Rationale and design of the Post-MI FREEE trial: a randomized evaluation of first-dollar drug coverage for post-myocardial infarction secondary preventive therapies.
BACKGROUND
Medication nonadherence is a major public health problem, especially for patients with coronary artery disease. The cost of prescription drugs is a central reason for nonadherence, even for patients with drug insurance. Removing patient out-of-pocket drug costs may increase adherence, improve clinical outcomes, and even reduce overall health costs for high-risk patients. The existing data are inadequate to assess whether this strategy is effective.


METHODS
The Post-Myocardial Infarction Free Rx and Economic Evaluation (Post-MI FREEE) trial aims to evaluate the effect of providing full prescription drug coverage (ie, no copays, coinsurance, or deductibles) for statins, beta-blockers, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers to patients after being recently discharged from the hospital. Potentially eligible patients will be those individuals who receive their health and pharmacy benefits through Aetna, Inc. Patients enrolled in a Health Savings Account plan, who are > or =65 years of age, whose plan sponsor (ie, the employer, union, government, or association that sponsors the particular benefits package) has opted out of participating in the study, and who do not receive both medical services and pharmacy coverage through Aetna will be excluded. The plan sponsor of each eligible patient will be block randomized to either full drug coverage or current levels of pharmacy benefit, and all subsequently eligible patients of that same plan sponsor will be assigned to the same benefits group. The primary outcome of the trial is a composite clinical outcome of readmission for acute MI, unstable angina, stroke, congestive heart failure, revascularization, or inhospital cardiovascular death. Secondary outcomes include medication adherence and health care costs. All patients will be followed up for a minimum of 1 year.


CONCLUSIONS
The Post-MI FREEE trial will be the first randomized study to evaluate the impact of reducing cost-sharing for essential cardiac medications in high-risk patients on clinical and economic outcomes.
Choudhry
Niteesh K
NK
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA. nchoudhry@partners.org
Brennan
Troyen
T
Toscano
Michele
M
Spettell
Claire
C
Glynn
Robert J
RJ
Rubino
Mark
M
Schneeweiss
Sebastian
S
Brookhart
Alan M
AM
Fernandes
Joaquim
J
Mathew
Susan
S
Christiansen
Blake
B
Antman
Elliott M
EM
Avorn
Jerry
J
Shrank
William H
WH
D000319:Adrenergic beta-Antagonists / Q000191:economics / Q000627:therapeutic use; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000191:economics / Q000627:therapeutic use; D002317:Cardiovascular Agents / Q000191:economics* / Q000627:therapeutic use*; D003266:Continuity of Patient Care / Q000191:economics*; D017047:Cost Sharing; D016527:Drug Costs; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics / Q000627:therapeutic use; D007356:Insurance, Pharmaceutical Services / Q000191:economics*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000628:therapy; D010349:Patient Compliance / Q000706:statistics & numerical data*; D018579:Patient Selection; D018570:Risk Assessment; D055502:Secondary Prevention; D012680:Sensitivity and Specificity
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D002317:Cardiovascular Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors