KEEP CALM AND CARRY ON: INAHTA MEMBERS’ VIEWS ON PLANNING FOR POTENTIALLY DISRUPTIVE HTAi Annual Meeting 18 June 2019 in Cologne, Germany

www.inahta.org ABOUT INAHTA International Network of Agencies for HTA

 Founded in 1993. Now a global network of 51 agencies (2019).  Member agencies support health system decision making that affects over 1 billion people in 32 countries.

Agencies by region: • 31Europe • 5 Latin America • 5 Canada & USA • 5 Asia • 3 Australia & New Zealand • 2 Africa

Agencies by country economic status: • 41 in high income countries • 1 in upper-middle income countries • 2 in lower-middle income countries

www.inahta.org INAHTA MEMBERS

 All INAHTA members are publicly-funded HTA agencies that:

. Assess in health care . Are non-profit organizations . Relate to a regional or national government . Are funded at least 50% by public sources . Provide access to publicly- available reports to other members upon request

www.inahta.org INAHTA BOARD OF DIRECTORS 2018/19

Dr. Sophie Söderholm Werkö Prof. Tracy Merlin SBU, Sweden AHTA, Australia Chair Vice Chair

Dr. Matthias Perleth Dr. Mouna Jameleddine G-BA, Germany INASanté, Tunisia Treasurer Director

Dr. Young Sung Lee Mrs. Debjani (Jani) Mueller NECA, Korea CMeRC, South Africa Director Director Ex officio members Dr. Brian O'Rourke Dr. Yingyao Chen Dr. Michelle Mujoomdar CADTH, Canada, Past Chair HTAi Board Observer CADTH, Canada Dr. Christopher McCabe IHE, Canada Director Head of Secretariat

www.inahta.org INAHTA’S MISSION INAHTA connects and empowers national and regional HTA agencies to create better health policy around the globe.

INAHTA´s mission is to: . Bring agency leadership and expertise to the global HTA community to advance the science and practice of HTA. . Demonstrate the value of HTA agencies as key components of modern health systems to support robust decision-making based on the best available scientific evidence. . Support best practice and for building and maintaining thriving HTA agencies. . Enable continuous exchange of knowledge and learning among member agencies.

www.inahta.org GLOBAL COLLABORATION  Memoranda of understanding with: • WHO • HTAi • EUnetHTA • HTAsiaLink • RedETSA • G-I-N • EuroScan

www.inahta.org CONTACT INAHTA

www.inahta.org Secretariat Executive Manager: Tara Schuller Tel (Canada): +1 780 401 1770 Email: [email protected]

www.inahta.org PANEL SESSION OVERVIEW

1. Summary of INAHTA World Café on disruptive technologies Dr. Michelle Mujoomdar, CADTH, Canada 2. HTA agency experiences evaluating disruptive technologies KEEP CALM AND CARRY ON: INAHTA Susanna Axelson, SBU, Sweden MEMBERS’ VIEWS ON 3. Challenges with genetic diagnosis and PLANNING FOR screening POTENTIALLY Dr. Li Ying (Grace) Huang, CDE, Taiwan, DISRUPTIVE Republic of China TECHNOLOGIES 4. Challenges of anticipating & evaluating HTAi Annual Meeting disruptive technologies 18 June 2019 in Cologne, Dr. Rossella Di Bidino, UVT-Gemelli, Italy Germany 5. Looking back at disruptive technologies – what made them disruptive? Dr. Claudia Wild, LBI-HTA, Austria 6. Q&A, discussion Moderator: Ken Bond, IHE, Canada

www.inahta.org THANK YOU !

www.inahta.org Secretariat Executive Manager: Tara Schuller Tel (Canada): +1 780 401 1770 Email: [email protected]

www.inahta.org World Café on Disruptive Technologies: Reflections from the 2018 INAHTA Congress

Michelle Mujoomdar, PhD HTAi 2019 18 June 2019 Disclosure

• Funded by federal, provincial, and territorial ministries of health. • Application fees for three programs: • CADTH Common Drug Review (CDR) • CADTH pan-Canadian Oncology Drug Review (pCODR) • CADTH Scientific Advice

