Cost-effectiveness of fluocinolone acetonide implant (ILUVIEN®) in UK patients with chronic diabetic macular oedema considered insufficiently responsive to available therapies

Abstract

BackgroundDiabetic macular oedema (DMO) may lead to visual loss and blindness. Several pharmacological treatments are available on the National Health Service (NHS) to United Kingdom patients affected by this condition, including intravitreal vascular endothelial growth factor inhibitors (anti-VEGFs) and two types of intravitreal steroid implants, releasing dexamethasone or fluocinolone acetonide (FAc). This study aimed to assess the value for money (cost-effectiveness) of the FAc 0.2 μg/day implant (ILUVIEN®) in patients with chronic DMO considered insufficiently responsive to other therapies.MethodsWe developed a Markov model with a 15-year time horizon to estimate the impact of changes in best-corrected visual acuity in DMO patients on costs and quality-adjusted life years. The model considered both eyes, designated as the “study eye”, defined at model entry as phakic with an ongoing cataract formation or pseudophakic, and the “fellow eye”. The model compared the FAc 0.2 μg/day implant with a 700 μg dexamethasone implant (pseudophakic patients only) or with usual care, defined as a mixture of laser photocoagulation and anti-VEGFs (phakic and pseudophakic patients). Costs were estimated from the perspective of the NHS and Personal Social Services; full NHS prices were used for drugs.ResultsIn patients who were pseudophakic at baseline, at 36 months, the FAc implant provided an additional gain of 4.01 and 3.64 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with usual care and the dexamethasone implant, respectively. Over the 15-year time horizon, this translated into 0.185 additional quality-adjusted life years (QALYs) at an extra cost of £3066 compared with usual care, and 0.126 additional QALYs at an extra cost of £1777 compared with dexamethasone. Thus, incremental cost-effectiveness ratios (ICERs) were £16,609 and £14,070 per QALY gained vs. usual care and dexamethasone, respectively. In patients who were phakic at baseline, the FAc 0.2 μg/day implant provided an additional gain of 2.96 ETDRS letters at 36 months compared with usual care, which, over 15 years, corresponded to 0.11 additional QALYs at an extra cost of £3170, resulting in an ICER of £28,751 per QALY gained.ConclusionThe FAc 0.2 μg/day implant provided good value for money compared with other established treatments, especially in pseudophakic patients.Electronic supplementary materialThe online version of this article (10.1186/s12913-018-3804-4) contains supplementary material, which is available to authorized users.

Stellungnahme der DOG, der RG und des BVA zur Therapie des diabetischen Makulaödems

“…Die Pharmakokinetik unterscheidet sich deutlich und bedingt eine häufige Wiederbehandlung, zumindest meist in den ersten 2 Jahren [186,187]. Die Notwendigkeit einer selteneren Behandlung mit Steroidimplantaten stellt einen möglichen Vorteil dar, der sich auch auf die Wirtschaftlichkeit positiv auswirken kann [188]. Obwohl für die Anzahl der Visiten auch die Kontrollen des Augendrucks zu berücksichtigen sind, kann insbesondere für weniger mobile Patienten oder für den Fall eines schlechten Allgemeinzustands die Belastung hierdurch reduziert werden.…”

Cost‐effectiveness of dexamethasone and triamcinolone for the treatment of diabetic macular oedema in Finland: A Markov‐model

“…There are very few previous studies concerning the cost-effectiveness of corticosteroids in the treatment of DMO. The cost-effectiveness of corticosteroids is studied compared to anti-VEGF injections and laser (Dewan et al 2012;Pershing et al 2014), and dexamethasone and fluocinolone are compared in pseudophakic eyes (Pochopien et al 2019). It seems that to date, there are no cost-effectiveness studies of triamcinolone injections compared to other corticosteroids for DMO nor the other macular oedemas.…”

“… 2014 ), and dexamethasone and fluocinolone are compared in pseudophakic eyes (Pochopien et al. 2019 ). It seems that to date, there are no cost‐effectiveness studies of triamcinolone injections compared to other corticosteroids for DMO nor the other macular oedemas.…”

Real-World Outcomes in Diabetic Macular Edema for the 0.2 μg/Day Fluocinolone Acetonide Implant: Case Series from the Midlands, UK

“…Even though the main difference between clinical trials and real-world studies is the under-treatment due to the high burden/noncompliance related to anti-VEGF or short-term corticosteroids therapies and not the reason above. 13,14 The objective of this study was to investigate the realworld effectiveness and safety profile of the FAc implant over three years of treatment in eyes with DME through an audit of three large treatment centres in the UK with the largest ethnic diversity outside of the southeast of the UK. 15…”

“…Even though the main difference between clinical trials and real-world studies is the under-treatment due to the high burden/noncompliance related to anti-VEGF or short-term corticosteroids therapies and not the reason above. 13 , 14 …”