Análisis de minimización de costes de brolucizumab en el tratamiento de la degeneración macular asociada a la edad neovascular / Cost minimization analysis of brolucizumab in the treatment of neovascular age-related macular degeneration

Introducción Brolucizumab es un nuevo fármaco antifactor de crecimiento endotelial vascular (anti-VEGF) administrado con una pauta fija de ocho o 12 semanas que en los estudios HAWK y HARRIER demostró ser no inferior a aflibercept con respecto a la mejor agudeza visual corregida, bajo una menor carga de administración. El objetivo del análisis fue comparar los costes directos sanitarios de ambos anti-VEGF como tratamiento en pacientes con degeneración macular asociada a la edad neovascular. Material y métodos Se realizó un análisis de minimización de costes bajo un horizonte temporal de 25 años y considerando el coste farmacológico, de administración, de pruebas de seguimiento y del manejo de eventos adversos. El uso de recursos fue obtenido de literatura relacionada y validada por expertos clínicos. Se llevaron a cabo diversos análisis de escenarios para comprobar la robustez de los resultados. Resultados Brolucizumab resultó con un menor coste por paciente en comparación con aflibercept, considerando el número de inyecciones derivadas de los estudios HAWK y HARRIER. Este resultado se mantuvo en los diferentes escenarios analizados, excepto frente al número de inyecciones de la pauta flexible de aflibercept del estudio ARIES, ya que la menor discontinuación de tratamiento con brolucizumab conlleva mantener el tratamiento de más pacientes. Al considerar la misma discontinuación, brolucizumab mantuvo los resultados observados en el caso base del análisis. Conclusiones El presente estudio muestra como la pauta de administración fija de brolucizumab puede ayudar a disminuir la carga asistencial para los centros sanitarios y los pacientes (AU)

Introduction Brolucizumab is a novel anti-vascular endothelial growth factor (anti-VEGF) drug administered in a fixed regimen of 8 or 12 weeks which, in the HAWK and HARRIER studies, was shown not to be inferior to aflibercept with respect to the best corrected visual acuity, with a less burdensome treatment regimen. The aim of the analysis was to compare the direct healthcare costs of both anti-VEGF as a treatment in patients with neovascular age-related macular degeneration.Material and methods A cost minimization analysis was performed under a 25-year time horizon and considering the drug costs, administration, follow-up tests, and management of adverse events. Resource use was obtained from the related literature and validated by clinical experts. Various scenario analysis were carried out to check the robustness of the results. Results Brolucizumab resulted in a lower cost per patient compared with aflibercept, considering the number of injections derived from the HAWK and HARRIER studies. This result was maintained in the different scenarios analysed, except for the number of injections of the flexible aflibercept regimen of the ARIES study, since the lower discontinuation of treatment with brolucizumab implies maintaining the treatment of more patients. Considering the same discontinuation, brolucizumab maintained the results observed in the base case of the analysis. Conclusions This study shows how the fixed administration regimen of brolucizumab can help reduce both healthcare and patients’ burden (AU)

Cost minimization analysis of brolucizumab in the treatment of neovascular age-related macular degeneration.

INTRODUCTION: Brolucizumab is a novel anti-vascular endothelial growth factor (anti-VEGF) drug administered in a fixed regimen of 8 or 12 weeks which, in the HAWK and HARRIER studies, was shown not to be inferior to aflibercept with respect to the best corrected visual acuity, with a less burdensome treatment regimen. The aim of the analysis was to compare the direct healthcare costs of both anti-VEGF as a treatment in patients with neovascular age-related macular degeneration. MATERIAL AND METHODS: A cost minimization analysis was performed under a 25-year time horizon and considering the drug costs, administration, follow-up tests, and management of adverse events. Resource use was obtained from the related literature and validated by clinical experts. Various scenario analysis were carried out to check the robustness of the results. RESULTS: Brolucizumab resulted in a lower cost per patient compared with aflibercept, considering the number of injections derived from the HAWK and HARRIER studies. This result was maintained in the different scenarios analysed, except for the number of injections of the flexible aflibercept regimen of the ARIES study, since the lower discontinuation of treatment with brolucizumab implies maintaining the treatment of more patients. Considering the same discontinuation, brolucizumab maintained the results observed in the base case of the analysis. CONCLUSIONS: This study shows how the fixed administration regimen of brolucizumab can help reduce both healthcare and patients' burden.

