Smart devices. How to unlock their potential in the real world. Tobias Handschuh, Ernst & Young

Smart devices How to unlock their potential in the real world Tobias Handschuh, Ernst & Young

Smart devices How to unlock their potential in the real world Smart injectors situation today Expectations for the future Critical hurdles What can be done TODAY, IN PRACTICE, BY THE INDUSTRY to address the hurdles and unlock the full potential?

Smart injector technologies are now a reality in many therapeutic indications and treatment situations Rebismart Betaconnect Rare diseases e.g. Multiple Sclerosis Treatment agnostic add-on devices Ypsomed Smart Devices solution DataPen BIOCORP Chronic Indications e.g. Type I Diabetes Emergency Medication e.g. Epinephrine ECHO pen Novo Veta Smart Case for Epipen autoinjector ESYSTA Pen Companion Medical s InPen (expected launch end 2017) Sources: www.rebismart.com, Betaferon Medical Congress Booth Graphics, Ypsomed Brochure, www.biocoprsys.com, https://www.aterica.com/product/veta-2, https://www.emperra.com/en/esysta-product-system/pen/, https://www.companionmedical.com/inpen Page 3 Smart Devices How to unlock their potential in the Real World PDA November 2017

For many years, there has been talk about the connected devices, and how they will revolutionize care Examples of common expectations (and goals) around the connected injector devices For patients For physicians For payers For policy makers For pharma & medtech Greater patient convenience Easier therapy management & adherence Better patient monitoring Improved outcomes Greater value realization Outcome based reimbursement Innovative & integrated care models Personalization of therapy Insights for future innovations Page 4 Smart Devices How to unlock their potential in the Real World PDA November 2017

There is some evidence that these some of these promises are being fulfilled Expectations Greater patient convenience Easier therapy management & adherence Better patient monitoring Improved outcomes Greater value realization Outcome based reimbursement Innovative & integrated care models Personalization of therapy Insights for future innovations Some exemplary evidence Rebismart observational study UK/IRE (June 2012) 63 patients naïve to sc interferon β-1a therapy 91% liked using the device 96% found it easy or very easy to use Autoinjector preference patient survey Germany (Aug 2017) Large proportion of patients highly satisfied - Betaconnect: 82%, Rebismart: 67%, vs. manual device Extavipro: 60% Smart diabetes pens e.g. InPen collects users' data and transmits it to an app alarm function if doses missed after scheduled mealtimes remote monitoring text message to up to 5 people Impact of adherence on sc interferon beta-1a effectiveness administered by Rebismart in patients with MS (April 2017) Retrospective analysis of 110 patients using Rebismart device >95% adherence rate over the duration 77.3% relapse free rate (over 140 week average duration) Clear link between better adherence and lower relapse rates References Patient assessment of an electronic device for subcutaneous self- injection of interferon β-1a for MS - D Arcy et al Patient preference and adherence 2012 Vol 6 Autoinjector preference among patients with multiple sclerosis: results from a national survey - Limmroth et al Patient preference and adherence - 3 August 2017 Vol 11 Product features reported for Companion Medical s InPen Impact of adherence on subcutaneous interferon beta-1a effectiveness administered by Rebismart in patients with multiple sclerosis - Spain Patient preference and adherence - April 2017 Page 5 Smart Devices How to unlock their potential in the Real World PDA November 2017

... but, despite these successes, we are still very far away from the revolution Expectations Greater patient convenience Easier therapy management & adherence Better patient monitoring Improved outcomes Greater value realization Outcome based reimbursement Innovative & integrated care models Personalization of therapy Insights for future innovations Some outstanding issues with handling/application of devices: Betaconnect 26%, Rebismart 22% of users desire improvements* Evidence based on retrospective small sample studies No head to head trials The shortfalls Data sharing is manual (showing it to the physician) No automation No analytics or direct link between measured data and future course of action Duplication (as some patients keep written and electronic records) Some retrospective analyses of study data, but samples too small for predictive analyses No new business model (no new revenues no data business) so what are the hurdles? * Autoinjector preference among patients with multiple sclerosis: results from a national survey - Limmroth et al. Patient preference and adherence - 3 August 2017 Vol 11 Page 6 Smart Devices How to unlock their potential in the Real World PDA November 2017

So, what are the critical hurdles that are holding us back? 1 The Devices & Services: Devices essentially work, but are not intuitive to use for all Patients are getting used to intuitive designs of services from the consumer world, that are based on user experience design 2 Evidence: To date very little clinical evidence on the incremental benefit provided by smart devices has been generated thus no basis for clinical or reimbursement decision-making 3 Data Infrastructure: Infrastructure to store, analyze and use the data does not exist. Physicians, payers and others do not know what to do with the data. Similarly, patients have limited means or incentives to share their data 4 Business Model & Revenue Streams: Incremental reimbursement for devices or services has not (yet) been achieved in the most part. No monetization leads to a lack of incentives to invest further. Page 7 Smart Devices How to unlock their potential in the Real World PDA November 2017

All stakeholders involved need to address their hurdles to build the right ecosystem for their device & service A fit-for-purpose and easy-to-use product with services fully integrated into the care ecosystem and valued by all stakeholders Consultations treatment Patients Data management Provides medicines & devices Health data provider Coordinates with medical professional Provides training, coaching and other services Shares selected data cuts Payer ILLUSTRATIVE EAMPLE Physicians Medical information and support Account manager Prescription management Marketing and service offering Sales force Pharmacists Product supply Trade management Prescription support Patient Services Coordinator Pharma & Device Company Designs joint services Customer insights team Patient Service provider Shares selected data cuts FDA EMA CE Regulator Legislator Reimbursement Marketing Authorization Service and data usage authorization so what can the industry do to accelerate progress? Page 8 Smart Devices How to unlock their potential in the Real World PDA November 2017

