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Understanding DTx:
Journey into Imagination
Emily Kunka, MS
Digital Business Transformation
Digital Therapeutics (DTx)
deliver medical interventions directly to patients
to prevent, improve, manage, or treat disease.
They are evidence-based, clinically evaluated
software.
Digital Health
Data capture, storage, and display for care
provision and management
Digital Medicine
The use of digital technologies as tools for
measurement and intervention in the
service of human health
Digital
Therapeutics
Deliver intervention to prevent,
improve, manage, or treat disease
A Closer Look
Digital Solutions
Digital Medicine
Adherence programs
Patient journey / experience
Software IN a medical
device (SiMD)
Software AS a medical
device (SaMD)
Software within hardware which
powers or controls the mechanics
of the physical device.
Direct refill services, fitness and
lifestyle trackers
Companion labeling app for a
marketed drug
Standalone software intended to
prevent, modify, or treat disease
DTx
Software as a Medical Device (SaMD)
is software intended to be used for one or more
medical purposes that can perform without
being part of the device hardware
Therapy Solution
3 Requires FDA approval or
clearance as SaMD
Digital Therapeutics vs. Digital Solutions
4 Generally reimbursable by
payers
High(er)
than
solution
Low
5 Cost to Develop
1 Generally requires an Rx to use
2 Evidence-based, supported by
clinical trial data
Regulatory Pathway Under Construction
Although there are guidelines (e.g. the Guidance on Mobile
Medical Applications), a formal SaMD pathway does not
currently exist and is in development
In the Meantime...
We are currently borrowing the existing medical device pathway
under the Center for Devices and Radiological Health (CDRH)
Premarket Submission Pathways
De Novo
○ Granted to novel devices of low to
moderate risk
○ Aims to prove superiority or non-inferiority of the product
to the standard of care
○ Clinical data is required to support reasonable assurance
of safety and effectiveness
Premarket Submission Pathways
○ Aims to demonstrate
substantial equivalence to
another approved “predicate”
product which is legally
marketed in the US.
510K Clearance
Breakthrough Designation
Devices with 510(k) clearance that also
● Are for serious, life-threatening, or
debilitating diseases or conditions
● Have preliminary clinical evidence of
substantial improvement over available
therapy
● Offer a distinct advantage over existing
devices
● Allow for expedited review
● Can make reimbursement easier
Trends in Existing DTx
● Mainly used in chronic disease
● Focus on real world data (RWD)
● Focus on outcomes allowing value-based payment
models
● Largely based on Cognitive
Behavioral Therapy (CBT)
○ Focus on changing patient’s
behavior or thinking
DTx
Development
Development Process
● Shorter development
lifecycle
● Flexible development
process
○ Able to update and
enhance the product in
between each dev
phase
Key Differences: DTx vs. Drug Development
It is an iterative and agile process from prototype to the
minimum viable product (MVP)
*only pivotal phase III product and its data are submitted
for approval
Key Differences: DTx vs. Drug Development
Implement
design controls;
a formal
methodology of
product
development
Key Differences: DTx vs. Drug Development
Independent (3rd party)
cybersecurity risk
assessments are performed
annually which consider how
new risks are mitigated and
design decisions are made
$45-55 MM
Cost to bring a concept through FDA submission is significantly lower
than for molecular drug development ($350 MM)
Clin Dev
2-5 years
As opposed to the 10-15 years clinical development
takes for molecular drugs
Mechanism of Action (MOA)
● How the product works e.g.
how it affects the outcome(s)
of interest
● Similar to an “active
ingredient” in a drug
Target Product Profile (TPP)
● Patient population(s) of interest
● Product concept and prototypes
○ Hypotheses testing product
usability and engagement
levels with each user (i.e.
HCPs, patients, caregivers)
○ Hypotheses testing
endpoints/potential impact
Development Standards
The precise path a DTx must
take and the level of clinical
evidence it must provide is
dependent on
● the novelty of the product
● how great a risk it poses
should it malfunction
RWD STUDIES
Post-Market Health
Economics and Outcomes
Research (HEOR) studies
to assess ability to lower
costs and improve
outcomes.
