digital therapeutics alliance€¦ · digital therapeutics empower patients, clinicians, and payers...

CONFIDENTIAL 1/30/2020

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Copyright © 2020 DTA

Digital Therapeutics:Combining Technology and Evidence-based

Medicine to Transform Personalized Patient Care


Presentation Agenda

Overview

• Digital Therapeutics Alliance

• International engagement

Understanding the Digital Landscape

• Product categories

Pharmacist & Clinician Next Steps

• Medical care pathways

• Patient access and product coverage

Regulatory Environment

• Quality standards

• Regulatory oversight

Discussion

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DTA | Confidential © 2020

DIGITAL THERAPEUTICS ALLIANCE

Priorities & International Engagement


Digital Therapeutics AllianceOur goal is to engage with patients, clinicians, payers, and regulators in order to provide them with the necessary tools to properly recognize, evaluate, and utilize digital therapeutics.

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International Engagement

The Digital Therapeutics Alliance’s 35-plus members represent 14 countries across four continents*

AustraliaBelgiumCanadaDenmarkFinlandFranceGermany

IrelandIsraelSouth KoreaSpainSwitzerlandUnited KingdomUnited States

Copyright © 2020 DTA*As of January 2020

Digital Therapeutics Alliance Members*

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https://dtxalliance.org/headspacehealth/

https://dtxalliance.org/membership

https://dtxalliance.org/membership

https://dtxalliance.org/silvercloud/


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UNDERSTANDING THE DIGITAL LANDSCAPE

Product Types & Functions


What direct treatment options are available to clinicians?

In-person therapy

Small molecule drugs

Biologics Digital therapeutics

Large molecule drugs

This list provides a high-level overview of

the medical field and is not all-inclusive.

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What is a digital therapeutic?

Digital therapeutic definition:

Digital therapeutics (DTx) deliver to patients evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

DTx products incorporate advanced technology best practices relating to design, clinical evaluation, usability, and data security. They are reviewed and cleared or approved by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.

Digital therapeutics empower patients, clinicians, and payers with intelligent and accessible tools for addressing a wide range of conditions through high quality, safe, and effective data-driven interventions.

Learn more about digital therapeutics at www.dtxalliance.org/aboutdtx/


How do clinicians navigate the digital landscape?

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What are differences between digital health products?


What is NOT a digital therapeutic?

‘Digital Health’ products that do not claim to prevent, manage, or treat a disease are not subject to the same standards and best practices as digital therapeutics. It is therefore important to differentiate which products are and are not a digital therapeutic.

Products considered to NOT be a digital therapeutic include:

• Lifestyle and fitness apps • Medication adherence tools• Diagnostic products• Telehealth and telemedicine platforms• Clinical decision support and/or predictive analytic products• Use of digital tools to support drug trials• Digitization of healthcare processes

What is a digital therapeutic?Delivers evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.

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Does it matter how products are used in practice?

Digital Health

• Medication reminders

• Fitness tracking

• Nutrition apps

• Wellness & lifestyle apps

• Consumer health information

• Telehealth platforms

• Electronic health records

• Clinical trial software

Digital Medicine

• Diagnostic products

• Remote patient monitoring

• Clinical decision support

• Ingestible sensors

• Connected drug delivery device

• Insulin pump

• Digital biomarkers

• Sensors that measure vitals and physiologic data

Digital Therapeutics

Deliver therapeutic interventions directly to patients via software, such as:

• Treat patients with substance use disorder (SUD)

• Improve asthma and COPD control and optimize healthcare utilization

• Deliver Cognitive Behavioral Therapy (CBT)

• Digital diabetes prevention and management programs

• Responsive delivery of physical exercises, behavioral therapy, and education for chronic back pain patients


Do product functions, claims, and risk matter?

Clinicians need to know: • What should I expect?• Does this provide actionable data or

insights?• Should I prescribe this?• How does it relate to other treatments?

Patients need to know:• What am I using?• Why am I using it? • How will it help?• Has someone verified it is

safe and effective?

Regulators need to know:• What level of risk does each product

pose to patients?• What is the appropriate level of

regulatory oversight?

Payers need to know: • What type of product are we

covering? • How will it benefit patients?• What type of value and clinical

outcomes should we expect?

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DIRECT LINES TO PHARMACY PRACTICE

Clinical Next Steps


Accounting for the diversity of products across the industry, digital therapeutics have the potential to:

• Provide patients, clinicians, and payers with novel therapy options for conditions that previously havebeen untreated or undertreated by traditional medications and therapies

• Address a large range of physical, behavioral, and mental disorders and diseases

• Improve clinical and health economic outcomes at the patient and population levels

• Personalize care based on individual patients’ needs and abilities

• Reduce stigma associated with the delivery of certain traditional therapies

• Lower side effect profile for than with traditional pharmaceuticals

• Work independently or in concert with medications, devices, or other therapies to optimize patientcare and health outcomes

• Expand access to evidence-based medical therapies locally, nationally, and globally

What clinical value do DTx products provide?

