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RCT questions cost-effectiveness of balloon kyphoplasty for vertebral fractures
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GOTHENBURG, Sweden — Balloon kyphoplasty could not be demonstrated as cost effective for treating vertebral compression fractures sustained within 3 months, according to a Swedish study.
“Balloon kyphoplasty (BKP) was significantly more costly to society after 2 years, with a possibly small difference in quality of life delivered,” Peter Fritzell, MD, of Falun Hospital/Ort Clinic in Falun, Sweden said at the International Society for the Study of the Lumbar Spine Annual Meeting 2011.
Fritzell noted the 70 patients included in the Swedish study were in the fracture reduction evaluation (FREE) trial (n=300), which involved those in eight European countries to compare the effectiveness of balloon kyphoplasty (BKP) with non-surgical treatment of vertebral compression fractures (VCF).
Subset of patients
Sixty-seven of the 70 Swedish patients in the FREE trial agreed to be enrolled in Fritzell’s study conducted from February 2003 to December 2005. Investigators randomized them into either a balloon kyphoplasty or standard treatment group. Both groups were similar in terms of preoperative demographics. No patients crossed over to the other treatment arm during the 2-year minimum follow-up, according to the abstract.
Fritzell and colleagues analyzed relevant direct and indirect costs for the treatments as noted at six time points in cost diaries kept by the patients. They determined a cost perspective for each treatment from both a societal and health care standpoint.
Investigators also used the EQ-5D to determine the clinical effectiveness of each modality and its impact on quality of life wherein a score of 0 denoted death and 1 denoted a perfect quality of life. They also calculated the cost per quality adjusted life year (QALY) for each treatment. For the study, Fritzell noted Incremental Cost Effective Ratio (ICER) is the same as cost per QALY.
Willingness to pay for a QALY in Sweden was set at €60,000.
Higher cost with kyphoplasty
At the 2-year follow-up, 63 patients were assessed and the cost response rate went from 97% to 79% in the BKP group and from 10% to 80% in the control group.
“The cost in the BKP group was higher,” Fritzell said. “In that the societal mean cost per patient was 10,500 euros greater in the balloon kyphoplasty group compared to the control group.”
After adjusting for baseline differences in EQ-5D values, and the clinical and quality of life improvements that patients in both groups reported, “the difference over 24 months in QALYs gained was 0.085 in favor of BKP (CI: -0.132 to 0.306),” according to Fritzell. But, he explained there was a high degree of statistical uncertainty based on the bootstrapping statistical analyses performed. Therefore, with willingness to pay for one QALY in Sweden set at €60,000, Fritzell said BKP could not be demonstrated to be cost-effective.
“This study should not be looked at as guidance for decisions made by health authorities, but [it is] important as a reminder in a time when vertebroplasty and kyphoplasty were increasingly advocated,” he said. – by Susan M. Rapp
Reference:
- Fritzell P, Ohlin A, Borgström F. Cost-effectiveness of balloon kyphoplasty (BKP) vs. standard medical treatment for vertebral compression fractures due to osteoporosis — a multicenter RCT with a two-year follow up in Sweden. Paper #P62. Presented at the International Society for the Study of the Lumbar Spine Annual Meeting 2011. June 14-18. Gothenburg, Sweden.
- Peter Fritzell, MD, can be reached at the Department of Orthopaedic Surgery, Falun Hospital, S-791 82 Falun, Sweden; +46 2379 5531; email: Peter.fritzell@Ltdalarna.se.
- Disclosure: Fritzell has no relevant financial disclosures.