Enhancing Patient Access to Digital Therapeutics - Insights from Trinity, LLC

This presentation by Trinity, LLC delves into enabling patient access to digital therapeutics, offering a deep dive into the current scenario, expected growth, and collaborations in the digital therapeutics market. Featuring expert panelists and insightful discussions, it sheds light on the evolving landscape of evidence-based therapeutic interventions driven by software programs.

• Patient access
• Digital therapeutics
• Trinity LLC
• Healthcare technology
• Pharmaceutical partnerships

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1. Enabling Patient Access to Digital Therapeutics The Optimal Approach? May 9th, 2023 This presentation is provided to you by Trinity, LLC. The presentation is meant to enhance discussions between your organization and Trinity, LLC. The substance of this presentation is confidential and may be legally privileged. This presentation is intended only for those in attendance. 1

2. Session Agenda Multi- stakeholder Perspective on Current DTx Status Closing and Audience Questions Introduction Q&A 2

3. Todays Panelists M nica Mart n de Bustamante Benjamin Parcher, PharmD, MS Lisa Marsch, PhD Fulton Velez, MD, MBA Director Senior Partner Global Market Access Lead CNS Digital Therapeutics, Boehringer Ingelheim Center for Technology and Behavioral Health, and of the Northeast Node National Drug Abuse Treatment Clinical Trials Network Dartmouth College Evidence Value Access and Pricing (EVAP) Moderator Digital and Healthcare Consultant Dr. Velez is an experienced professional in Medical Affairs, HEOR, Market Access, and RWE. He most recently worked as the Head of HEOR at Pear Therapeutics, leading their evidence development programs, which ultimately demonstrated the value of digital therapeutics in patient-relevant outcomes and healthcare resource utilization. Monica has over 10 years experience in global pricing and market access. Focused on understanding the barriers to access and reimbursement challenges posed by evolving healthcare systems and evidence requirements. Benjamin is responsible for digital therapeutic market access strategy in CNS, focusing on the development, execution of pilots, and implementation around digital approaches of data generation and analysis, in close collaboration with cross-functional teams and external stakeholders. Lisa has led the development, evaluation, and implementation of digital therapeutics for addiction treatment, HIV prevention, mental health, chronic pain management, substance abuse prevention, smoking cessation, and binge eating disorder. 3

4. Introduction to Digital Therapeutics Current Scenario of DTx Digital therapeutics (DTx) are evidence-based therapeutic interventions that are driven by high quality software programs to treat, manage or prevent a disease or disorder - DTx may require a prescription (e.g., Pear Therapeutics reSET for substance use disorder) or not require it (e.g., Big Health s Sleepio for insomnia) DTx are particularly prevalent in the cognitive and mental health space, but are becoming more common in areas such as diabetes and hypertension Expected Growth of DTx The U.S., DTx markets are expected to grow from 3.2 billion USD in 2021 to up to 15 billion USD by 2028 There is an increasing potential for DTx companies to collaborate with pharmaceutical manufacturers through development partnerships, licensing of digital technologies, and even digital device/drug combinations - Sanofi recently signed a 30 million USD strategic agreement with Dario Health to accelerate the commercial adoption of Dario s full suite of DTx and expand their digital health solutions 4

5. Commercialization Pathways for DTx Consumer Health Digital Formulary Pharma-like Pharmacy & Therapeutics (P&T) Committee None paid for through OOP payments Combination of different payers (such as P&T Committee, Medical Technologies Committee) Responsible committee Patient-relevant outcomes measured over a long-term period, economic impact (i.e., healthcare resource utilization, cost offsets) Sufficient to drive utilization by patients Requirements adjusted from pharma-like model to enable data collection over time (through the introduction of value-based contracts [VBCs]) Evidence Requirement Payment limited to app, limited reimbursement for HCP time in assessing results, limited price vs. pharma products None paid for through OOP payment Coverage for app use and physician time, additional flexibility around app pricing, especially if VBCs introduced Reimbursement Consideration Ongoing Conversations to Enable Implementation 5

6. Who should be responsible for the financing of DTx? Placeholder for ISPOR QR code 6

7. Session Agenda Multi- stakeholder Perspective on Current DTx Status Closing and Audience Questions Introduction Q&A 7

8. Lisa Marsch, PhD Director of the Center for Technology and Behavioral Health, and of the Northeast Node National Drug Abuse Treatment Clinical Trials Network Dartmouth College Academia Perspective 8

