Managing Adherence with a Mobile Population Leslie Yendro, RN

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Managing Adherence with a Mobile Population Leslie Yendro, RN Vice President, Business Development Avella Specialty Pharmacy

Objectives Discuss the impact of non-adherence on patient outcomes. Review various messaging strategies and how specialty pharmacies are uniquely suited to implement these programs. Understand adherence initiatives and challenges, including barriers to enrollment. Case studies on successful programs and partnerships in adherence. 2

If medication non adherence was a disease, it would be an epidemic. Anonymous Drugs work in only those that take them. Charles Everrett Koop, MD 3

Non-adherence A patient is considered to be non-adherent if he or she misses doses, takes additional doses to those prescribed, or takes doses either in the wrong quantity or at the wrong time (Ruddy, Mayer & Partridge, 2009). Ruddy, K., Mayer, E., & Partridge, A. (2009). Patient adherence and persistence with oral anticancer treatment. CA: A Cancer Journal for Clinicians, 59, 56 66 4

U.S. Patients Do Not Take Medications as Prescribed -12% -12% -29% 100% 88% 76%* 47%* Rx prescribed Rx filled Rx taken Rx continued * 22% of U.S. patients take less of the medication than is prescribed American Heart Association: Statistics you need to know. http://216.185.102.50/cap/pro/prof_statistics2.html Accessed July 27, 2002. 5

The Real Drug Problem Wall Street Journal - October 21, 2003 31% of all prescriptions are not filled the first time 15% of all hospital visits ($47 billion/annually) are due to medication non-adherence 60% of all patients cannot identify their own medications 27% of breast cancer survivors fall off their Tamoxifen therapy 67% forget to take their medication at times 9% said they would keep taking a medication if they started feeling worse 6

Timeline of Medical Community Interest in Adherence 1948 1960 1970 1980 1990 2000 2008 1 st Article Hypertension HAART Resistance Hardy MC. JAMA Hecht et al. N Engl J Med 1998;339:307 8

Relation Between Adherence and Treatment Failure Adapted from Maggiolo et al. Clin Infect Dis. 2005;40:158 63. NNRTI = nonnucleoside reverse transcriptase inhibitor; PI = protease inhibitor. 9

Consequences of Non-adherence Drug resistance Suboptimal response to therapy Disease progression Death 10

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Impact of Medication Adherence on Hospitalization Risk 60 50 40 30 Diabetes Hypertension Hypercholesterolemia 20 10 0 1-19* 20-39* 40-59* 60-79* 80-100 Medication Possession Ratio *P<0.05 when compared to the 80-100% group Sokol etal. Med Care 2005;43: 521-530 12

Increased Medication Adherence Relates to Reduced Overall Medical costs Takemoto and associates reviewed over 12,000 Medicare claims for renal transplant patients and compared medication adherence to overall medical costs: Patients with higher adherence or MPR rates had an overall reduction (15% less) in medical costs over a 3 year period of time compared to patients that had a lower adherence rate. ($31,000 versus $58,900) Takemoto SK., Pinkey B., Woodward RS., Outcomes and Costs Associated with Immunosupressive Compliance. Conclusion: Increased adherence and persistence equates to lower overall medical expenditure. 13

Current Practice Patterns for Oral Chemotherapy: Results of a National Survey Janna C Roop, Horng-Shiuann Wu Oncology Nursing Forum (Impact Factor: 1.91). 12/2013; DOI:10.1188/14.ONF.41-02AP 14

What is Specialty Pharmacy? Complex biotech drugs with different routes of administration: injected, infused, oral and/or medical device Cold chain of custody that maintains temperature, stability, integrity, and delivery to a set of standards High cost, with substantial patient out-of-pocket costs Clinical support from pharmacists who educate patients about drug, disease, side effects, and adherence 15

Specialty vs. Retail Pharmacies Retail Specialty Patient Contact Reactive Proactive Drug Availability Limited Carried in stock Clinical support Limited knowledge Specialized knowledge about lots of drugs Availability of clinical staff Regular hours 24/7 Dispensing vs. patient care Low patient contact High Touch Adherence/Persistence Tools Limited to none Numerous Billing Multiple challenges Split Billing Financial Assistance/Prior Authorizations Limited to none Core service 16

Evolution of Adherence Programs Traditional / Past Your doctor tells you what you need to know about your medication. You get a brochure at the office telling you about your medication and disease Pick up your prescription at the retail pharmacy and talk with the pharmacist. Your pharmacy calls you to remind you to refill your medication. 17

Evolution of Adherence Programs Specialty / Future A nurse tells you what you need to know about your medication before you leave the doctor s office. Your pharmacy calls you to educate you on your disease and medication, help you with funding and your medication arrives at your door. Specialty pharmacies enroll you in customized programs to provide you specific information. Technology is employed to address the mobile environment and the expectation of immediate information and feedback. 18

Types of Adherence Initiatives Passive Mailings or brochures One directional web sites Live Interventions By phone In person counseling Technology Driven Text messaging Electronic reminder devices Web based interactions Other 19

Passive 20

Hepatitis C Clinical Management Process Day 1: Hepatitis C Program Enrollment (Opt-in/out) Outbound Patient Call Day 10: Mid-therapy Assessment- Outbound Patient Call Day 24: Refill/Wellness Check-Outbound Patient Call 21

Impact of Live Counseling Oral Oncology Agent Patients Called 170 Patients Opted Out 53 Ave Days on Therapy Opt In 235 Ave Days on Therapy Opt Out 194 22

