harnessing the power of real-world data insights to help ......in co-operation with the société...

1

Harnessing the power of real-world data insights to help deliver quality cancer care and treatment access for patients

Brussels, 4th December 2018

CODE Belgium Launch Event in co-operation with Société des Infi rmier(e)s en Oncologie (SIO)

2 3

Contents

Introduction 03

Executive Summary 05

Event Overview 07

Welcome and Introduction to CODE 07

The Mission of CODE and the Benefits of Oncology Data Network 08

Healthcare Provider Participation: 10 Joining the Oncology Data Network – Gelre Ziekenhuizen

SIO and CODE: The Benefits of a Collaboration 11

The Advantages of the Oncology Data Network for the Oncology 13 Community - CAPRI III

The CODE Healthcare Analytics Platform 14

Highlights from Panel Discussion 15

The Collaboration for Oncology Data in Europe (CODE) and the Oncology Data Network (ODN) officially launched in Belgium during “The many facets of communication in oncology” event organised in co-operation with the Société des Infirmier(e)s en Oncologie (SIO) on 4 December 2018 at the Tangla Hotel in Brussels.

The goal of this event was to tangibly demonstrate how the multistakeholder oncology community can harness the impact of real-world data to derive greater value from anti-cancer medicines for patients. The speaker presentations were followed by a panel discussion with healthcare management experts followed by Q&A.

Introduction

Speakers and Panelists:

Karolien Haese

CEO & Strategic Director, Clinique Saint-Jean, Bruxelles

Dr. Marie Mailleux

Medical Oncologist, Clinique Saint-Luc Bouge

Dr. Didier Vander Steichel

Director General, Belgian Cancer Foundation

Ayhan Findik

National and International Relations Manager, SIO

Dr. Ashley Woolmore

CODE Lead and Senior Vice President, Real World and Analytics Solutions Global Team, Head of European Data and Evidence Networks, IQVIA

Mirella Koenjer

Programme Manager Oncology, Gelre Ziekenhuizen

Patrick Crombez

President, SIO, Head Nurse, Department of Onco-Haematology, Institut Jules Bordet

Malou Kuppen

Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Netherlands

Dr. Shivam Natarajan

CODE Product Advisor, Surgical Oncologist

Myriam Guiral

CODE Country Lead Benelux

4 5

Introduction Executive Summary

The growing number of effective anti-cancer medicines is leading to more complex and personalised treatment regimens. With more than 4 million new cases of cancer in Europe every year1, a greater understanding of how these medicines are actually used in clinical practice could make a substantial contribution to better inform patient care and to help manage the potential financial impact on healthcare systems.

Just under 80,000 of the new cases of cancer in Europe occur in Belgium, with breast, lung, colorectal, prostate and bladder cancer being the five most frequent cancers2. The Belgian Minister of Public Health highlighted support of real-world data strategies in the ‘Pact of the Future’ which was signed in 2015 to improve patient access to innovative medicines.

CODE is an innovative collaborative effort aiming to significantly increase knowledge of how European anti-cancer medicines are being used by supporting the creation of the Oncology Data Network (ODN).

This is a co-operative data sharing network for Europe’s oncology community. For the first time, treatment centres joining the ODN will be able to explore near real-time, comparable, clinically robust, information that will describe how anti-cancer medicines are being used, for which patient groups, and in which combinations and sequences. This will support clinicians and other stakeholders in improving patient care as well as facilitate new models to help inform novel payment models which may enhance patients’ access to innovative medicines. The platform and processes have

Event Programme

Welcome and Introduction to CODEMyriam Guiral (Country Lead CODE BeNeLux)

The Mission of CODE and the Benefits of Oncology Data NetworkDr. Ashley Woolmore (CODE Lead and Senior Vice President, Real World and Analytics Solutions Global Team, Head of European Data and Evidence Networks, IQVIA)

Healthcare Provider Participation: Joining the Oncology Data Network – Gelre ZiekenhuizenMirella Koenjer (Programme Manager Oncology, Gelre Ziekenhuizen)

SIO and CODE: The Benefits of a CollaborationPatrick Crombez (President, SIO, Head Nurse, Department of Onco-Haematology, Institut Jules Bordet)

The Advantages of the Oncology Data Network for the Oncology Community – CAPRI III Malou Kuppen (Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Netherlands)

The CODE Healthcare Analytics Platform Dr. Shivam Natarajan (CODE Product Advisor, Surgical Oncologist)

Panel Discussion with Q&A Karolien Haese, Dr. Marie Mailleux, Dr. Didier Vander Steichel, Ayhan Findik and Patrick Crombez

1. http://gco.iarc.fr/today/data/factsheets/populations/994-who-europe-region-euro-fact-sheets.pdf

2. https://gco.iarc.fr/today/data/factsheets/populations/56-belgium-fact-sheets.pdf

6 7

Executive Summary

been designed to ensure the highest standards of patient and clinician privacy and data protection, information governance and security. All data contributed pass through a highly secure, multi-stage process to be rendered non-identified and are aggregated before analysis and release.

