American Heart Journal
Volume 156, Issue 1 , Pages 31-36 , July 2008

Rationale and design of the Post-MI FREEE trial: A randomized evaluation of first-dollar drug coverage for post–myocardial infarction secondary preventive therapies

  • Niteesh K. Choudhry, MD, PhD

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • Corresponding Author InformationReprint requests: Niteesh K. Choudhry, MD, PhD, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
    • ,
  • Troyen Brennan, MD, JD, MPH

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Michele Toscano, MS

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Claire Spettell, PhD

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Robert J. Glynn, ScD, PhD

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • ,
  • Mark Rubino, MHA, RPh

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Sebastian Schneeweiss, MD, ScD

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • ,
  • Alan M. Brookhart, PhD

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • ,
  • Joaquim Fernandes, MS

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Susan Mathew, MPH

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Blake Christiansen, MS, RPh

      Affiliations

    • Aetna Inc Hartford, CT
    • ,
  • Elliott M. Antman, MD

      Affiliations

    • Division of Cardiology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • ,
  • Jerry Avorn, MD

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA
    • ,
  • William H. Shrank, MD, MSHS

      Affiliations

    • Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA

Received 26 November 2007 ,Accepted 12 March 2008.

References 

  1. Yusuf S, Reddy S, Ounpuu S, et al. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001;104:2746–2753
  2. Rosamond W, Flegal K, Furie K, et al. Heart disease and stroke statistics—2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008;117:e25–e146
  3. Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. Br Med. 2002;324:71–86
  4. Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366:1267–1278
  5. Lopez-Sendon J, Swedberg K, McMurray J, et al. Expert consensus document on angiotensin converting enzyme inhibitors in cardiovascular disease. The Task Force on ACE-inhibitors of the European Society of Cardiology. Eur Heart J. 2004;25:1454–1470
  6. Lopez-Sendon J, Swedberg K, McMurray J, et al. Expert consensus document on beta-adrenergic receptor blockers. Eur Heart J. 2004;25:1341–1362
  7. Lau J, Antman EM, Jimenez-Silva J, et al. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 1992;327:248–254
  8. Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996;335:1001–1009
  9. Antman EM, Hand M, Armstrong PW, et al. 2007 Focused Update of the ACC/AHA 2004 Guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Canadian Cardiovascular Society endorsed by the American Academy of Family Physicians: 2007 Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the management of patients with ST-elevation myocardial infarction, writing on behalf of the 2004 Writing Committee. Circulation. 2008;117:296–329
  10. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 Guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007;116:e148–e304
  11. McGovern PG, Jacobs DR, Shahar E, et al. Trends in acute coronary heart disease mortality, morbidity, and medical care from 1985 through 1997: the Minnesota Heart Survey. Circulation. 2001;104:19–24
  12. Stafford RS, Radley DC. The underutilization of cardiac medications of proven benefit, 1990 to 2002. J Am Coll Cardiol. 2003;41:56–61
  13. Tricoci P, Roe MT, Mulgund J, et al. Clopidogrel to treat patients with non-ST-segment elevation acute coronary syndromes after hospital discharge. Arch Intern Med. 2006;166:806–811
  14. Benner JS, Glynn RJ, Mogun H, et al. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002;288:455–461
  15. Ramsay SE. Personal communication. In; 2006.
  16. Ho PM, Spertus JA, Masoudi FA, et al. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006;166:1842–1847
  17. Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007;297:177–186
  18. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487–497
