The document discusses the need for effective patient support globally. It notes that managing complex diseases has more similarities than differences across different locations. Many patient needs around disease symptoms, therapy burdens, self-care, and communicating with healthcare providers are universal. However, support must be tailored locally considering language, culture, and available channels. The goal of patient engagement is to improve real-world outcomes and reduce costs by enhancing patient self-management.

1. Effective Patient Support Globally

2. Matt Hall: Speaker Matthew P. Hall , CEO Human Care Systems, Inc. Direct: 617.649.2118 Mobile: 617.501.1818 [email_address] www.humancaresystems.com Matt is the CEO of Human Care Systems (HCS), which he founded in 2008. HCS provides better tools to clinicians and patients to manage complex diseases, particularly focused on behaviors and decisions. HCS was spun-out from the Kerdan Group, a biopharma and medtech consulting firm. Matt co-founded Kerdan in 2001. Prior to Kerdan, Matt ran several healthcare-related businesses, worked in venture capital and was a consultant at Bain & Company. Matt has lived and worked in the US, Europe, Japan, South Africa, and South Korea. Matt has a BA with honors from Williams College.

3. Industrial vs. information age healthcare Individual self-care Friends and family Self-help network Professionals as facilitators Professionals as partners Professionals as authorities INFORMATION AGE HEALTHCARE Professional care Self-care (off the map) Tertiary Secondary Primary INDUSTRIAL AGE HEALTHCARE $ ¢ Discouraged Encouraged

4. How does poor patient self-management impact you? Missed initiation opportunity Delayed initiation opportunity Unhealthy lifestyle habits Interrupted course of therapy Confounding biochemical events Decreased overall adherence Premature therapy termination Increased hospital admissions Lack of return to therapy ...due to... Poor self-management: Reduces the positive outcomes associated with your diagnostic/therapy/solution Results in more safety problems in real world use Increases clinician and patient burdens associated with treatment Decreases the health economics from your solution

5. Many differences and many similarities

6. What is the goal of patient engagement and support? Biopharmaceuticals and medical technologies are facing pricing pressure in nearly every global market. Rising co-pays in Private Pay markets. Price discounting in National Pay markets. Self-pay barriers in Emerging markets. Manufacturers must ‘increase the value’ of their solutions in response. Re-shape value propositions from active comparators and TPPs to real-world solutions to complex, difficult, expensive health problems. Globally, the capabilities of the patient to take medicines as prescribed and manage the disease more broadly are clearly linked to Quality of Life, outcomes and health economics. Valuable relationship with patients and clinicians do not come from a carefully scripted series of marketing emails. Automation of noise is not the goal. The goal is authentic service relationships to accompany clinicians, patients, and families in their experiences. Give patients and family the right self-management support at the right times through the right channels. Provide clinicians with timely, helpful answers to questions and simple tools to improve decisions and patient self-management.

7. Key Trends: Competitive Markets Competitive. Biopharma must show added value to payers/employers, as well as increasingly self-paying patients (through high deductibles). At the same time, prescribers have enormous choice in most classes and must see meaningful differentiation to prescribe. Finally, FDA is increasingly requiring risk management programs where enhanced support must be provided to patients, prescribers and pharmacists. Competitive Markets Price-Reference Markets Health Economic Markets Emerging/ Cash Markets Markets (private) (Medicare Part D) ( (PMPRB) (DoD/Medicaid) (NICE) (Provincial) and Scandinavia

8. Key Trends: Health Economic and Price-Reference Health Economic and Price Reference. In both health economic and price reference markets, it’s all about what can be proven as valuable and, in the case of price reference, what is new. In addition, EMEA, MHLW and other regulatory bodies are increasingly requiring risk management programs where enhanced support must be provided to patients, prescribers and pharmacists. Competitive Markets Price-Reference Markets Health Economic Markets Emerging/ Cash Markets Markets (private) (Medicare Part D) ( (PMPRB) (DoD/Medicaid) (NICE) (Provincial) and Scandinavia