Speakers, representing treatment centres, healthcare professionals and researchers highlighted their reasons for joining the ODN or collaborating with CODE. The need for CODE within the oncology community is clearly demonstrated with the first cancer centre engaged in Belgium along with collaborations formed with stakeholder bodies.

• The healthcare providers highlighted the need for improvement in data collection to meet the Belgian standards and availability of real world evidence to help inform discussions and decision making about reimbursement for innovative medicines.

• For medical oncologists, the direct impact on daily clinical practice from up to date analyses allows for better evaluation and decisions about treatment regimens. The presence of robust data strengthens communication amongst stakeholders involved in treating patients.

• Nurses play an important role in data gathering and usage to inform patient care and policy and their engagement with CODE helps maximise value for patients. The oncology nursing community, who provide care for patients, benefit from the ODN generated information to keep nursing practices up to date by identifying nursing research needs and developing better knowledge about new medicines.

All speakers and panelists agreed that the ultimate benefit of CODE and the ODN is to gain insight into clinical practice to help optimise cancer care and treatment access to patients.

In its first three years CODE aims to actively engage with 200 cancer treatment centres across seven European countries, with a view to extending this collaboration to some 2,000 treatment centres over the next 10 years. Just under 100 cancer treatment centres have already joined the ODN, ratifying that CODE is on the path to achieving its goal.

Event Overview

Welcome and Introduction to CODE

Myriam Guiral, Country Lead CODE BeNeLux, welcomed participants and thanked SIO for a productive collaboration. She then showed a short video entitled ‘A New Era of Quality Cancer Care’, which introduced the Collaboration for Oncology Data in Europe (CODE) and the Oncology Data Network (ODN). The video was produced as part of a series for the European CanCer Organisation (ECCO)3, and launched at the annual ECCO Summit in September 2018.

• She explained that CODE aims to better understand cancer treatment in a real-world setting. Recent years have seen significant advances in cancer care and a better understanding of how patients are actually being treated with anti-cancer medicines is needed. Real-world data on cancer treatment can help to develop this better understanding; this is what CODE is aiming to address.

• In addition, healthcare systems are under pressure, not least because of costly innovative treatments. Better information on the use of these drugs can help

address these challenges of financial sustainability; CODE’s data can support the development of novel payment models that help address these challenges.

• CODE is an ambitious initiative that aims to engage with 2000 cancer treatment centres over the next 10 years. Centres that join the ODN will also be able to benchmark with other treatment centres in the Network. She emphasised that data protection is of the utmost importance to the initiative and that hospitals remain in control of their data.

She stated that the Launch provides a platform to present the aims, features and benefits of CODE: several high-level speakers would introduce the initiative while others would present their reasons for joining the Network.

Myriam Guiral announced the positive news that only the day before this launch event, the Belgian Cancer Foundation (Stichting tegen Kanker/Fondation contre le Cancer) decided to work with CODE.

3. ECCO: federation that exists to uphold the right of all European cancer patients to the best possible treatment and care, promoting interaction between all organisations involved in cancer at European level www.ecco-org.eu

8 9

The Mission of CODE and the Benefits of Oncology Data Network

Dr. Ashley Woolmore started by highlighting the importance of data in healthcare provision to help deliver the best treatment for patients. “Data saves lives,” he underlined – sentiments expressed by the Estonian Minister of Health during its recent EU Presidency4 – that CODE and the ODN will support cancer treatment centres to continue driving improvements in quality of care.

He added that the network makes use of cutting edge technology infrastructure and data science capabilities which incorporate “data protection by design” principles, with infrastructure and related processes that adhere to GDPR requirements. The use of advanced technology reduces the administrative burden on clinical teams. He indicated that participation in the ODN is an open invitation; there is no cost to ODN members. Participating centres keep control over their data.

He described how the team behind the ODN are taking a proactive approach

to engaging and partnering with European and national organisations, including patient representatives. Policies are in place to ensure that the oncology community has access to analyses from the ODN.

Dr. Woolmore emphasised the importance of low latency, i.e. the delay between a clinical event and our ability to access analysis of that event. In his view, this is an under-appreciated characteristic of real-world data which is highly relevant for clinical, research and access applications.

