Background and Importance Due to the high cost of the implant of fluocinolone acetonide (FAc) 190 µg, it is especially important to realise an economic evaluation and budget impact analysis before inclusion in the pharmacotherapeutic guide of any health institution.

Aim and Objectives Realise an economic evaluation and a budget impact analysis to assess its inclusion in our regional pharmacotherapeutic guide, maintaining the financing conditions of our National Health System (NHS).

Material and Methods PubMed and reports from independent evaluators were consulted: National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) among others.

Results According to the product information, an implant releases FAc for a maximum of 36 months, and an additional implant can be placed after 12 months if vision decreases or retinal thickness increases. Pivotal studies and the IRISS observational study concluded in the need to use 1.3 implants/eye and 1.13 implants/eye affected during the first 3 years respectively, this last value being the one considered by the ERG (Evidence Review Group). Taking this last reference, the cost of treatment/affected eye at €1558.84/eye/year or €4676.53/eye/3 years.

To estimate the target population, we used the criteria of the SMC evaluation report in which they considered a total of 179 patients with pseudophakic chronic DME eligible for treatment in the first year, increasing to 186 in the fifth year. Unlike the SMC, our NHS restricts its funding to third-line, after anti-angiogenic agents and in patients with a suboptimal response to various intravitreal dexamethasone implants or pseudophakic patients.

Making a parallelism with the Scottish population, 33.5 patients/1st year–34.8 patients/5th year would be candidates to receive FAc in our region.

NICE and the ERG found that in clinical practice 35% of patients would require bilateral treatment. Thus 12 patients/year would need treatment in both eyes in our population. The economic impact in our region would range between €5,3000.56/year if it were inserted in only one eye and €71,706.64/year in both eyes.

Conclusion and Relevance The financing conditions of our NHS position the drug in the third-line, which in a certain way contains the budget impact.

Since SMC restricting the conditions of use more than our NHS, the budget impact could be underestimated.

Conflict of Interest No conflict of interest