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A study has revealed that a budgetary saving per treated patient with the fluocinolone acetonide implant (Iluvien) versus ranibizumab (Lucentis) could lead to a significant cost-saving to NHS England.
In the UK, diabetic macular oedema (DMO) has a prevalence of 6.81%1 and, if left untreated, the disease can lead to vision loss. There are several licenced intravitreal therapies approved for use in DMO, including anti-VEGF agents aflibercept (Eylea, Regeneron) and ranibizumab (Lucentis, Novartis), and the steroid implants dexamethasone (Ozurdex, Allergan) and longer-acting fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences).
In 2012, Iluvien was licenced in Europe for the treatment of vision impairment associated with chronic DMO considered insufficiently responsive to available therapies.2 This was based on the efficacy and safety data from the FAME (Fluocinolone Acetonide for Diabetic Macular Edema) trials, which showed the implant was particularly effective in chronic DMO patients when compared against the standard of care at the time for DMO3.
However, for a medicine to be reimbursed it needs to be shown to be cost effective. In November 2013, based on the FAME data, the National Institute for Health and Care Excellence (NICE) approved technology appraisal guidance ‘TA301’ and restricted the fluocinolone acetonide implant’s use to the treatment of chronic DMO patients with a pseudophakic lens.
This was based on a cost-to-effectiveness calculation that accounted for costs such as cataract removal surgery and meant Iluvien would be available through NHS England via a patient access scheme.4 This guidance is only effective in the UK, where individual funding requests are required to treat patients that have a phakic lens.
A recent study by Dr Quhill and Dr Beiderbeck5 assessed the fluocinolone acetonide implant’s cost effectiveness in patients with either phakic or pseudophakic lenses. Calculations were based on NHS list prices and did not include manufacturer-agreed discounts provided through patient access schemes.
The study reported that implant had a cost advantage versus ranibizumab irrespective of lens status. Indeed, the purpose of the research was to explore the cost of treating DMO patients with either phakic or pseudophakic lenses with the implant, and to also compare these costs with those incurred had the patients continued treatment with ranibizumab.
In the Iluvien-treated patients, it was estimated that over a 3-year period it cost £8,205.43 to treat a patient with a pseudophakic lens and £8,931.97 to treat a patient with a phakic lens, which included the cost of cataract extraction surgery in four out of five cases.
The second aspect of the study assessed the cost of continued treatment with ranibizumab and to determine potential cost advantages that could offer future savings for NHS England. Results showed that continued ranibizumab treatment (14 injections over 3 years) cost £14,273 per treated eye.
Over a 3-year period, therefore, the fluocinolone acetonide implant offers a potential cost saving of £6,068 per pseudophakic eye and £5,341 per phakic eye versus repeated usage of ranibizumab.
In conclusion, the results from Royal Hallamshire Hospital represent a budgetary saving per treated patient with the fluocinolone acetonide implant versus ranibizumab and, if reflected across multiple centres, could lead to a significant cost-saving to NHS England, whilst still providing a good quality of care to chronic DMO patients.
The current analysis also shows that these savings can be achieved with a single intravitreal injection over a 3-year period even when the cost of additional DMO treatments and cataract surgery (required in four out of five patients) was factored into the calculation.
Furthermore, Iluvien’s single injection technology means its use in routine clinical practice can help to relieve the pressure for clinic appointments, and, indeed, it may also help to maintain patient compliance by avoiding potential delays in follow-up appointments.
1. Yau JWY, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-564. doi:10.2337/dc11-1909.
2. ILUVIEN 190 micrograms intravitreal implant in applicator - Summary of Product Characteristics (SPC) - (eMC). https://www.medicines.org.uk/emc/medicine/27636. Accessed September 21, 2017.
3. Campochiaro PA, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology. 2012;119(10):2125-2132. doi:10.1016/j.ophtha.2012.04.030.
4. NICE. Technology appraisal guidance [TA301]. Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy. 27 Nov 2013. https://www.nice.org.uk/guidance/ta301. Published 2013.
5. Quhill F, Beiderbeck A. Cost advantage of fluocinolone acetonide implant (ILUVIEN®) versus ranibizumab in the treatment of chronic diabetic macular oedema. Glob Reg Heal Technol Assess. 2017;4(1). doi:10.5301/grhta.5000268.
Dr Fahd Quhill
Dr Quhill is a consultant ophthalmic surgeon at the Royal Hallamshire Hospital, appointed in 2010 with a special interest in medical retina and uveitis. Dr Quhill has received financial support from Allergan; Alimera Sciences; Heidelberg Engineering; Bayer; Sanofi; and Novartis.