  19. Roblin DW, Platt R, Goodman MJ, et al. Effect of increased cost-sharing on oral hypoglycemic use in five managed care organizations: how much is too much?. Med Care. 2005;43:951–959
  20. Goldman DP, Joyce GF, Escarce JJ, et al. Pharmacy benefits and the use of drugs by the chronically ill. J Am Med Assoc. 2004;291:2344–2350
  21. Shrank WH, Hoang T, Ettner SL, et al. The implications of choice: prescribing generic or preferred pharmaceuticals improves medication adherence for chronic conditions. Arch Intern Med. 2006;166:332–337
  22. Lester W. The Associated Press/Ipsos Poll: almost a third of Americans say paying for drugs is a problem in their families. Available at: http://www.ipsos-na.com/news/pressrelease.cfm?id=2064#Last accessed April 23, 2004
  23. Rector TS, Venus PJ. Do drug benefits help Medicare beneficiaries afford prescribed drugs?. Health Aff. 2004;23:213–222
  24. Piette JD, Wagner TH, Potter MB, et al. Health insurance status, cost-related medication underuse, and outcomes among diabetes patients in three systems of care. Med Care. 2004;42:102–109
  25. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. J Am Med Assoc. 2007;298:61–69
  26. Adams AS, Soumerai SB, Ross-Degnan D. Use of antihypertensive drugs by Medicare enrollees: does type of drug coverage matter?. Health Aff (Millwood). 2001;20:276–286
  27. Fendrick AM, Smith DG, Chernew ME, et al. A benefit-based copay for prescription drugs: patient contribution based on total benefits, not drug acquisition cost. Am J Manag Care. 2001;7:861–867
  28. Choudhry NK, Avorn J, Antman EM, et al. Should patients receive secondary prevention medications for free after a myocardial infarction? An economic analysis. Health Aff (Millwood). 2007;26:186–194
  29. Choudhry NK, Patrick AR, Antman EM, et al. Cost-effectiveness of providing full drug coverage to increase medication adherence in post-myocardial infarction Medicare beneficiaries. Circulation. 2008;
  30. Briesacher BA, Stuart B, Ren X, et al. Medicare beneficiaries and the impact of gaining prescription drug coverage on inpatient and physician spending. Health Serv Res. 2005;40(5 Pt 1):1279–1296
  31. Mahoney JJ. Reducing patient drug acquisition costs can lower diabetes health claims. Am J Manag Care. 2005;11(5 Suppl):S170–S176
  32. Chernew ME, Shah MR, Wegh A, et al. Impact of decreasing copayments on medication adherence within a disease management environment. Health Aff (Millwood). 2008;27:103–112
  33. Leibowitz A, Manning WG, Newhouse JP. The demand for prescription drugs as a function of cost-sharing. Soc Sci Med. 1985;21:1063–1069
  34. Petersen LA, Wright S, Normand SL, et al. Positive predictive value of the diagnosis of acute myocardial infarction in an administrative database. J Gen Intern Med. 1999;14:555–558
  35. Austin PC, Daly PA, Tu JV. A multicenter study of the coding accuracy of hospital discharge administrative data for patients admitted to cardiac care units in Ontario. Am Heart J. 2002;144:290–296
  36. Birman-Deych E, Waterman AD, Yan Y, et al. Accuracy of ICD-9-CM codes for identifying cardiovascular and stroke risk factors. Med Care. 2005;43:480–485
  37. Lin DY, Wei LJ. The robust inference for the proportional hazards model. J Am Stat Assoc. 1989;84:1074–1078
  38. Contoyannis P, Hurley J, Grootendorst P, et al. Estimating the price elasticity of expenditure for prescription drugs in the presence of non-linear price schedules: an illustration from Quebec, Canada. Health Econ. 2005;14:909–923
  39. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. Br J Radiol. 1971;44:793–797
  40. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976;34:585–612
  41. Kripalani S, Yao X, Haynes RB. Interventions to enhance medication adherence in chronic medical conditions: a systematic review. Arch Intern Med. 2007;167:540–549
  42. Spertus JA, Kettelkamp R, Vance C, et al. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006;113:2803–2809

 Trial Registration Number: NCT00566774.

 Funding information: This work was supported by a research grant from Aetna Inc to Brigham and Women's Hospital.

PII: S0002-8703(08)00231-7

doi: 10.1016/j.ahj.2008.03.021

American Heart Journal
Volume 156, Issue 1 , Pages 31-36 , July 2008

Article Tools