At least 1 year
$1MM - onward
1,000s of patients
DISCOVERY
Target Product Profile
(TPP) defines the desired
characteristics, intended
use, and target
population(s). Feasibility,
usability.
6 months to 1 year
$1-5MM
0 patients
PIVOTAL STUDY
Patients of a wider
demographic to show
efficacy. Almost
always an RCT with
control arm.
1-2 years
$7-20MM
200-600 patients
POC & PILOTS
Proof of concept
and pilot studies to
show mechanism of
action working and
safety. Explores
patient engagement.
6 mo - 1 yr
$1-5MM
150-300 patients
Development Lifecycle
APPROVAL
PDT Pilot Studies
● Gather data on optimizing
usability, engagement, and
efficacy
● Improve the user experience
while not affecting the
mechanism of action
● Explore a range of “dosing”
regimens
Developing Treatment Regimens
based upon physician optimization from observation
and experience, rather than dose-response theory or
logic.
Methodology is empirical
PDT Validation Studies (RCTs)
● Trials go direct-to-patient using a
decentralized clinical trial (DCT) model
○ Quicker speed of recruitment
● Endpoints are largely digital versions of
traditional clinical measures, but can
also be novel digital biomarkers
(dBMs)
● dBMs are compared to existing gold
standard endpoints accepted by
providers and payers
Control Arm / Sham Product
● Use of a control group may be
unethical or not feasible (unable to
mask) in some cases
● Sham app mimics the digital
intervention software without
including the MOA
○ Need to ensure sham product
does not create a clinical
response through placebo effect
Sham Real
Unique Challenges
● Hitting “okay” button ≠ sufficient consent
● MOA can be unclear
● Poorly defined exposure (using time,
frequency, duration) makes response
relationship and therapeutic target
(optimum exposure) difficult to measure
● Inter-individual variability in response
Treatment Paradigms
1. Monotherapy - First line therapy on its own
2. Concert therapy - Designed to be used with
other (oftentimes traditional) interventions
* Some products can be used as both monotherapies and concert
therapies, depending on design and evidence
Concert Therapies
Companion - Designed be used to treat a condition alongside
pharmacological product and/or HCP treatment. Usually not
FDA approved.
Combination - Designed to be used in conjunction with a
specific pharmacological product (single national drug code
unique device identifier [NDC-UDI])
Adjunct - Designed to be used with a category of
pharmacological interventions or treatments
Advantages to Pursuing FDA Approval
● Increased scientific and clinical credibility with HCPs
● Creates higher barrier of entry to competitors
● Allows companies to make a claim regarding a
specific condition
● Brings product legitimacy/acceptance and ability to
be reimbursable from payers
● Generally allows for a higher price point
Drawbacks of Pursuing FDA Approval
● Slower, more costly
development process
● Less flexibility to
continuously improve the
product
● Incurs commercial risk as it
defers ROI
Benefits
● FDA approval does not
guarantee payor uptake or
patient engagement
● Iteration of the product
after FDA approval can
require additional
approvals
Risks
● Collect usability data
○ Give visibility into
personalized care
delivery
● Reduced safety concerns
● Dev timeline is shorter
● Cost of goods decreases
with volume
● Requires less human
capital
Post Market
Post Market SaMD Surveillance
● Must demonstrate continued safety,
effectiveness, and performance in the
real world
● Data from several sources:
○ SaMD product itself
○ Registries
○ Electronic health information
sources
■ National Evaluation System for
health Technology (NEST)
Real World Performance Data (RWPD)
Real World
Health Data
(RWHD)
User
Experience
Data (UXD)
Product
Performance
Data (PPD)
Real World Health Data (RWHD)
Outputs and outcomes related to the SaMD
definition statement. Used to monitor product’s
continued safety and effectiveness.
Can inform changes to the intended use of a
product, and support expanded functionalities
and use in broader target populations.
User Experience Data (UXD)
Outputs derived from user experiences related to
the real-world use of a product.
Facilitates timely identification and correction
of user issues, and improves the utilization and
effectiveness of the software.
Product Performance Data (PPD)
Outputs and outcomes demonstrating the
accuracy, reliability, and security of a product.
PPD monitoring allows for timely patches and
updates to correct software bugs and security
vulnerabilities. Can support modification of
claims.