9. Key Trends: Competitive Markets Emerging/Cash Markets . Across most emerging markets, there is need to engage and show truly greater value to the holy trinity of largely self-pay patients, powerful neighborhood pharmacists and physicians. This is critical for both brands and branded generics. At the same time, regulatory bodies and physician groups are clamping down on ‘added value’ practices of the past (eg, CFM 1939 in Brasil). High mobile phone penetration presents opportunities to use integrated voice, text and web to engage patients in their care, and to better loop in the pharmacist. Competitive Markets Price-Reference Markets Health Economic Markets Emerging/ Cash Markets Markets (private) (Medicare Part D) ( (PMPRB) (DoD/Medicaid) (NICE) (Provincial) and Scandinavia

10. Effective Patient Support Globally Global Patient Needs Local Tailoring Evaluating what you have & Building what you need

11. The World If the world were a village of 100 people... 61 are from Asia 15 live in the Western hemisphere 20 are white 2 have college educations 17 are illiterate 47 in cities and 53 in rural areas 17 are undernourished 33 have internet access 67 have a cell phone 33 are Christian 21 are Muslim 16 are non-religious 2 will give birth within the year 1 will die within the year

12. Managing complex disease has more similarities than differences, whether you live in Anchorage, Bahrain or Cape Town.

13. Many Patient Needs are Universal Disease symptoms and burdens. Therapy burdens and side effects. Taking therapies as prescribed. Financial issues. Self-care and behavioural elements of managing disease and therapy (eg, motivation, self-confidence, resilience). Managing feelings of fear, anxiety, guilt, shame and anger. Productively involving family. Working effectively with Health Care Providers.

15. Patient/Clinician Communication Clinician communicates information about disease, therapy and self-care Patient goes home Patient acts on clinician recommendations Source: Health Literacy & The Prescription Drug Experience: The Front Line Perspective From Patients, Physicians and Pharmacists, Roper ASW, May 2002 Mayo Clinic proceedings British Medical Journal Clinician and patient often start visits on a weak basis 72% of patients unable to list medications they take 58% of patients unable to recite their own diagnosis Patients rarely ask questions, across cultures Physicians interrupt patients who do ask questions within 30 seconds, on average Many clinicians use a strategy of ‘scare and scold’ to encourage patient self-management 47% of what clinician says is never understood by patient ~50% of what the patient understood, is forgotten by the time patient gets home 40% of what is understood and remembered, is acted upon by patient

16. How well does your doctor communicate? Source: Worldwide Independent Network of Market Research, Patient-Doctor Global Communication Assessment, Fall, 2010. N = 22,581 Q: Thinking of your most recent visit, please rate the doctor’s communication with you.

17. Would you recommend your doctor? Source: Worldwide Independent Network of Market Research, Patient-Doctor Global Communication Assessment, Fall, 2010. N = 22,581 Q: Please rate the doctor you most recently met with on a scale of 0-10, where 0 means you would never recommend and 10 means you would definitely recommend this doctor Promoters: Rating 9-10 Fence Sitters: Rating 7-8 Detractors: Rating 0-6 No Answer

18. How is your health? Source: Worldwide Independent Network of Market Research, Patient-Doctor Global Communication Assessment, Fall, 2010. N = 22,581 Q: How would you rate your health?

19. Do you want your doctor to give you choices? Source: Worldwide Independent Network of Market Research, Patient-Doctor Global Communication Assessment, Fall, 2010. N = 22,581 Q: I prefer that my doctor give me choices Q: I prefer that my doctor just tell me what to do rather than give me choices Want choices Want to be told what to do No answer

20. How do people define value? Patient Value

21. “ Value is the difference between what I give up for a product and the benefits that I receive” People are Rational about Value Real World Outcomes Costs (financial, hassle, safety)

22. It’s About Patient Value As voters in National Pay markets, payers of increasing co-pays in competitive markets and self-payers in developing markets, it’s about the patient. € ¥ Prescribers Regulators Payers Patient Associations & Disease Advocacy Groups Pharmacies & Other Channel Partners Patients & Family

23. Self-Management Drives Value Levers to impact Value Equation: Change patient self-management Change diagnostic or therapy Change clinical practice Change reimbursement Real World Outcomes Costs (financial, hassle, safety)

24. 4 Areas of Global Unmet Need Set goals, take actions, monitor progress Internalize critical knowledge and understanding Overcome emotional, cognitive, and behavioral barriers to change Clinician and pharmacist tools, effective direct support Take Action Engage Gain Insight Learn