Centres that join the ODN will be able to continue using their own systems. Data from their systems will be translated into a ‘common language’, a full common data model of anti-cancer treatment, without the risk of becoming ‘lost in translation’. Significant work has been done to build an evidence-based reference called the Core Regimen Reference List (CRRL) which will facilitate interpretation.

Participating centres will get a better insight into their own data (and ways that it might be enhanced) and clinical practice. A centre’s own practice can also be contextualised by linking it with others in the network (either across the network or with sub-networks) and the CRRL. Connections amongst ODN members and communities of practice can be created. Furthermore, the ODN can serve as the ‘backbone’ for more ambitious data collection including, for example, metrics relating to pragmatic outcomes identified in the collaborative research project between ECCO and CODE5, appending

study-specific data items and processes and extending data sources.

Dr. Woolmore reinforced the commitment to data protection and set out the governance bodies that are in place to oversee the initiative’s work. He referenced the Clinical and Analytical Steering Committee (CASC), made up of international clinicians and academics who work at European level to provide overall guidance to the initiative. In addition, Country Advisory Groups (CAGs) at country level involve a broad range of stakeholders to provide local governance for the initiative.

He also referenced the collaborative multi-company approach of the six biopharmaceutical companies who are supporting CODE’s mission. In particular, he highlighted the commitment set out

in the “CODE Charter”6 to help address the challenges of financial sustainability. He indicated that very clear rules govern the types of analyses that commercial organisations can access and the purposes for which these analyses can be used, particularly around their use to help inform novel payment agreements.

Dr. Woolmore indicated that seven European countries were already involved in CODE, with a combined population of some 300 million citizens. He concluded by saying that significant progress towards building CODE has already been achieved, with nearly a hundred centres from across 5 countries having joined. However, CODE will not stop there and is ambitious in its aim, i.e. to expand the network to 2000 centres over the next ten years.

Event OverviewEvent Overview

"CODE will also reduce the complexity and effort of generating insights from real-world data. It will create a fast feedback system, using data that are already being collected and facilitating cross-centre, cross-country comparability."

Dr. Ashley Woolmore, CODE Lead and Senior Vice President, Real World and Analytics Solutions Global Team, Head of European Data and Evidence Networks, IQVIA

6. https://www.code-cancer.com/code-informing-patient-care-enabling- the-independent-development-of-flexible-payment-agreements-realising -financial-sustainability-goals/

4. https://twitter.com/SoMinEstonia/status/919871109650092033 5. Understanding Pragmatic Outcome Measures in Oncology, Poortmans et al, 2018 https://www.ecco-org.eu/

Policy/ECCO-CODE-Project

10 11


Healthcare Provider Participation: Joining the Oncology Data Network – Gelre Ziekenhuizen

Mirella Koenjer set out the reasons why her hospital – the first in Netherlands – had decided to join the ODN. Their principle starting point was the need for the best possible care and treatment for patients. CODE has the potential to contribute to this for patients, irrespective of age, gender or any other personal characteristics. Better use of data will help clinicians to align on and offer the best possible treatment by providing insights and information; healthcare professionals will be better able to answer patients’ questions regarding the most appropriate treatment and will also gain insights with respect to the quantity as well as quality of treatments in place. The cost of both treatment and care might decrease as resources are being put to use more efficiently. Most importantly, treatment can be better adapted to the needs and requirements of the individual patient.

CODE addresses many of the challenges that need to be overcome for this type of data generation and cooperation to work, such as the required confidence in the data generated. There will be no extra burden on staff in terms of data registration and the user interface is simple. However, other challenges remain, such as the fact that data are not always complete; for instance, apart from the treatment offered in hospital, there may be treatment at home for which data are not available. For the future,

other outcomes – such as quality of life, and Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) could possibly be integrated as well.

She added that CODE will go ‘live’ in Gelre Ziekenhuizen in May 2019 and it is hoped that many more treatment centres will join the network.

"CODE holds much promise to offer every individual (and unique) patient the treatment that will contribute to and support the highest quality of life. This is why Gelre Ziekenhuizen7 made the decision to join."

Mirella Koenjer, Programme Manager Oncology, Gelre Ziekenhuizen

SIO and CODE: The Benefits of a Collaboration

Patrick Crombez underlined the power of SIO and CODE joining forces.

He mainly focused on the role of the CODE Country Advisory Groups (CAGs), multidisciplinary groups including oncologists, patient organisations and nurses’ organisations, taking an advisory role to support the development of the network and to engage with national

relevant bodies and clinical practice at national level. He indicated that, in Belgium, hospitals have shown an interest in participating in the ODN but due to the complexity of the Belgian national health system, finalising their involvement may take some time.

