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The Future of Connected Medicines - Promise and Pitfalls

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The Future of Connected Medicines - Promise and Pitfalls

  1. 1. The Future of Connected Medicines: Promise and Pitfalls
  2. 2. ● 170+ marketed prescription drug products worldwide equipped with Aptar devices ● Successful track record of 34 approved NDAs, more than 65 approved ANDAs and 40 INDs in the U.S. ● Worldwide leader in pMDIs (aerosol metering valves) for Asthma & COPD Sai Shankar Vice President, Digital Healthcare ● Digital health company focused exclusively on connected medicines for respiratory ● Founded in 2010; acquired by ResMed in 2019 ● Pharma partnerships with GSK, BI, Novartis, Orion, 3 unannounced ● Over 70 commercial programs in the US and EU Chris Hogg Chief Commercial Officer
  3. 3. Agenda Digital transformation is coming to healthcare (whether we like it or not) What patients, providers, payers and pharma want from connected medicines Why hasn’t it scaled? Lessons learned Scale is coming What is changing? The future of connected medicines
  4. 4. Digital transformation in healthcare is inevitable Source: McKinsey and Co.
  5. 5. In our field, this means connected medicines are coming Connected inhalers Connected injectors Connected nasal inhalers Connected orals ● Medication monitoring ● Adherence improvements ● Breath sounds and flow measurements ● Clinical status and level of impairment ● Change in status or clinical worsening ● Prediction of exacerbation risk ● Abuse detection and prevention
  6. 6. Connected medicines and digital therapeutics Enhance the efficiency of delivery and make medicines more personalized, contectextual and precise Improved adherence to treatment plan Patient Engagement Provider Engagement Robust Clinical Outcomes Health System Integration
  7. 7. Impact of a digital medicines ecosystem Outcome-Based Reimbursement Consumerization of Healthcare Better Clinical Outcomes Improved Care Delivery
  8. 8. What stakeholders want from connected medicines Propeller has been actively selling connected respiratory medicines into the healthcare market since 2012. We have done over 75 commercial programs with healthcare systems, provider organizations with payers, and have enrolled over 75,000 patients to date. Here are some of our learnings about what different stakeholders want, and some of the key barriers inhibiting scale. Patients Providers Payers Pharmaceutical manufacturers
  9. 9. What patients want from connected medicines Top Patient Wants: ● Being able to see the big picture about how I am doing now and what my COPD symptoms look like over time ● Having access to information I can share with my doctor ● Learning what causes my COPD symptoms ● Being part of something bigger than myself that is helping improve and advance how COPD is being treated and managed ● Getting reminders for my daily medication Source: Propeller COPD User Research, 2018 (N = 234)
  10. 10. What clinicians want from connected medicines Top Clinician Wants: ● I want reliable data that I can trust and use to make treatment decisions ○ I want it to feel simple, not information overload ○ I want only to see the information and data I need to make a decision ○ I want to be able to take a quick glance and get a sense of how the patient is doing ● I want to know who I need to pay closer attention to ● I want to save time and see the impact of any new intervention ● They want to get paid for their time using these new clinical tools Source: Propeller Physician User Research, 2018
  11. 11. What payers want from connected medicines Top Payer Wants: ● Identify, manage and lower cost of most expensive members (top 1-5%) ● Enroll patients who are specifically identified on a list vs. using broad clinical criteria ● Want data to make payer care management more efficient and effective ● Want to do things on their own, but are beginning to understand the necessity of involving providers Source: Propeller commercial experience with US payers, 2016-2019
  12. 12. What pharma wants from connected medicines Top Pharma Wants: ● Improved controller medication adherence ● Increased market share and brand loyalty, including a direct relationship with patients ● First mover advantage and differentiation ● Change relationship with payers and providers via focus on outcomes ● Identify patients who may be appropriate for biologics ● Opportunities for new product offerings and life cycle management Source: Propeller commercial experience with global respiratory pharmaceutical companies, 2014-2019
  13. 13. There is now ample evidence that connected respiratory medicines ‘work’ 54% Sources: Merchant et al. 2018. Impact of a digital health intervention on asthma resource utilization. World Allergy Organization Journal.; Merchant et al. 2016. Effectiveness of Population Health Management Using the Propeller Health Asthma Platform: A Randomized Clinical Trial. Journal of Allergy and Clinical Immunology: In Practice.; Alshabani et al. 2018 (abstract, manuscript in prep); Propeller Health (data on file); Propeller user research, 2018; Merchant et al. 2018. Digital Health Intervention for Asthma: Patient-Reported Value and Usability. JMIR Mhealth Uhealth.6(6):e133 Reduction in asthma related ED/hospitalizations 35% Reduction in COPD related ED/hospitalizations 50-100% Increase in medication adherence 15+ FDA Clearances / CE Marks 70+ Peer reviewed publications 80% Patient satisfaction Over 3 company exits Propeller, Gecko, Inspiro
  14. 14. While belief in the market is high, nothing has yet scaled The main question remains: Why hasn’t it scaled? Patients, Providers, Payers and Pharma now see connected medicines as an inevitable part of the future of respiratory management.
  15. 15. Building and implementing connected medicine solutions is hard PROGRAM DESIGN & IMPLEMENTATION ● Physician adoption ● Changes to clinical workflows ● EMR integration USER CENTRIC DESIGN ● Pairing and onboarding ● Seamless functionality ● Simplify interactions DIGITAL PLATFORM ● Intuitive user interface ● Secure data platform ● Insightful analytics DEVICE & TECHNOLOGY INNOVATION ● Bluetooth, NFC, Direct-to-Cloud ● Chip design ● On device diagnostics ● Battery optimization