Regulatory Oversight and Policing
Responsibility may depend on the
regulatory designation
○ Food and Drug Administration
○ Federal Trade Commission
○ Federal Communications
Commission
○ National Institute of Standards and
Technology
○ Office of the National Coordinator
for Health Information Technology
Post Approval Obligations
Failure to comply with
post-clearance or approval
regulatory requirements could
subject the company to
○ Substantial penalties
○ Recall/withdrawal of
product from the market
Commercialization
Launch Strategy
● Marketing must also educate and drive
awareness
○ Utilize medical science liaisons, key
opinion leaders
○ Attend industry events which speak
to the data and answer questions
○ Publications to peer reviewed
journals
Scale and Commercialization
● Pathways to scale and
commercialize are still
largely uncharted
● The market is rapidly
evolving, getting
increasingly competitive
○ Difficult to forecast
demand
Customer Economic Model Contract Terms
Providers and
Employers
Risk-sharing Per member per
month (PMPM)
Payors % Savings Recurring
Pharma Licensing, royalty,
milestone
Recurring or term
Patients Free with
reimbursement
Over-the-counter
Example
Payment
Model
by
Customer
Business Model - B2C
Advantages
Early revenue opportunities
Demonstrate product traction
Disadvantages
High costs to commercialize
Not covered by insurance
Business Model - B2B Self-Insured Employers
Advantages
Faster sales cycle
Disadvantages
Requires an additional sales step
to employee to capture usage fee
Labor intensive, deal by deal
Business Model - Health Systems, Payers, PBMs
Advantages
Set rate for DTx usage
Use of digital formulary
Disadvantages
Long contracting process
May require pilot or testing period
Fee-For-Service
PBM Formularies - Examples
● CVS Caremark
○ Sleepio
○ Daylight
○ Hinge Health
○ Hello Heart
○ Torchlight
○ Whil
○ Vida
○ Naturally Slim
○ Weight Watchers
○ Kurbo
● Express Scripts
○ Livongo
○ Propeller Health
○ Omada Health
○ LifeScan
○ Learn to Live
○ SilverCloud Health
○ Wildflower
○ Quit Genius
○ Prevail Health
○ Back with Care
○ Hinge Health
○ RecoveryOne
Business Model - Health Systems and Payers
Advantages
Based on cost savings
Disadvantages
Difficult to quantify cost savings
Value Based Reimbursement
Advantages
Uses CPT codes
Disadvantages
Requires FDA approval and path
to FDA approval is still undefined
Device-Like Reimbursement
[Alternatives under consideration]
PDT Pricing in the Market
Price of DTx is significantly less than conventional therapies
*Rx is typically for a 3-6 month treatment period
Pricing Strategies
Moving from a direct-to-consumer (DTC) offering to
a medical benefit, to a pharmacy benefit can 10x
the price each time
$20/month
$200/month $2,000/month
DTC Medical
Benefit
Pharmacy
Benefit
Perspectives
Patient Perspective
If an FDA-approved
app or online tool was
available to treat your
medical condition,
how likely would you
be to try it?
Very likely 21%
Somewhat likely 33%
Somewhat unlikely 15%
Very unlikely 14%
I don’t know 17%
Source: PwC Health Research Institute’s Annual Report
HCP Perspective - Rx Anecdote
A doctor has 500 patients… but only 100 are prescribed the PDT. Why?
100 patients “Do everything I ask them to do. They don’t need a PDT.”
100 patients “Never do anything I ask them to do. They would never use a PDT.”
100 patients “Don’t have a smartphone, and can’t use the PDT.”
100 patients “Don’t have a health plan that would pay for a PDT.”
“After this triage, there are only 100 left who can use the PDT.”
Summary
Paradigm Shifts
Hardware Software
Deterministic Risks of
Physical Products
Evolving Risks of Digital
Products
Stable and Predictable
Volume
Potential for
Exponential Volume
Reality Check
● Patient, provider, and payer appetite for DTx is
still uncertain
○ We still need to show long term patient
engagement with DTx products
● PDTs considered software as a medical device
(SaMD) do not currently have a benefit category
recognized by the Centers for Medicare and
Medicaid Services (CMS)
Unmet Needs / The Road Ahead
● Integrate DTx into electronic prescribing, dispensing, and
medical record platforms and HCP workflows
● Expand outside of chronic diseases
● Build payer reimbursement models (dedicated national codes!)
