Post-Myocardial Infarction Free Rx Event and Economic Evaluation - MI FREEE

Nov 14, 2011
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Aetna and the Commonwealth Fund
Date Presented:
01/01/2011
Date Published:
01/01/2011
Date Updated:
11/14/2011
Original Posted Date:
11/14/2011
References

Description:

Adherence with evidence-based medications in patients with coronary artery disease is low. One of the most commonly implicated reasons is medication cost. The current trial sought to study if eliminating copayments for statins, beta-blockers and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (ACEI/ARBs) would be associated with improved clinical outcomes and reduced health care costs in patients with a recent myocardial infarction (MI).

Hypothesis:

Eliminating copayments for statins, beta-blockers, and ACEI/ARBs would be associated with reduced vascular events and revascularizations, and reduced health care costs in patients with a recent MI.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Aetna as primary insurance
  • Hospitalization for acute MI

    Number of enrollees: 5,855
    Duration of follow-up: 3 years
    Mean patient age: 53.7 years
    Percentage female: 25%

Exclusions:

  • Age >65 years
  • Did not have both drug and medical coverage
  • Enrolled in ineligible plan

Primary Endpoints:

  • First major vascular event or revascularization

Secondary Endpoints:

  • Total major vascular events and revascularization
  • First major vascular event
  • Medication adherence
  • Pharmacy and medical spending

Drug/Procedures Used:

In a cluster-randomized design, Aetna beneficiaries discharged from the hospital after an MI were randomized (mean 49 days post-MI) to full coverage of all beta-blockers, ACEI/ARBs, and statins (irrespective of generic vs. branded) or usual levels of prescription insurance coverage. Randomization was at the plan sponsor (not individual patient) level.

Concomitant Medications:

Prior to hospitalization: beta-blockers (65%), ACEI/ARB (54%), clopidogrel (54%), statin (61%)

Principal Findings:

A total of 5,855 patients were enrolled from 2,980 plan sponsors: 2,845 to full prescription coverage and 3,010 to usual prescription. Baseline characteristics were similar between the different arms. About 28% had congestive heart failure, 16% had chronic obstructive pulmonary disease, 34% had diabetes, and 6% had prior stroke. During the index hospitalization, 94% underwent coronary angiography, and 67% percutaneous coronary intervention (PCI). The mean copayment prior to randomization was $13.50 for ACEI/ARBs, $12.70 for beta-blockers, and $24.90 for statins. Of the patients enrolled, about 5% lost insurance eligibility prior to randomization.

Absolute medication adherence during follow-up improved for all medications individually in the full prescription coverage arm (ACEI/ARB: 41.1% vs. 35.9%; beta-blockers: 49.3% vs. 45.0%; statins: 55.1% vs. 49.0%) and for all three combined (43.9% vs. 38.9%) (p < 0.001 for all). Similarly, patients who were fully adherent with these medications also improved.

The primary endpoint of major vascular event or revascularization was similar between the two arms over the duration of follow-up (17.6% vs. 18.8%, hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.82-1.04, p = 0.21). The secondary endpoint of major vascular events was, however, significantly lowered in the full prescription coverage arm (11.0% vs. 12.8%, p = 0.03).

Health care spending by insurers for prescription drugs was higher in the full prescription coverage arm ($4,847 vs. $3,921, p < 0.001), although total spending (including nondrug spending) was numerically lower ($59,898 vs. $66,076, p = 0.77). Patient spending was decreased for both costs ($802 vs. $1,164, and $1,282 vs. $1,781, respectively, p < 0.001 for both). Similar trends were noted for cardiovascular spending.

Interpretation:

The results of this trial indicate that providing medication free (no copayment) for statins, beta-blockers, and ACEI/ARBs to patients recently discharged with a MI is associated with improved medication adherence and lower patient costs, with a modest improvement in clinical outcomes. Medication adherence is a growing concern for clinicians, health care systems, and other stakeholders (such as payers), because of increasing evidence of its association with both short- and long-term adverse outcomes and higher costs of care. This is a very important trial, since medication costs are often implicated as a barrier to patient adherence. Despite its overall negative results for the primary endpoint, this strategy appears to be very promising, and needs to be further explored.

Reasons for the overall negative results for the primary endpoint could be that other post-MI medications such as clopidogrel were not provided, and that the mean time to randomization after MI discharge was about 1.5 months. Also, patients older than age 65 were excluded, who may benefit more due to higher risk. It is also insightful to note that although medication adherence improved with this strategy, absolute rates were still <50%. Other measures to improve patient adherence are urgently needed.

References:

Choudhry NK, Avorn J, Glynn RJ, et al. Full coverage for preventive medications after myocardial infarction. N Engl J Med 2011;Nov 14:[Epub ahead of print].

Presented by Dr. Niteesh Choudhry at the American Heart Association Scientific Sessions, Orlando, FL, November 14, 2011.

Keywords: Angiotensin Receptor Antagonists, Myocardial Infarction, Stroke, Follow-Up Studies, Platelet Aggregation Inhibitors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Ticlopidine, Health Care Costs, Purinergic P2Y Receptor Antagonists, Percutaneous Coronary Intervention, Medication Adherence, Pulmonary Disease, Chronic Obstructive, Insurance, Pharmaceutical Services, Coronary Angiography, Heart Failure, Confidence Intervals, Diabetes Mellitus


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