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Effective Adherence:
             A complex problem addressed with
             comprehensive behavioral programs




Boston | London | Los Angeles | Philadelphia     1
Standard of Care and Therapy Adherence

               •   For every disease, the Standard of Care includes multiple
                   behavioral and self-care elements.

               •   People struggle to adhere to their total therapies – medicines
                   as well as behavior modification and lifestyle changes –
                   negatively impacting outcomes and health economics.

               •   The Human Care Systems solution is a customizable software
                   platform to help biopharmaceutical companies engage with and
                   support patients and family to learn the habits of total therapy
                   adherence.
                       Increase medicine adherence
                       Add value and connect with patients and family
                       Comply with regulatory requirements
                       Differentiate to prescribers and remove prescribing barriers
                       Improve health economics
                                                                                       2
Personalized Adherence


           Causes of non-adherence

           Comprehensive solution for complex problem

           Personalized adherence program: “Mary”

           Efficacy data




                                                        3
Question:
Why don’t people adhere to their medicine
regimens and other therapies?


Answer:
Each person has his or her own set of complex
and interrelated reasons.




                                                4
Patients Report Range of Non-Adherence Causes
              Reasons why patients don’t fill prescriptions
              or comply with drug regimens (patient views)

              (Percentage of patient respondents citing each reason)

                                  Other
                                  Don’t know how to use the drug
                                  Can’t get prescription filled, picked up, or delivered

                                  Don’t think I need the drug



                                  The drug costs too much



                                  Don’t want the side effects




                                  Sometimes forget to use or refill



              Sources: BCG analysis; Harris Interactive 10,000 Patients Survey, 2002.
Physicians Report Range of Non-Adherence Causes
                Reasons why patients don’t fill prescriptions
                or comply with drug regimens (physician views)

                (Percentage of physician respondents citing each reason)
                                 Other
                                 Patient is suspicious of pharmaceutical companies
                                 Doesn’t understand how to use/administer drug
                                 Lack of productive family involvement
                                 Can’t get prescription filled, picked up or delivered
                                 Doesn’t think drug works

                                 Underlying emotional issues

                                 Doesn’t think he/she needs drug

                                 Lack of motivation and self-confidence



                                 Forgetfulness



                                 Side effects



                                 Cost/co-pay



             Source: Human Care Systems Physician Survey, 315 physicians, 2010. .
Each Adherence Barrier has Behavioral Drivers
                   Adherence Barrier                                   Behavioral Drivers
    Doesn’t understand how to use/administer drug         Information processing style, misconceptions, emotionality, self-efficacy

               Lack of productive family involvement      Avoidance, relationship skills / strain, stimulus control, living environment

  Can’t get prescription filled, picked up or delivered   Social capital, problem-solving, communication, self-efficacy

                            Doesn’t think drug works      Defense mechanisms, interpersonal skills, learning style, social capital

                         Underlying emotional issues      Cognitive skills, mind / body relationship, life environment

                    Doesn’t think he/she needs drug       Defense mechanisms, cognitive-emotional skills, life environment

              Lack of motivation and self-confidence      Self-efficacy, social capital, mind / body relationship, cognitive skills

                                        Forgetfulness     Emotionality, defense mechanisms, cognitive dysfunction

                                          Side effects    Cognitive skills, mind / body relationship, self-efficacy, stimulus control

                                          Cost/co-pay     Cognitive skills (coping), emotionality (anger), problem-solving (prioritizing)
Personalized Adherence


           Causes of non-adherence

           Comprehensive solution for complex problem

           Personalized adherence program: “Mary”

           Efficacy data




                                                        8
The Problem Defines the Solution
                                        Symptom                                Therapy
                                        Physical                               Pharmacology

                                        Cognitive
                                                                               HCS Solutions
                                        Emotional                              Behavior Science, Cognitive-Behavior
                                                                               Therapy, Pedagogical Science,
                                        Behavioral
                                                                               Relationship Coaching, Mind-Body
                                        Environmental                          Exercises


 Complex Problem:                       Comprehensive Solution:
 Nuanced interplay of cognitive,        HCS behavioral approach addresses
 emotional, behavioral, environmental   patient thoughts, feelings, actions,
 factors                                surroundings




                                                                                                                      9
Effective Adherence is Holistic and Patient-centered


       “The odds that an adherence strategy will be successful are
       related to how well the strategy can first identify the varying
       needs of individual patients, and then match services
       accordingly.