● Develop better reporting metrics on DTx utilization
● Grow more comprehensive DTx formularies
● Develop regulatory evaluation and commercialization
pathways for other major health authorities (EMA, TGA, etc.)
UCB DBT’s Vision in DTx
● Partner externally to co-develop and
co-commercialize new DTx products
● Add DTx into a more comprehensive portfolio of
products for which UCB can synchronize our
products and services for more a holistic,
continuous patient care continuum
Imagination, imagination.
A dream, can be, a dream come true.
With just that spark, from me and you.
One little spark, of inspiration
Is at the heart, of all creation.
Right at the start, of everything that's new.
One little spark, lights up for you.
Thank You!
● https://www.darkdaily.com/fda-approves-digital-therapeutics-technologies-to-treat-pati
ent-behavioral-conditions-that-interfere-with-positive-healthcare-outcomes/#:~:text=D
igital%20therapeutics%20combine%20apps%20and,focus%20on%20specific%20clinical%
20outcomes.
● https://dtxalliance.org/understanding-dtx/#:~:text=Digital%20therapeutics%20(DTx)%20
deliver%20medical,spectrum%20of%20diseases%20and%20disorders.
● https://www.nature.com/articles/d41586-019-02873-1
● https://www.fda.gov/media/112680/download
● https://www.fda.gov/media/112901/download
● https://www.pwc.com/us/en/industries/health-industries/library/digital-health-needs-evi
dence-and-buy-in.html
● https://www.nature.com/articles/s41746-020-00370-8
● https://torreya.com/publications/digital-therapeutics-and-future-of-pharma_torreya-feb
2020.pdf
● https://medrhythms.medium.com/looking-back-ahead-at-the-digital-therapeutics-indus
try-2e8454d342c5
● https://www.fda.gov/media/106331/download
● https://www.fda.gov/media/80958/download
● Digital Therapeutics, Dawn of a New Treatment Class, Ahead of the Curve, Cowen and
Company
Sources

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Understanding Digital Therapeutics: Journey into Imagination

  • 1. Understanding DTx: Journey into Imagination Emily Kunka, MS Digital Business Transformation
  • 2.
  • 3. Digital Therapeutics (DTx) deliver medical interventions directly to patients to prevent, improve, manage, or treat disease. They are evidence-based, clinically evaluated software.
  • 4. Digital Health Data capture, storage, and display for care provision and management Digital Medicine The use of digital technologies as tools for measurement and intervention in the service of human health Digital Therapeutics Deliver intervention to prevent, improve, manage, or treat disease
  • 5. A Closer Look Digital Solutions Digital Medicine Adherence programs Patient journey / experience Software IN a medical device (SiMD) Software AS a medical device (SaMD) Software within hardware which powers or controls the mechanics of the physical device. Direct refill services, fitness and lifestyle trackers Companion labeling app for a marketed drug Standalone software intended to prevent, modify, or treat disease DTx
  • 6. Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that can perform without being part of the device hardware
  • 7. Therapy Solution 3 Requires FDA approval or clearance as SaMD Digital Therapeutics vs. Digital Solutions 4 Generally reimbursable by payers High(er) than solution Low 5 Cost to Develop 1 Generally requires an Rx to use 2 Evidence-based, supported by clinical trial data
  • 8. Regulatory Pathway Under Construction Although there are guidelines (e.g. the Guidance on Mobile Medical Applications), a formal SaMD pathway does not currently exist and is in development
  • 9. In the Meantime... We are currently borrowing the existing medical device pathway under the Center for Devices and Radiological Health (CDRH)
  • 10. Premarket Submission Pathways De Novo ○ Granted to novel devices of low to moderate risk ○ Aims to prove superiority or non-inferiority of the product to the standard of care ○ Clinical data is required to support reasonable assurance of safety and effectiveness
  • 11. Premarket Submission Pathways ○ Aims to demonstrate substantial equivalence to another approved “predicate” product which is legally marketed in the US. 510K Clearance
