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Collaborating for Impact
National Forum for Heart Disease and Stroke Prevention 12th Annual Meeting October 22, 2014
Helene D. Clayton-Jeter, O.D. Fortunato Fred Senatore MD, PhD, FACCDirector, Cardiovascular and Endocrine Liaison Program Medical OfficerCommissioner’s Office of External Affairs Division of Cardiovascular and Renal ProductsFood and Drug Administration Food and Drug Administration
1
Presenter Disclosure
The opinions and content in this presentation are based on personal views and do not reflect positions or policies of the FDA.
2
Million Hearts®
• National initiative co-led by CDC and CMS
• In partnership with federal, state, and private organizations innovating and implementing
• To address the causes of 1.5M events and 800K deaths a year, $312.6 B in annual health care costs and lost productivity and major disparities in outcomes
3
Goal: Prevent 1 million heart attacks and strokes by 2017
From presentation by Janet Wright, MD, FACC, Executive Director, MH Initiative
Key Components of Million Hearts®
Keeping Us HealthyChanging the context
Excelling in the ABCSOptimizing care
Prioritizing the ABCS
Health tools and technology
Innovations in care delivery
TRANSFAT
Health Disparities
Health Disparities
From presentation by Janet Wright, MD, FACC, Executive Director, MH Initiative
Million Hearts• Three things must happen to prevent 1
million heart attacks and stroke– 6.3 million smokers quit
– 10 million more people control their hypertension
– 20% reduction in sodium intake
Focus on populations with greatest burden and at greatest risk
5
From presentation by Janet Wright, MD, FACC, Executive Director, MH Initiative
Preventing a Million: Targets for Our Environment
Intervention2009-2010
Pre-Initiative Estimate
2017 Target
Smoking prevalence
26% 10% reduction
Sodium reduction 3580 mg/day 20% reduction
Trans fat reduction0.6% of calories
100% reduction
National Survey on Drug Use and Health 2009-2010 National Health and Nutrition Examination Survey 2009-2010
From presentation by Janet Wright, MD, FACC, Executive Director, MH Initiative
Preventing a Million: Targets for the ABCS
Intervention
2009-2010 Pre-
Initiative Estimate
2017 Population
-wide Target
2017 Clinical Target
Aspirin when appropriate
54% 65% 70%
Blood pressure control
52% 65% 70%
Cholesterol management
33% 65% 70%
Smoking cessation 22% 65% 70%
National Ambulatory Medical Care Survey, National Health and Nutrition Examination Survey
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PartneringFor Public
Health
FDA
Patients/Societies/Payers
Government/Academia
Scientific Scientific ResearchResearch
Medication Medication AdherenceAdherenceStrategiesStrategies
ImprovedImprovedHealthcare andHealthcare andCare Delivery Care Delivery
Collaborating for Impact
9
Assess, Address, and Reduce Health Disparities Assess, Address, and Reduce Health Disparities
FDA Action Items to support Million Hearts
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Translate and Disseminate Knowledge
Implement and Innovate for Population Health
Research*
Liaison program, newsletters, and webinars targeting CV health practitioners, patients, patient advocates, and consumers
Nutritional Fact Label Campaign•Label Youth Outreach•Menu and Vending
Enhanced adherence strategies for CV meds
Link MH website with FDA’s CV webpage.
Conduct “the real cost” tobacco cessation program
Evidence synthesis focused on improved patient outcomes
Publication:•sodium levels for food•partially hydrogenated oils are not generally recognized as safe * Response to the
challenge to “push the envelope”
Adherence: Multifaceted faceted issue
11
Adherence
TI
TI = Therapeutic Index
Patient Attitude and awareness
Cost of drugs
Pill Burden/Day
PCP-Patient Relationship
Symptom of Disease
Test for Adherence
Health Equity
RescueTherapy
Convenience
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Evidence-synthesis on improved patient outcomes
Increased public / sector awareness
Strategy for enhanced adherence
TI Pill burden
ACL and Administration on Aging
TI = Therapeutic Index; ACL= Administration of Community Living
Improved Care Delivery
Professional Academies and Colleges
Rescue Therapies
Research Action Item-MH Outcome Metrics Alliance
Why is adherence important?
