ORLANDO, Fla.—Researchers recommended widespread adoption of a program that eliminates co-payments for preventive MI medications after it was shown to reduce rates of major vascular events at no added cost to insurers. The results of the Post-MI FREEE trial were presented Nov. 14 at the American Heart Association’s 2011 Scientific Sessions.

The study was simultaneously published online in the New England Journal of Medicine.

Adherence to medications prescribed after an MI is “amazingly bad,” said Niteesh K. Choudhry, MD, PhD, an associate physician at Brigham and Women’s Hospital in Boston, partly due to the cost of medication even among insured patients. “Eliminating out-of-pocket costs for evidence-based therapies may promote better adherence and may lead to better outcomes and also reduce costs,” he suggested.

To test that hypothesis, Choudhry and colleagues designed the Post-MI FREEE trial (Post-Myocardial Infarction Free Rx and Economic Evaluation), a cluster randomized, controlled policy study. The researchers enrolled insured patients who had been discharged with an MI and randomized them by their insurance plan sponsor, Aetna. One group consisted of 1,494 plans with 2,845 patients who had fully paid prescription coverage while a second group consisted of 1,486 plans with 3,010 patients who had standard prescription coverage. Drugs for both groups included statins, beta-blockers, ACE inhibitors and ARBs.

“We purposely selected people who had been discharged from MI precisely because the costs are so enormously high,” Choudhry said in a press conference. “This is an enormously expensive condition.”

The primary outcome was a first major vascular event or revascularization. Secondary outcomes were rates of total major vascular events and revascularization; first major vascular event; medication adherence; and pharmacy and medical expenditures. They used validated health service claims to assess outcomes and Cox modeling to calculate adherence and expenditures. Median follow-up was 394 days.

While there was no significant difference between the groups for the primary outcome, the fully covered group had better adherence, reduced rates of total major vascular events or revascularization and a reduced rate of first major vascular event. Eliminating co-payments added no costs to the insurer and reduced costs for patients.

The control group had rates of adherence between 35.9 percent and 49 percent while rates for the fully covered group were consistently higher.  “Adherence went up four to six percentage points,” Choudhry said. “In relative terms, adherence went up 30 to 40 percent. “

The primary outcome was similar for both groups, but the rates of total major vascular events were lower in the fully covered group: 21.3 percent compared with 23.3 percent. “That is a relative reduction of 14 percent, which is statistically significant,” he said.

Expenditures for the fully covered group were lower as well, with mean total spending at $66,008 for the fully covered group compared with $71,778 for the control group. Insurers paid more on pharmacy items for the fully covered group but less on non-pharmacy services. Patients in the fully covered group paid 26 percent less in overall out-of-pocket costs compared with the control group, as well.

“The results appear cost-effective and it is a rarity for an intervention to actually improve patient affordability,” Choudhry said. “Moreover, the intervention we evaluated is easy, scalable and could be started as soon as tomorrow if insurers chose to do so.”

As the discussant, Eric D. Peterson, MD, MPH, a professor of medicine at Duke University School of Medicine and associate director of the Duke Clinical Research Institute, both in Durham, N.C., focused on the challenges of getting patients to take their medications as prescribed. “A drug only works if taken, and in this country taking drugs is a challenge, long term,” he began.  “As we’ve heard, adherence is a huge problem. We typically blame costs.”

Post-MI FREEE provided researchers with a platform to study whether waiving co-payments would help promote adherence.  “The study found that adherence in America is miserable,” he said. He added that the intervention had only a modest effect on adherence and failed to meet its primary outcome. Nonetheless, he was enthusiastic about what he termed a remarkable effort.

“This is one time where widespread adoption can be recommended,” Peterson said. “It did improve outcomes on total vascular events and the program essentially paid for itself.”