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Using real-world data to transform patient care and to meet the major challenge of fi nancial sustainability

Monaco, 1st February 2018

Pr. Jean-Yves Blay, Director General of the Léon Bérard Centre

Pr. Xavier Pivot, Director General of the Paul Strauss Centre, Strasbourg, and Administrator of the Alsace Regional Cancer Institute

CODE France Launch Event at the 13th Biennale Monégasque de Cancérologie 2018

A symposium conducted with the institutional support of IQVIA™

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Launch of the European initiative Collaboration for Oncology Data in Europe (CODE) in France, and of the Oncology Data Network (ODN)

The Biennale of Cancérologie in Monaco has been a key event in French oncology for over 20 years. This event is the leading national cancer congress, covering multiple topics where more than 1,300 professionals come together to meet and discuss advances in oncology. It is attended by members of Academic Hospitals, General Hospitals, Cancer Care Centres, clinics, as well as representatives from UNICANCER and the health authorities. The 13th edition was held from 31st January to 3rd February 2018.

It was at this event that the Collaboration for Oncology Data in Europe, CODE, was officially launched in France. CODE was developed by IQVIATM with the support of six leading biopharmaceutical companies. CODE is supporting the creation of the Oncology Data Network (ODN), designed to provide reliable, up-to-date information on how anti-cancer medicines are actually used in clinical practice, which can be used to:

• Address today’s information gap by providing timely information on anti-cancer medicine use back to the healthcare system

• Enable flexible payment agreements, to address financial sustainability which may improve access to innovation.

CODE's launch event at the symposium dedicated to the use of real-world data in oncology was chaired by Professor Blay, a member of CODE’s international Clinical and Analytical Steering Committee (CASC). He was joined by keynote speaker Professor Xavier Pivot, Director General of the Paul Strauss Centre and Administrator of the Regional Cancer Institute, who’s also president of the Biennale, and set up his vision on the clinical impact of data analysis. Then Dr. Ashley Woolmore, Senior Vice President of IQVIATM and CODE Lead, introduced the CODE initiative.

These presentations were followed by a constructive discussion among a panel of clinical experts on how the use of real-world data can transform patient care and help address the challenges of financial sustainability. They highlighted how their personal experiences had driven them to support this initiative. Several in-depth exchanges with the audience then followed these discussions, which explored the perception, questions and various points of view of the oncology community concerning the CODE initiative.

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Introduction Introduction

Speakers and Panellists:

Prof. Jean-Yves Blay

Chair Oncologist, researcher and professor in medical oncology, Director General of the Léon Bérard Centre, President of the French Sarcoma group and Coordinator of the European Reference Network dedicated to rare solid tumours in adults - ERN EURACAN

Prof. Xavier Pivot

Keynote speaker Professor of Oncology, Director General of the Paul Strauss Centre, Strasbourg Administrator of the Alsace Regional Cancer Institute

Dr. Ashley Woolmore

Speaker Senior Vice President, Real-World & Analytical Solutions Global Team IQVIATM, Head of European Data and Evidence Networks CODE Lead

Prof. Gilles Calais

Panelist Oncologist and radiotherapist, Hospital Practitioner at the Faculty of Medicine and at the Academic Hospital of Tours, President of the Establishment Medical Committee, member of the Supervisory Board and Board of Directors at the Tours Academic Hospital, President of FHF Cancer

Prof. Samuel Limat

Panelist Professor of Clinical and Therapeutic Pharmacy, Hospital Pharmacist at Besançon UHC, President of the Establishment Medical Committee at the Besançon UHC, President of the National Conference of UHC Pharmacists

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Event Overview

A French and European collaborative issue

Prof. Blay introduced the symposium by describing the limitations of randomised clinical trials carried out on selected patients, giving healthcare professionals a partial view of patient care in the real world.

In Prof. Blay’s opinion “the verification of results obtained in randomised trials, on real-world patients, whether or not they meet the criteria for trial inclusion, are a major challenge in our health systems."

He then spoke of the international aspect of the CODE initiative, also highlighted by Prof. Pivot during his plenary presentation.

Event Overview

About CODE

Dr. Woolmore described the CODE initiative in his presentation and went on to answer participants' questions.

The CODE initiative aims to collate up-to-date and reliable data on how anti-cancer medicines are currently used in clinical practice in Europe.

Building a cooperative data sharing network, the Oncology Data Network (ODN) will enable the achievement of two parallel and equally important objectives:

To address today’s information gap by providing timely information on anti-cancer medicine use back to the healthcare system.

To enable flexible payment agreements, to address financial sustainability which may improve access to innovation.

The ODN is designed to allow any HCPs/cancer treatment centres across Europe who wish to join to share their data about anti-cancer treatment practice in a way that addresses the challenge of different data standards, information systems, regimens and treatment plans. The aim is to collaborate with 200 cancer treatment centres in seven European countries over the first three years of the network, and then to continue to expand the network to approximately 2,000 treatment centres throughout Europe over the following 10 years.

In response to participants’ questions, Dr. Woolmore clarified certain specific points related to the protection of personal data and the current changes to regulations: "The business of IQVIATM (which was the result of a merger of IMS Health and Quintiles) is data analysis. Three years ago, we started with a blank slate to create a system that is fully compatible with the General Data Protection Regulation (GDPR). In addition, the French Information Governance Authority, CNIL, has authorised the establishment of a data warehouse for the ODN*, fully in line with the GDPR’s approach. We are prepared for the upcoming changes." He also set out the importance of data protection by adding: "Hundreds and hundreds of hours have been spent developing the different steps to render the data non-identified". He also clarified that the various methods for sharing analyses are designed to preserve the identity of each participating centre. Finally, in response to a question on the project’s business model, it was explained that the initiative was primarily financed by the company IQVIATM itself. Additional funding is provided by the Biopharmaceutical members.

