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Laser-assisted cataract surgery failed to pass a cost-effectiveness test versus standard phacoemulsification cataract surgery (PCS), data from the randomized trial showed.

Femtosecond laser-assisted cataract surgery (FLACS) not only cost more than PCS, but yielded less improvement in quality-adjusted life years (QALY) versus PCS (0.788 vs 0.792). The cost of surgery averaged €1,124 ($1,214) for FLACS and €565.50 ($610.75) for PCS. Total cost of care at 12 months averaged €7,085 ($7,652) FLACS and €6,502 ($7,023) PCS.

Combining the higher cost of FLACS and lower QALY resulted in an incremental cost-utility ratio of -€136,476 ($147,394), reported Antoine Bénard, MD, PhD, of the University of Bordeaux in France, and co-authors, in .

"FLACS, in its current state of development, was not cost-effective and should not be reimbursed by healthcare systems," the authors concluded. "Nonetheless, investment in research and development is worthwhile, and a more advanced femtosecond laser may represent a valuable option in cataract surgery in the future."

The study provided "conclusive evidence of lack of incremental value" of FLACS versus PCS, according to the author of an .

"FLACS was introduced about 12 years ago with much excitement and anticipation," wrote Oliver Schein, MD, MPH, of the Johns Hopkins Wilmer Eye Institute in Baltimore. "Here was an elegant procedure with the promise of greater precision and enhanced clinical outcomes compared with conventional ultrasound phacoemulsification for cataract surgery, the most performed operation."

"For many years, achievement of that promise was claimed based on small studies from enthusiastic early adopters," Schein wrote. "However, the strength of evidence showing no incremental benefit is now substantial."

The concept of value in healthcare depends on an individual's perspective, Schein continued. His personal preference is "health outcomes achieved that matter to patients relative to the cost of achieving those outcomes."

"In the U.K. or France ... the estimated per-case difference in costs [between FLACS and PCS] was in the range of $200 to $300," he added. "From the perspective of the surgeon, an extra $300 per case would probably not justify the extra time and expense of FLACS, especially in the known absence of clinical benefit."

Enthusiasm surrounding FLACS turned into disappointment when showed that FLACS was neither clinically superior to PCS nor cost-effective. A second randomized trial () showed that FLACS was not inferior to PCS. FACT investigators published two subsequent reports, both of which showed FLACS is not cost-effective versus PCS.

Collectively, results of the two randomized trials showed that clinical results with FLACS "were below a clinically meaningful difference," Bénard and co-authors stated.

French and British collaborators in FEMCAT performed a prespecified cost-utility analysis to calculate QALYs for FLACS and PCS. They noted that "utility in health economics is more a function of how individuals value their life than of how they value their health. Hence, a cost-utility analysis may not necessary reflect the results observed on an efficacy endpoint but rather provide additional information on the benefits of a healthcare intervention to decision makers."

The analysis included 870 randomized patients, almost two thirds of whom had bilateral cataract surgery. The analysis showed that the cost of surgery and total costs at 12 months both favored PCS. The difference in QALYs also favored PCS, but the difference did not achieve statistical significance (-0.004, 95% CI -0.028 to 0.021).

A cost-effectiveness probability curve ranging from €0 to €100,000 showed little variation in the likelihood that FLACS would be cost-effective (14-25%). For example, if a lower threshold of €30,000 per QALY were used to defined acceptability (as compared with the standard €50,000 to €100,000), the probability that FLACS would be cost effective is 15.7%.

Investigators also performed a value-of-information analysis, estimating the expected value of perfect information (EVPI), which is the opportunity cost of being wrong when deciding to reimburse an intervention that appears cost-effective or not reimbursing an intervention that does not appear cost-effective. Using the €30,000 per QALY threshold, the analysis yielded an EVPI of €246,139,079 for a wrong decision not to reimburse FLACS.

"The cost-utility analysis of the FACT trial also reported a very small difference in costs, just as we did," the authors stated. "All these results are very consistent, with outcomes of FLACS and PCS very close to each other and always to the disadvantage of FLACS. This is a sign of robustness of our results."

"We believe that an EVPI of approximately €250 million fully justifies budgetary investments in the development of a more efficient laser before spreading this technology," they added.

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