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How are DTx products’ clinical value delivered in practice?

• Treat conditions not adequately addressed through traditionaltherapies

• Enhance the impacts of – or optimize the use of – traditionalmedications

• Address specific comorbidities, side effects, or affiliatedconditions to offer a more complete and well-roundedtherapy

• Provide active treatment through direct activation of neuralnetworks

• Deliver cognitive behavioral therapy and other evidence-basedtreatments

• Provide disease management and prevention programs


Do DTx products have a traditional mechanism of action?

Medications Digital Therapeutics

DTx equivalent of PK/PD = patient engagement

• Engaging and relevant product design

• Time of product use

• Duration of product use

• Frequency of product use

• Strength of digital intervention

• Clinical team engagement and support

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What indicates a high quality DTx product?

✓ Prevent, manage, or treat a medical disorder or disease

✓ Produce a medical intervention that is driven by software

✓ Incorporate design, manufacture, and quality best practices

✓ Engage end users in product development and usability processes

✓ Incorporate patient privacy and security protections

✓ Apply product deployment, management, and maintenance best practices

✓ Publish trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals

✓ Reviewed and cleared or approved by regulatory bodies as required to support product claims of risk, efficacy, and intended use

✓Make claims appropriate to clinical validation and regulatory status

✓ Collect, analyze, and apply real world evidence and/or product performance data

All products claiming to be a digital therapeutic must adhere to these foundational principles:


What diseases do DTx products target?

• Asthma

• Attention-deficit/hyperactivity disorder

• Autism spectrum

• Cardiovascular disorders

• Chronic obstructive pulmonary disease

• Concussion

• Chronic pain

• Depression

• Diabetes

• Epilepsy

• Gastrointestinal disorders

• Hypertension

• Insomnia

• Motor, speech, and cognitive dysfunction

• Multiple sclerosis

• Neurologic disease and injury

• Obesity

• Oncology

• Opioid use disorder

• Panic disorders

• Parkinson’s disease

• Post-traumatic stress disorder

• Schizophrenia

• Sleep disorders

• Stroke rehabilitation

• Substance use disorder

• Traumatic brain injury

…and others

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How do DTx products and drugs work together?

In-person therapy

Small molecule drugs

Biologics Digital therapeutics

Large molecule drugs

Multimodal therapy (i.e. substance abuse)

Phased start(i.e. behavioral disorders)

Medication optimization(i.e. diabetes)

✓ ✓✓

Therapy optimization(i.e. chemo side effects)

✓ ✓

✓ ✓✓

Drug 1st ,

DTx 2nd

DTx 1st ,

Drug 2nd

Standalone therapy(i.e. chronic back pain)

✓


What types of outcomes are demonstrated?• On average, over 50% of patients with uncontrolled asthma achieve controlled status within one year of starting on

Propeller. These consistent results are seen across randomized clinical studies and in diverse commercial programs. Analyzing all patients on the Propeller System, daily rescue inhaler use drops rapidly and persistently, with a 79% average reduction in rescue inhaler use at 1 year.1

• For patients with Substance Use Disorder related to alcohol, cannabis, cocaine, or stimulants, abstinence rates fromthese substances more than doubled (40% vs 18%). Treatment retention rates also increased by nearly 15% (76% vs 63%) for patients randomized to Pear Therapeutic’s reSET compared to treatment as usual.2

• Welldoc’s BlueStar has demonstrated through 45 peer-reviewed clinical publications, studies, and posters that their DTxproduct for diabetes consistently delivers an A1C improvement of 1.7-2.0 points. Using A1c reduction data andadjudicated claims data, BlueStar has the ability to lower Medicare costs on average by:3

• $3,672 annually for beneficiaries who begin using BlueStar with an initial A1c greater than or equal to 9;

• $3,048 annually for those with an average initial A1c greater than or equal to 8; and,

• $1,392 annually for beneficiaries with an average initial A1c greater than or equal to 7

• Palo Alto Health Science’s Freespira resulted in 81% of subjects being designated as panic free one year post-treatment,with 94% of patients demonstrating significant reductions in panic symptoms.4

• In addition to clinical improvements, all-source medical spending was reduced by 50% in the year following Freespiratreatment, including a 53% reduction in medication costs, and 64% reduction in emergency department costs

• Akili Interactive's AKL-T01 delivered similar improvements in children taking stimulant medications for ADHD and inthose not taking stimulants. Improvements increased with a longer duration of treatment and showed a safety profile with no serious adverse events observed.5

1 https://www.propellerhealth.com/outcome/

2 https://www.resetforrecovery.com/effectiveness

3 https://www.welldoc.com/health-plans/

4 https://freespira.com/results/

5 https://www.akiliinteractive.com/news

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https://www.propellerhealth.com/outcome/

https://www.resetforrecovery.com/effectiveness

https://www.welldoc.com/health-plans/

https://freespira.com/results/

https://www.akiliinteractive.com/news


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DIRECT LINES TO PHARMACY PRACTICE

Operational Next Steps


What operational value do DTx products provide?