1 Disclosure - individual • Engaged as an individual external expert: • EC (June 2017 – Aug 2017; May 2018 – Aug 2018) • ZIN (April 2018 – May 2018) • Advisory roles for several IMI projects • PREFER (travel expenses paid by University of Uppsala) • PARADIGM (travel expenses paid by HTAi and European Patients’ Forum) • EHDEN (coordinated through Erasmus University) • Other travel expenses paid by CIRS (Sept 2018) and CIHR grants on which CADTH is a knowledge user (March 2019 and May 2019)

2 World Café Methodology

• Related to the concept of “group intelligence” • A topic of mutual interest is discussed in small groups • At least 3 x 20-minute rounds, each round with a different question or focus • At the end of each round, participants move to next table • Building knowledge – we are “Wiser Together”

3 Groups / Areas of Focus per round

• Pharmaceuticals • Devices / medtech • Public Health / screening / other

4 Objectives

1. Develop an common understanding of what a “disruptive health technology” is and how it is different from incremental technology. 2. Compile examples of disruptive medicines, devices/procedures, and screening/prevention technologies. 3. Develop recommendations for how HTA agencies should deal with disruptive technologies in the three areas. 4. Determine if there are any special considerations to be given to disruptive technologies (i.e., sources of evidence) and raise any other issues or ways of thinking about these disruptive technologies.

5 Findings

• ATMPs / cell and gene therapy • ‘curative’ therapies • • 3D-printing • Next generation sequencing • Cannabis • Mobile apps – self-monitoring • Self-testing • Tissue engineering, bionic limbs

6 Findings

• Change • Change in the way that patients are treated, change in system, workforce • Doesn’t “fit” into current way of working • Potentially results in disinvestment • HTA agencies need to shift from reactive to proactive • Life-cycle approach • Additional data collection, reassessment • Social, ethical, legal, environmental, and privacy considerations

7 Plan Forward

• Prioritised the topic of disruptive technologies for a Position Statement by INAHTA • INAHTA Task Group formed • Criteria on how HTA agencies can define a disruptive technology and manage it from an assessment point of view • Draft statement available for consultation with INAHTA members by end of 2019

8 9 SWEDISH AGENCY FOR HEALTH TECHNOLOGY ASSESSMENT AND ASSESSMENT OF SOCIAL SERVICES

Disruptive technologies panel session Cologne June 2019 Susanna Axelsson, SBU A disruptive technology in healthcare impacts:

• Patient outcomes • Care pathway • Healthcare delivery system • Payment mechanisms Example

• Testing for human papilloma virus (HPV) can replace cytology as screening test for cervical cancer – analysis – Easy to standardize – Expected lower costs Report from SBU, guidelines from NBHW

• Health care delivery system and Care pathway • Longer ”protection”, 6 compared to 4 years for cytology

• Patient outcomes • Better sensitivity

• Payment outcomes • Lower costs (NBHW) HTA and disruptive technologies • Stakeholders along the technology lifecycle work together • Patient involvement • Dynamic assessment procedures • Early Reassessment • Need for real world evidence to show progress and maintain access – The National Quality Register for Prevention of Cervical Cancer • Monitoring and follow-up of the process and effect Evidence generation

• HTA community should advocate the need for proper clinical evidence to allow access • Evidence can be accelerated and timely generated • Evidence generation plan, e.g. parallel consultation (scientific advice) involving various decision-makers to ensure evidence generation meets different needs • Preparedness of patient registries to collect relevant information in a robust manner (post-licensing evidence) Key elements

• Need for proper clinical evidence, robust data (RCT) to allow access • Joint assessments supposed to accelerate access • A dynamic assessment procedure • Real world evidence required to confirm the initial assessment SWEDISH AGENCY FOR HEALTH TECHNOLOGY ASSESSMENT AND ASSESSMENT OF SOCIAL SERVICES Keep Calm and Carry On: INAHTA Members’ Views on Planning for Potentially Disruptive Technologies- Diagnostic and Screening

HTA Disruptive technologies session Panel Grace Li-Ying Huang, PhD Director, Division of Health Technology Assessment Center For Drug Evaluation, Taiwan View our website: http://nihta.cde.org.tw/ June 18, 2019 Disclaimer

• This presentation was not officially cleared, and the views offered here do not necessarily represent the official positions at MOHW, including NHIA. Outline

• Development of HTA in Taiwan

• Genomic analysis into routine care?

• Potentially Disruptive Technologies in HTA Development of HTA in Taiwan

• Since 2007, Taiwan began conducting health technology assessments (HTA) to support National Health Insurance Administration (NHIA)’s reimbursement decisions for drugs. • HTA’s extension to: – medical devices in 2011 – medical services in 2014 – social care in 2016 • The Division of HTA operates under the Center of Drug Evaluation (CDE), Taiwan.

