hta

1. Summer school 2018
MAJOR CHANGES AHEAD IN HTA – HOWTO
ENGAGE WITH EUNETHTA
HTA FOR PATIENTS- PATIENTS IN HTA
François Houÿez
128/06/2018

2. 2
THE 3 STEPS
Regulatory b/r
Can the product
work?
In the context of a
clinical trial
REA
Does the product
work and improve
care?
In clinical practice
Reimbursement
decision & pricing
Is society willing to
pay?
Based on REA and
economic aspects
228/06/2018

3. 3
HTA domains
Clinical domains Economic domains
Description of the technology
Intended use
Budget impact
Efficacy Cost benefit analysis
Safety Cost utility analysis
Relative effectiveness Modelling
Patient and social aspects
Other domains
Ethical aspects
Organisational aspects
Legal aspects

4. 4
You can engage in:
HTA early dialogues
 to minimise the risks that inadequate information are submitted at a later stage
Scoping
 which domains/topics/questions should be answered?
Assessment
 Providing the answers: how does the technology compare with available treatments?
(Appraisal)
 Making the decision to cover/reimburse

5. 5
Our principles

6. 6
PICO
Population
Intervention
Comparator
Outcome
EUnetHTA
81 HTA bodies
2016-2020
80 assessments
18 million €
Joint action

7. 7

8. 8

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10. 10

11. JOINT ASSESSMENTS

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13. 13

14. 14

15. 15

16. 16
EU joint assessment, national assessment

17. 17
As of today, different agencies assess a same product
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Data requirements in 8 countries + EUnetHTA for a diabetes product

18. 18

19. 19
Efficacy, safety, quality
-140
-210
Submission of the marketing
authorisation application (public
domain)
HTA bodies notified
1st rapporteurs’ report
+/- patients consulted at national
level (rapporteurs’ NCA)
Scoping: patients consulted by
REA authors (national level?)
+/- ScientificAdvisory Meeting at
EMA
+/- patients @ CHMP oral
explanation
+/- patient preferences
elicitations (IMI PROTECT)
2nd rapporteurs’ report
Patients’ views on REA aspects
Patients’ views on b/r
Patients review documents for
the public: package leaflet, EPAR
summary, Q&A…
Patients review REA report for
the public
Patients involved
PRIME, horizon scanning…
patients
28/06/2018

20. 20
Some remarks
COMP significant benefit = qualitative judgement yes/no
HTA relative effectiveness = quantitative assessment that can be translated into economic
terms
E.g. product A 8 large pills three times a day, new product B 1 pill a day
 Major improvement to patients’ care
Adherence to A: 30%, adherence to new product: 90%
Scenario 1: with A, 40% cured, with B 45% cured
Scenario 2: with A 40% cured, with B 66% cured

21. 21
Thank you!
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