* Decision number 2017-347 of 21st December 2017 authorising the company IQVIATM Operations France to implement an automated processing of personal data whose purpose is the establishment of a personal data warehouse in oncology for the purposes of research, study and evaluation in the field of health. CNIL

"The CODE initiative is of strategic importance and has the particular benefit of not just providing insights in France but also enabling us to compare ourselves with other countries, and this will be an important point in the years to come."

Prof. Jean-Yves Blay

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Event Overview

Data extraction: feedback from experience and challenges to address

Prof. Pivot shared his experiences from two occasions with the CODE team. First, with Prof. Limat at the Besançon Academic Hospital and the Franche Comté region, "one of the first centres to partner with CODE," where the implementation turned out to be "easy". Since the data was already digitised, connections between the academic hospitals IT system and the ODN platform simply required the development of a data extraction and transfer system, as well as the development of a common terminology for data collected.

A second experience was shared from Strasbourg, where the use of several IT systems across academic hospitals and cancer treatment centres gave rise to the need to develop a partnership with the CODE project in order to make the tools used compatible, facilitating data extraction.

Prof. Calais of the Tours Academic Hospital spoke of the technical challenges faced, in particular given the amount of personal data files as well as the need to optimise their structure. He said that he was ready to promote the “many benefits of becoming an ODN member. [...] For multi-pathological treatment centres such as ours, the data made available via the ODN and CODE will be highly useful."

Prof. Limat highlighted the slow uptake of using health data in France. Medical teams need to regain control of their information systems by defining the answers that these systems can provide. “In the future, patients who visit a treatment centre will be able to ask doctors to show them in advance that they can offer the same chances of a positive outcome as other patients. For example, a cancer treatment centre should be able to report their rates of relapse, survival, and complications,” he said.

"The certification of tomorrow's treatment centres should not be based on procedures, but on results. This means structuring our data to be able to answer these questions and projects like CODE will be a step towards helping us do that."

Prof. Samuel Limat

Event Overview

The benefit of real-world data from large patient populations

Prof. Pivot reviewed the use of real-world cohort data analyses in previous published studies and found that, despite having a strong clinical impact, they were probably largely under-utilised.

For example, the analysis of Fiteni et al. [1], conducted on patients undergoing the combination of trastuzumab and chemotherapy for the treatment of metastatic breast cancer showed that survival medians varied depending on the treatment centre and survival rates could double based on the patient's care location.

The results of cohort studies are important in order to analyse the quality of practices at national and European levels. The European Competence-Based Approach (CBA) standard emphasises the importance of working with real-world results obtained from randomised clinical trials.

Moreover, these studies make use of particularly relevant statistical approaches, such as the propensity score or Inverse

Probability of Treatment Weighting (IPTW), which makes it possible to obtain reliable results and perfectly robust conclusions. This is how neoadjuvant treatment has been shown to give the same results as adjuvant, and how concomitant and sequential treatments give broadly similar results.

Benefiting from the data derived from large populations of patients in real world will allow for an evaluation of practices and a validation of treatment protocols. Hence the importance of a prospective record of care strategies, reasons for strategy changes, relapse dates, etc., will allow for confirmation that daily practices are aligned on the results of randomised trials.

Prof. J.-Y. Blay, Symposium Chair, and the other panelists from left to right, Prof. X. Pivot, Prof. G. Calais, Prof. S. Limat and Dr. A. Woolmore, answering questions from participants.

"Treatment centres must invest in collectively recording their patient care strategies; that is how we will build clinical trials on therapeutic strategies and design quality controls on how we perform our oncology practice. In the modern world, this is a necessity. The CODE project can largely meet this need."

Prof. Xavier Pivot

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Further exchanges within the room confirmed high levels of interest among participants in the ODN, with an awareness of the importance of structuring data. It was therefore agreed that the CODE initiative, by supporting the creation of the ODN, is fully in line with the approach that each treatment centre must either start the process or continue working to ensure their data is suitable to facilitate data extraction.

To conclude the discussion and meeting, Prof. Blay invited participants to take part in this long-term work, emphasising its “importance over the years to come, of measuring ourselves, our performance and in general the efficiency of the healthcare system."

Find out more at www.code-cancer.com

Conclusion Discussion

Panel discussion and participants feedback

Healthcare Professional

"CODE is a very interesting initiative. However, not all treatment centres are fortunate enough to have digitised records with structured data."

Response of Prof. Blay

"Evaluating practices will, in my opinion, be an accreditation criteria for continuing to care for our patients, which is why structured data is important."

National Institution

"I can only be enthusiastic about this European initiative! There are nowadays debates on the access of certain patient organisations or health authorities to data on the performance of hospitals and care centres; results by hospitals are not part of the results CODE can provide?"

Response of Dr. Woolmore

“Once a centre has agreed to be part of the network, it can look at its own data. If he wishes, he can identify himself in the network with others. It is possible to find a quorum of participating centres without identifying them by the name of the centre. This type of sharing information can be conceived in the system."

Academic Statistician

"The value of this database is twofold: 1. for patients’ therapeutic care, 2. for generating research hypotheses.”

References: [1] F. Fiteni, C. Villanueva, F. Bazan, S. Perrin, L. Chaigneau, E. Dobi, P. Montcuquet, L. Cals, N. Meneveau, V. Nerich, S. Limat, X. Pivot. Long-term follow-up of patients with metastatic breast cancer treated by trastuzumab: impact of institutions. Breast 2014 Apr 23(2):165-9.

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Find out more at www.code-cancer.com

To register your interest in joiningthe Oncology Data Network, email CODE Country Lead France, Claire Lamotte at claire.lamotte@iqvia.com

CODE Founding Members:

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