9. Promise of Digital Therapeutics Extends the reach and impact of clinicians Functions like a therapist in your pocket Delivers treatment with fidelity to best practices Virtually all populations have access to mobile devices Offers scalable, science-based behavioral healthcare Improve access, quality and outcomes of care while reducing cost 9 https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/

10. Digital Therapeutics have shown robust effects in a multitude of health domains Increase treatment retention, abstinence rates and quality of life among persons with SUDs Reduce healthcare costs for people with panic disorder, SUD, and OUD Decrease mental health symptoms in people with ADHD, anxiety, depression, PTSD, OCD, and schizophrenia Support medication adherence in patients with ADHD,bipolar disorder, depression, PTSD, schizophrenia, and SUD Improve remission rates in people living with depression and panic disorder Improve functional outcomes in people with depression, panic disorder, and schizophrenia Improve pain management and reduce ED visits among individuals with chronic pain 10

11. Evidence Generation of Digital Therapeutics User-Centered Design Pivotal Clinical Trials Data demonstrating effectiveness are critical But, the following are also essential for widespread adoption and sustained engagement Implementation Science Real World Evidence 11

12. Digital Therapeutics Can be Transformative in Health Care Growth inDigital Health Industry Surging demand forRemote Care Growing global Behavioral Health Needs Evolving Payment Landscape Multiple paths to Deployment 12

13. Benjamin Parcher, PharmD, MS Global Market Access Lead, CNS Digital Therapeutics, Boehringer Ingelheim Industry Perspective 13

14. 43 Prescription Digital Therapeutics Developers (PDTs) | U.S. 2023 43 Prescription Digital Therapeutics Developers (PDTs) | U.S. 2023 Oncology (2) Women s Health (2) CNS (30) Gastro- intestinal (2) Ophthal- mology (2) Respiratory (1) Cardio- metabolic (4) 14 https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/

15. 29 PDTs on Market with 16 authorized by the FDA Product Disease Company Date Product Disease Company Date DTHR-ALZ Alzheimer's Dthera Sciences 23-Aug-18 LIMBIX SparkRx Depression Limbix 8-Oct-21 COVID19 EUA Autism Therapeutic Autism Cognoa 6-Feb-19 Sleepio Insomnia Big Health 10-Mar-23 TLC-001 Stroke Constant Therapy 14-Apr-20 Daylight Anxiety Big Health 10-Mar-23 MR-001 Stroke MedRhythms 15-Jun-20 01 Depression MDD Feel Therapeutics 2023 Breakthrough Designation Alzheimer's Tx Alzheimer's Cognito Therapeutics 12-Jan-21 02 Anxiety GAD Feel Therapeutics 2023 Exmpt Woebot - PPD Post Partum Depress. Woebot Health 26-May-21 JOGO-Gx Cerebral Palsy Jogo N/A BiovitalsHF CHF Biofourmis 29-Jul-21 Oleena Cancer - General Voluntis 31-Jan-19 Stanza Fibromyalgia Swing Therapeutics 11-Aug-21 Insulia Diabetes Voluntis 9-Nov-16 Pear-009 Alcohol Use Disorder Pear Therapeutics 22-Nov-21 Bluestar Diabetes Welldoc 15-Jul-10 BNT-200 Anxiety in AML Bluenote Therapeutics 6-Jan-22 iSage Rx Diabetes Amalgam Rx 7-Mar-17 DCH-001 Smoking Cessation DynamiCare Health 22-Feb-22 Freespira PTSD Freespira 23-Aug-18 510(k) WYSA MSK Pain MSK Pain Wysa 13-May-22 reSET-O Opioid Use Disorder Pear Therapeutics 23-May-19 gameChange Pain BehaVR 22-Jun-22 Leva Urinary Incontinence Renovia 22-Nov-19 CT-132 Migraine Click Therapeutics 20-Dec-22 Somryst Chronic Insomnia Pear Therapeutics 23-Mar-20 Pear-004 Schizophrenia Pear Therapeutics 29-Apr-20 Mahana IBS Irritable Bowel (IBS) Mahana Therapeutics 2-Jun-21 Skylar's Run ADHD ATENTIV Health 1-Jun-20 Regulora Irritable Bowel (IBS) metaMe Health 24-Nov-21 Deprexis Depression GAIA 1-Jul-20 reSET Substance Abuse D. Pear Therapeutics 14-Sep-17 COVID19 EUA Vorvida Alcohol Use Disorder GAIA 15-Jul-20 Endeavor Rx (8-12 yrs) ADHD Akili Interactive 15-Jun-20 De Novo Attune (BNT-001) Anxiety Bluenote Therapeutics 21-Jan-21 Nightware PTSD Nightware 6-Nov-20 Cerena Wellbeing Bluenote Therapeutics 21-Jan-21 Luminopia One Amblyopia Luminopia 10-Oct-21 Ensemble Depression & Anxiety Happify Health 22-Jul-21 RelieVRx Pain AppliedVR 16-Nov-21 Stanza Fibromyalgia Swing Therapeutics 11-Aug-21 BT-001 T2 Diabetes Better Therapeutics Under Review Note: https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/ FDA authorized = Exempt + 510(k) + DeNovo, BT-001 is under review as of publication FDA s waiver for COVID19 EUA will end on Nov 7, 2023 as announced on March 27, 2023 (https://www.fda.gov/media/155038/download) 15