       An ideal adherence strategy should be patient-centered and
       holistic taking into account everything from lifestyle to cultural
       and belief systems.”
       Source: New England Health Care Institute, Client Conference, May 20, 2008
A Holistic and Patient-centered Solution




                                           11
A Comprehensive Behavioral System

We use behavioral           Behavior                         Pedagogical
science, translated to     Modification                        Science
user-friendly software,
to help patients change
problematic patterns and                       Cognitive
learn new, healthy
thoughts, feelings,          Classical                        Integrative
behaviors, and              Conditioning                       Learning
relationships.                                Emotional

                             Operant                          Experiential
                            Conditioning                       Learning
                                              Behavioral


                              Social                            Timed
                            Conditioning                       Learning
                                             Environmental



                                           Dimensions of
                                              Change                         12
Thoughts and Feelings are Biochemistry


                                                                   Mind-body exercises change thought pathways
 •   Mind-body therapies have broad, dramatic impact on
     perception, information processing, decision making, and              neutral              meditative
                                                                            state                 state
     lifestyle change

 •   Powerful interventions integrate all dimensions of change –
     cognitive, emotional, behavioral, environmental elements

 •   HCS solutions use standard, scientifically proven mind-body
     protocols
                                                                                      Proc. Natl. Acad. Sci. USA 2004 101 (46) 16369 - 16373
Human Care Systems


           Who We Are
           Experts in software, healthcare, psychology, user engagement, and
           technology.

           Clients are biopharmaceutical, medical device and diagnostics companies;
           as well as health systems, employers and payers.

           Headquartered: 1 Faneuil Hall, Boston, MA.
           Other locations: Philadelphia, Los Angeles and London.

           Formed as spin-out from the Kerdan Group (biopharma consultancy) in 2008.




                                                                                       14
Personalized Adherence


           Causes of non-adherence

           Comprehensive solution for complex problem

           Personalized adherence program: “Mary”

           Efficacy data




                                                        15
Therapy for Complete Adherence: “Mary”
  Adherence Assessment                              Adherence Profile                         Adherence Guided Program

                   I’m skeptical, overwhelmed,                     My disease is physical.                  I must address myths
                    and agitated. I’d rather not                    My experience of my                     that cause my negative
                   think about this! I’m tired of                    disease is holistic.                   feelings. When I am
                  being nagged. What the heck                     My adherence involves all                 emotionally invested, I
                   is a mind-body relationship?                           of me.                            can move forward.



  Thoughts                                                                                    1. Education exercise
  Perceptions of self and                                                                        “Myths and misconceptions”
  condition
                                                                                              2. Cognitive-behavior exercise
  Feelings
                                                                                                 “Shame”, “Fear”
  Reactions of anger, fear, shame,
  guilt, anxiety                                                                              3. Mind-body exercise
  Behaviors                                                                                     “Self-awareness”
  Compliance with providers and
                                                                                              4. Problem-solving exercises
  treatment plan; self-care habits
                                                                                                “Cost”, “Inconvenience”
  Environment
                                                                                              5. Goal-Setting and tracking
  Relationship and tactical
  obstacles to compliance                                                                       “Goals and emotions”



                                                                                                                                      16
Mary Engages Through Multiple, Integrated
Channels


             Web & Email          Live Phone




        Mobile & SMS              Automated Phone (IVR)




                           Mail




                                                          17
Mary Picks a Virtual Guide
Social conditioning involves interactions with others, including modeling, coaching, social learning, contracting, and
interpersonal support.




                         Virtual Guides
                         Guides are selected based on decades of robust socio-cultural research
                         including micro-expression analysis.
                         Guides can answer questions using a heuristics engine and database.




