Connected drug delivery systems : Increase patient compliance and enable comprehensive, coordinated treatments

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Connected drug delivery systems : Increase patient compliance and enable comprehensive, coordinated treatments Eric Dessertenne, PharmD, MBA Head of Business Development & Commercial Operations edessertennne@biocorp.fr +33 (0)6 08 02 14 51

Non-adherence: definition and scope of the problem Medication non-adherence Adherence can be defined as the extent to which patient behavior corresponds with recommendations from a health care provider Adherence is commonly divided into two types: Primary adherence: patients do not fill their prescriptions Secondary non-adherence: prescriptions are filled but the medication is not taken as prescribed. The patient may not follow the number of doses prescribed or may take incorrectly his medication. Primary non-adherence rates are usually lower than secondary non-adherence rates: a study in the Journal of General Internal Medicine in the US estimated the primary non-adherence rate at about 20%. The secondary non-adherence rates are often much higher than this, as we will see further. Source : Adherence to long-term therapies: evidence for action World Health Organization; 2003. / Primary Medication Non-Adherence: Analysis of 195,930 Electronic Prescriptions, Journal of General Internal Medicine, April 2010, Michael A. Fischer MD, MS, Margaret R. Stedman PhD, Joyce Lii MS, MA, Christine Vogeli PhD, William H. Shrank MD, MSHS, M. Alan Brookhart PhD, Joel S. Weissman PhD

Non-adherence: definition and scope of the problem Medication non-adherence rates Primary non-adherence (US) 24% Prescriptions never submitted to pharmacy for filling 31% Prescriptions for chronic conditions never submitted to pharmacy for filling Secondary non-adherence (US) Nearly 3 out 4 Americans admit they do not always take their medication as directed Source : Prescription Abandonment infographic, DrFirst and Patient Advisor / Med Adherence infographic, American College of Cardiology based on Medication Adherence: making the case for increased awareness, Duke University Medical Center and the National Consumers League

Non-adherence: definition and scope of the problem Medication non-adherence consequences (1/2) Clinical consequences (US) 20% Hospitals and longterm care facility admissions related to non-adherence 125 000 Deaths Per Year attributed to nonadherence 80% Higher rate of additional heart attacks for heart attack survivors Source : Prescription Abandonment Infographic, DrFirst and Patient Advisor / Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence

Non-adherence: definition and scope of the problem Medication non-adherence consequences (2/2) Financial consequences (US) $2 000 per person Additional costs to the US healthcare system $188 billions Pharmaceutical revenue loss due to medication nonadherence Source : Prescription Abandonment Infographic, DrFirst and Patient Advisor / Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence

Non-adherence: definition and scope of the problem Medical Non-adherence reasons Don t understand need for medication Don t understand how to take medication?? Forget to take medication Personal beliefs against taking medication Can t afford medication Unwelcomed medicine side effects Source : Prescription Abandonment Infographic, DrFirst and Patient Advisor

Chronic conditions Chronic conditions: a real need for improvement in patient adherence Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments Haynes RB Adherence to long-term therapy for chronic illnesses in developed countries averages 50%. In developing countries, the rates are even lower. In order to increase adherence to treatments, new solutions have to be developed: Long-term therapies such as those for chronic diseases require patient engagement. They also require patient support. It is necessary to help patients track and manage their treatment so they can avoid non-adherence short and long-term risks. Source : Haynes RB. Interventions for helping patients to follow prescriptions for medications. Cochrane Database of Systematic Reviews, 2001, Issue 1. / Adherence to long-term therapies: evidence for action, WHO 2003 / Améliorer l observance, Traiter mieux et moins cher, IMS Health et Cercle de réflexion de l industrie pharmaceutique, 2015

Chronic conditions Diabetes as a first case example Number of diabetics in the world (2013 2035) Diabetes is rising globally, with major clinical and financial consequences Global human and financial cost of Diabetes Diabetes treatment is hard to manage: Low compliance rate with only 70% of type 1 diabetes patients who are compliant Diabetes is a chronic condition that requires daily treatment and careful follow-up Recording and aggregating glycaemia levels and insulin doses is essential to engage patients in their treatments and avoid risky behavior Source: graphs and pictures: IDF Diabetes Atlas 6th edition / figures: The economic rationale for adherence in the treatment of diabetes mellitus, Howard Wild, April 17 2012

Chronic conditions Other diseases that need patient engagement and support Adherence rates in 4 chronic diseases (%) Non-adherence related revenue loss in the US biopharmaceutical industry (2011) $ Billion 45 40 50 45 46 35 40 30 35 25 20 15 40 35 34 30 25 20 15 21 12 10 5 0 Multiple sclerosis* Rheumatoid Arthritis** Growth hormone deficiency*** 13 Asthma 10 5 0 6.3 7.1 1.3 Respiratory agents Autoimmune diseases Multiple sclerosis Revenue Revenue lost due to non-adherence Source : *Treatment adherence and other patient-reported outcomes as cost-determinants in multiple sclerosis, December 4 2014 ; **Medication adherence in patients with rheumatoid arthritis: a critical appraisal of the existing literature, May 2012, ***Non-Compliance with Growth Hormone Treatment in Children Is Common and Impairs Linear Growth, June 31 2011 0Améliorer l observance, Traiter mieux et moins cher, IMS Health et Cercle de réflexion de l industrie pharmaceutique, 2015 Source : Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence, Capgemini Consulting 2011 ; Avoidable Costs in US Healthcare, IMS Health, June 2013