Int J Technol Assess Health Care. 2019 Feb 28:1-5. doi: 10.1017/S0266462319000011. [Epub ahead of print] About the Disruptive Technologies idea in HTA – Focus on Diagnostic and Screening

5 Genomic analysis into routine care?

• In UK, Health and Social Care announces ambition to sequence 5 million genomes within five years. • Genomics England working with the NHS to introduce genomic analysis into routine care, with rare disease and cancer patients receiving diagnoses that lay the foundation for more effective treatments.

• In sequencing up to 5 million genomes in the next five years, understanding of the link between genetic information and the risk of disease will grow, bringing new discoveries, new awareness and wider benefits to patients, and deliver the most efficient, effective and equitable healthcare system in the world.

https://www.genomicsengland.co.uk/matt-hancock-announces-5-million-genomes-within-five-years/ 6 Brainstorming

1. Genetic Diagnosis of Human Disease: – Basis of Precision Medicine – Personal Genomic Sequence book? 2. Public Fund? 3. What Data must be collected? 4. - potentially important developments

7 Role of Horizon Scanning in HTA

• Technique for detecting early signs of potentially important developments through a systematic examination of potential threats

• Identify, filter and prioritise new and emerging health technologies; to assess or predict their impact on health, costs, society and the healthcare system; and to inform decision makers and planners.

• Informs and primes providers and commissioners to proactively implement management strategies EuroScan International Network, 2018 https://www.euroscan-network.global/index.php/en OECD, Overview of Methodologies,2018 https://www.oecd.org/site/schoolingfortomorrowknowledgebase/futuresthinking/overviewofmethodologies.htm Hearing loss- screening tests

• The most common sensory disorder in humans • One in 500 newborns has hearing loss and that number increases to 1 in 100 children by school age. • Clinical diagnosis often does not distinguish among different types of hearing loss. • Universal newborn screening tests assess for rare but serious conditions in babies just after birth.

Reference: http://seqaboo.bwh.harvard.edu/ 9 Cochlear implant Project (2015)

• Per the opinions of the patient groups and HTA evaluation, Cochlear implant are safe, efficient, and cost-effective for adults and children with severe-to- profound deafness. • Additionally, Cochlear implant facilitate the education of hearing-impaired children in mainstream schools and the reintegration of adult patients into society, thereby reducing societal burden.

Int J Technol Assess Health Care. 2019 Feb 28:1-5. doi: 10.1017/S0266462319000011. [Epub ahead of 10print] Impact on policy

• In 2017, Cochlear implant, along with speech processors, were incorporated into the NHI reimbursement scheme in the category of medical devices with innovative function. • However, the coverage was only for unilateral implants and limited to once in a lifetime, with priority given to patients aged <18 years

Int J Technol Assess Health Care. 2019 Feb 28:1-5. doi: 10.1017/S0266462319000011. [Epub ahead of 11print] Economic Evaluations of Childhood Hearing Loss Screening Programmes: A Systematic Review and Critique Objectives • To update and expand previous systematic reviews of economic evaluations of childhood hearing screening strategies, and explore the methodological differences.

Conclusions and Implications • Most economic evaluations concluded that childhood hearing screening is value for money. However, there were significant methodological limitations with the evaluations.

Appl Health Econ Health Policy. 2019 Jun;17(3):331-357. doi: 10.1007/s40258-018-00456-1. 12 Potentially Disruptive Technologies in HTA • Genetic approach to identify new molecules involved in hearing loss by screening – Are we ready to face this impact? – How could we better use our limited resources? – Could we foresee and be prepared? Conclusion • HTA has become an important priority-setting process and is inherently an evidence-based process that adopts the principles of procedural justice and is used to inform policy and access decision. • Both scientific evidence and evidence on social values are relevant, and their joint consideration in health technology decision-making is both necessary and challenging.

