Wednesday, November 17, 2004

SCD-HeFT Study: Simple Life-Saving Shock Device Worth Cost
By Julie McKeel

Daniel Mark, MD

Less-costly versions of implanted heart devices represent a good value for most patients who need them, according to a cost analysis study presented at the American Heart Association (AHA) Scientific Sessions on Wednesday. This study confirms U.S. regulators' recent decision to encourage the use of lower-cost, single-chamber implantable cardioverter defibrillators (ICDs), which protect patients from potentially deadly heart rhythms.

"The study provides evidence for single-chamber devices, and the burden of proof is on people who want to use the more expensive devices," Dr. Daniel Mark, Director of the DCRI’s Outcomes Research and Assessment Group, told Reuters at the press conference.

The cost-effectiveness study was a secondary analysis incorporated into the design of the landmark Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which found that single-chamber ICDs reduced the rate of sudden death within 5 years by 23% compared with a placebo or amiodarone, a drug that corrects abnormal heart rhythms.

The federal Centers for Medicare and Medicaid Services (CMS) in late September said it would expand coverage of the ICDs, allowing 25,000 more patients in the first year to have them implanted. However, under the new guidelines from Medicare, patients who qualify for the device would receive a lower-end ICD that protects only against potentially deadly heart rhythms. The newer ICDs not only shock an errant heartbeat back into rhythm but can also perform as pacemakers and deliver health information to a stricken patient's doctor.

According to Medicare's proposed guidelines, to qualify for a more advanced ICD, doctors would need to show through clinical studies that it was medically necessary.

In the cost-benefit analysis, Mark said the price tag for each year of life added to heart failure patients with the simple ICDs was about $33,000. He compared this favorably to the estimated $50,000 per life year paid for by Medicare for kidney dialysis patients.

The cost analysis found that "ICD therapy (with the single-chamber device) is both more effective and more expensive than placebo but represents an economically attractive way to increase societal health benefits."

"The study doesn't say anything about whether there might be an incremental benefit for using a more fully featured, more expensive device," Mark told the heart.org. "As far as I'm concerned as an outcomes researcher, the burden of proof is on the people who . . . want to use the more expensive devices to prove that you're not simply spending more money to provide the same benefit. Is it like buying an expensive car versus an inexpensive car to make the same journey? Even though the outcome is the same, the cost per mile is higher."

Several doctors said in practice, the scaled-down devices should be tried first, especially in light of the steep price of more advanced devices and fixed Medicare budgets.

At the press conference, Dr. Raymond Gibbons of the Mayo Clinic and chairman of the AHA Scientific Sessions panel said, "If you can do the same thing with a less expensive model, that is more efficient."

Gus Grant, a former AHA president and professor of medicine at Duke University, said "a vast majority of people will stick with the devices with no bells and whistles" used in the SCD-HeFT trial.

Following Mark's formal presentation of the data, Dr. William Weintraub, Director for the Center for Outcomes Research at Emory University, suggested that the costs could be much higher when the pricier ICDs often used in the U.S. are considered, given the number of eligible patients. "When we're dealing with cost-effectiveness ratios and are beginning to get close to the [limits] of society's willingness to pay we're talking about spending really a lot of money we have to think through whether we have enough information for good policy making. And I'm not sure we're really there yet."

Mark conducted the study for the National Heart, Lung, and Blood Institute.