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/GreeceMember Steering Committee HTAi/PCISG

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

Credibility = TRUSTECPC 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)

Is HTA purely technical?

J.F.P. Bridges, Chr. Jones-Johns Hopkins Bloomberg School of Public Health-3 rd Annual Meeting of HTAi Intl-2006

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

“a bridge between the world of research

& the world of decision-making”

HTA should be

• 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 forEuropean Cancer Patients

Today’s reality

Drivers for patient involvement• Patient empowerment accelerated by widespread

internet access• Basic Right of public involvement in decision

making processes affecting health care (Recommendation

adopted by the Committee of Ministers of the Council of Europe; February 24, 2000)• Patients become vocal about their unmet needs• Need to align pharmaceutical innovation to unmet

patient needs• Importance of “Experiential knowledge” of

patients to inform research

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

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

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

HTAi-PCISGPatients & Citizens Interest Sub-Group

Patient participation or tokenism?

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

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

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

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

The best drug that does not reach the

patient in time & at reasonable price

is of no benefit to patients

Thank for your attention

CHAMPIONING THE INTERESTS OF EUROPEAN CANCER PATIENTS

email : kathi.apostolidis@ecpc.org

@cancereu

European Cancer Patient Coalition

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