Teleoftalmología para el cribado de la retinopatía diabética: experiencia de 8 años / Tele-ophthalmology for diabetic retinopathy screening: 8 years of experience

OBJETIVO: Mostrar los resultados de un programa de cribado de la retinopatía diabética desde el ámbito de la atención primaria. MÉTODOS: Se realizó un estudio retrospectivo de los datos recogidos mediante registro informático automatizado desde el 1 de enero de 2007, hasta el 31 de diciembre de 2015. RESULTADOS: El número de pacientes cribados aumentó progresivamente desde 7.173 en 2007 hasta 42.339 en 2015. Asimismo, la habilidad de los médicos de familia en la interpretación de retinografías mejoró progresivamente, clasificando como normales un 55% de las retinografías en 2007, llegando a un 68% en 2015. El número de retinografías consideradas no valorables disminuyó a lo largo del programa, registrándose picos de hasta el 15% y situándose en un 7% en 2015, en parte gracias a un cambio en la normativa, que permitió dilatar la pupila. Se detectaron cada vez menos casos graves, pasándose de un 14% de retinopatías diabéticas no proliferativas severas y proliferativas al inicio del programa a un 3% en 2015. CONCLUSIONES: El cribado de la oftalmopatía diabética mediante teleoftalmología se reveló como un método muy valioso en una población en crecimiento como es la diabética, facilitando las revisiones al usuario, ayudando a descongestionar los servicios de atención especializada y detectando los casos tratables con mayor precocidad. Sin embargo, los efectos de la implantación no fueron inmediatos, obteniéndose unos resultados modestos en los primeros años del proyecto, que mejoraron en los años subsiguienteS

PURPOSE: To describe the results of a diabetic retinopathy screening program implemented in a primary care area. METHODS: A retrospective study was conducted using data automatically collected since the program began on 1 January 2007 until 31 December 2015. RESULTS: The number of screened diabetic patients has progressively increased, from 7,173 patients in 2007 to 42,339 diabetic patients in 2015. Furthermore, the ability of family doctors to correctly interpret retinographies has improved, with the proportion of retinal images classified as normal having increased from 55% in 2007 to 68% at the end of the study period. The proportion of non-evaluable retinographies decreased to 7% in 2015, having peaked at 15% during the program. This was partly due to a change in the screening program policy that allowed the use of tropicamide. The number of severe cases detected has declined, from 14% with severe non-proliferative and proliferativediabetic retinopathy in the initial phase of the program to 3% in 2015. CONCLUSIONS: Diabetic eye disease screening by tele-ophthalmology has shown to be a valuable method in a growing population of diabetics. It leads to a regular medical examination of patients, helps ease the workload of specialised care services and favours the early detection of treatable cases. However, the results of implementing a program of this type are not immediate, achieving only modest results in the early years of the project that have improved over subsequent years

Tele-ophthalmology for diabetic retinopathy screening: 8 years of experience. / Teleoftalmología para el cribado de la retinopatía diabética: experiencia de 8 años.

PURPOSE: To describe the results of a diabetic retinopathy screening program implemented in a primary care area. METHODS: A retrospective study was conducted using data automatically collected since the program began on 1 January 2007 until 31 December 2015. RESULTS: The number of screened diabetic patients has progressively increased, from 7,173 patients in 2007 to 42,339 diabetic patients in 2015. Furthermore, the ability of family doctors to correctly interpret retinographies has improved, with the proportion of retinal images classified as normal having increased from 55% in 2007 to 68% at the end of the study period. The proportion of non-evaluable retinographies decreased to 7% in 2015, having peaked at 15% during the program. This was partly due to a change in the screening program policy that allowed the use of tropicamide. The number of severe cases detected has declined, from 14% with severe non-proliferative and proliferativediabetic retinopathy in the initial phase of the program to 3% in 2015. CONCLUSIONS: Diabetic eye disease screening by tele-ophthalmology has shown to be a valuable method in a growing population of diabetics. It leads to a regular medical examination of patients, helps ease the workload of specialised care services and favours the early detection of treatable cases. However, the results of implementing a program of this type are not immediate, achieving only modest results in the early years of the project that have improved over subsequent years.

[Management of aflibercept in routine clinical practice]. / Manejo de aflibercept en la práctica clínica habitual.