  16. 16. When a new medicine is approved, the system just works 1. Medicine approved (1)
  17. 17. When a new medicine is approved, the system just works 1. Medicine approved 2. Medicine gets unique identifier code (1) (2) Unique Identifier
  18. 18. 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
  19. 19. 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
  20. 20. 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
  21. 21. 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
  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 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)
  23. 23. When a new digital therapeutic is cleared, the system doesn’t just work Unique Identifie r (1) (2) (3) (4) (5)(6) 1. Connected medicine / digital therapeutic approved 2. Connected medicine does not get unique identifier code 3. Connected medicine does not shows up in EMR eRx flow 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. New: Data has to get back to the patient’s provider (7)
  24. 24. We are building new rails one step at a time
  25. 25. Attempts at new flows: Provider enrollment / monitoring ● No simple way for clinicians to refer a patient for a connected medicine and no easy way to get data from the connected medicine back into the physician’s EMR ● Adds work for the clinic staff but no traditional reimbursement for physicians or clinic staff to enroll and monitor patients ● Transition to value based payments has been slow, making it difficult for physicians to purchase additional services ● Best enrollment conversion, engagement, retention and clinical outcomes Physician identifies patient and ‘prescribes’ connected medicine Clinic staff creates account and sets up connected medicine(s) Patient uses connected medicine and is monitored by clinic care managers 26 programs
  26. 26. Attempts at new flows: Pharmacist enrollment / monitoring ● Pharmacists are an underutilized resource but have similar enrollment conversion, engagement, retention and clinical outcomes to provider enrollment/monitoring ● Time consuming and resource intensive for pharmacy with no reimbursement for pharmacists time ● Pharmacists often had to select patients from a list, determined by payer or healthcare system ● No easy way to get data from the connected medicine back to pharmacist Pharmacist identifies patient for connected medicine Pharmacist creates account and sets up connected medicine(s) Patient uses connected medicine and is monitored by pharmacists or other care managers 3 programs
  27. 27. Attempts at new flows: Direct to patient (DTP) Optional Patient marketed to online Patient enrolls online and connected medicine / sensors shipped to patient’s home Patient uses connected medicine and is optionally monitored by care managers ● Highly scalable method to acquire patients and connect their medicines ● Patients don’t pay (yet) ● Lower engagement, retention and clinical outcomes compared to physician- or pharmacist-driven programs ● Difficult to link patients acquired via DTP back to physicians, care managers and payers ● Currently US only; legally ambiguous in EU 12 programs
  28. 28. Attempts at new flows: Payer direct to member ● Very ineffective strategy with low enrollment rates, low engagement and subpar clinical outcomes ● Payers tend to focus on a small number of very sick and expensive patients, who are challenging to enroll and engage, leading to low conversion (typically only 1-2% of a given list) ● Payer care managers perform worse than provider care management, presumably due to lack of existing relationships with patients ● This strategy completely excludes physicians from patient identification and management Payer creates list of most expensive patients Propeller markets directly to patients ships sensors to patient’s home Patient uses connected medicine and is monitored by Payer care managers 9 programs
  29. 29. We believe the answer is going to be a more traditional provider / payer flow Reimbursement for device and set up time Reimbursement for physician / clinic time for ongoing monitoring and outreach Physician identifies patients for connected medicine Patient enrolls in clinic, in pharmacy or via home delivery Ongoing service and monitoring $
  30. 30. We are at the precipice of scale. What is changing? The respiratory drug delivery sector has proven the ability connect medicines, improve outcomes and conduct successful pilots in the healthcare system. Broad scale is the next step. There are a number of positive developments in the market that make us very optimistic that scale is coming. 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 clinical organizations? Can we achieve ubiquitous payment / reimbursement? Can we own financial and clinical risk around asthma and COPD? We are here $
  31. 31. The landscape for connected medicines is evolving INTEGRATED ADD-ON DIAGNOSTICINTEGRATEDADD-ON
  32. 32. Device architecture and supply chain optimized for scale Cost Adoption Model ARCHITECTURE COGS VOLUMES PLATFORM CUSTOMER
  33. 33. Significant improvements in technology are impacting device performance Chip / Firmware Optimization Connectivity Protocols Sensor Development Battery Optimization
  34. 34. Connectivity options to improve pairing What is changing: Connecting directly to the cloud
  35. 35. Connectivity options are increasing What is changing: Connecting directly to the cloud
  36. 36. Connecting directly to the cloud
  37. 37. ● Understanding user & therapy challenges ● Demographics & design features ● Human factors & customer engagement ● Training & onboarding Leveraging user-centered design to effectively utilize connected medicine data
  38. 38. 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 connected medicines from the EMR Health Systems are investing in centralized enrollment services The ability to integrate seamlessly into multiple EMRs is getting easier Unique Identifier