• Assessing the Impact of Medication Adherence on Long-term Outcomes Post Myocardial Infarction – Bansilal S, Castellano JM, Wei HG, Garrido E, Freeman E,
Spettell CM, Garcia-Alonso F, Steinberg G, Sanz G, Fuster V; ESC Congress 2014
• Outcome: Time to MACE (death, hospitalization for MI, stroke, coronary revascularization) by Adherence Levels (Portion of Days Covered for both statin and ACE-I as determined by prescription pattern x 6 months
13
Time to MACE by Adherence Levels
14
Collaborating for Impact• Conclusion
– Million Hearts promotes collaboration in CV risk modification involving ABCS
– Million Hearts involves a multitude of government agencies each tasked with specific action items
– Mechanisms to enhance medication adherence being examined
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For additional information, contact the Commissioner’s Office of External Affairs, Office of Health and Constituent Affairs, Million Hearts Liaison
Helene Clayton-Jeter, O.D. at [email protected] or 301.796.8452
Collaborating for Impact
17
Back-up
Assessing the Impact of Medication Adherence on Long-term Outcomes Post Myocardial Infarction
S. Bansilal, JM. Castellano, HG. Wei, E. Garrido, A. Freeman, CM. Spettell, F. Garcia-Alonso, G. Steinberg , G. Sanz, V. Fuster
European Society Of Cardiology Congress 2014
18Bansilal et al, ESC 2014
Adherence Study-Background
• Evidence based medications for secondary prevention of cardiovascular disease (CVD) have led to a 50% reduction in mortality
• Nearly half of the patients are non adherent within the first year post event.
• Long-term studies linking adherence with outcomes are limited.
• We attempted to study the association between levels of medication adherence and long-term major adverse cardiovascular events in patients post myocardial infarction (MI).
19Bansilal et al, ESC 2014
Adherence Study-Objectives• Evaluate the association of levels of medication adherence
with long-term major cardiovascular events- death,
hospitalization for MI, stroke and coronary revascularization.
• Evaluate the association of levels of medication adherence
with ‘softer’ cardiac outcomes –hospitalization for angina,
All-cause and cardiac –related visited to ED.
• Evaluate the association of levels of medication adherence
with resource utilization- outpatient visits to a cardiac
specialist and cardiac testing.
20Bansilal et al, ESC 2014
Adherence Study-Methods
• 2010-2013 data from Aetna Commercial & Medicare
Advantage population databases
• Enrolment records, medical and pharmacy health
insurance claims.
• Records linked for comprehensive tracking of individuals’
use of healthcare resources and clinical outcomes over
time and across providers.
• Symmetry Episode Risk Groups (ERG®) Scores &
publicly available data from the U.S. Census 2010 file
used21Bansilal et al, ESC 2014
Adherence Study: Inclusion/Exclusion
Inclusion Criteria:•Adults who initiated both statin and ace-inhibitor (ACEI) medications following a hospitalization discharge for myocardial infarction (MI) based on ICD codes with a length of stay of more than 2 days, between January 1, 2010, and February 28, 2013.
•Continuous eligibility for both medical and prescription drug benefits from Aetna during 6 months before and after the MI.
Exclusion Criteria:•Pregnant
•Diagnosis codes indicating psychoses, dementia, bipolar disorder, major depressive disorder (severe with psychotic behaviours) or alcohol/substance abuse
•Living in a nursing home or in a hospice or respite care.
•Patients who had a refill for ARB medication within 6 months following the discharge date of the MI
22Bansilal et al, ESC 2014
Adherence Study: Endpoint Selection
• Most recurrent events post MI occur within the first year• Patients ‘reveal’ their adherence patterns as early as a
month post MI, but their stable pattern is best apparent around 6 months and beyond
• Studies evaluating adherence have typically selected a 6-12 month exposure period
• We chose a 6 month adherence assessment period to optimize rigor while maintaining power
23
1. Smolina K et al. Circ Cardiovascular Qual. Outcomes 20122. Ho PM etal.- Arch. Int Med 2006 ; Am Heart J 2008; Circulation 2009 3. Jackevicius CA et al. Circulation 20084. Choudhry NK et al. Am Heart J 2014
Bansilal et al, ESC 2014
Adherence Study: Assessment
• Proportion of days covered (PDC) for both statin and ACEI during 6 months of follow-up after the index prescription.
• Patients were considered to be adherent if they were getting the refill of both ACEI and statin prescriptions.
• Based on their PDCs, we categorized patients into one of three groups using standard thresholds: ≥80% (‘fully adherent’), 40–79% (‘partially-adherent’), and <40% (‘non-adherent’).
24Bansilal et al, ESC 2014
Adherence Study: Statistical Analysis• Descriptive analyses were conducted to compare
baseline characteristics between adherence exposure groups.
• Time to MACE for the three exposure groups was compared using Cox Proportional Hazards regression.
• Adjustment for significant confounders including those related to the “healthy adherer effect”.
• Event counts were compared using Negative Binomial regression with adjustment for confounders as above.