Aflibercept is a new anti-vegf drug that, unlike ranibizumab and bevacizumab blocks both vegf-A and placental growth factor. Moreover, it binds with much greater strength and affinity to human VEGF-A165 than other endogenous vegf receptors, conferring it with a more extended effect and allowing a lower frequency of intravitreal injections. This facilitates the adoption of fixed treatment regimens other than monthly or individual regimens such as "treat and extend". Aflibercept is indicated for the treatment of neovascular (exudative) age-related macular degeneration (ARMD), visual alteration due to macular edema secondary to central retinal vein occlusion (CRVO) and visual alteration due to diabetic macular edema (DME). The present article reviews the management of aflibercept in routine clinical practice, based on the specifications of its new core data sheet, which includes all the therapeutic indications in which its use has been approved and evaluating the distinct alternatives and treatment regimens after the initial loading doses.

Manejo de aflibercept en la práctica clínica habitual / Management of aflibercept in routine clinical practice

El aflibercept es un nuevo fármaco anti-factor de crecimiento del endotelio vascular (vegf) que, a diferencia del ranibizumab y el bevacizumab, bloquea tanto al vegf-A al vegf-B y al factor de crecimiento placentario (pigf). Además se une con mucha mayor fuerza y afinidad al vegf-A165 humano que otros receptores endógenos del vegf, lo que le confiere un efecto más prolongado y permite una menor frecuencia de inyecciones intravítreas facililitando la adopción de pautas fijas de tratamiento distintas a la mensual o de pautas individualizadas como el 'treat and extend'. El aflibercept está indicado para el tratamiento de la degeneración macular asociada a la edad neovascular (exudativa), de la alteración visual debida al edema macular secundario a la oclusión de la vena central retiniana y de la alteración visual debida al edema macular diabético. En este capítulo se revisa el manejo de aflibercept en la práctica clínica habitual sobre la base de las especificaciones de su nueva ficha técnica, que incluye todas las indicaciones terapéuticas en las que su uso ha sido aprobado, y valorando las distintas alternativas y pautas de tratamiento tras las dosis de carga iniciales

Aflibercept is a new anti-vegf drug that, unlike ranibizumab and bevacizumab blocks both vegf-A and placental growth factor. Moreover, it binds with much greater strength and affinity to human vegf-A 165than other endogenous vegf receptors, conferring it with a more extended effect and allowing a lower frequency of intravitreal injections.33-35 This facilitates the adoption of fixed treatment regimens other than monthly or individual regimens such as 'treat and extend'. Aflibercept is indicated for the treatment of neovascular (exudative) age-related macular degeneration (armd), visual alteration due to macular edema secondary to central retinal vein occlusion (crvo) and visual alteration due to diabetic macular edema (dme). The present article reviews the management of aflibercept in routine clinical practice, based on the specifications of its new core data sheet, which includes all the therapeutic indications in which its use has been approved and evaluating the distinct alternatives and treatment regimens after the initial loading dosess

[Guidelines of clinical practice of the SERV (Spanish Retina and Vitreous Society): management of ocular complications of diabetes. Diabetic retinopathy and macular oedema]. / Guías de práctica clínica de la SERV: manejo de las complicaciones oculares de la diabetes. Retinopatía diabética y edema macular.

OBJECTIVE: Diabetes mellitus is considered the most common cause of blindness in the working population of industrialized countries, with diabetic macular edema being the most common cause of decreased visual acuity and proliferative diabetic retinopathy (PDR) being responsible for the most severe visual deficits. We have therefore tried to establish a guide for clinical intervention whose purpose is to provide orientation on the treatment of diabetic retinopathy and its complications. This is necessary at a time when many treatment options have emerged whose role is not yet fully defined. METHOD: A group of expert retina specialists selected by the SERV (Vitreous-Retina Spanish Society) assessed the published results of different treatment options currently available, suggesting lines of action according to the degree of diabetic retinopathy present and the presence or absence of macular edema. RESULTS: PDR is primarily treated with pan-retinal photocoagulation. For clinically significant diabetic macular edema without signs of vitreomacular traction, the treatment of choice continues to be focal/grid photocoagulation. Similarly, retinovitreal surgery is indicated for both conditions. The use of antiangiogenic drugs was also analyzed but remains inconclusive. CONCLUSION: Laser therapy is effective in the management of diabetic retinopathy and diabetic macular edema. The role of antiangiogenics is not yet sufficiently defined.

