Collaborating for Impact National Forum for Heart Disease and Stroke Prevention 12th Annual Meeting...

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

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Presenter Disclosure

The opinions and content in this presentation are based on personal views and do not reflect positions or policies of the FDA.

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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

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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


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

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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


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


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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

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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

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Time to MACE by Adherence Levels

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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

mailto:[email protected]


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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).


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.


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


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

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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’).


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.


Adherence Study: Covariates for adjustment


Adherence Study: Disposition

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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%)


Adherence Study: Baseline Characteristics

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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


Adherence Study: Time to MACE by Adherence Level


Adherence Study: Primary Outcome Measures

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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


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


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.


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