16. 29 PDTs on Market with 20 potential upcoming launches Upcoming Launches (2023+ Late Development Programs) Products on Market as of 3/21/2023 Welldoc - Bluestar Diabetes: 2010 Amalgam Rx - iSage Rx Diabetes: 2017 Voluntis - Insulia Diabetes: 2017 Freespira - Freespira PTSD: 2018 Pear Therapeutics - reSET Substance Abuse Disorder: 2019 Pear Therapeutics - reSET-O Opioid Use Disorder: 2019 Renovia - Leva Urinary Incontinence: 2019 Voluntis - Oleena - Cancer General: 2019 Jogo - JOGO-Gx Cerebral Palsy: 2020 Akili Interactive - Endeavor Rx (8-12 yrs) ADHD: 2020 Pear Therapeutics - Pear-004 Schizophrenia: 2020 ATENTIV Health - Skylar's Run ADHD: 2020 GAIA - Deprexis Depression: 2020 GAIA - Vorvida Alcohol Use Disorder: 2020 Pear Therapeutics - Somryst Chronic Insomnia: 2020 Mahana Therapeutics Mahana IBS IBS: 2020 Nightware - Nightware PTSD: 2020 Bluenote Therapeutics - Attune (BNT-001) Anxiety: 2021 Bluenote Therapeutics - Cerena Wellbeing: 2021 Twill Health - Ensemble Depression & Anxiety: 2021 Limbix - LIMBIX SparkRx Depression: 2021 Luminopia - Luminopia One Amblyopia: 2021 AppliedVR - RelieVRx Pain: 2021 metaMe Health - Regulora IBS: 2021 Big Health - Sleepio Insomnia: 2022 Big Health - Daylight Anxiety: 2022 Feel Therapeutics - 01 Depression Depression: 2022 Feel Therapeutics - 02 Anxiety Anxiety: 2022 Swing Therapeutics - Stanza Fibromyalgia: 2022 Better Therapeutics - BT-001 Diabetes: In Review via De Novo DynamiCare Health - DCH-001 Smoking Cess. Woebot Health - PPD Woebot Health - Adolescent Depression Akili Interactive - Endeavor (13-17 yrs) ADHD Click Therapeutics + Otsuka - CT-152 Depression ~ 2010 2017 2023+ 2018 2019 Akili Interactive - Endeavor (18+ yrs) ADHD GAIA + Orexo - Modia Opioid Use Disorder Jogo - JOGO-002 Chronic Pain Jogo - JOGO-003 Cancer Pain Biofourmis - BiovitalsHF CHF ~ PDT U.S. Launch Timeline (U.S. 2010 2023+) 2020 Click Therapeutics + Boehringer Ingelheim CT-155 Schizophrenia Oui Therapeutics - Aviva Suicide Cognito Therapeutics - CogTx-001 Alzheimer s Disease Bluenote Therapeutics - BNT-200 AML ~ 2021 BehaVR - gamChange Schziophrenia MedRhythms - MR-001 Chronic Stroke Cognito Therapeutics - CogTx-002 MCI DynamiCare Health - DCH-002 Alcohol Use Disorder MindMaze - Toap Run Parkinson s Disease 2022 510(k) DeNovo Exempt COVID EAU Est. Upcoming FDA Breakthru https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/ 16

