Smart devices How to unlock their potential in the real world
Tobias Handschuh, Ernst & Young
• 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 devices How to unlock their potential in the real world
Page 3 Smart Devices – How to unlock their potential in the Real World PDA November 2017
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
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
Re
bis
ma
rt®
Be
taco
nn
ect®
Ypsomed“Smart Devices” solution
”DataPen” BIOCORP
Chronic Indications – e.g. Type I Diabetes Emergency Medication – e.g. Epinephrine
Companion Medical’s InPen
ESYSTA Pen
ECHO pen
Veta Smart Case for Epipen® autoinjector
(expected launch end 2017)
Novo
Page 4 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
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
Examples of common expectations (and goals) around the connected injector devices
Page 5 Smart Devices – How to unlock their potential in the Real World PDA November 2017
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
There is some evidence that these some of these promises are being fulfilled…
Expectations
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
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
Some exemplary evidence…
Autoinjector preference among patients with multiple sclerosis: results from a national survey - Limmroth et al
Patient preference and adherence - 3 August 2017 Vol 11
Patient assessment of an electronic device for subcutaneous self- injection of interferon β-1a for MS - D’Arcy et al
Patient preference and adherence2012 Vol 6
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
References
Page 6 Smart Devices – How to unlock their potential in the Real World PDA November 2017
► 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
► 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)
. . . but, despite these successes, we are still very far away from the “revolution”
… so what are the hurdles?
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 X
X
X
X
X
Expectations
X
X
X
X
* Autoinjector preference among patients with multiple sclerosis: results from a national survey - Limmroth et al. Patient preference and adherence - 3 August 2017 Vol 11
The shortfalls…
Page 7 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
consumer world, that are based on user experience design1Evidence: 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-making2Data 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 data3Business 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.4
Page 8 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…
… so what can the industry do to accelerate progress?
Physicians
PatientsHealth data
provider
Product supply Designs
joint
services
Medical
information
and support
Marketing and
service
offering
Consultations
treatment
Provides
medicines &
devices
Prescription
management
Provides training,
coaching and
other services
Data management
Shares
selected
data cuts
Shares
selected
data cuts
Pharmacists
Patient Service
provider
Trade
managementPatient
Services
Coordinator
Customer
insights
team
Account
manager Pharma & Device Company
Sales
force
Prescription
support
Coordinates with
medical professionalPayer
Regulator
Legislator
Reimbursement
Marketing Authorization
Service and data usage authorization
EMA
FDA
CE
ILLUSTRATIVE EXAMPLE
A fit-for-purpose and easy-to-use product… with services fully integrated into the care “ecosystem”… and valued by all stakeholders
Page 9 Smart Devices – How to unlock their potential in the Real World PDA November 2017
Overcoming Hurdle 1 – Building intuitive and effective products and services
What to build…
1
Easy and intuitive to understand and
use by patients or others
Safe and effective: meet all regulatory
requirements (MDR)
A clear purpose, fulfilling an unmet need
Connectivity to existing systems
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.)
ILLUSTRATIVE EXAMPLE
How leaders are approaching this …
► Starting with a clear goal:
► A validated unmet need to be addressed
► Focus on key features that will add value, and
take out unnecessary (nice to have) features
► Making the user experience central to the
development process:
► 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
► In highly innovative situations, work directly with
the regulator to shape the new regulations
Page 10 Smart Devices – How to unlock their potential in the Real World PDA November 2017
Overcoming Hurdle 2 – Generating evidence to support the additional benefits
2
What to build…
A body of evidence
for the drug + device
+ service
► Clinical Endpoints
► Outcomes
► Health Economics
► Stratification data
► Personalization
EMAFDA
CE
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/
How leaders are approaching this …
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 EXAMPLES
► For many chronic indications, behavior directly impacts outcomes
(e.g. Diabetes, CV indications, etc.)
► Behavioural therapy specialists are investing in creating evidence:
Page 11 Smart Devices – How to unlock their potential in the Real World PDA November 2017
Overcoming Hurdle 3 – Building an end-to-end infrastructure through to actionable results
3
What to build…
Capture
Store
Connect
Analyse
Act
Transmit
A
B
C
Automated and
effortless live
data capture
and
transmission.
Compatible
with existing
health data
systems
(format and
storage).
Automatically
analysed to
provide
actionable
insights (triage,
intervention,
etc.)
► 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
► 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)
How leaders are approaching this …
► 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.
ILLUSTRATIVE EXAMPLES
Page 12 Smart Devices – How to unlock their potential in the Real World PDA November 2017
Overcoming Hurdle 4 – Business model innovation and new revenue streams
4
Potential upsides…
Insights for future
innovation and treatment
personalisation
Outcome
based
reimburse-
ment
Validation of
product value
(and price)
How leaders are approaching this today…
► 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.
ILLUSTRATIVE EXAMPLES
Page 13 Smart Devices – How to unlock their potential in the Real World PDA November 2017
► Clear purpose
► Demonstrated benefits and evidence
► Easy to understand, explain and use
► Integrated into the therapeutic pathway, ecosystem, and local key stakeholders
Manufacturers CAN take practical steps TODAY to unlock the full potential of their digital devices in the real world
► 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
► 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
Think about your
solution from end-
to-end
Collaborate or
partner with other
stakeholders
Now is the right
time to start
When? What? How?
Page 14 Smart Devices – How to unlock their potential in the Real World PDA November 2017
Thank you !For questions, please contact the author:
Tobias HandschuhEmail: [email protected]
LinkedIn: www.linkedin.com/in/tobiashandschuh/
Web: parthenon.ey.com/po/en/expertise/life-sciences
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