Is HTA purely technical? drivers for patient involvement in HTA patient participation or tokenism medicines do not reach patients due to delays in HTA evaluation need for harmonized HTA

1. Is there patient involvement in HTA?
Can patients influence HTA decision making?
ISPOR2015 - “European Regulation & Health Technology Assessments in Immunotherapy”
Kathi Apostolidis
Vice President ECPC-European Cancer Patient Coalition
Chair DE.DI.DI.KA. –Intergroup Cancer Patient Righs Advocacy Committee/Greece
Member Steering Committee HTAi/PCISG

2. ECPC: Nothing about us, without us
• Representing 370 cancer patient groups in 44 countries
• All cancers – common and rare
• Reducing disparity and inequity across the EU
• Promoting timely access to appropriate prevention, screening,
early diagnosis, treatment, care & follow-up for all cancer patients
• Encouraging the advance of cancer research & innovation
• Increasing cancer patients' influence over European health and
research policy
• Run and governed by patients

3. Credibility = TRUST
ECPC as a partner of EU institutions
• European Commission
• Joint Action on Cancer Control – CanCon
• European Commission’s Expert Group on Cancer Control
• European Commission Initiative on Breast Cancer-Quality
Assurance Scheme Development Group (ECIBC/QASDG)
• European Medicines Agency
• Patients’ and Consumers’ Working Party
• Health Technology Assessment International
• Patients and Citizens Involvement Group (HTAi/PCIG)

4. Is HTA purely technical?
J.F.P. Bridges, Chr. Jones-Johns Hopkins Bloomberg School of Public Health-3rd Annual Meeting of HTAi Intl-2006

5. Several other disciplines besides EBM
must be involved:
• Outcomes research
• Medical decision making
• Medical ethics
• Medical Sociology
• Pharmacoeconomics
all together form today’s HTA
HTA cannot be solely
a technical evaluation

6. “a bridge
between the world of research
& the world of decision-making”
HTA should be

7. • HTA processes in Europe are fragmented
• Approximately half of EU Member States have
an HTA agency
• Other MS rely on non-harmonised solutions
• Patients are not involved in HTA or similar
procedures
This is a BIG PROBLEM for
European Cancer Patients
Today’s reality

8. Drivers for patient involvement
• Patient empowermentaccelerated by widespread internet access
• Basic Right of public involvement in decision making processes
affecting health care (Recommendation adopted bytheCommitteeofMinisters oftheCouncilof
Europe;February24,2000)
• Patients become vocal about their unmet needs
• Need to align pharmaceuticalinnovation to unmet patient needs
• Importance of “Experiential knowledge” of patients to inform
research

9. Patients: ready to be full
partners of HTA procedures
E-patients= empowered, equipped,
enabled, engaged patients of today
request HTA agencies to
• Focus on the patients’ problems
• Take the patients’ perspective
• Accomodate the patients’ preferences
• Give them a seat at the decision making
table

10. HTAs can respond to the challenge
• Allow & invite patients’ participation
• Preserve & build upon patient-doctor
relationships
• Empower patients to improve their
health
• Patients participation in HTA agencies
should be encouraged & institutionalized

11. Patients:
An integral part of the solution
• Is it enough to give a seat at the decision making
table to “professionalized” patients?
• Limited adoption of this hesitant approach by HTA
agencies
• The patient: most important stakeholder in
decision making for HTA
• Doctors: key in medical decision making-trusted
by patients

12. HTAi-PCISG
Patients & Citizens Interest Sub-Group

14. Patient participation or tokenism?

15. Types of involvement
• Surveys and citizens juries (NHS)
• Institutionalized involvement (NICE, EMA, FDA)
• Toolkits (G-I-N, INVOLVE, The Participatory Methods and
Value+ Toolkit)
• Dialogue model and priority setting partnerships
• Checklists and criteria
But
• Patients’ facilitation & education
• Evaluation of types of involvement
• Measuring impact of patient involvement in
decision making
ARE MISSING

16. We live a Paradox!
• EMA evaluates all cancer drugs in Europe
• Availability of innovative & effective drugs
but not to all patients across EU
• Unacceptable delays in the reimbursement
of new lifesaving drugs across Europe
due to delays in HTA evaluation
• Lack of harmonisation in the evalution of
same products

18. ECPC leverages on European institutions
for a solution to these delays
• World Cancer Day 2015 declaration: 160 MEPs supported ECPC
to fight inequalities in cancer care
• Debate in Plenary, European Parliament September 2015: MEPs
ask the Commissioner for more sustainable healthcare systems &
denounced problem of access to innovative treatments
• Written declaration 30/2015: ECPC & 19 MEPs ask the European
Parliament to take a position on sustainability of healthcare,
requesting the Commission to do more to harmonise HTA process
at EU level
• Amendments to the EMA regulation 726/2004: ECPC supported
the amendments to the regulation to pave the way for the EMA
to centralise the HTA assessment at the EU level and increase
harmonisation

19. Europe of Disparities in Cancer
• Strengthen role of EUnetHTA
• We need to further harmonise HTAs in Europe to
reach EU-wide HTA reference evaluation
– Non-binding evaluation, at European level, linked to the EMA
– Pricing and reimbursement decisions shall remain national
– Avoid duplication and delays in evaluation
• Institutionalise patients’role in HTA bodies
• Enhanced importance to survivorship in HTA
evaluation
– Today we have 8.5 million survivors
– Many can be considered “cured”
– HTA MUST take into consideration economic value of survivors

20. The best drug
that does not reach the patient
in time & at reasonable price
is of no benefit to patients

21. Thank for your attention
CHAMPIONING THE INTERESTS OF EUROPEAN CANCER PATIENTS
email : kathi.apostolidis@ecpc.org
@cancereu
European Cancer Patient Coalition
ECPCtv