  39. 39. New payment and reimbursement Advances in US and global payer policies point to imminent integration of connected medicines in traditional healthcare delivery models. National commercial coverage of CGM tools New CPT codes for digital monitoring As of 2018, nearly all commercial payers, covering ∼200 million lives now reimburse for CGM monitoring Effective Jan 2019, CMS will launch 3 new RPM codes developed by AMA’s Digital Medical Payment Advisory Group 2018 CMS announced Medicare coverage for CGM monitoring. 2017, NHS reimbursements for selected digital tools Effective Jan 2019, Cigna expands Omada Health’s Diabetes Prevention Program to all national and regional employer clients Public insurance coverage of digital health services Payer coverage of Digital Diabetes Prevention Program CPT 99453 One time setup CPT 99454 Device/service (monthly) CPT 99457 Physician interpretation (monthly)
  40. 40. Bringing technology closer to the medicine Technology is now being embedded directly into medicines and drug delivery devices to create line-extension or de novo products. Teva’s Digihaler Proteus’ ingestible sensor
  41. 41. Pharma is embracing digital Pharma is clearly embracing connected medicines, digital therapeutics and digital more broadly. All are still piloting and doing sub-scale programs, but the pace of activity is increasing quickly Biopharma Digital News GSK / BI / Novartis / Orion Propeller Development and commercial deals signed in 2014 (Boehringer Ingelheim), 2016 (GSK), 2017 (Novartis), Orion (2018) Novartis Pear Therapeutics 2/28/18: Announce collaboration to develop digital therapeutics for Schizophrenia and Multiple Sclerosis Otsuka Proteus 11/15/17: Received FDA approval (NDA) of digital medicine (pill with embedded sensor) Novo Nordisk Glooko 7/17/17: Announce partnership to develop and market app for diabetes management Roche MySugr 6/30/17: Roche acquires MySugr (popular app for diabetes self management) Bayer BetaConnect 5/30/17: Beyer gets FDA approval (sBLA) for BetaConnect (connected betaseron pen injector for MS) Sanofi Verily 9/12/16: Jointly create OnDuo joint venture with $500M investment Teva CareTRx 9/27/15: Teva acquires Gecko Health for its respiratory CareTRx platform and apps AZ Adherium 8/19/15: AstraZeneca invests $3M in Adherium and signs commercial agreement
  42. 42. New models are leveraging subscriptions and mail order Companies like Truepill have created medication delivery by API, to easily create a new product or experience that includes Rx medicines. Initial applications are built on re-branding generic medicines for ‘lifestyle’ diseases.
  43. 43. Going out on a limb with a prediction: 1 million patients Using connected medicines by the end of 2022 (3 years) What will the world look like with ubiquitous use of connected medicines?
  44. 44. Patient journey with connected medicines A patient meets with her doctor, who evaluates her. Her doctor selects the appropriate therapy, and she leaves with a prescription.
  45. 45. Patient journey with connected medicines The patient goes to the pharmacy and picks up her Rx. Her doctor selected a connected medicine, so her medicine comes connected and with an app.
  46. 46. Patient journey with connected medicines As she goes about her normal life, she uses her medicines as she normally does. She also receives a software-based intervention, and starts to improve.
  47. 47. Patient journey with connected medicines Meanwhile… Many patients have been prescribed connected medicines that are delivering data back to physicians, hospital systems and payers
  48. 48. Patient journey with connected medicines Healthcare providers and care managers use the data from connected medicines to risk stratify patients and prioritize outreach.
  49. 49. Patient journey with connected medicines Patient returns to her doctor and they review data on adherence and disease status from her connected medicine. Her physician uses the data from her connected medicine to get her to the right therapy regimen. Disease severity and level of control
  50. 50. Connected medicines present new opportunities for patients, healthcare providers and payers Patients will have more therapy options, will get to the best therapy regimen faster, and have better control of their health. Care teams will have better data on how patients are doing, and be able to offer better solutions to their patients. Payers and hospitals will lower utilization and costs, and have data on which therapies are most useful in which patient groups.
  51. 51. Quiz
  52. 52. To date, how many sensors for inhaled medications have been deployed worldwide? Quiz - Question 1 A) Under 100,000 sensors B) 100,000 - 250,000 sensors D) 500,000 - 1,000,000 sensorsC) 250,000 - 500,000 sensors E) Over 1,000,000 sensors
  53. 53. What is the biggest barrier to adoption of connected medicines? Quiz - Question 2 A) Physicians are hesitant to adopt new technologies B) Lack of reimbursement for devices and physician time C) Lack of ability to order connected medicines from the EMR and get data back into the EMR D) Regulatory challenges and concerns
  54. 54. How many patients with respiratory disease will be using connected medicines by 2024 (5 years from today) Quiz - Question 3 A) Under 500,000 patients B) 500,000 - 1,000,000 patients D) 2,500,000 - 5,000,000 patientsC) 1,000,000 - 2,500,000 patients E) Over 5,000,000 patients
  55. 55. In what year will we pass 1 million patients using connected medicines, worldwide? Quiz - Question 4 A) 2020 (next year) B) 2022 (3 years) D) 2030 (10 years) C) 2025 (5 years) E) It will never happen
  56. 56. What is the most important measurement a sensor needs to make when a patient is using a connected inhalation device? Quiz - Question 5 A) Compliance to dosing regimen (Date and time of administration) B) Inhalation technique (inspiration rate)
  57. 57. When designing or selecting a connected device, identify what key feature you would like to see added to the inhaler. Quiz - Question 6 A) Dose counter B) Audible feature D) Flow measurement / inspiration rate C) Visual feature E) Angle of inspiration
  58. 58. When designing or selecting a connected device which of the following criteria plays the biggest role in the selection process? Quiz - Question 7 A) Cost of device B) Regulatory pathway C) Sustainability D) Device functionality / features
  59. 59. Q&A

