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Overcoming Barriers to Scale in Digital Therapeutics

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Presentation at Clinically Validated DTx Conference in Boston (November 2019). What paths have DTx products taken toward commercialization, what are the barriers, what is changing?

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Overcoming Barriers to Scale in Digital Therapeutics

  1. 1. Overcoming Barriers to Scale in Digital Therapeutics @cwhogg Chris Hogg Chief Commercial Officer
  2. 2. Digital transformation is coming to healthcare
  3. 3. Healthcare transformation is inevitable, just slow Source: McKinsey and Co. @cwhogg
  4. 4. Pharmaceuticals: Traditional medicines → Digital therapeutics For us this means the rise of digital therapeutics @cwhogg
  5. 5. We have overcome many barriers thus far in the development of DTx Can we make a tech product that positively impacts important clinical outcomes? Can we prove outcomes in RCTs and real-world clinical programs? Can we successfully run pilots with leading healthcare organizations? Can we scale within leading healthcare organizations? Can we achieve ubiquitous payment / reimbursement? Can we own financial and clinical risk? We are here $ @cwhogg
  6. 6. We have generated significant evidence DTx work @cwhogg
  7. 7. 0.1% - 0.2% patient share Yet, even the leading companies have tiny patient shares >250,000 patients 208,000 patients >100,000 patients Diabetes 30M Pre- diabetes 84M High blood pressure 78M High cholesterol 78M Asthma 25M COPD 16M @cwhogg
  8. 8. While belief in the market is high, nothing has scaled The main question remains: Why hasn’t it scaled? Patients, Providers, Payers and Pharma now see DTx as an inevitable part of the future of disease management. @cwhogg
  9. 9. Historically, digital health companies have used 3 primary commercial models, each with unique barriers and challenges What are the barriers? It depends on the path... Direct to Patient (DTP) Employer/Payer to Patient Provider to Patient 1 2 3 @cwhogg
  10. 10. Direct to patient (DTP) Optional Patient marketed to online Patient enrolls and devices shipped to patient’s home (if needed) Patient uses DTx Key Learnings/Blocks: ● Possible to enroll a lot of people, quickly ● Patients pay for wellness and vanity but don’t (yet) pay for ‘clinical’ ● Monetization of these patients via other channels is challenging Optional: Patient is monitored by company care managers 1 @cwhogg
  11. 11. Digital health is littered with DTC failures (and pivots) @cwhogg
  12. 12. We may be getting closer to patient pay for clinical use cases @cwhogg
  13. 13. Employer/Payer to patient Key Learnings/Blocks: ● If enrolling from payer list to member, you need high conversion and retention ● Most successful companies here are full stack service providers ○ Provides enabling services, not just tech ○ Allows billing as in-network provider (service, not a product) Employer/Payer creates list of eligible members DTx/Payer markets directly to members and ships hardware to patient’s home Patient uses DTx and is monitored by care managers 2 @cwhogg
  14. 14. Going around the current doctor / patient relationship Company sells directly to employer or payer Market to members from list Member uses product and benefits Member has access to clinical services Process goes around current doctor/patient relationship @cwhogg Data back to employer/payer
  15. 15. Most successful companies in this approach look more like providers than DTx. Companies with most traction in this case are in diabetes, pre-diabetes and mental health, and include coaches, therapists and physicians. DTx or Provider 2.0? @cwhogg
  16. 16. Provider to patient Key Learnings/Blocks: 1. If you want providers to be your referal channel, you need universal reimbursement a. Reimbursement for product and provider time b. Reimbursement for VBC and FFS patients 2. No current clinical workflows to order/prescribe and monitor Physician identifies patient and prescribes DTx Patient uses DTx Clinic staff creates account or patient self-enrolls Optional Patient is optionally monitored by care managers 3 @cwhogg
  17. 17. Who else uses this provider-directed approach? Basically, everyone…. @cwhogg
  18. 18. Providers must be incentivized to change workflow Today the majority of providers are practicing in a ‘mixed risk’ environment. They are at risk for some outcomes, with some of their patients. Additionally most providers do not want to treat patients differently based on payer status. Financially at risk (VBC) Fee-for-Service (FFS) Clinicians need coverage for their entire population: 1) Coverage for product/service 2) Payment for clinician time Physician might be motivated Physician not motivated without traditional coverage@cwhogg
  19. 19. Even with incentives, we must make it simple for providers to use DTx @cwhogg “And this is where our clinical workflow redesign team went insane”
