ARTICLE IN BRIEF
In a detailed analysis of pooled data from three trials comparing the costs of decompressive hemicraniectomy versus medical management, investigators reported that after factoring in the cost of death and mild, moderate, or severe disability, conservative management expenses were an average of $85,178 versus $210,670 for decompressive hemicraniectomy.
The cost of medical procedures has come under increased scrutiny in recent years as pressures mount to reduce US health care expenditures. In response to these concerns, a research team from Minnesota set out to measure the cost of one surgical procedure — decompressive hemicraniectomy — for malignant ischemic stroke — and to determine whether it was more cost-effective than conventional therapy.
Decompressive hemicraniectomy — the removal of part of the skull in order to allow a swelling brain room to expand — is used to treat elevated intracranial pressure that is unresponsive to conventional treatment modalities.
The investigators at Zeenat Qureshi Stroke Research Center in Minnesota based their findings on data from a previously published analysis of three European randomized controlled trials, which demonstrated that decompressive hemicraniectomy, when performed within 48 hours of stroke onset, reduced mortality and improved functional outcome in patients with malignant ischemic stroke. That analysis, however, did not consider the relative cost of decompressive hemicraniectomy, explained author Tenbit Emiru, MD, PhD, a fellow in the neurology department at the University of Minnesota.
Although decompressive hemicraniectomy reduces mortality and improves clinical outcomes, it comes with a very high price tag, Dr. Emiru told Neurology Today. “We wanted to make sure that people were aware of what it costs,” said Dr. Emiru, who reported the findings at the AAN annual meeting in San Diego in March.
The investigators analyzed the results from an earlier pooled analysis of data from three European trials published in The Lancet Neurology (http://bit.ly/14qKila) on decompressive hemicraniectomy in malignant infarction of the middle cerebral artery versus conservative management (medication, or other treatment without surgery). They performed a prospective analysis of the data using hospitalization cost measures from the National Inpatient Survey (NIS), which is the largest publicly available all-payer inpatient care database in the US.
The researchers averaged the total of costs in each group for acute hospitalization, moderate to severe disability from stroke (obtained from a previous study and inflation-adjusted for 2012), and death (obtained from a previous study and inflation-adjusted for 2012). “The quality adjusted life years (QALYs) were estimated by weighing the QALY at 1 year with the frequency of each mRS associated with each treatment modality,” the authors wrote.
From The Lancet Neurology paper, the investigators looked at frequency for disability according to scores on the modified Rankin Scale (mRS) at one year for both hemicraniectomy and conservative management groups. In this pooled analysis, 93 patients were included. The primary endpoint was the mRS at one year, which was then dichotomized between favorable (0 to 4 points) — meaning no disability to moderately severe disability — and unfavorable (5 points) indicating severe disability, and death (6 points). Investigators found that more patients in the decompressive craniectomy group than in the control group had an mRS ≤4 (75 percent vs. 24 percent) with a pooled absolute risk reduction of 51 percent, an mRS ≤3 (43 percent vs. 21 percent) with a pooled absolute risk reduction of 23 percent, and survived (78 percent vs. 29 percent) with a pooled absolute risk reduction of 50 percent. The surgery's effect was highly consistent across the three trials, according to The Lancet paper.
The total QALYs associated with the hemicraniectomy group was $74,336 and the total QALYs associated with conservative management was $9,880, Dr. Emiru and colleagues found.
After factoring in the cost of death and mild, moderate, or severe disability, the authors reported an average total cost of $85,178 for conservative management, versus $210,670 for decompressive hemicraniectomy; therefore, decompressive hemicraniectomy cost an additional $272,092 to gain one additional QALY compared with conservative management. Most interventions that are considered to be cost-effective are below $200,000 per QALY.
Among the limitations of the analysis, Dr. Emiru said, is that the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment was estimated at one year, but not as a lifetime estimate. “So, it really depends on the patient's age when the stroke occurred. If the patient was middle-aged at the time of the stroke and their life expectancy is ten more years, the cost-per-quality [year] they would achieve from surgery is different from a twenty-year-old with a stroke that is expected to live another four decades.”
Additionally, Dr. Emiru told Neurology Today that generalizing the findings as cost per QALY may not be easy to do on an individual level. “These are averaged cost estimates, but they may not accurately reflect costs for individual patients,” since, for example, hospital discharge times and complexities may vary.