Editor's Notes

  • Patients want fewer symptoms and more control over their disease. They want help adhering to complicated treatment plans and medication regimens, and want an improved relationship with their physician.

    All responses are >80% of respondents
  • Clinicians want better outcomes for their patients. They need better data to inform treatment decisions, but cannot be overwhelmed with new data. Clinicians want to focus more time and energy on patients that need it, and less time on patients who are controlled and doing well.
  • Payers want to identify and manage the highest risk and most costly patients via targeted disease management efforts. They want to specifically identify each patient who is eligible, enroll them, then predict and prevent costly exacerbations and hospitalizations
  • Pharmaceutical manufacturers are interested in connected medicines for a variety of reasons, from the simple (improve adherence) to the complex (evolve what they offer payers and providers). Pharma companies are all looking for advantage, sometimes in different ways, but are all looking to be the first to broadly scale their offering.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • When a manufacturer gets approval for a new medicine, it easily fits into the existing distribution system. While building awareness and advocacy of this new medicine is hard, the system ‘just works’.
  • With a connected medicine there is no existing distribution system. The flows we take for granted with new medicines are absent, so each step must be developed and optimized, including new steps that don’t exist for analogue medicines

  • These are considered new combination medicines and can leverage some of the existing medicine distribution system for ordering and fulfillment
    Uptake is currently very low, with uncertain payment and reimbursement

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