, Brussels

infoBack-to-back with The Health Technology Assessment Course on 26 November 2019, Brussels

This course takes place at the Courtyard Marriott Brussels Hotel which is located 15 minutes from Brussels National Airport by complimentary hotel shuttle or taxi and 30 minutes by taxi from Brussels South train station (Thalys, TGV, Eurostar). 

courtyard_photo_website.jpg

Address: Avenue des Olympiades 6, 1140 Brussels, Belgium
Tel: +32 2 337 08 08
 

Hotel Booking Assistance

Having built a strong relationship with each hotel, C.E.L.forpharma has secured preferential room rates for our delegates who book their accommodation three weeks or more prior to the course. Upon your registration, we will help you make your hotel booking. For any assistance in this matter please do not hesitate to contact Sarah Nissen, Senior Programme Coordinator (sarah.nissen@celforpharma.com, tel +32 (0)2 709 01 46).

Included in the Registration Fee​

  • Course Material (Digital & Print Versions)
  • Coffee, Tea & Refreshments During the Course
  • Lunch During the Course
  • Certificate of Attendance Signed by the Experts

 

Group Discounts

Team discounts can be offered to 3 or more delegates from the same company.
Contact Inge Cornelis, Director Commercial Communications, (inge.cornelis@celforpharma.com) for more details.

 

How to Register

  1. Click the "Register Here" button on this page.
  2. Choose a course date, then fill out your personal details and company / invoicing details.
  3. Choose to pay via bank transfer / invoice or by credit card.
  4. Click "Confirm Registration". You will be sent an automatic email confirming your registration followed by a personal email containing an invoice and further payment instructions.

For assistance in registering, raising a PO or invoicing, please do not hesitate to contact Kealeigh Steel.
(email: kealeigh.steel@celforpharma.com or call: +32 2 709 01 45)

 

Transfer & Cancellation Policy

Flexible Transfer

  • If a registrant cannot attend the scheduled course, he/she can avoid any cancellation charge by sending a suitable replacement participant.
  • Alternatively, the registrant can transfer once on a “space available” basis at no extra cost, until 3 weeks prior to the event, to another course held within one year of the original course date.

Participant Cancellation

  • Up to 6 weeks prior to the course: cancellation fee of € 400 per participant.
  • Up to 5 weeks prior to the course: 25% of the invoiced registration fee.
  • Up to 4 weeks prior to the course: 50% of the invoiced registration fee.
  • Up to 3 weeks prior to the course: 75% of the invoiced registration fee.
  • Fewer than 3 weeks or if no notification received: registrant liable to pay invoiced registration fee.
  • If a registrant postpones his/her participation to a future course, and cancels again, no refund can be claimed for registration fees.

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