At this point, she said, the next steps would be to define who is actually is going to benefit from decompressive hemicraniectomy — even when the cost is considered. “The patient selection [for decompressive hemicraniectomy] should be more rigorous than it has been previously so that they can get better quality or benefit from the procedure.”
Commentators agreed that this study made some necessary strides towards considering cost-effectiveness of a highly morbid procedure, but they raised questions about the study design and how the findings would translate to practice.
The issue of cost-effectiveness is an important one, said Kevin N. Sheth, MD, chief of the Division of Neurocritical Care and Emergency Neurology and director of the Neurosciences Intensive Care Unit at Yale New Haven Hospital, especially with regard to critically ill patients.
“I think the criticism that lifetime costs are not considered in the analysis is a significant limitation. Hospital costs are very important for people who are looking at acute hospitalization costs. However, from a QALY and public health perspective, the long-term care costs for a patient with disability over time are always going to outweigh any short-term costs,” he added.
This study may prove useful for those considering short-term hospital administration costs and for insurance providers, said Dr. Sheth, who is also a member of the Neurology Today editorial advisory board. [Dr. Sheth shared his insights about the study in a brief video interview: http://bit.ly/XgS6E5.]
Seemant Chaturvedi, MD, professor of neurology at Wayne State University School of Medicine and director of the Wayne State/Detroit Medical Center Comprehensive Stroke Program, told Neurology Today that the analysis is “intriguing,” but it would not impact current medical practice.
“The studies that they referred to evaluating hemicraniectomy for large strokes with life-threatening edema clearly showed that the surgical procedure reduces mortality without causing an increase in severe disability. If patients die within 30 days of the stroke with conservative management, the associated costs will be less,” he said.
However, Dr. Chaturvedi continued, “we should keep in mind that the procedure is frequently done in patients older than 60 years of age, so if the procedure can extend their life with reasonable neurologic function, then the cost effectiveness is a secondary issue.”
Sherman Stein, MD, clinical professor of neurosurgery at University of Pennsylvania School of Medicine, said that these types of studies are important as medical procedures come under increased scrutiny “and it's important for us to justify a lot of what we are doing in terms of cost to society.” But Dr. Stein, who is an expert in applications of decision analysis for neurosurgery, was not convinced by these findings. “Cost-effectiveness calculations follow a standard protocol, which was not followed here. This study intends to [address such questions], but I think it has several flaws which invalidate its conclusions.”
For one, he said, they only use data that they obtained from the NIS, which includes hospital charges and not overall costs — and “what a hospital charges bears little relation to costs.”
Importantly, Dr. Stein continued, “people with strokes leave the hospital, and those who are more affected, require nursing care, custodial care, rehabilitation care — and that's not reflected in their calculations.”
Dr. Sheth agreed with this, stating that the study should have accounted for additional outpatient costs that may accrue after hospital stay.
“Future studies should take into account other costs other than those limited to the acute hospitalization. And outcome can't be limited to one year because these people live for several years,” said Dr. Stein. The idea of doing a study like this is excellent, he said, but the methods used here were not ideal.
A ‘BEST PAPER’ PICK:Neurology Today editorial advisory board member Kevin N. Sheth, MD, selected this as one of the “best papers” on neurocritical care from the AAN annual meeting. Dr. Sheth is chief of the Division of Neurocritical Care and Emergency Neurology and director of the Neurosciences Intensive Care Unit at Yale New Haven Hospital.
TUNE IN: What is the clinical importance of new research on the cost-effectiveness of decompressive hemicraniectomy for malignant stroke? In a video interview, Kevin N. Sheth, MD, chief of the Division of Neurocritical Care and Emergency Neurology and director of the Neurosciences Intensive Care Unit at Yale New Haven Hospital, discusses implications and next steps: http://bit.ly/XgS6E5. Dr. Sheth is a member of the Neurology Today editorial advisory board.
LISTEN UP: Is performing decompressive hemicraniectomy in patients with malignant stroke cost-effective? In a podcast, Tenbit Emiru, MD, PhD, a fellow in the neurology department at the University of Minnesota, describes new data on the relative cost of this procedure in highly morbid patients: http://bit.ly/rCBryX.