                                                                                                                         18
Mary Follows an Integrated, Step-by-Step Program




                                              19
Mary Completes Simple Assessments to
Personalize her Experience




                                       20
Mary Engages in Tailored, Effective Learning
                                                       Multi-media options              Challenging, calibrated to an 85%
            Regulated by                               configured to learning style     correct response rate
            cognitive
            dissonance as
            a window for
            insight


       Hierarchically chunked
       education (3-5 items at
       a time) for optimal
       working memory and
       information processing




           Continuous
           reinforcement             SEE MY LEARNING
                                          STYLE
           schedule drives               PROFILE
           engagement


                      Learner-centered, driven         Flash animation is interactive               Interactive, immediate feedback
                      by user choice and profile                                                    for optimal learning



                                                                                                                                      21
Mary Works on her Thoughts and Feelings,
in a Judgment free and Private place




                                           22
Mary does Personalized Exercises
             Patients require multi-dimensional assistance for internal and external environments including prohibitive thoughts and feelings
             like shame, anger, fear, guilt, anxiety.
                                                                                                                          Adherence to biochemical therapies
                                                                 Smart software predicts and
                                                                                                                          involve mind / body learning.
                                                                 times Mary’s questions.
The system
knows Mary
                                                                                                                                            Mary’s profile tells
struggles with
                                                                                                                                            the software that
shame.
                                                                                                                                            her fear
                                                                                                                                            immobilizes her,
                                                                                                                                            keeping her from
                                                                                                                                            compliance.
 Just like in a
 therapist’s
 office, Mary
 quantifies her                                                                                                                             According to her
 feelings.                                                                                                                                  profile, Mary will
                                                                                                                                            become activated by
 These are
                                                                                                                                            converting fear to
 included in
                                                                                                                                            anger.
 her treatment
 algorithm.



                                            Guides are selected based on decades               Information combined with the right
                                            of robust socio-cultural research                  emotional engagement leads to insight.
                                            including micro-expression analysis.


                                                                                                                                                                   23
Mary Involves her Husband
           Social interventions involve interactions with others, including modeling, coaching, social learning, contracting, and
           interpersonal support.

Problem: Mary’s           Solution: Mary’s spouse                                                                     Problem: According to her
spouse has strong         learns new relationship                                                                     profile, Mary’s anger is
opinions, preventing      skills like empathy,                                                                        getting in the way of going
him from listening.       support, and                                                                                to the pharmacy.
Mary ignores him and      communication.
her self care too!
                                                                                                                      Solution: The system
                                                                                                                      gives Mary an action
Problem: When her         Solution: The system                                                                        plan personalized to her
spouse comes home         leads the spouse                                                                            psychological profile.
from work angry,          through self-awareness
Mary’s adherence is       and de-stress exercises.
threatened.



Problem: Mary             Solution: Smart software
resents her spouse        guides family members
nagging, because he       into behavior contracts with
doesn’t follow            each other that are
doctors’ orders either.   mutually reinforcing.




                                                                                                                                                    24
Why does Mary Engage with her Program?

                                  For the first time in my life, I            „”I really like that it‟s
                                  feel like I have the right plan            just for me. It learns
                                  and support for me. Like I‟m              about me and grows as
                                             in control.”                             I grow.”




                                                                       “My husband used to always hassle me
                                                                         about my weight. Now, he used the
                                                                        coach training program a bit and he‟s
“it‟s reassuring and it gave me
                                                                         actually somewhat helpful with meal
good steps.”
                                                                        planning and our daily walks. He can
                                                                                   be objective now.”

                                   “It helps bring out feelings that
                                      I wasn‟t aware of before. It
                                        was good in helping me
                                     handle my feelings in some
                                         kind of perspective.”

                                                                                                                25
Personalized Adherence


           Causes of non-adherence

           Comprehensive solution for complex problem

           Personalized adherence program: “Mary”

           Efficacy data




                                                        26
Efficacy Evidence: Medicine adherence

In a trial of medicine
adherence (refills) among
50 diabetic patients (42
completed), HCS
significantly improved
adherence.




                            Trial conducted March 1, 2009 to August 31, 2010 in United States




                                                                                                27
Efficacy Evidence: Cardiometabolic Markers
12 month study of 100 diabetics measuring four cardiometabolic markers: LDL, BP, BMI, A1c.