  20. 20. When a new medicine is approved, the system just works 1. Medicine approved (1) @cwhogg
  21. 21. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code (1) (2) Unique Identifier @cwhogg
  22. 22. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow (1) (2) (3) Unique Identifier @cwhogg
  23. 23. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow 4. Doctor knows where to find it and Rx it (1) (2) (3) (4) Unique Identifier @cwhogg
  24. 24. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow 4. Doctor knows where to find it and Rx it 5. Rx magically goes to pharmacy (1) (2) (3) (4) (5) Unique Identifier @cwhogg
  25. 25. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow 4. Doctor knows where to find it and Rx it 5. Rx magically goes to pharmacy 6. Wholesalers get medicine to pharmacies (1) (2) (3) (4) (5) (6) Unique Identifier @cwhogg
  26. 26. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow 4. Doctor knows where to find it and Rx it 5. Rx magically goes to pharmacy 6. Wholesalers get medicine to pharmacies 7. Patient knows to pick up medicine at pharmacy (1) (2) (3) (4) (5) (6) Unique Identifier (7) @cwhogg
  27. 27. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code 3. Medicine shows up in EMR eRx flow 4. Doctor knows where to find it and Rx it 5. Rx magically goes to pharmacy 6. Wholesalers get medicine to pharmacies 7. Patient knows to pick up medicine at pharmacy 8. Manufacturer gets paid (1) (2) (3) (4) (5) (6) Unique Identifier (7) $$ (8)
  28. 28. When a new digital therapeutic is cleared, nothing works Unique Identifie r (1) (2) (3) (4) (5)(6) 1. DTx approved/cleared 2. DTx does not get unique identifier code 3. DTx does not show up in the EMR (anywhere) 4. Doc does not know where to find it and Rx it 5. New: Patient needs to create account 6. New: Patient has to get kit individually fulfilled and set up 7. Manufacturer does not get paid @cwhogg
  29. 29. Then data from these DTx must get back to providers We must close the loop. Data from DTx are valuable to prioritize outreach, make medication changes and improve quality of in-person visits. @cwhogg
  30. 30. DTx data allow stratification based on need With DTx data, providers and health systems can more efficiently and effectively allocate scarce resources @cwhogg
  31. 31. We are building new rails one step at a time @cwhogg
  32. 32. Time for optimism: What is changing? 1. Product Evolution 2. Infrastructure 3. Reimbursement @cwhogg
  33. 33. Making DTx look more like a drug We are beginning to make DTx products look more like today’s medicines, and are helping them find their proper places in treatment algorithms Teva’s Digihaler @cwhogg
  34. 34. We are building more complete solutions We are learning how to build complete solutions that fill needed gaps, and that integrate into the healthcare system and workflows From App to Complete Solution @cwhogg
  35. 35. We are building new distribution infrastructure New products, services and capabilities are making it easier for physicians to order connected medicines, get patients enrolled and get data back into the physician’s EMR. Lobbying for drug-like IDs to include in eRx lists New tools to order DTx products from the EMR Health Systems are investing in infrastructure The ability to integrate seamlessly into multiple EMRs is getting easier Unique Identifier @cwhogg
  36. 36. We are establishing payment and reimbursement Advances in US and global payer policies point to clear progress in adding DTx to traditional healthcare payment models. PBM benefit Reimbursement Medical benefit Reimbursement (RPM) Ex-US Reimbursement January 2019 CPT 99453 One time setup CPT 99454 Device/service CPT 99457 Physician interpretation May 2019 ES announced plans to launch first ‘digital formulary’ in 2020 June 2019 CVS Caremark followed suit with similar announcement 2017 UK’s NHS has been reimbursing for select tools since 2017. November 2019 The German Parliament passed the Digital Supply Law @cwhogg
  37. 37. Patients will have more therapy options, will get to the best therapy regimen faster, and have better control of their health. Physicians will have more therapy options, and care teams will have better data on how patients are doing. Payers and hospitals will lower utilization and costs, and have data on which therapies are most useful in which patient groups. Lack of current scale is not due to lack of underlying value proposition With DTx: @cwhogg
  38. 38. Digital therapeutics represent the next era of development in medicine @cwhogg
  39. 39. With digital therapeutics, we will finally be able to deliver on the main promise of digital health The ability to deliver... ...the right intervention ...to the right patient ...at the right time. @cwhogg
  40. 40. Overcoming Barriers to Scale in Digital Therapeutics @cwhogg
  41. 41. Q&A @cwhogg

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