After a Swedish study, published in Spine, was not able to show that balloon kyphoplasty was cost-effective compared with standard medical treatment, further analysis is needed.
The study randomised 63 patients who had an acute or subacute (<3 months) vertebral compression fracture due to osteoporosis to either balloon kyphoplasty (32) or standard medical treatment (31). Peter Fritzell, Center for clinical research, Nissers väg 3, Sweden, and his co-investigators assessed quality of life using the EQ-5D score and used accumulated quality life of years gained (QALY) and cost per QALY to measure cost–effectiveness.
They found that both balloon kyphoplasty and standard medical treatment significantly improved quality of life in the two years after treatment, with the most significant improvement occurring in the first three months. Fritzell et al noted: “The difference in QALYs gained over 24 months was 0.085 (95% CI=-0.132 to 0.306) in favour of balloon kyphoplasty.” However, this difference was not significant.
The cost per QALY gained using balloon kyphoplasty instead of standard medical treatment was found to be 884,682 Swedish Krona (SEK; worth €92,154 or US$134,043 at the time of the study). According to the investigators, if it is assumed that the maximum the Swedish society is prepared to pay is SEK 600,000 (€62,500 or US$90,910 at the time of the study) for a QALY gained, “there is a less than 40% chance that balloon kyphoplasty is cost-effective in this population.” However, they added that there was some uncertainty in the sensitivity analysis and that this needed to be considered.
Fritzell et al reported most researchers agree that while balloon kyphoplasty may stabilise a fracture and provide rapid pain relief, patients who are treated conservatively will “catch up with time”. They wrote: “The question of cost-effectiveness that includes the time variable therefore becomes crucial; that is, what is the society willing to pay for a more rapid pain relief and increase in quality of life? Late complications could also be an issue.”
They concluded: “We could not document that balloon kyphoplasty was cost-effective, but it should be remembered that the current study to a certain extent is hypothesis generating. However in a time when cementing osteoporotic vertebral fractures in the elderly on an almost routine basis is advocated by some, our results should certainly be a mind raiser.”
Fritzell told Spinal News International: “I think balloon kyphoplasty could be used in carefully selected patients with osteoporotic vertebral fractures but from what we know from the literature today probably not as a routine procedure.”