Our solution How to develop an integrated standard of care? Treatment Device Physician Patient

Our solution A new global tool (1/2) 2005: Farewell to Pope John Paul II at St. Peter s Basilica

Our solution A new global tool (2/2) 2013: Pope Francis is installed at St. Peter s Basilica

Our solution Mobile phones are omnipresent globally There are more people who own a mobile phone than a toothbrush (Source: Mobile Marketing Association Asia) It takes 90 minutes for the average person to respond to an email. It takes 90 seconds for the average person to respond to a text message (Source: CTIA.org) 91% of all U.S. citizens have their mobile device within reach 24/7 (Source: Morgan Stanley).

Our solution Our solution: the DataPen A smart injection pen A smartphone app Patient that transmits data to that gives real-time information on treatment to Who can share data with Physician Family

Our solution An advanced automatic injection pen Patient injects the right dose at all-times thanks to an ultra-precise dosage range Size Weight Specs 16.8 cm Less than 100g The injection is safe and comfortable; the patient can choose his injection preferences (speed, ) The injection is effortless thanks to an electromechanical system Compatible with Standard 3mL cartridges Records all injections data and transmits information automatically to the associated smartphone app

Our solution Connected to a dedicated app (1/2) The app is very easy-to-use and helps patients manage their treatment everyday The app has been developed with the collaboration of clinicians and patients to ensure all patients needs are met The patient s data is secure at all times, encrypted by our experts and then stored in a secure database

Our solution Connected to a dedicated app (2/2) Patients can access in real-time all the information on their treatment: Logbook Charts Statistics Many tools are added to the app to increase treatment adherence: Reminders and alerts Stock management (doses and needles left) Patients can share their data with: Physicians who can adapt their recommendations Their family who can check on them and provide support

Our solution The DataPen for Diabetes (1/2) Step 1 Input blood glucose level and number of insulin doses to inject Step 2 Screw needle and inject Data is automatically sent to the app in a new entry 6,0 mmol/l 15 IU

Our solution The DataPen for Diabetes (2/2) Step 3 Add notes and information Step 4 Analyze your statistics and manage your treatment Step 5 Send reports to your physician for more accurate recommendations OK have to be more! careful, before big dinners

Our expertise With a perfect understanding of pharmaceutical requirements A proven track record of pharmaceutical devices with an extensive know-how A partner of the pharmaceutical industry for more than 20 years Research & Development Industrialization Manufacturing Certification 30 products marketed 10 scientists and web developers Experience in scalability Experience in maximizing costefficiency 3 000 square meters manufacturing plant Internal quality control CE marking FDA certification

Our expertise And data security BIOCORP s high security protocol for data treatment Encrypted data during the whole process Data anonymization: User information system and data managing systems are totally independent The patient only can link these two flows of information Only authorized application can access the system with a unique identification code provided with each DataPen commercialized Data Hosting in a Datacenter certified Tier III Multi-Site (for France Auvergne and Rhones Alpes) Certified for hosting related health data

Benefits of connected solutions A solution beneficial for patients Thanks to safe, comfortable and effortless injections, patients are less reluctant to take their treatment. Patients finally have the tools to manage their treatment on a daily basis. The data is automatically transmitted from the DataPen to the app and the patient can use real-time analytics and insights. The app takes care of everything and makes life easier for patients: reminders for each injection, stock management to never be out of stock, etc. The system boosts patient engagement, which improves patient adherence to treatment and diminishes short and long-term risks associated to their condition

Benefits of connected solutions A solution beneficial for pharmaceutical companies A way to Differentiate their offer in the highly competitive pharmaceutical market Answer more thoroughly patients needs Give physicians and patients a tool to interact easily and efficiently Help patients manage their treatment and follow more seriously their physicians prescriptions and recommendations Gather anonymous and aggregated data for phase IV studies

Benefits of connected solutions A solution beneficial for payers A way to Educate patients to help them understand the risks associated with non-adherence and to prevent further complications Decrease the financial burden of prescribed drugs Monitor easily patients progress Move from inpatient to outpatient programs: Reduces needs for medical staff Reduces number of hospital admissions and hospitalization length

Benefits of connected solutions A solution beneficial for physicians A way to Gather quickly all the information on patients treatment in one practical material Use reliable information to understand the causes behind each alert Give precise recommendations and warn about risky behavior Develop patient interest and engagement

Benefits of connected solutions Why today? Why BIOCORP? Today, patients own much more smartphones than ever before. Studies also show that they are ready to use health mobile apps and they are eager to try new technologies to improve their condition. Healthcare systems are struggling with rising costs and uneven quality. They need new solutions that are adapted to the current situation. There is no other company in the pharmaceutical industry with both expertise in medical devices and in software development and data processing. Thanks to our history and our double expertise, we have been able to develop a unique solution, an answer to the needs of patients, pharmaceutical companies, payers and physicians.

Thanks! Thank you for your interest, feel free to ask any question! Eric Dessertenne, PharmD, MBA Head of Business Development & Commercial Operations edessertennne@biocorp.fr +33 (0)6 08 02 14 51