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

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


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





Improved outcomes





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


► 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?




Improved outcomes





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…


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


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


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


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/


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:


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)


► 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.



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.



► 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?


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