AAPS Inhalation & Nasal Technology Focus Group Lecture: Adherence Monitoring in RDD: Why do it and who will pay for it. Garth Sutherland, COO, Nexus6 Ltd May 4, 2011 Email: garths@smartinhaler.com Cell: +64 216 533 44 Web: http://www.smartinhaler.com/
Contents Tools for Measuring Adherence Electronic Adherence Monitoring Architectures Current Technology In Use Stories Who is using it Who is paying for it Future of Electronic Adherence Monitoring in RDD
Tools for Measuring Adherence Interviews & Questionnaires Patient Diaries Prescription Records Inhaler Dose Counters Electronic Diaries Enterprise Architecture Monitoring & Enhancement Note: Choice of tool impacts outcome.
Electronic RDD Monitor Architectures Attachment Embedded Combination
Electronic RDD Monitor Architectures Stand-alone Communications Connected
Examples of Connected (USB) Adherence Monitors Smartinhaler Range
Measurements: Electronic Monitor Device Demonstrations
Adherence Agorithm Clinical Trials Example Assumptions Doses & Prescription Calculated daily (AM, PM) Day starts at 6am and finishes at 3am Single Medication formula only It is an average over a window Dependent upon daylight savings Where patient agrees with Doctor, A ave = C ave Payors interested in C ave
Example of a Contemporary OEM RDD Combination Proprietary Delivery, Monitoring & Enhancement System MicroDose Nexus6
MicroDose with SmartinhalerLive Real-time dosing and compliance tracking MicroDose DPI electronics captures dosing information in real-time Wireless docking station receives and stores dosing information from DPI Transfers dosing information to docking station Reporting website tracks and manages dosing information and compliance Cellular wireless transmission to website
Solution Features DPI communications module Embeds in DPI Runs off DPI battery Comprises IO, uc, Memory, comms Buffers actuation & inhalation history Communicates/transfer data direct to docking station communications module to embed In DPI Wireless Docking Station Wireless GSM Stores and tansmits data to website LED screen and menu system Battery w/wall plug charger Reporting Website Storage & reporting of data
Solution Features DPI communications module Embeds in DPI Runs off DPI battery Comprises IO, uc, Memory, comms Buffers actuation & inhalation history Communicates/transfer data direct to docking station communications module to embed In DPI Wireless Docking Station Wireless GSM Stores and tansmits data to website LED screen and menu system Battery w/wall plug charger Reporting Website Storage & reporting of data
Stories
Feedback - Physician Dr Andre Schultz, Perth. Once used it, cant treat patients without it
Reminder Trial Feedback Example Feedback via clinical trial researcher: A young guy was telling me how he always used to forget, now he hardly ever misses a dose and how his soccer has improved as his asthma is so much better.
Todd Hunter The Smartinhaler is brilliant and the ability to share real information about my asthma drug use with my GP is really helpful for both of us. This inhaler has had the most impact in improving my asthma management than anything else I have tried."
John McCarthy Having my son with me every second weekend places enough stress having to worry about his health and well being. The Smartinhaler gives me relief in a different sense, knowing I can keep track of his Asthma. Its information that my ex wife and I can both share between us for the well being of Max. (30 doses)
ED Study South Auckland Family: Mother hide reminder device from child, despite representation of child at ED twice
Very surprised by results of Teenager consuming two inhalers over Easter Holiday period Teenage taking 6 puffs at a time Hospital Physician
Child experiencing poor control due to non compliance Unusual dose taking pattern Asthma Nurse Physician had prescribed different doses of ICS on alternate days
Husband started using reminder Couldn t believe how good Flixotide worked after all these years! Asthma Nurse Nurse thinks she might get another 10 years out of him!
Asthma Nurse Child asthma oscillating in and out of control Child using preventer like reliever and releiver like a preventer
Me Reminders off in summer Need to manage on daily basis for 9 months / yr Really surprised by iphone app Will easily go through 20 puffs of Ventolin if not taking my preventer Want so many more features!
Current Solution Technology 9 Servers from Enterprise Server Application 5 External Servers Integrated Memory 16G on RDD device TCP/IP Stack in inhaler Some applications moving up to 40MByte data
Current Solution Technology Spatial Monitoring Remote Firmware Updates, asset management Stress Test Analysis to 500K (100K x 5 Server) Users Multi-Channel: GPRS / 3G, VOIP, WiFi, POTS, Ethernet Web, Email, SMS, VAT, iphone, Windows7 Health Vault Integration Asymmetric Public/Private Key Encryption
Architecture of a Contemporary RDD Monitoring & Enhancement System - SmartinhalerLive
Current Solution Technology Cost & Prices USB monitors unit pricing. Reporting and Communications TCO Transaction / Subscription Based Service access generally is subscription based
Who is Paying? Clinical Trials: Gov & Private Grants including Pharma Sponsorship OEM: RDD, Pharma Collaborative Agreements
Who is Paying? Primary Care (New Patient Device Reimbursement): Device Manufacturer Disease Management: Payers & Pharma
Percentage compliance Increasing Adherence in Clinical Trials 100 75 50 25 0 AVRF Control AVRF Control AVRF Control AVRF Control AVRF Control Visit 1 Visit 2 Visit 3 Visit 4 Visit 5
Future of Adherence RDD Technology Low Cost Communications Ubiquitous Breakthrough in battery storage & life Increased Richness in Connected User Experience Very cool looking devices
Future of Adherence RDD Increased adoption in Clinical Trials Delivery of Tools for use in Primary Care Focus on device driven efficacy of interventions Disruption most likely to be Payor-led
Future of Adherence RDD
Future of RDD Adherence Monitoring 640K ought to be enough for anybody
END FOR FURTHER INFORMATION CONTACT GARTHS@SMARTINHALER.COM