Accounting for the diversity of products across the industry, digital therapeutics have the potential to:

• Be used independently or in conjunction with other therapies

• Enhance, support, and optimize current medical treatments

• Reduce reliance on certain pharmaceuticals or other therapies

• Integrate into medical guidelines and best practices

• Be prescribed and dispensed as a “prescription-only” product

• Be provided to a patient as an “over the counter” product

• Provide care independent of a patient’s schedule and in the privacy of their own environment (e.g.,home, office, on-the-go, etc.)

• Provide patients, caregivers, and clinicians with secure updates on personalized goals and outcomes

• Incorporate real world data to improve product design, engagement, personalization, usage, andoutcomes

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What standards do DTx products adhere to?International Oversight National Oversight:

United States

National Oversight:

United Kingdom

Software design and manufacture IEC 62304, ISO 14971, IEC 62366-1,

AAMI TIR 45, IEEE P2675, ISO 13485

Patient-centered design ISO 9241-210, ISO 62366

Product interoperability ISO/IEEE 11073

Product security HITRUST certification, SOC 2

certification

Patient privacy Health Insurance Portability and

Accountability Act (HIPAA)

General Data Protection

Regulation (GDPR)

Evaluation of product safety* Food and Drug Administration

(FDA)

Medicines and Healthcare

Products Regulatory Agency

Evaluation of clinical efficacy* Food and Drug Administration

(FDA)

National Institute for Health

and Care Excellence (NICE)

Oversight of product claims, labeling,

and advertising

Federal Trade Commission (FTC) National Institute for Health


Cost-effectiveness National Institute for Health


Market affordability National Health Service (NHS)

* As required to support product claims of risk, efficacy, and intended useDRAFT – under development


How do DTx products parallel medication “rights”?

Patient Healthcare Rights Drugs? DTx products? Applicability to DTx products

The right drug or therapy ✓ ✓ Targeted therapies for specific indications

The right patient ✓ ✓ Personalized interventions

The right dose and dosage form ✓ ✓ Varying product strengths and types

The right time and frequency ✓ ✓ Dosing frequency and utilizations times

The right route ✓ ✓ Mobile device, tablet, desktop, VR headset

The right reason ✓ ✓ Timing of therapy start, duration, and end

The right response to therapy ✓ ✓ Clinical outcomes documented by product

The right assessment ✓ ✓ Summary data shared with clinician(s)

The right to refuse ✓ ✓ Patient consent documented by product

The right patient education ✓ ✓ Patient onboarding by product or clinician

The right outcomes documentation ✓ ✓ Integration of product outcomes into EHR

The right evaluation ✓ ✓ Adverse events, non-optimal outcomes, and lack of utilization tracked by product

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How do DTx products relate to traditional practice?

Medical Practice

• Make traditional medical claims:

• Improve a health function

• Manage a disease

• Treat a disease

• Deliver medical-grade therapeuticinterventions

• Produce and measure clinical outcomes

• Generate ongoing product performancedata in real world settings

Practice Integration

• Comply with evidence-based medicineprinciples and practices

• Product development best practices andstandards

• Clinical trials and ongoing evidencegeneration

• Incorporated into medical practiceguidelines

• Integrate into EHRs, dispensing systems, andworkflows


How do patients access DTx products?


Regulated as a Medical Device

Prescription Only

Processed via specialty

pharmacy

Delivered through EHR platform

Activation code delivered via third

party payor

Over the Counter

Recommendation or referral by clinician

Activation code delivered via EHR, third-party payor,

or employer

Not subject to regulatory oversight

Direct to Consumer

Recommendation or referral by clinician

Activation code delivered via EHR, third-party payor,

or employer

DRAFT – under development

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How are DTx products covered?