He emphasised the importance of involving nurses in the initiative, highlighting that SIO can provide local expertise and support the identification of trends in clinical practice at national level.

At the same time, he highlighted that oncology nurses would benefit from SIO’s participation by gaining greater visibility of epidemiological data and access to research data, developing a better knowledge of (new) treatments, and standardisation of procedures. Clinical practice would be better informed; evidence-based practice could be developed, and research needs for nursing could be identified. In addition, it would support advocacy related to nursing and standardisation

"The need to share data is a real need and CODE provides a highly useful, innovative and effective answer to that need."

Patrick Crombez, President, SIO, Head Nurse, Department of Onco-Haematology, Institut Jules Bordet

7 Leading medical training hospital situated at two locations in the Dutch Province of Gelderland

"The CAGs are a direct opportunity to actively engage nurses in CODE. Engaging nurses in this way in this initiative would help maximise the value for patients by guiding the engagement with national bodies, identifying opportunities to grow the network and exploring opportunities for national analysis and research to help identify trends in clinical practice."


12 13


of cancer nursing qualifications. Last but not least, he saw that the ODN will serve as a continuously updated source of information to keep cancer nursing practice up to date.

He highlighted that the European Oncology Nursing Society (EONS) is aligned with CODE’s work. There is scope for collaboration in areas such as advocacy, communication, research and education.

Nurses play an important role in data gathering and usage to inform patient care and policy in a variety of ways such as supporting patients to enhance Patient Reported Data, supporting patient advocacy in multi-disciplinary teams and reporting clinical data in electronic medical records. Furthermore, nurses can help ensure patients understand how their data will be used and make them aware of the mechanism to opt-out.

This is linked to EONS’ broader advocacy work aimed to ensure recognition of oncology nursing as a discipline across Europe as this is unfortunately not yet the case (e.g. in Belgium). This needs to change as research has clearly demonstrated that in countries where specific oncology cancer nursing does exist as a separate specialism, substantially fewer undesired events are reported than in countries where this is not the case. The organisation’s ‘ReCAN’ project aims to increase recognition of the value and contribution of cancer nursing across Europe resulting in a European directive to recognise the role of Oncology Nursing. EONS intends to work with CODE to develop a survey and training programme for oncology nurses entitled ‘Oncology Nurses – at the heart of realising the potential for data to inform patient care and policy’.

The Advantages of the Oncology Data Network for the Oncology Community – CAPRI III

Malou Kuppen provided the audience with a direct example of the use and importance of CODE for clinical research. She introduced an initiative called CAPRI (Castration-resistant Prostate Cancer Registry); this is an investigator-initiated registry with successful collaboration between professionals, patients, researchers and pharmaceutical companies, with the goal of enabling every patient to obtain the best innovative new treatment. Over 3,500 patients were involved in this project which ran from 2010-2016. The registry was considered as the source of data on appropriate care by the Dutch Health Care Institute. However, the project was very resource intensive, both in terms of costs as well as in terms of labour; some 40,000 records were manually collected in 20 hospitals. 80% of the time spent was devoted to data collection and only 20% to data analysis.

The current phase of CAPRI (2018-2023) has the same aim as before. However, by establishing a collaboration with CODE, acting as an external partner providing electronic data collection, the time spent now will be reversed: 80% will be spent on data analysis, 20% on collection. This will allow for inclusion of more patients, more hospitals, more data, while the

budget remains the same. There will be international validation, quality control, data linking and most importantly, data protection will be ensured.

Malou Kuppen emphasised three requirements for data collection technologies to be deployed properly, i.e. the data level has to be research-grade, there have to be significant savings in terms of resources (time/funds) and there has to be full compliance with GDPR and country-specific data protection and privacy laws. CODE fulfils all of these conditions.

In future projects, there will be the possibility of involving more stakeholders.

"The collaboration between CAPRI III and CODE benefits all partners in this project: patients will have access to the best and most appropriate treatments. The university has the best possible analysis which could have a major impact on cancer health care, personalised cancer care as well as data sharing for research. For physicians, there will be clarity on best practice and more insights into value-based health care. Sponsoring companies will know more about the added value of their products and diagnostics."

Malou Kuppen, Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Netherlands

14 15

Highlights from Panel DiscussionEvent Overview

The CODE Healthcare Analytics Platform

Dr. Shivam Natarajan presented a live demonstration of the Healthcare Analytics platform which is the technology to which members of the Oncology Data Network will have access to analyse their own centre’s information as well as information from across the Network. He emphasised that when he was working as a surgical oncologist 20 years ago, only a few regimens were in use; currently some 45,000 can be identified. Clearly, the oncology landscape has truly become much more complex.

