how to unlock the potential of smart devices in the real world.

15 Pages·2017·1 MB·English

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
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
Novo
 Veta Smart Case for
Epipen® autoinjector
ECHO pen
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
Rebismart®
Betaconnect®
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
 Greater patient convenience
 Easier therapy management & adherence
For physicians
 Better patient monitoring
 Improved outcomes
For payers  Greater value realization
 Outcome based reimbursement
For policy makers  Innovative & integrated care models
 Personalization of therapy
 Insights for future innovations
For pharma & medtech
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 Some exemplary evidence… References
 Greater patient Patient assessment of an electronic
Rebismart observational study UK/IRE (June 2012) device for subcutaneous self- injection
convenience of interferon β-1a for MS - D’Arcy et al
• 63 patients naïve to sc interferon β-1a therapy
Patient preference and adherence
 Easier therapy • 91% liked using the device 2012 Vol 6
management &
• 96% found it “easy or very easy to use”
adherence
 Better patient
Autoinjector preference patient survey Germany (Aug 2017) wAuittho minjuelctitpoler psrceleferroesnisc:e r easmuoltnsg f rpoamti ean ts
monitoring national survey - Limmroth et al
• Large proportion of patients “highly satisfied” - Betaconnect: 82%, Patient preference and adherence - 3
 Improved Rebismart: 67%, vs. manual device Extavipro: 60% August 2017 Vol 11
outcomes
 Greater value Smart diabetes pens – e.g. InPen Product features reported for
realization Companion Medical’s InPen®
• collects users' data and transmits it to an app
 Outcome based • alarm function if doses missed after scheduled mealtimes
reimbursement • remote monitoring – text message to up to 5 people
 Innovative &
Impact of adherence on subcutaneous
integrated care interferon beta-1a effectiveness
models Impact of adherence on sc interferon beta-1a effectiveness waditmh imniusltteipreled sbcyle Rroesbisis m- Saprta®in in patients
administered by Rebismart® in patients with MS (April 2017) Patient preference and adherence -
 Personalization of April 2017
therapy • Retrospective analysis of 110 patients using Rebismart device
• >95% adherence rate over the duration
 Insights for future
• 77.3% relapse free rate (over 140 week average duration)
innovations
• Clear link between better adherence and lower relapse rates
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 The shortfalls…
 Greater patient
convenience X ► Some outstanding issues with handling/application of devices:
 Easier therapy Betaconnect 26%, Rebismart 22% of users desire improvements*
management &
X
adherence ► Evidence based on retrospective small sample studies
 Better patient
monitoring X ► No head to head trials
 Improved
outcomes X ► Data sharing is manual (showing it to the physician)
 Greater value ► No automation – No analytics or direct link between measured data
realization X
and future course of action
 Outcome based
reimbursement X ► Duplication (as some patients keep written and electronic records)
 Innovative &
integrated care X ► Some retrospective analyses of study data, but samples too
models
small for predictive analyses
 Personalization of
therapy X ► No new business model (no new revenues – no data business)
 Insights for future
innovations X
… 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?
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
1 consumer world, that are based on user experience design
Evidence: To date very little clinical evidence on the incremental benefit
provided by smart devices has been generated – thus no basis for clinical or
2 reimbursement decision-making
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.
3 Similarly, patients have limited means or incentives to share their data
Business Model & Revenue Streams: Incremental reimbursement for devices or
services has not (yet) been achieved in the most part. No monetization leads to a
4 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
Data management
Health data
Patients provider Shares
Consultations Provides Provides training, selected
treatment medicines & coaching and data cuts
devices other services
Coordinates with Payer
medical professional
P
mraensacgriepmtioen t
sPurepspcorript tion Patient Service FEDMA
Physicians
provider CE
Regulator
Marketing and Pharmacists
service
Medical offering Product supply Djoeinsti gns
i
annfdo rsmuaptpioonrt services Shares
Trade selected
Sales management Patient data cuts Legislator
force Services
Coordinator Reimbursement
Marketing Authorization
Customer
Account Service and data usage authorization
insights
manager Pharma & Device Company
team
ILLUSTRATIVE EXAMPLE
… 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
Overcoming Hurdle 1 – Building intuitive and
effective products and services
What to build… How leaders are approaching this …
Easy and intuitive to understand and
► Starting with a clear goal:
use by patients or others
► A validated unmet need to be addressed
Safe and effective: meet all regulatory ► Focus on key features that will add value, and
requirements (MDR) take out unnecessary (nice to have) features
► Making the user experience central to the
A clear purpose , fulfilling an unmet need development process:
► Work with all stakeholders who will come into
Added functionality, e.g.: contact with the device, services or data flows
► automation of manual tasks or calculations
► If you don’t have an in -house capability for this,
► advanced functionality (e.g. closed loops commission an agency that offers this service
enabling personalization of therapy, or dosing)
► Work with regulatory & legal from the start
► Automated data capture and/or transmission
► Relevant additional services if they are ► Get multi -disciplinary input (internal or as an
needed (e.g. remote monitoring, analytics, etc.) external service) to identify requirements
► In highly innovative situations, work directly with
Connectivity to existing systems the regulator to shape the new regulations
ILLUSTRATIVE
EXAMPLE
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… How leaders are approaching this …
► For many chronic indications, behavior directly impacts outcomes
A body of evidence
(e.g. Diabetes, CV indications, etc.)
for the drug + device
► Behavioural therapy specialists are investing in creating evidence:
+ service
2morrow – digital behavioural change therapy for smoking cessation:
FDA
► Completed: Randomized, Controlled Pilot Trial of a Smartphone App for
EMA
CE 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
► Clinical Endpoints
Replacement Therapy (NRT) Versus NRT Alone for Tobacco Cessation
► Outcomes
► Health Economics Other Examples include:
► Sleeping disorders (Sleepio insomnia)
► Stratification data
► Weight management (2morrow health)
► Personalization
► Astma and COPD therapy (propeller health)
ILLUSTRATIVE EXAMPLES
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