Health policy 2007; 82(1):37-50. 14 J. Health Organ. Manage. 2016; 30 (5): 736-750. Thank you for your attention! The challenges of evaluating disruptive technologies Dr. Rossella Di Bidino

lug. ’19 Agenda

• Disruptive technologies in healthcare • What: confusion or definitions • When: how to be proactive? • How: assessment of disruptiveness • Conclusions

lug. ’19 2 Disruptive technologies in healthcare

February 1995 February 2011 February 2016

lug. ’19 3 What: confusion or definitions

The Expert Panel understands describes a “disruptive innovation” in health care process by which a product or service as a type of innovation that creates initially takes root in simple new networks and new organisational Which criteria should applications at the bottom of a cultures involving new players, and market—typically by being less satisfied a health that has the potential to improve expensive and more accessible—and health outcomes and the value of technology to be then relentlessly moves upmarket, health care. This innovation displaces eventually displacing established considered disruptive? older systems and ways of doing competitors things. What: evolution in time

Patient- centred care When: how to be proactive?

The need to respond to a need

It’s time to forget Perception of disruptiveness about disruptive technology

Studying disruptiveness

Disruptive technology for all Disruptiveness is real

On the market When: how to be proactive?

A real case A real challenge

lug. ’19 7 https://www.atmpforum.com/index.php/it/ When: how to be proactive? Real HTA experiences

lug. ’19 8 https://www.atmpforum.com/index.php/it/ How: assessment of disruptiveness

Specificity

Generalizability Using The Disruptive Innovation Framework When Assessing

• Does it change the position of diagnosis or treatment of disease on the continuum from precision medicine to intuitive medicine? • What is the current business model for provision of the service (Solution Shop, Value Added Process or Facilitated Network)? • What is the business model likely to arise after the innovation is adopted? • How are the skill sets needed by providers changed by the innovation? Are changes in training needed to provide a suitable labor supply? • Is the legal, social and cultural environment consistent with, and supportive of, the new business model? • Is the new business model likely to be introduced within existing organizations or within new organizations? • Is the existing funding mechanism consistent with the new business model? lug. ’19 Conclusions

 Define disruptive technology

 Find it & being proactive

 Methods for HTA

lug. ’19 10 Disruptive Technologies: A retrospective critical appraisal

Claudia Wild [email protected] Why concerns about disruptive technologies ?

• Concerns about HTA methodologies notfit for purpose? • Concerns about early identification (Horizon Scanning, Technology Forecast)? • Concerns to oversee their implications? methodology

• Selective (non-systematic) retrospective critical apraisal of Austrian assessments (ca 150; 2008-2019) • Mapping of disruptive definition • Selective perspective whether HTA- methodologies failed EXPH definition used

• Disorder old systems (equivalent to Uber & AirBnB) by creating new services and better access • Empower patients • Person-centred delivery • Provide improved health outcomes AND cost-effective • Create new professional roles/ capacities (incl. new values) • Introduce transformative change

Source: EXPH 2016 https://ec.europa.eu/health/expert_panel/sites/expertpanel/files/012_disruptive_innovation_en.pdf Examples from EXPH

• Technological (HCV-drugs) • Organisational (integrated care) • Products & Services (palliative care) • Human resources (diabetic self- management) Examples from LBI-HTA Technological Yes (patient access from rural areas): • intraoperative Radiotherapy (IORT) in primary breast- cancer No (more expensive, indication-creep): • TAVI (high-risk, intemediate-risk, low-risk) • ATMP: Autologous Chondrocytes (MACI, ChondroCelect), Allogeneic mesenchymal stem cells for the treatment of complex perianal fistulae associated with Crohn's disease • Robot-assisted surgery • Many, many more Examples from LBI-HTA Organisational

Yes (empowerment and person-centred, improved outcomes/cost-effective, Create new professional roles/ capacities ): • Family outreach in pregnancy and early childhood; • support services of children of mentally ill parents; • Choosing Wisely/ Appropriateness Initiatives/ 2nd opinions before elective surgery • Task-Shifting, Access to vaccination No: ? Examples from LBI-HTA Products & Services

• Yes (better access, empowerment of patients, person-centred delivery, improved health outcomes AND cost- effective) • Inhalation sedation with nitrous oxide (N2O) as part of anxiety management in dentistry • Telemonitoring of chronic patients No (only change of organisation): • Day-surgery • Triage-Biomarker (Mammaprint, ….) • Gene-Panels (FoundationOne,….) Examples from LBI-HTA Human resources

Yes (empowerment and person-centred): • All kind of self-management support (depression, parenting, chronic disease…..) • Community engagement, social prescribing

No: ? Hype or support: distraction from critical appraisal?

• Question: is there a need for a new terminology an/or are we more distracted than supported by it ?