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Considering Economic and Social Issues Affecting Your Practice

Doubling FLACS cost-effectiveness might make it more competitive with manual phaco. By Howard Larkin

As currently practiced, femtosecond laser-assisted cataract surgery (FLACS) is not cost effective compared with manual phacoemulsification surgery, according to three large European randomised clinical trials. FLACS would have to nearly double operating theatre productivity and/or dramatically reduce its per-patient costs to become cost competitive, according to Alexander C Day PhD, FRCOphth.

When introduced in Europe nearly a decade ago, many potential benefits were touted for FLACS over manual phaco. These included more-accurate capsulotomy positioning, shape, and size; better IOL centration; less lens tilt and fewer higher order aberrations; and lower phacoemulsification energy leading to less endothelial loss.

In the real world, however, these theoretical benefits have not translated into meaningfully better patient outcomes in three large European randomised controlled clinical trials (RCT), Dr Day said in a presentation at the 39th Congress of the ESCRS in Amsterdam.

In the largest RCT comparison to date, the French multicentre FEMCAT study involving 907 patients, researchers did not find any significant differences in intra- or postoperative complications, visual outcomes, or patient-reported outcomes.

The UK multicentre FACT study, involving 785 patients, found only a one-letter advantage in binocular corrected distance visual acuity after one year favouring the FLACS group. This was statistically but not clinically significant, Dr Day said, and there was no difference in endothelial cell loss.

And the UK single-centre St Thomas’ study involving 400 patients found only a slight difference in posterior capsule tears favouring FLACS, 3% versus none, though this may be a statistical anomaly, Dr Day said.

“What have we learned from the large European RCTs? There is no difference or very little difference in outcomes between the two techniques,” he said.

EFFICIENCY AND COSTS Whatever marginal improvements FLACS may provide come at a high cost in both resources and money. One is surgical theatre time. Both the FACT and St Thomas’ studies showed slightly shorter surgery times for FLACS but longer overall procedure times of four to five minutes due to added time for laser treatment, Dr Day reported.

So, if the outcomes are similar and theatre productivity is no better, the cost of the equipment and fees associated with manual phaco and FLACS must be considered, Dr Day said. Focusing on capsulotomy alone, the cost of a cystotome or rhexis forceps or bent insulin needle for manual procedures is less than £10 compared to a £100–150 click fee per FLACS procedure—not to mention the £250,000 for the FLACS platform.

Using the incremental cost-effectiveness ratio (ICER) per quality of life-adjusted year (QALY) gained gives a more global look at cost-effectiveness, Dr Day said.

“For something that gives a small incremental improvement, it is going to be hard to justify a higher price.”

Applying this measure to FACT study data, FLACS costs a mean of £167.62 more per patient for a gain of 0.001 QALYs. This translates to an ICER for FLACS of £167,620—or more than eight times the threshold ICER value of £20,000 per QALY that UK authorities consider cost effective.

“Very clearly, you can see FLACS is not cost effective in the UK National Health Service,” he noted.

Similarly, micro-costing analysis of the FEMCAT data revealed FLACS was more expensive than manual phaco by a mean of €305 and less effective by three percentage points, Dr Day said. Looking at the cost-effectiveness, this translates to an ICER savings of €10,703 per additional patient who had manual phaco cataract surgery.

“In all sensitivity analyses, FLACS was more expensive and less effective than phacoemulsification surgery,” he added.

IMPROVING COST-EFFECTIVENESS For FLACS or any future technique to be cost effective, it needs to be cheaper, increase productivity, and/or improve outcomes for the short- and long-term, Dr Day said. In one economic model, FLACS could be less expensive than manual phaco if the number of surgeries per theatre list increased by more than 100% or if the cost per procedure reduced by 70%.

Increasing theatre productivity may be the most promising route, Dr Day said. Since only about half of surgeons’ time in theatre is devoted to actual surgery, increasing the use of other health professionals to do tasks such as writing operating notes and adding staff to move patients in and out more quickly might approximately double productivity. Switching to immediate sequential bilateral cataract surgery might also help, he added.

Still, significant numbers of FLACS are undertaken, mostly in private settings where cost-effectiveness is not a big issue, Dr Day said. But the question remains as to how new technologies can be implemented when the current manual phaco is highly cost effective.

Alexander C Day PhD, FRCOphth, is a consultant ophthalmic surgeon at Moorfields Eye Hospital, London, UK, and honorary senior lecturer at the University College London Institute of Ophthalmology, UK. alex.day@ucl.ac.uk

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