Bi-Directional Text Messaging Program Text messaging program Daily reminders to take medication Reminders for lab work Educational tips, e.g. blood pressure monitoring Motivational messaging Patient surveys Gather lab values Pharmacist intervention for any indication of non-compliance Clinician notified Weekly emails to clinical staff Refill Reminders 23

Bi-Directional Text Messaging Program Increase in Refill Rates after Adoption 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% 69.4% 89.4% % Growth in refill rate after adoption of text messaging program 30.0% 20.0% 10.0% 0.0% Pre-adoption rate Post-adoption rate24

25

26

MEMS Device 28

Pill-Aide Organizes medication in advance Alerts patient when it is time to take their medication Device can be filled by pharmacist, Caregiver, or patient Alarm sounds and/or flashes for up 30 minutes or until patient takes the medication. 29

Glow Cap 30

31

Higher Risk Patients for Non-Adherence Medically Underserved Age >65yo Patient perceptions Lack of Support Poor communication Psychiatric illness Knowledge Forgetfulness Medication Costs Multiple daily dosing Complicated administration instructions Specialty Drugs 32

Benchmark Adherence Rates Disease Epilepsy Arthritis Hypertension Diabetes Oral contraceptives HRT Asthma Kidney Transplant Heart Transplant Liver Transplant CML (Imatinib) Rates of Non-Adherence 30% to 50% 50% to 71% 40% (average) 40% to 50% 8% 57% 20% 35.6% 14.5% 6.7% 25% Cochrane Review, Oct, 2005; Transplantation (2007;83:858 873) Blood (2007;109:58 60) 33

Variability in Persistence in Clinical Trials and Real- World Setting Clinical Trial Real World Therapy % adherence Duration (yrs) % adherence Duration (yrs) Imatinib(CML) 1 91 1.67 56 1 Letrozole 1 84 4.3 77 1 Tamoxifen 2 71.7 3.9 77.9 1 Capecitabine 3 Clinical Trial 83 0.35 Tamoxifen 4 initial hormonal therapy for women </= 40yo 50.7 <5yrs 1 J Onc Prac vol 7 issue 1 Jan 2011 2 Cancer 109:832 839, 2007 3 J Clin Onc 28:2418 2422, 2010 4 Br J of Cancer April 26 2011 34

Abandonment of Oral Oncolytics J Onc Practice May 2011,vol.7 no.3s;46s-51s Methods: Review reversed claims from 2007-2009 WK data base of Medicare and Commercial Abandonment defined as reversal of a paid claim without a subsequent paid claim within 90 days Results: 10% abandonment rate Copays > $500 accounted for 25% of the abandoned prescriptions High cost, age, increased prescription activity, lower income, Medicare coverage were associated with higher abandonment 35

Measuring Adherence Patient self-reports Clinical outcomes Pill counts Refill records Biological & chemical markers Microelectronic monitoring systems (MEMS) MAS Medication Adherence Scale BMQ Brief Medical Questionnaire ITAS & ITBS IST Adherence Scale IST Barrier scale LTMBS Long-term Medication Behaviour Self-Efficacy scale 36

The Role of the Nurse in Facilitating Oral Medication Adherence Assess adherence ASK -20 survey (Hahn et al, 2008) ASK -12 survey (Matza et al, 2009) ASK-20SM is a valid and reliable selfadministered survey for patients that can identify 20 specific, actionable barriers to medication adherence across a spectrum of chronic diseases. Hahn, S.R., Park, J., Skinner, E.P., Yu Isenbert, K.S., Weaver, M.B., Crawford, B., & Flowers, P.W. (2008). Development of the ASK 20 adherence barrier survey. Current Medical Research and Opinion, 24, 2127 2138. 37

Adherence Pilot Program Objective of Pilot: Assess the effectiveness of adherence tools (e.g. GlowCap) on Gleevec and Tasigna patients. Patient Selection: Patients with at least 6-mo history prior to program start Patient Disease States All Gleevec GIST patients All Tasigna CML patients 39

How Do GlowCaps Remind Patients? 1. GlowCap flashes orange at reminder time for the 1 st hour 2. GlowCap flashes orange and plays ringtone for the 2 nd hour 3. Patient receives automated phone call A quick reminder from your friends at Vitality: Don't forget to take your <time of day>pill in your GlowCap. 40

Key Program Elements Patients were screened for eligibility and optedin both verbally and via signed consent form. Pharmacy enrolled patients into the vendor portal based on the prescribed regimen. Behaviors that triggered pharmacy interventions: No activity for > 72 hours Weekly adherence rates of less than 85% Refills not matching the device activity Prescribers also were notified of the adherence 41

Patient Adherence Comparison between Avella GlowCap Users vs. Non-Users. Early data show Avella patients with GlowCap had better adherence in their first 4 months of therapy. The gap between the groups seems to grow over time, especially for Tasigna patients. 100.0% 90.0% 80.0% 70.0% 60.0% 100.0% Tasigna Patient Adherence by GlowCap Use (Oct. 2011 Jan. 2012) 100.0% 82.6% 92.2% 89.5% 90.0% 80.4% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 1 2 3 4 TAS: GlowCap (n=23) TAS: No GlowCap (n=51) 42

Our pilot program demonstrated a 50% increase in medication adherence at month 4 of therapy for Tasigna patients using GlowCap (vs. control group). 43

Considerations for Successful Adherence Programs Easy for patient to obtain and understand ACTIVE interventions a device alone will not be as effective Prescribers are aware and supportive of the programs The program meets the needs of the patient and the therapy Measurable results HIPAA compliant 44

Questions? 45

Thank You! 46