          Started Trial                                                      Completed Trial



          50 patients                                                        46 patients
                                                                                               Final (12 months)
                                                                                               SBP decrease of 11mm
                                                                                               Hg vs. control*
                                                                                               5% average BMI reduction*
                                                                                               .3 A1c reduction*

          50 patients                                                        41 patients

                                                                                               (*) denotes statistical significance
                                                                                               (95% Cl)


          Trial conducted April 1, 2009 to March 31, 2010 in United States




                                                                                                                                  28
Human Care Systems Value to Biopharma Clients

                                                                                           €
     Differentiate to            Engage and Support        Comply with Regulatory         Impact Health            Track and Learn
      Prescribers                  Patient & Family           Requirements                 Economics



Prescribers and other        Particularly in complex,       REMS and other            The largest lever to        Multidimensional
clinicians want help         multi-faceted diseases,        regulatory requirements   impact health economics     reporting, including
encouraging therapy          patients and family may        increasingly require      in any disease is therapy   usage and efficacy data,
adherence.                   be overwhelmed.                biopharmaceutical         adherence: taking           informs sales, marketing,
                                                            companies to support      medicines, working          regulatory, development,
Patient non-adherence        Establishing a direct          patients in managing      productively with           and health economics
is a source of               connection to patients         therapy, including        physicians, managing        outcomes.
frustration to clinicians.   and family is critical in a    adherence.                behavioral and
                             world of increasing                                      emotional issues.
Remove prescribing           patient self-pay due to
barriers.                    higher co-pays.

                             .