1 What to build Overcoming Hurdle 1 Building intuitive and effective products and services How leaders are approaching this Easy and intuitive to understand and use by patients or others Starting with a clear goal: A validated unmet need to be addressed Safe and effective: meet all regulatory requirements (MDR) Focus on key features that will add value, and take out unnecessary (nice to have) features A clear purpose, fulfilling an unmet need Making the user experience central to the development process: Added functionality, e.g.: automation of manual tasks or calculations advanced functionality (e.g. closed loops enabling personalization of therapy, or dosing) Automated data capture and/or transmission Relevant additional services if they are needed (e.g. remote monitoring, analytics, etc.) Work with all stakeholders who will come into contact with the device, services or data flows If you don t have an in-house capability for this, commission an agency that offers this service Work with regulatory & legal from the start Get multi-disciplinary input (internal or as an external service) to identify requirements ILLUSTRATIVE EAMPLE Connectivity to existing systems In highly innovative situations, work directly with the regulator to shape the new regulations Page 9 Smart Devices How to unlock their potential in the Real World PDA November 2017

2 Overcoming Hurdle 2 Generating evidence to support the additional benefits What to build A body of evidence for the drug + device + service Clinical Endpoints Outcomes Health Economics Stratification data Personalization FDA EMA CE How leaders are approaching this For many chronic indications, behavior directly impacts outcomes (e.g. Diabetes, CV indications, etc.) Behavioural therapy specialists are investing in creating evidence: 2morrow digital behavioural change therapy for smoking cessation: Completed: Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy (N-198) In Progress: Randomized, controlled study of SmartQuit N=1,600 Recruiting: Randomized Control Trial of the SmartQuit Plus Nicotine Replacement Therapy (NRT) Versus NRT Alone for Tobacco Cessation Other Examples include: Sleeping disorders (Sleepio insomnia) Weight management (2morrow health) Astma and COPD therapy (propeller health) ILLUSTRATIVE EAMPLES Sources: http://www.2morrowinc.com/, Espie, C.A. et al. (2012). A randomized, placebo-controlled, trial of online CBT for chronic Insomnia Disorder delivered via an automated media-rich web application, https://www.propellerhealth.com/enterprise/clinical-research/published-research/ Page 10 Smart Devices How to unlock their potential in the Real World PDA November 2017

3 Overcoming Hurdle 3 Building an end-to-end infrastructure through to actionable results What to build How leaders are approaching this ILLUSTRATIVE EAMPLES Capture Transmit Automated and effortless live data capture and transmission. Technology: Ipsomed, Biocorp, Qualcomm Life, and many others have built such systems. Areas for future development include: quality of sensors & automation of data capture Getting patients to share data: UnitedHealthcare & Qualcomm: Fitbit based reward program where patients can earn $1,500 p.a. Connect Store Compatible with existing health data systems (format and storage). Making the data usable: Partnering with a Data integrator, such as: Redox www.redoxengine.com translating data streams to match clinical information systems and electronic patient records. Online platforms e.g. Glooko connecting patients and physicians A C B Analyse Act Automatically analysed to provide actionable insights (triage, intervention, etc.) Taking action: Aetna and Merck & Co AetnaCare partnership using Real time predictive analytics to identify specific hypertension and diabetes patients and stratifying these into customized care plans (note this does not currently use data from devices) In development: Insulin Automated dosing (e.g. InSmart implant) Page 11 Smart Devices How to unlock their potential in the Real World PDA November 2017

4 Overcoming Hurdle 4 Business model innovation and new revenue streams Potential upsides How leaders are approaching this today ILLUSTRATIVE EAMPLES Insights for future innovation and treatment personalisation Validation of product value (and price) Outcome based reimbursement Amgen and Humana collaboration Analyses of real-world evidence from Humana's members with data from wearable devices, apps and smart drug delivery devices Objective: Develop predictive algorithms that can identify patients at risk of adverse events early, before they occur Amgen & Harvard Pilgrim Healthcare for Repatha : Amgen will fully refund drug cost if patient is hospitalized for stroke or MI Condition: patient must have been on Repatha and stuck to regimen Opportunity: using data from a delivery device (currently not enabled) There are in hundreds of similar deals in EU and US The old business model: no reimbursement The MS and diabetes patient programs and management tools around smart injectors are not reimbursed incrementally The main business model in these cases is to provide additional value and make the offering more competitive and attractive. Page 12 Smart Devices How to unlock their potential in the Real World PDA November 2017

Manufacturers CAN take practical steps TODAY to unlock the full potential of their digital devices in the real world When? What? How? Now is the right time to start Think about your solution from endto-end Collaborate or partner with other stakeholders There is a lot of activity and investment, going well beyond pilots by industry participants and new entrants Key elements of the new ecosystem will be shaped in between now and 2020, and there will be disruptive forces Clear purpose Demonstrated benefits and evidence Easy to understand, explain and use Integrated into the therapeutic pathway, ecosystem, and local key stakeholders Partner where necessary to build infrastructure and service offerings (or buy in the capability) Work with other stakeholders to share the burden of creating new regulations where needed Page 13 Smart Devices How to unlock their potential in the Real World PDA November 2017

Thank you! For questions, please contact the author: Tobias Handschuh Email: Tobias.Handschuh@ch.ey.com LinkedIn: www.linkedin.com/in/tobiashandschuh/ Web: parthenon.ey.com/po/en/expertise/life-sciences Page 14 Smart Devices How to unlock their potential in the Real World PDA November 2017

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