  • 12. Breakthrough Designation Devices with 510(k) clearance that also ● Are for serious, life-threatening, or debilitating diseases or conditions ● Have preliminary clinical evidence of substantial improvement over available therapy ● Offer a distinct advantage over existing devices ● Allow for expedited review ● Can make reimbursement easier
  • 13. Trends in Existing DTx ● Mainly used in chronic disease ● Focus on real world data (RWD) ● Focus on outcomes allowing value-based payment models ● Largely based on Cognitive Behavioral Therapy (CBT) ○ Focus on changing patient’s behavior or thinking
  • 15. Development Process ● Shorter development lifecycle ● Flexible development process ○ Able to update and enhance the product in between each dev phase
  • 16. Key Differences: DTx vs. Drug Development It is an iterative and agile process from prototype to the minimum viable product (MVP) *only pivotal phase III product and its data are submitted for approval
  • 17. Key Differences: DTx vs. Drug Development Implement design controls; a formal methodology of product development
  • 18. Key Differences: DTx vs. Drug Development Independent (3rd party) cybersecurity risk assessments are performed annually which consider how new risks are mitigated and design decisions are made
  • 19. $45-55 MM Cost to bring a concept through FDA submission is significantly lower than for molecular drug development ($350 MM)
  • 20. Clin Dev 2-5 years As opposed to the 10-15 years clinical development takes for molecular drugs
  • 21. Mechanism of Action (MOA) ● How the product works e.g. how it affects the outcome(s) of interest ● Similar to an “active ingredient” in a drug
  • 22. Target Product Profile (TPP) ● Patient population(s) of interest ● Product concept and prototypes ○ Hypotheses testing product usability and engagement levels with each user (i.e. HCPs, patients, caregivers) ○ Hypotheses testing endpoints/potential impact
  • 23. Development Standards The precise path a DTx must take and the level of clinical evidence it must provide is dependent on ● the novelty of the product ● how great a risk it poses should it malfunction
  • 24. RWD STUDIES Post-Market Health Economics and Outcomes Research (HEOR) studies to assess ability to lower costs and improve outcomes. At least 1 year $1MM - onward 1,000s of patients DISCOVERY Target Product Profile (TPP) defines the desired characteristics, intended use, and target population(s). Feasibility, usability. 6 months to 1 year $1-5MM 0 patients PIVOTAL STUDY Patients of a wider demographic to show efficacy. Almost always an RCT with control arm. 1-2 years $7-20MM 200-600 patients POC & PILOTS Proof of concept and pilot studies to show mechanism of action working and safety. Explores patient engagement. 6 mo - 1 yr $1-5MM 150-300 patients Development Lifecycle APPROVAL
  • 25. PDT Pilot Studies ● Gather data on optimizing usability, engagement, and efficacy ● Improve the user experience while not affecting the mechanism of action ● Explore a range of “dosing” regimens
  • 26. Developing Treatment Regimens based upon physician optimization from observation and experience, rather than dose-response theory or logic. Methodology is empirical
  • 27. PDT Validation Studies (RCTs) ● Trials go direct-to-patient using a decentralized clinical trial (DCT) model ○ Quicker speed of recruitment ● Endpoints are largely digital versions of traditional clinical measures, but can also be novel digital biomarkers (dBMs) ● dBMs are compared to existing gold standard endpoints accepted by providers and payers
  • 28. Control Arm / Sham Product ● Use of a control group may be unethical or not feasible (unable to mask) in some cases ● Sham app mimics the digital intervention software without including the MOA ○ Need to ensure sham product does not create a clinical response through placebo effect Sham Real
  • 29. Unique Challenges ● Hitting “okay” button ≠ sufficient consent ● MOA can be unclear ● Poorly defined exposure (using time, frequency, duration) makes response relationship and therapeutic target (optimum exposure) difficult to measure ● Inter-individual variability in response
  • 30. Treatment Paradigms 1. Monotherapy - First line therapy on its own 2. Concert therapy - Designed to be used with other (oftentimes traditional) interventions * Some products can be used as both monotherapies and concert therapies, depending on design and evidence