Dr. Natarajan reminded the audience that CODE invites cancer treatment centres across Europe to join the Oncology Data Network (ODN).

He showed the complex technology behind the functioning of the ODN platform, underlining the various benefits of the system, i.e. real-time data, the ability to continuously refresh data and the possibility to network with other centres across Europe.

Various ‘dashboards’ were presented, clearly showing their interactive nature and ability to filter information e.g. by different types and stages of cancer. He demonstrated how the user can set information filters, enabling flexible analysis of the available information and customisation for different stakeholders with different analytical requirements. Having access to the right data e.g. drug use across different patients – can help monitor treatment and support prescription and cost decisions. But of course, the system doesn’t just provide information about individual drugs; the information generated is broader e.g. analysis by regimen and can help support policy and procurement decisions as well.

The presentation was concluded by once again underlining the usefulness of CODE and the ODN and, crucially, its benefits for patients.

"In return for their active participation, members of the ODN receive - at no cost - the tools to explore validated, near real-time aggregated analyses that protect patient, physician and centre privacy through rigorous de-identification processes."


"The ODN maps data to international standards without adding any extra administrative burden. Centres joining CODE can also indicate what types of analytics would be interesting and useful for them; it is a living tool that can be adapted to the needs of its users."


Myriam Guiral briefly introduced the panel members.

Karolien Haese underlined the importance of real-time data and the improvement in data collection as compared to the current situation.

She added that it will also help to promote and target research. This evidence base can be used to inform and facilitate discussions with policymakers; the evidence, based on practice and linked to benefits for patients could help save budgets and support sustainability.

The insights can support regimen choices, which can be made based on the genetic molecular profile of individual patients. Real-time, robust data can also help in the communication with other stakeholders involved with the treatment, enabling the best possible treatment regimes. She announced that her centre has just joined the ODN and is looking forward to exciting results.

Dr. Didier Vander Steichel then emphasised the advantages of real-time and comparable data for patients. He highlighted the fact that his organisation had now also expressed its intention to collaborate with CODE as a very positive development which signalled the potential value of the project.

"Discussions about reimbursement of innovative pharmaceutical products and new molecules will be greatly supported by a better evidence base about the effects and use of these medicines in clinical practice in real time."

Karolien Haese, CEO & Strategic Director, Clinique Saint-Jean, Bruxelles

"The use of real time data will be a big support in evaluating and deciding on daily clinical practice. It will allow for up to date analyses; ensuring an updated evidence base and allowing for comparison and discussion with other centres."

Dr. Marie Mailleux, Medical Oncologist, Clinique Saint-Luc Bouge

"With the data generated by the ODN, we can design the best possible treatment for patients; it will empower patients as the data generated can help to strengthen the patient voice, also in advocacy efforts. Modern oncology can be compared with a complex puzzle; CODE can be one of the core pieces in solving it."

Dr. Didier Vander Steichel, Director General, Belgian Cancer Foundation

16 17

Highlights from Panel Discussion

While some aspects (e.g. radiotherapy) are not yet part of the project, he said the future holds much promise and greater cooperation on the basis of robust data should be welcomed as an opportunity. He also noted that CODE will generate positive arguments in the debate to recognise cancer nursing as a specialty and will help nurses take a stronger position in this debate at Belgian and also at EU level, flagging that this was a priority for SIO.

Speaking with one common voice will strengthen the field of oncology and will also help make the case for the recognition of oncology nurses. In the future, CODE can support this debate by providing data on the vital role of nursing in generating information in oncology treatment.

Myriam Guiral concluded the session by thanking SIO for their co-operation in organising the event and also thanked the speakers and the audience and underlined once again CODE’s benefit for patients.

"The implementation of CODE should not be problematic as the various stakeholders involved with cancer treatment and care already have a shared and common vision."


"Getting involved with CODE seemed like a dream come true. When presented with the possibility there were two options: either get involved, even if not entirely sure about the outcome; or do not get involved and potentially miss a powerful opportunity."

Ayhan Findik, National and International Relations Manager, SIO

18

Find out more at www.code-cancer.com

To register your interest in joining the Oncology Data Network, email CODE Country Lead Benelux, Myriam Guiral at [email protected]

All trademarks are the property of their respective owners.Copyright© 2019 IQVIA. All rights reserved.

harnessing the power of real-world data insights to help ......in co-operation with the société...

Documents