25. What works for most people Engage them where they are. Language and culture. Channel (clinician, pharmacist, mobile, paper, web). Specific needs at that time. Help solving real problems. Help with understanding the disease and therapy in an actionable way. Socratic questioning. This is a logical, positive approach that teaches people to reason with the reality around and inside them and discover solutions. Targeted, relevant information. Interactive learning Where possible, providing tools and resources to clinicians and pharmacists to better use their positions to educate effectively Support to learn productive health behaviors Build resilience, strength, motivation, calm. ‘the answer is inside you. Adhere to medicines Better manage diet, exercise, smoking cessation and other behaviors Learn to work more effectively with HCPs Involve family productively Build change that is part of daily life Learn to set useful goals and track them through to success. Use simple tools for keeping track of appointments, medicines and other parts of therapy. “ You are not a victim; you are a survivor.”

26. Self-Management is Universal Relationship with healthcare providers Effective Self-management Thoughts & Feelings Knowledge & Understanding Social and family environment Behaviors

27. What doesn’t work for most people ‘ Scare and scold’ clinician counseling. Reminders and other one-off tools. Generic education. Support that doesn’t incorporate context (e.g., social, emotional, family, cultural) To keep plugging away in the same behaviors.

28. Effective Patient Support Globally Global Patient Needs Local Tailoring Evaluating what you have & Building what you need

29. The Opportunity to Think Local and Build Global Situation: Substantial investment in marketing and patient support across geographies, yielding varying rates of patient engagement and ROI. Some geographies have low promotion of patient programs. Some geographies have low penetration of patient programs Think ‘Local and Build Global’ Objectives: People have far more in common than they have differences. They have the same problems, and need the same things to manage complex diseases. Help each geography provide effective patient engagement and support, building on existing assets. Diagnose the total treatment environment, patient journey and inflection points for that geography. Define the shared fact-set. Determine fit with market access strategies. Develop regional and global best practices. Deploy to each geography.

30. 5 Critical Areas Must Be Localized Language & Cultural References Reimbursement Channels Legal & Regulatory Partners

31. What is local culture? The learned, shared, transmitted values and beliefs and practices of a particular group that guide the thinking, actions, behaviors, interactions, emotions and view of the world. Art Beliefs about: Relationships Family obligations Customs Gender Roles Clothing Preventative Health Environment Illness and death Economics Sexuality Religion Diet

32. How do culture and language impact health behaviors? Health, healing and wellness belief systems; Illness, disease and how causes are perceived; How health care treatment is sought and attitudes toward providers, impacting treatment; Delivery of health care services by providers.

33. Language Pitfalls

34. Areas to watch for: Language Localization Language that patients use to refer to… Access/reimbursement Pharmacies Providers Symptoms Side-effects Drug efficacy Behaviors and self-management

35. Areas to watch for: Cultural Localization Cultural differences… Role of individuals vs. group Role of family Role of elders vs. young Views toward illness and medication Views toward Western medicine vs. traditional medicine Color and image meanings Tools and training systems for clinicians: how much choice did the patient have in their therapy options? how much access does the patient have to care providers, medications? how much patient knowledge is there about basic care practices, hygiene, human anatomy, etc?

36. Reimbursement Localization Public Insurance Private Insurance Self Pay Increasingly high co-pays on new treatments. Not all patients have coverage. Need to work directly with the doctor to introduce the support program because insurers are so fragmented that they have no relationship with the patient. Resolving patients ability to pay issues should be a top concern. Focus on value cards, and patient assistance programs. Usually good coverage with lower co-pays, but high limitation on treatment options. Look for opportunities to work with public payers - potentially tying results to different pricing schemes. Access to all new treatments. But Patients must pay themselves. Patients require more education on the benefits of their medication - particularly in asymptomatic chronic conditions. Resolving patients ability to pay issues should be a top concern. Focus on value cards, and patient assistance programs. Impact on Patient Impact on Support Program Map out healthcare journey for each country including how and when the drug gets paid for to help make the right decisions.

37. Legal & Regulatory Localization Direct to Patient. Nearly every country globally allows manufacturers to provide necessary education and support with therapies. However, there are many differences between countries as to where education/support end and marketing begins. Branding : Branded or unbranded? Implications for naming, colors, links, mentions of specific medications & devices, etc. Adverse event reporting : Ensuring the appropriate data capture, screening, and reporting steps are taken in each market. Privacy Requirements : Tailoring data capture & disclaimers to local requirements. Claims Language: Identifying any unusual watch-outs on claims in specific markets that must be managed. Review Process : What will be the formal review process in each market that the patient support program will need to go through.