17. Key Data Points PDTs PDT Developers PDT Areas of Focus 154 PDTs were identified with U.S. market intentions; 15 more than last year s 139 43 PDT developers were identified (3 more than last year) The top therapeutic areas for PDTs are CNS (119), Cardiometabolic (18), Gastrointestinal (11), Oncology (9), and Women s Health (5) 29 PDTs are on-market when combining FDA authorized (16; same as last year) and COVID EUA (13; 5 more than last year) The largest PDT developers are Pear Therapeutics (17), Arcade Therapeutics (Formerly Wise, 12), Jogo Health (10), Click Therapeutics (9), Akili Interactive (8), and MedRhythms (7) The top indications for PDTs are anxiety disorders (12), pain (9), multiple sclerosis (9), depression (8), ADHD (7), and migraine (6) 27 PDTs are being commercialized by start- up developers, while the remaining two are commercialized via Orexo pharmaceuticals A handful of pharma companies are active in PDT development such as Orexo/GAIA, Otsuka/Click, Boehringer Ingelheim/Click, and Biogen/MedRhythms The overall PDT pipeline decreased to 124 from 139, furthermore, several leading PDTs such as Pear Therapeutics (13)[2] and Akili Interactive (3) [3] have noted that they will pause several programs while focusing on commercial operations 19 PDTs are in late development and have the potential to launch in the next few years 17 https://bluematterconsulting.com/prescription-digital-therapeutics-us-market-outlook-2023/

18. Fulton Velez, MD, MBA Digital and Healthcare Consultant Payer and evidence development perspective 18

19. Current and future evidence development and reimbursement models for digital therapeutics in the US market, and where the market will head as digital therapeutics become available for larger indications 19

20. Evidence Development Current Future (2-5 years) Emphasis on efficacy and safety (clinical trials), or evidence of clinical benefit supported by previous studies (pre-post, vs. control) Long-term durability of clinical and impact, including impact on other chronic conditions (e.g., cardiovascular health) Small sample sizes, pilot-study focus (often inconclusive due to small sample sizes) Larger sample sizes, emphasis on multi-stakeholder (or multi- state) evidence generation Emphasis on patient outcomes Impact on population health - Change in patient-important outcomes (e.g., reduced mortality, improved QoL, functioning) - Impact on mental health, health inequities Comparative effectiveness of DTx to treat same disease Onset of action (rapid vs. gradual), disease modification Impact on patient journey Patient engagement and use patters and correlation with outcomes Primary prevention of onset of illness in high-risk groups Health care utilization/cost impact (short-term vs. long-term) 20

21. Reimbursement Models Current Future (2-5 years) Confusing, multiple stakeholders with no central coordination Streamlined, Pharmacy and Therapeutics Committee-led evaluations with input from mental/behavioral health experts - Leveraging AMCP dossier format Lack of standardized format for DTx evaluations B2B, B2C B2B, B2C with reduction of premiums due to improved population, employee health Value-based contracts informed by measurable HCRU/economic impact) - Payer fear of financial risk Value-based, with enriched targeting of groups with unmet need and greater potential clinical and economic benefit - Payer understanding of limited risk, pressure-test mentality - Conducted with informed clinicians, who have been fully trained on the implementation of the DTx Based on replacement of physical services (non-expansion paradigm) - Not enough counselors, perpetuates mental health inequity - Evaluate patient benefit first, then impact on utilization of F2F counseling Based on expanded delivery of evidence-based and guideline- recommended behavioral treatments (expansion paradigm) - Coverage enriches face-to-face interactions - Larger populations treated lead to better effectiveness evaluations by industry/payers 21

22. Market trends as digital therapeutics become available for larger indications Responders/subgroups Additional insights generated by HEOR, Data Science, Machine learning Intervention and deployment at earlier stages of the patient journey Greater integration with wearables Collaboration between like-minded DTx companies to augment clinical and economic impact Increased attention from traditional biopharmaceutical companies to boost effectiveness of their products Multi-payer engagement to improve population health, lower costs and reduce health inequities Improved tracking of individuals health and better assessment of intervention opportunities 22

23. Do you believe the evidence bar for DTx should follow that of pharmaceuticals? Placeholder for ISPOR QR code 23

24. Session Agenda Multi- stakeholder Perspective on Current DTx Status Closing and Audience Questions Introduction Q&A 24

25. How should insurers assess the value attribution of a digital therapeutic? Where should the bar be set? 25

26. What should the responsibility of an insurer vs. a patient be when speaking about financing of DTx? 26

27. What evidence would be sufficient and should be required to make an informed coverage decision? 27

28. What trends outside of evidence development and reimbursement might make DTx commercialization challenging? 28

29. Any advice for pharma companies scoping out partnerships with DTx companies? Advice for standalone DTx developers looking to launch? 29

30. Where do you see the DTx space moving in the future? 30

31. Questions Panel Discussion 31