  • 31. Concert Therapies Companion - Designed be used to treat a condition alongside pharmacological product and/or HCP treatment. Usually not FDA approved. Combination - Designed to be used in conjunction with a specific pharmacological product (single national drug code unique device identifier [NDC-UDI]) Adjunct - Designed to be used with a category of pharmacological interventions or treatments
  • 32. Advantages to Pursuing FDA Approval ● Increased scientific and clinical credibility with HCPs ● Creates higher barrier of entry to competitors ● Allows companies to make a claim regarding a specific condition ● Brings product legitimacy/acceptance and ability to be reimbursable from payers ● Generally allows for a higher price point
  • 33. Drawbacks of Pursuing FDA Approval ● Slower, more costly development process ● Less flexibility to continuously improve the product ● Incurs commercial risk as it defers ROI
  • 34. Benefits ● FDA approval does not guarantee payor uptake or patient engagement ● Iteration of the product after FDA approval can require additional approvals Risks ● Collect usability data ○ Give visibility into personalized care delivery ● Reduced safety concerns ● Dev timeline is shorter ● Cost of goods decreases with volume ● Requires less human capital
  • 36. Post Market SaMD Surveillance ● Must demonstrate continued safety, effectiveness, and performance in the real world ● Data from several sources: ○ SaMD product itself ○ Registries ○ Electronic health information sources ■ National Evaluation System for health Technology (NEST)
  • 37. Real World Performance Data (RWPD) Real World Health Data (RWHD) User Experience Data (UXD) Product Performance Data (PPD)
  • 38. Real World Health Data (RWHD) Outputs and outcomes related to the SaMD definition statement. Used to monitor product’s continued safety and effectiveness. Can inform changes to the intended use of a product, and support expanded functionalities and use in broader target populations.
  • 39. User Experience Data (UXD) Outputs derived from user experiences related to the real-world use of a product. Facilitates timely identification and correction of user issues, and improves the utilization and effectiveness of the software.
  • 40. Product Performance Data (PPD) Outputs and outcomes demonstrating the accuracy, reliability, and security of a product. PPD monitoring allows for timely patches and updates to correct software bugs and security vulnerabilities. Can support modification of claims.
  • 41. Regulatory Oversight and Policing Responsibility may depend on the regulatory designation ○ Food and Drug Administration ○ Federal Trade Commission ○ Federal Communications Commission ○ National Institute of Standards and Technology ○ Office of the National Coordinator for Health Information Technology
  • 42. Post Approval Obligations Failure to comply with post-clearance or approval regulatory requirements could subject the company to ○ Substantial penalties ○ Recall/withdrawal of product from the market
  • 44. Launch Strategy ● Marketing must also educate and drive awareness ○ Utilize medical science liaisons, key opinion leaders ○ Attend industry events which speak to the data and answer questions ○ Publications to peer reviewed journals
  • 45. Scale and Commercialization ● Pathways to scale and commercialize are still largely uncharted ● The market is rapidly evolving, getting increasingly competitive ○ Difficult to forecast demand
  • 46. Customer Economic Model Contract Terms Providers and Employers Risk-sharing Per member per month (PMPM) Payors % Savings Recurring Pharma Licensing, royalty, milestone Recurring or term Patients Free with reimbursement Over-the-counter Example Payment Model by Customer
  • 47. Business Model - B2C Advantages Early revenue opportunities Demonstrate product traction Disadvantages High costs to commercialize Not covered by insurance
  • 48. Business Model - B2B Self-Insured Employers Advantages Faster sales cycle Disadvantages Requires an additional sales step to employee to capture usage fee Labor intensive, deal by deal
  • 49. Business Model - Health Systems, Payers, PBMs Advantages Set rate for DTx usage Use of digital formulary Disadvantages Long contracting process May require pilot or testing period Fee-For-Service