38. Channel Localization Clinician tools and support Different media – mobile, internet, paper, etc. Different HCPs – nurses, other allied professionals, specialists, primary care. Different roles for family. Patients Family & Caregivers

39. Effective Patient Support Globally Global Patient Needs Local Tailoring Evaluating what you have & Building what you need

40. Evaluate & Build Diagnose the total treatment environment, patient journey and inflection points. Define the shared fact-set. Determine fit with market access strategies. Develop regional and global best practices. Deploy to each geography.

41. Diagnose Diagnose the total treatment environment, patient journey and inflection points and understand differences by geography and culture . What are the key distinctions Who/where does the patient interact for healthcare? What is the experience of the disease & therapy? What is the underlying human experience (physical, social, behavioral, cognitive, emotional)? What are the inflection points along the way where intervention is needed and impactful?

42. Diagnose journeys… 1 2 3 Guiding Questions Why it Matters Healthcare journey Which people & organizations does the patient interact with on his or her journey? Determine what communication channels can be used to reach patients at their inflection points. Disease & Therapy journey How and why do the the specific diagnostic & monitoring tests, and classes & brands of treatment change through the journey? Identify opportunities to drive optimal use of your therapy. Human journey What are the physical, cognitive, emotional, behavioral, and social experiences the patient goes through? Understand the medical and self-management needs that impact the course of the patient journey.

43. … and understand inflection points An intervention is needed, impactful, or critical e.g., initiation of injectable insulin Not intervening could be dangerous e.g., vaccination When benefits of intervention outweigh risks e.g., immunosuppressant after transplant When which interventions are best e.g., aspirin or ACE inhibitor or beta blocker for CHD ✔ ✔ ✔ Small or large windows of opportunity where science helps us decide... Moments when patient risk factors and protective factors coalesce to be exponentially powerful predictors of outcome e.g., 2 nd trimester for fetal brain development, adolescence in general Life events that are physical, cognitive, emotional, behavioral, or social e.g., initial diagnosis of a condition, relapse, change in disease status

44. Identify highest impact needs and points to intervene A patient journey has critical inflection points... key moments in patient experience where variables intersect to predict outcomes. Patient decisions and actions at this time have a significant impact on long term outcomes. Long-time diabetic has been warned, “If you can’t control this, we’ll have to put you on the needle.” Now is the time. 10 year-old hemophilia patient wants more independence with his condition. His mom is nervous, but now is the time. Dialysis patient finds out that a compatible kidney has been found. A new self-care routine is starting. Today my doctor told me I have Crohn’s. I feel like my whole life stopped. I’m in a daze. What do I do?

45. Define Define the shared fact-set . What is the investment vs. penetration vs. ROI on existing patient support programs for each geography? What are the relevant assets and investments in each geography?

46. Define: ROI Cost Increased Initiation Improved Share of Class Better Adherence + +

47. Define: Fact-Set Country D Country A Country B Country C ROI Penetration Stop Invest Country G Country H Country I Country E Country F Change Costs Learn From & Enhance = €1M Investment per year (fully loaded)

48. Determine Determine fit with market access strategies . What ‘total solution’ evidence is most impactful for each geography?

49. Develop Develop regional and global best practices . What combination of effective programming, tools and systems will allow each geography to maximize patient support investments? What training, support and tools will allow clinicians in each geography to most effectively support patient adherence and disease management?

50. Deploy Deploy to each geography . Support each geography with translation, legal and regulatory, as well as multi-channel promotion and engagement to leverage existing investments within context of global parameters. Create a plan for each affiliate to leverage existing assets and investments within context of global parameters. Work with each affiliate to implement patient engagement and adherence programming, tailored to each indication. Provide structure and support for ongoing measurement, learning and improvement.

51. Global Capabilities, Highly Effective Local Support Take Action Engage Gain Insight Learn

52. HCS: Valuable Stakeholder Relationships Engagement Closer to the real patient experience by understanding the dimensions and inflection points of the patient journey Action from Information Not just words and data, but understanding that drives actions that change outcomes Connection Integrated multi-channel: web, mobile, phone, printed, social

53. Q&A Questions?