                                                                                                                                       29

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Effective Adherence

  • 1. Effective Adherence: A complex problem addressed with comprehensive behavioral programs Boston | London | Los Angeles | Philadelphia 1
  • 2. Standard of Care and Therapy Adherence • For every disease, the Standard of Care includes multiple behavioral and self-care elements. • People struggle to adhere to their total therapies – medicines as well as behavior modification and lifestyle changes – negatively impacting outcomes and health economics. • The Human Care Systems solution is a customizable software platform to help biopharmaceutical companies engage with and support patients and family to learn the habits of total therapy adherence.  Increase medicine adherence  Add value and connect with patients and family  Comply with regulatory requirements  Differentiate to prescribers and remove prescribing barriers  Improve health economics 2
  • 3. Personalized Adherence Causes of non-adherence Comprehensive solution for complex problem Personalized adherence program: “Mary” Efficacy data 3
  • 4. Question: Why don’t people adhere to their medicine regimens and other therapies? Answer: Each person has his or her own set of complex and interrelated reasons. 4
  • 5. Patients Report Range of Non-Adherence Causes Reasons why patients don’t fill prescriptions or comply with drug regimens (patient views) (Percentage of patient respondents citing each reason) Other Don’t know how to use the drug Can’t get prescription filled, picked up, or delivered Don’t think I need the drug The drug costs too much Don’t want the side effects Sometimes forget to use or refill Sources: BCG analysis; Harris Interactive 10,000 Patients Survey, 2002.
  • 6. Physicians Report Range of Non-Adherence Causes Reasons why patients don’t fill prescriptions or comply with drug regimens (physician views) (Percentage of physician respondents citing each reason) Other Patient is suspicious of pharmaceutical companies Doesn’t understand how to use/administer drug Lack of productive family involvement Can’t get prescription filled, picked up or delivered Doesn’t think drug works Underlying emotional issues Doesn’t think he/she needs drug Lack of motivation and self-confidence Forgetfulness Side effects Cost/co-pay Source: Human Care Systems Physician Survey, 315 physicians, 2010. .
  • 7. Each Adherence Barrier has Behavioral Drivers Adherence Barrier Behavioral Drivers Doesn’t understand how to use/administer drug Information processing style, misconceptions, emotionality, self-efficacy Lack of productive family involvement Avoidance, relationship skills / strain, stimulus control, living environment Can’t get prescription filled, picked up or delivered Social capital, problem-solving, communication, self-efficacy Doesn’t think drug works Defense mechanisms, interpersonal skills, learning style, social capital Underlying emotional issues Cognitive skills, mind / body relationship, life environment Doesn’t think he/she needs drug Defense mechanisms, cognitive-emotional skills, life environment Lack of motivation and self-confidence Self-efficacy, social capital, mind / body relationship, cognitive skills Forgetfulness Emotionality, defense mechanisms, cognitive dysfunction Side effects Cognitive skills, mind / body relationship, self-efficacy, stimulus control Cost/co-pay Cognitive skills (coping), emotionality (anger), problem-solving (prioritizing)
  • 8. Personalized Adherence Causes of non-adherence Comprehensive solution for complex problem Personalized adherence program: “Mary” Efficacy data 8
  • 9. The Problem Defines the Solution Symptom Therapy Physical Pharmacology Cognitive HCS Solutions Emotional Behavior Science, Cognitive-Behavior Therapy, Pedagogical Science, Behavioral Relationship Coaching, Mind-Body Environmental Exercises Complex Problem: Comprehensive Solution: Nuanced interplay of cognitive, HCS behavioral approach addresses emotional, behavioral, environmental patient thoughts, feelings, actions, factors surroundings 9
  • 10. Effective Adherence is Holistic and Patient-centered “The odds that an adherence strategy will be successful are related to how well the strategy can first identify the varying needs of individual patients, and then match services accordingly. An ideal adherence strategy should be patient-centered and holistic taking into account everything from lifestyle to cultural and belief systems.” Source: New England Health Care Institute, Client Conference, May 20, 2008
  • 11. A Holistic and Patient-centered Solution 11
  • 12. A Comprehensive Behavioral System We use behavioral Behavior Pedagogical science, translated to Modification Science user-friendly software, to help patients change problematic patterns and Cognitive learn new, healthy thoughts, feelings, Classical Integrative behaviors, and Conditioning Learning relationships. Emotional Operant Experiential Conditioning Learning Behavioral Social Timed Conditioning Learning Environmental Dimensions of Change 12
  • 13. Thoughts and Feelings are Biochemistry Mind-body exercises change thought pathways • Mind-body therapies have broad, dramatic impact on perception, information processing, decision making, and neutral meditative state state lifestyle change • Powerful interventions integrate all dimensions of change – cognitive, emotional, behavioral, environmental elements • HCS solutions use standard, scientifically proven mind-body protocols Proc. Natl. Acad. Sci. USA 2004 101 (46) 16369 - 16373
  • 14. Human Care Systems Who We Are Experts in software, healthcare, psychology, user engagement, and technology. Clients are biopharmaceutical, medical device and diagnostics companies; as well as health systems, employers and payers. Headquartered: 1 Faneuil Hall, Boston, MA. Other locations: Philadelphia, Los Angeles and London. Formed as spin-out from the Kerdan Group (biopharma consultancy) in 2008. 14
  • 15. Personalized Adherence Causes of non-adherence Comprehensive solution for complex problem Personalized adherence program: “Mary” Efficacy data 15