  • 50. PBM Formularies - Examples ● CVS Caremark ○ Sleepio ○ Daylight ○ Hinge Health ○ Hello Heart ○ Torchlight ○ Whil ○ Vida ○ Naturally Slim ○ Weight Watchers ○ Kurbo ● Express Scripts ○ Livongo ○ Propeller Health ○ Omada Health ○ LifeScan ○ Learn to Live ○ SilverCloud Health ○ Wildflower ○ Quit Genius ○ Prevail Health ○ Back with Care ○ Hinge Health ○ RecoveryOne
  • 51. Business Model - Health Systems and Payers Advantages Based on cost savings Disadvantages Difficult to quantify cost savings Value Based Reimbursement Advantages Uses CPT codes Disadvantages Requires FDA approval and path to FDA approval is still undefined Device-Like Reimbursement [Alternatives under consideration]
  • 52. PDT Pricing in the Market Price of DTx is significantly less than conventional therapies *Rx is typically for a 3-6 month treatment period
  • 53. Pricing Strategies Moving from a direct-to-consumer (DTC) offering to a medical benefit, to a pharmacy benefit can 10x the price each time $20/month $200/month $2,000/month DTC Medical Benefit Pharmacy Benefit
  • 55. Patient Perspective If an FDA-approved app or online tool was available to treat your medical condition, how likely would you be to try it? Very likely 21% Somewhat likely 33% Somewhat unlikely 15% Very unlikely 14% I don’t know 17% Source: PwC Health Research Institute’s Annual Report
  • 56. HCP Perspective - Rx Anecdote A doctor has 500 patients… but only 100 are prescribed the PDT. Why? 100 patients “Do everything I ask them to do. They don’t need a PDT.” 100 patients “Never do anything I ask them to do. They would never use a PDT.” 100 patients “Don’t have a smartphone, and can’t use the PDT.” 100 patients “Don’t have a health plan that would pay for a PDT.” “After this triage, there are only 100 left who can use the PDT.”
  • 58. Paradigm Shifts Hardware Software Deterministic Risks of Physical Products Evolving Risks of Digital Products Stable and Predictable Volume Potential for Exponential Volume
  • 59. Reality Check ● Patient, provider, and payer appetite for DTx is still uncertain ○ We still need to show long term patient engagement with DTx products ● PDTs considered software as a medical device (SaMD) do not currently have a benefit category recognized by the Centers for Medicare and Medicaid Services (CMS)
  • 60. Unmet Needs / The Road Ahead ● Integrate DTx into electronic prescribing, dispensing, and medical record platforms and HCP workflows ● Expand outside of chronic diseases ● Build payer reimbursement models (dedicated national codes!) ● Develop better reporting metrics on DTx utilization ● Grow more comprehensive DTx formularies ● Develop regulatory evaluation and commercialization pathways for other major health authorities (EMA, TGA, etc.)
  • 61. UCB DBT’s Vision in DTx ● Partner externally to co-develop and co-commercialize new DTx products ● Add DTx into a more comprehensive portfolio of products for which UCB can synchronize our products and services for more a holistic, continuous patient care continuum
  • 62. Imagination, imagination. A dream, can be, a dream come true. With just that spark, from me and you. One little spark, of inspiration Is at the heart, of all creation. Right at the start, of everything that's new. One little spark, lights up for you.
  • 64. ● https://www.darkdaily.com/fda-approves-digital-therapeutics-technologies-to-treat-pati ent-behavioral-conditions-that-interfere-with-positive-healthcare-outcomes/#:~:text=D igital%20therapeutics%20combine%20apps%20and,focus%20on%20specific%20clinical% 20outcomes. ● https://dtxalliance.org/understanding-dtx/#:~:text=Digital%20therapeutics%20(DTx)%20 deliver%20medical,spectrum%20of%20diseases%20and%20disorders. ● https://www.nature.com/articles/d41586-019-02873-1 ● https://www.fda.gov/media/112680/download ● https://www.fda.gov/media/112901/download ● https://www.pwc.com/us/en/industries/health-industries/library/digital-health-needs-evi dence-and-buy-in.html ● https://www.nature.com/articles/s41746-020-00370-8 ● https://torreya.com/publications/digital-therapeutics-and-future-of-pharma_torreya-feb 2020.pdf ● https://medrhythms.medium.com/looking-back-ahead-at-the-digital-therapeutics-indus try-2e8454d342c5 ● https://www.fda.gov/media/106331/download ● https://www.fda.gov/media/80958/download ● Digital Therapeutics, Dawn of a New Treatment Class, Ahead of the Curve, Cowen and Company Sources