25Bansilal et al, ESC 2014
Adherence Study: Covariates for adjustment
26Bansilal et al, ESC 2014
Adherence Study: Disposition
27
Adults post- MI 1/10/10-2/28/13
N=14,119
Adults post- MI 1/10/10-2/28/13
N=14,119 7012 (49.6%) No fill of both ACEI and Statin during 6 months post
MI
7012 (49.6%) No fill of both ACEI and Statin during 6 months post
MIAdults post MI with ACEI and Statin fill within 6 month post
eventN=7107
Adults post MI with ACEI and Statin fill within 6 month post
eventN=7107
Adults post MI with ACEI and Statin fill within 6 month post event, No exclusion
N=5776
Adults post MI with ACEI and Statin fill within 6 month post event, No exclusion
N=5776
1331 excluded •29% mental disorders•1% pregnant/delivery•10% Hospice•23% Nursing facility•33% ARB fill during 6 months post MI•4% MI was not index event
1331 excluded •29% mental disorders•1% pregnant/delivery•10% Hospice•23% Nursing facility•33% ARB fill during 6 months post MI•4% MI was not index event
1761 without 6 months pre-period
1761 without 6 months pre-periodAdults post MI with ACEI
and Statin fill within 6 month post event, No
exclusion, with 6 mth pre-period
N=4015
Adults post MI with ACEI and Statin fill within 6 month post event, No
exclusion, with 6 mth pre-period
N=4015
Fully-Adherent (>80%) N=1721
(43%)
Fully-Adherent (>80%) N=1721
(43%)
Partially-Adherent (40-79%) N=1031
(31%)
Partially-Adherent (40-79%) N=1031
(31%)
Non-Adherent (<40%) N=1263
(26%)
Non-Adherent (<40%) N=1263
(26%)
Bansilal et al, ESC 2014
Adherence Study: Baseline Characteristics
28
Low PDC
Mid PDC High PDC p value
Age (mean) 56.6 57.8 56.2 0.0002 Male gender (%) 74.01 76.72 79.31 0.005 PDC (mean) 21 62 93 <0.0001 Diabetes (%) 34.05 34.20 25.63 <0.0001
Hyperlipidemia (%) 91.76 94.62 95.41 0.0003
Hypertension (%) 68.19 77.12 68.97 <0.0001 Previous CAD (%) 31.30 34.52 21.50 <0.0001 Previous CVD (%) 5.92 7.21 5.69 0.215
Previous PAD (%) 7.57 8.79 5.75 0.006
Obesity (%) 4.46 5.78 4.65 0.259 CHF (%) 20.66 20.43 17.26 0.033 CRF (%) 4.17 5.86 3.78 0.021
Prospective risk score (ERG) (mean) 2.96 3.29 2.50 <0.0001
Charlson Comorbidity Score (mean) 1.91 2.04 1.82 <0.0001
Length of Stay - Index Admission (mean) 4.2522 4.5701 4.0622 0.0084 Household income in zip code (median) 64336 66058 66827 0.031 Copays for all medications during adherence period (mean)
488 570 592 <0.0001
Bansilal et al, ESC 2014
Adherence Study: Time to MACE by Adherence Level
29Bansilal et al, ESC 2014
Adherence Study: Primary Outcome Measures
30
Event Low PDC (N=1031)
Mid PDC (N=1263)
High PDC (N=1721)
PDC group comparison Ratiop value
Composite Cardiac Events 18.1 (281) 17.2 (329) 12.8 (328) High v. Low 0.72 0.002High v. Mid 0.81 0.01 Mid v. Low 0.90 0.18
Coronary/MI Hospitalization 4.8 (74) 4.4 (84) 2.3 (58) High v. Low 0.54 0.001High v. Mid 0.59 0.01 Mid v. Low 0.90 0.57
Stroke Hospitalization 1.2 (18) 0.9 (17) 0.6 (16) High v. Low 0.54 0.09High v. Mid 0.94 0.86 Mid v. Low 0.58 0.14
Revascularization Procedures (IP or OP)
14.4 (224) 13.1 (249) 10.8 (277) High v. Low 0.78 0.01
High v. Mid 0.86 0.12 Mid v. Low 0.90 0.30
Bansilal et al, ESC 2014
Adherence Study: Limitations
• Insurance and pharmacy claims database
• Lack of benefit for secondary outcomes
• Overlap of outcomes with the adherence assessment period
• Unable to directly establish causality
• Confounding bias
• Treatment initiation
31Bansilal et al, ESC 2014
Adherence Study: Conclusions
• High levels of adherence to guideline recommended therapies are associated with a lower rate of major cardiovascular events compared to partial or non-adherence.
• There appeared to be a threshold effect for this benefit at >80% adherence.
• Novel approaches to improve adherence such as a polypill that may enable >80% adherence with secondary preventive therapies may lead to a significant reduction in CV events post MI.
32Bansilal et al, ESC 2014