Product coverage examples include:

• Express Scripts’ Digital Health Formulary: A Foundation for the Future of Pharmacy (12 December 2019)

• Blue Cross and Blue Shield of Minnesota Launches Omada’s Type 2 Diabetes Management Program (13 November 2019)

• Big Health’s Sleepio product receives coverage by the NHS (20 May 2019)

• WellDoc’s BlueStar product receives coverage by Business Health Care Group (14 May 2019)

• Omada Health’s product receives coverage by Priority Health (3 October 2018)

• Palo Alto Health Sciences’s Freespira product receives coverage by Highmark Inc. (24 September 2018)

• Omada Health’s product receives coverage by Cigna (18 September 2018)

• Propeller Health’s product receives coverage by Anthem Blue Cross and Blue Shield (16 August 2018)

• Voluntis’ Insulia product receives coverage by WellDyneRx (14 May 2018)

• Propeller Health’s product receives coverage by Express Scripts (16 November 2017)


REGULATORY ENVIRONMENT

Ethical Standards & Regulatory Oversight

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https://www.express-scripts.com/corporate/articles/digital-health-formulary-announced

https://www.omadahealth.com/press/press-release-blue-cross-and-blue-shield-of-minnesota-launches-omadas-type-2-diabetes-management-program

https://apnews.com/Globe%20Newswire/f96d41edcbae1f906ff30afeb46fddaa

https://www.welldoc.com/news/business_health_care_group_welldoc_partnership/

https://www.omadahealth.com/press/press-release-priority-health-first-to-offer-omada-health-virtual-diabetes-prevention-tool-to-michigan

https://freespira.com/highmark-inc-adds-coverage-for-medical-innovations-in-treatment-of-panic-attacks/

https://www.omadahealth.com/press/press-release-cigna-expands-personalized-diabetes-prevention-program-in-collaboration-with-omada-health

https://www.propellerhealth.com/2018/08/16/anthem-blue-cross-blue-shield-collaborates-propeller-health-support-consumers-copd/

http://www.voluntis.com/en/news/news-1/2018/voluntis-signs-contract-with-us-payer-welldynerx-for-coverage-of-a-digital-therapeutic

https://www.propellerhealth.com/2017/11/16/propeller-health-express-scripts-partnership-offers-innovative-digital-respiratory-care-improve-health-people-asthma-copd/


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DTx Industry Code of Ethics

1. Demonstrate a commitment to patient safety.Do no harm.

2. Develop interventions that improve thequality of care, clinical outcomes, and qualityof life.

3. Protect patients’ rights to privacy, consent,and knowledge of data use.

4. Directly align the product definition, claims,benefits, and risks with all analytical andclinical evaluation outcomes.

5. Make claims appropriate to product statuswithin each applicable regulatory jurisdiction.

6. Ensure that credible evidence supportingproduct claims and outcomes is readilyavailable to patients, caregivers, clinicians,and payors.

7. Bring products to market in a responsible way.

8. Verify that products perform as expected anddeliver on stated claims.

9. Ensure that product security, data, andfunctionality are not compromised.

10. Maintain a culture of quality andorganizational excellence.


How are DTx products regulated in the US?


Regulated as a Medical Device

(CDRH)

Class I and Class II (510k exempt)

General Controls“Registered”

FDA facility registration

Class IISpecial Controls

“Cleared”

510(k) submission (Substantial

equivalence to predicate device)

Class I, IIDe Novo

“Ordered, Granted, Cleared”

De Novo Classification

(no predicate device)

Class III

Premarket Approval (PMA)

“Approved”

PMA Application

Regulated as Combination Product

/ Prescription-Related Software

Combination drug & DTx pathway

(CDER, CBER, CDRH)

Prescription drug-use-related software

(OPDP)

Not actively regulated by FDA

Exempted by FDA Guidance

Mobile Medical Apps with enforcement discretion (CDRH)

Class I & II

Not Subject to FDA Oversight

Service-based digital therapeutics that do

not involve the manufacturing or sale

of a product

Traditional Medical Device

Software as Medical Device (SaMD)

Pre-Certification Program (Pilot)

DRAFT – under development

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DTx Product Quality Standards

Collaboration established in May 2018 with the U.S. Pharmacopeia to explore the development of appropriate standards and guidelines for digital therapeutics

Questions under consideration:

• Are there additional ways to enable patients and clinicians to have even greater confidenceusing digital therapeutics?

• What would quality standards for digital therapeutics entail?

• How do we identify the active ingredient and mechanism of action of a DTx product?

• Is it reasonable to create a monograph for a DTx product?

• How do we identify potential counterfeit or adulterated products?


DTA Legislative Initiative: DTx Benefit Category

To encourage the recognition and coverage of this new category of medicine, DTA is building a coalition of national and regional organizations, including:

• Patient advocacy and representative organizations

• Clinician and representative organizations

• Medical device manufacturers and industry associations

• Pharmaceutical and life science companies and industry associations

• Payors and healthcare decision makers

• Standard setting and certification bodies

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Founded in 2017, the Digital Therapeutics Alliance (DTA) is a non-profit trade association of industry leaders and stakeholders engaged in the evidence-driven advancement of digital therapeutics (DTx).

For more information, visit www.dtxalliance.org.

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http://www.dtxalliance.org

digital therapeutics alliance€¦ · digital therapeutics empower patients, clinicians, and payers...

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