Summary of Research: Cost­Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis.

This is a summary of the original article ?Cost­Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis". DMO, a serious eye condition that can lead to vision loss in people with diabetes, is a significant health concern and a lack of knowledge exists about the cost-effectiveness (the balance of a treatment's cost and its effectiveness) of new treatments. This research assessed the cost-effectiveness of a new medication named faricimab, using a mathematical model that simulated the progression of DMO and its treatment over 25 years. The model compared faricimab against relevant therapeutic alternatives for DMO in the UK, including ranibizumab, aflibercept, and bevacizumab. The research discovered that faricimab could offer improved vision results and be cost saving or cost-effective. It also suggested that faricimab could lessen the strain on healthcare services due to its less frequent dosing schedule. Overall, such findings suggest that faricimab is a promising new treatment option for DMO that could benefit patients and the healthcare system. This could have implications for future treatment guidelines and the management of DMO in clinical practice.

Cost-Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis.

AIM: The aim of this work was to evaluate the cost-effectiveness of faricimab against relevant therapeutic alternatives used in clinical practice for the treatment of diabetic macular oedema (DMO) in the UK. METHODS: A state-transition (Markov) model, with health states based on visual acuity scores and treatment pathways, was developed to conduct cost-utility analysis of faricimab treat and extend (T&E) regimen versus ranibizumab pro re nata (PRN) and aflibercept PRN over a time horizon of 25 years. Comparison against bevacizumab PRN was considered in scenario analysis. Effectiveness data for faricimab was sourced from the pivotal YOSEMITE and RHINE double-blind randomised controlled trials, and from a network meta-analysis for comparators. Costs and (dis)utilities were taken from nationally published sources or literature. The base case included indirect costs (productivity gains, informal care) given the wider impacts of DMO on society. Sensitivity analyses were conducted. RESULTS: In the base case, faricimab T&E dominated ranibizumab PRN and aflibercept PRN, being more effective and resulting in cost savings (between 0.16 and 0.36 mean QALYs gained, and £5483-9655 mean cost savings). In scenario analysis, faricimab was more effective but costlier compared with bevacizumab, with an incremental cost-effectiveness ratio (ICER) of £8898 per QALY gained. Considering only healthcare payer costs, the ICER of faricimab compared with ranibizumab PRN was £7991 per QALY gained and faricimab dominated aflibercept PRN. CONCLUSIONS: Faricimab T&E has the potential to reduce the burden of vision loss on society, giving people living with DMO greater independence and contributing to increased healthcare system capacity. At a threshold of £20,000, faricimab T&E is cost-effective compared with relevant comparators, and potentially cost saving.

Comparative Efficacy, Durability and Safety of Faricimab in the Treatment of Diabetic Macular Edema: A Systematic Literature Review and Network Meta-Analysis.

INTRODUCTION: A systematic literature review (SLR) and network meta-analysis (NMA) were conducted to evaluate the comparative efficacy, durability and safety of faricimab, used in a Treat & Extend (T&E) regime with intervals up to every 16 weeks (Q16W), relative to other therapies currently in use for treatment of diabetic macular oedema (DME). Of particular interest were anti-vascular endothelial growth factor (VEGF) therapies applied in flexible dosing regimens such as Pro re nata (PRN) and T&E, which are the mainstay in clinical practice. METHODS: An SLR identifying randomised controlled trials (RCTs) published before August 2021 was conducted, followed by a Bayesian NMA comparing faricimab T&E treatment to aflibercept, ranibizumab, bevacizumab, dexamethasone and laser therapy. Outcomes included in the analysis were change in best-corrected visual acuity (BCVA), change in central subfield thickness (CST), injection frequency, ocular adverse events (AE) and all-cause discontinuation, all of which were evaluated at 12 months. Subgroup analyses including patients' naïve to anti-VEGF were conducted where feasible. RESULTS: Twenty-six studies identified in the SLR were included in the NMA. Most importantly for decision making in clinical practise, faricimab T&E was associated with a statistically greater (95% credible intervals exclude zero) and clinically meaningful decrease in retinal thickness compared to all other flexible dosing regimens (greater retinal drying by 55-125 microns). Anatomical outcomes determine treatment efficacy and retreatment of patients. The NMA also showed a statistically greater increase in mean change in BCVA for faricimab T&E vs. flexible regimens using ranibizumab and bevacizumab (increase of 4.4-4.8 letters) as well as a numerical improvement vs. aflibercept PRN (two letters, 95% credible intervals including zero). Accordingly, the injection frequency was numerically lower versus other treatments using flexible dosing regimens (decrease by 0.92-1.43 injections). The analyses also indicated that the safety profile of faricimab T&E was comparable to those of ranibizumab and aflibercept, which have well-established safety profiles, with similar results for the number of all-cause discontinuations. CONCLUSION: Faricimab provides a new treatment option in DME with dual-pathway inhibition of VEGF and angiopoeitin-2 (Ang-2). To the authors' knowledge, this is the first indirect comparison of faricimab T&E in DME. The analyses indicate that faricimab T&E is associated with superior retinal drying along with numerically fewer injections compared to all other treatments given in flexible dosing regimens. It also showed superior visual acuity outcomes compared to ranibizumab and bevacizumab.

Lack of association between Y chromosome haplogroups and male infertility in Japanese men.

The Y chromosome carries several genes involved in spermatogenesis, which are distributed in three regions in the euchromatic part of the long arm, called AZFa (azoospermia factor a), AZFb, and AZFc. Microdeletions in these regions have been seen in 10-15% of sterile males with azoospermia or severe oligozoospermia. The relatively high de novo occurrence of these microdeletion events might be due to particular chromosome arrangements associated with certain Y chromosome haplogroups. To test whether there is any association between Y chromosome types and male infertility, we studied a sample of 84 Japanese oligozoospermic or azoospermic males. The patients were analyzed for the presence of Yq microdeletions and also typed with a battery of unique event polymorphisms (UEPs) to define their Y haplogroups. Six of the infertile patients presented likely pathological microdeletions detectable with the sequence tagged sites (STS) markers used. There was no significant association between Y chromosome haplogroups and the microdeletions. We also compared the Y haplogroup frequencies in our subset sample of 51 idiopathic azoospermia patients with 57 fertile control Japanese males, and did not observe any significant differences. Contrary to previous reports, our data suggest that Y microdeletions and other molecular events causally associated with male infertility in Japan occur independently of the Y chromosome background.