  • 16. Therapy for Complete Adherence: “Mary” Adherence Assessment Adherence Profile Adherence Guided Program I’m skeptical, overwhelmed, My disease is physical. I must address myths and agitated. I’d rather not My experience of my that cause my negative think about this! I’m tired of disease is holistic. feelings. When I am being nagged. What the heck My adherence involves all emotionally invested, I is a mind-body relationship? of me. can move forward. Thoughts 1. Education exercise Perceptions of self and “Myths and misconceptions” condition 2. Cognitive-behavior exercise Feelings “Shame”, “Fear” Reactions of anger, fear, shame, guilt, anxiety 3. Mind-body exercise Behaviors “Self-awareness” Compliance with providers and 4. Problem-solving exercises treatment plan; self-care habits “Cost”, “Inconvenience” Environment 5. Goal-Setting and tracking Relationship and tactical obstacles to compliance “Goals and emotions” 16
  • 17. Mary Engages Through Multiple, Integrated Channels Web & Email Live Phone Mobile & SMS Automated Phone (IVR) Mail 17
  • 18. Mary Picks a Virtual Guide Social conditioning involves interactions with others, including modeling, coaching, social learning, contracting, and interpersonal support. Virtual Guides Guides are selected based on decades of robust socio-cultural research including micro-expression analysis. Guides can answer questions using a heuristics engine and database. 18
  • 19. Mary Follows an Integrated, Step-by-Step Program 19
  • 20. Mary Completes Simple Assessments to Personalize her Experience 20
  • 21. Mary Engages in Tailored, Effective Learning Multi-media options Challenging, calibrated to an 85% Regulated by configured to learning style correct response rate cognitive dissonance as a window for insight Hierarchically chunked education (3-5 items at a time) for optimal working memory and information processing Continuous reinforcement SEE MY LEARNING STYLE schedule drives PROFILE engagement Learner-centered, driven Flash animation is interactive Interactive, immediate feedback by user choice and profile for optimal learning 21
  • 22. Mary Works on her Thoughts and Feelings, in a Judgment free and Private place 22
  • 23. Mary does Personalized Exercises Patients require multi-dimensional assistance for internal and external environments including prohibitive thoughts and feelings like shame, anger, fear, guilt, anxiety. Adherence to biochemical therapies Smart software predicts and involve mind / body learning. times Mary’s questions. The system knows Mary Mary’s profile tells struggles with the software that shame. her fear immobilizes her, keeping her from compliance. Just like in a therapist’s office, Mary quantifies her According to her feelings. profile, Mary will become activated by These are converting fear to included in anger. her treatment algorithm. Guides are selected based on decades Information combined with the right of robust socio-cultural research emotional engagement leads to insight. including micro-expression analysis. 23
  • 24. Mary Involves her Husband Social interventions involve interactions with others, including modeling, coaching, social learning, contracting, and interpersonal support. Problem: Mary’s Solution: Mary’s spouse Problem: According to her spouse has strong learns new relationship profile, Mary’s anger is opinions, preventing skills like empathy, getting in the way of going him from listening. support, and to the pharmacy. Mary ignores him and communication. her self care too! Solution: The system gives Mary an action Problem: When her Solution: The system plan personalized to her spouse comes home leads the spouse psychological profile. from work angry, through self-awareness Mary’s adherence is and de-stress exercises. threatened. Problem: Mary Solution: Smart software resents her spouse guides family members nagging, because he into behavior contracts with doesn’t follow each other that are doctors’ orders either. mutually reinforcing. 24
  • 25. Why does Mary Engage with her Program? For the first time in my life, I „”I really like that it‟s feel like I have the right plan just for me. It learns and support for me. Like I‟m about me and grows as in control.” I grow.” “My husband used to always hassle me about my weight. Now, he used the coach training program a bit and he‟s “it‟s reassuring and it gave me actually somewhat helpful with meal good steps.” planning and our daily walks. He can be objective now.” “It helps bring out feelings that I wasn‟t aware of before. It was good in helping me handle my feelings in some kind of perspective.” 25
  • 26. Personalized Adherence Causes of non-adherence Comprehensive solution for complex problem Personalized adherence program: “Mary” Efficacy data 26
  • 27. Efficacy Evidence: Medicine adherence In a trial of medicine adherence (refills) among 50 diabetic patients (42 completed), HCS significantly improved adherence. Trial conducted March 1, 2009 to August 31, 2010 in United States 27
  • 28. Efficacy Evidence: Cardiometabolic Markers 12 month study of 100 diabetics measuring four cardiometabolic markers: LDL, BP, BMI, A1c. Started Trial Completed Trial 50 patients 46 patients Final (12 months) SBP decrease of 11mm Hg vs. control* 5% average BMI reduction* .3 A1c reduction* 50 patients 41 patients (*) denotes statistical significance (95% Cl) Trial conducted April 1, 2009 to March 31, 2010 in United States 28
  • 29. Human Care Systems Value to Biopharma Clients € Differentiate to Engage and Support Comply with Regulatory Impact Health Track and Learn Prescribers Patient & Family Requirements Economics Prescribers and other Particularly in complex, REMS and other The largest lever to Multidimensional clinicians want help multi-faceted diseases, regulatory requirements impact health economics reporting, including encouraging therapy patients and family may increasingly require in any disease is therapy usage and efficacy data, adherence. be overwhelmed. biopharmaceutical adherence: taking informs sales, marketing, companies to support medicines, working regulatory, development, Patient non-adherence Establishing a direct patients in managing productively with and health economics is a source of connection to patients therapy, including physicians, managing outcomes. frustration to clinicians. and family is critical in a adherence. behavioral and world of increasing emotional issues. Remove prescribing patient self-pay due to barriers. higher co-pays. . 29