Guías de Práctica Clínica de la SERV: Manejo de las complicaciones oculares de la diabetes. Retinopatía diabética y edema macular / Guidelines of Clinical Practice of the SERV: Management of ocular complications of diabetes. Diabetic retinopathy and macular oedema

Objetivo: La diabetes mellitus está considerada como la causa más frecuente de ceguera en lapoblación activa en los países industrializados,siendo el edema macular diabético la causa más frecuentede disminución de la agudeza visual y laretinopatía diabética proliferante la responsable delos déficit visuales más severos. Por ello hemosintentado establecer una guía de actuación clínicacuyo propósito es proporcionar unas directrices quesirvan de orientación para el tratamiento de la retinopatía diabética y sus complicaciones. Esto sehace necesario en un momento en el que han aparecidonumerosas alternativas terapéuticas cuyo papelaún no está completamente definido.Método: Un grupo de expertos retinólogos seleccionadospor la SERV han evaluado los resultadospublicados sobre las distintas opciones terapéuticasque existen en la actualidad, en base a lo cual sesugieren líneas de actuación según el grado de retinopatíadiabética que presenta el paciente y la presenciao no de edema macular.Resultados: El tratamiento princeps de la RDP esla panretinofotocoagulación (PFC). El tratamientode elección en el edema macular diabético clínicamentesignificativo sin signos de tracción vítreomacular continúa siendo la fotocoagulaciónfocal/rejilla. La cirugía retinovítrea tiene así mismosus indicaciones en ambas afecciones. Se discute eluso de fármacos antiangiogénicos.Conclusión: La laserterapia es efectiva en el manejode la RD y del EMD. El papel de los antiangiogénicosaún no está suficientemente definido (AU)

Objective: Diabetes mellitus is considered the most common cause of blindness in the working populationof industrialized countries, with diabetic macularedema being the most common cause of decreasedvisual acuity and proliferative diabetic retinopathy(PDR) being responsible for the most severevisual deficits. We have therefore tried to establisha guide for clinical intervention whose purpose is toprovide orientation on the treatment of diabetic retinopathyand its complications. This is necessary at a time when many treatment options have emergedwhose role is not yet fully defined.Method: A group of expert retina specialists selectedby the SERV (Vitreous-Retina Spanish Society)assessed the published results of different treatmentoptions currently available, suggesting lines ofaction according to the degree of diabetic retinopathypresent and the presence or absence of macularedema.Results: PDR is primarily treated with pan-retinalphotocoagulation. For clinically significant diabeticmacular edema without signs of vitreomacular traction,the treatment of choice continues to befocal/grid photocoagulation. Similarly, retinovitrealsurgery is indicated for both conditions. The use ofantiangiogenic drugs was also analyzed but remainsinconclusive.Conclusion: Laser therapy is effective in the managementof diabetic retinopathy and diabetic macularedema. The role of antiangiogenics is not yet sufficiently defined (AU)

[Review of the protocol for the treatment of diabetic retinopathy]. / Revisión del protocolo para el tratamiento de la retinopatía diabética.

We present general guidelines to help us with the treatment of diabetic retinopathy (DR) at a time when numerous therapeutic alternatives have been developed although their role has not yet been adequately defined. This protocol is not directed at experienced retinologists but rather at general ophthalmologists who require a practical and up to date guide of a pathology as prevalent as RD. The different therapeutic options available, and their most accepted indications depending on the degree of diabetic retinopathy that patients have, are reviewed. We propose what to do in cases of mild, moderate and severe non-proliferative diabetic retinopathy as well as in cases of proliferative diabetic retinopathy (panphotocoagulation/antiangiogenic drugs/vitreorretinal surgery). The treatment of diabetic macular edema depending on its angiographic and topographic characteristics is also discussed. The importance of metabolic control of the patient is stressed (tight glycemic control, control of arterial hypertension and dyslipemia) in aiding the treatment of diabetic retinopathy. This therapeutic proposal has been discussed widely by retinologists from the four largest hospitals in the Canary Islands, and is therefore an agreed text based on recent scientific literature.

Revisión del protocolo para el tratamiento de la retinopatía diabética / Revision of the protocol for the treatment of diabetic retinopathy

Se presentan unas directrices generales con el objetivode proporcionar una orientación en el manejo dela retinopatía diabética (RD) en un momento en elque han aparecido numerosas alternativas terapéuticascuyo papel aún no está suficientemente definido.Este protocolo está dirigido no a retinólogos expertossino a oftalmólogos generales que precisen una guíapráctica y actualizada de una patología tan prevalentecomo la RD.En este documento se revisan las distintas opcionesterapéuticas disponibles y su indicación más aceptadasegún el grado de retinopatía diabética que presenteel paciente. Se plantea así que hacer con unaretinopatía diabética no proliferativa (RDNP) leve,moderada (ambas control por su oftalmólogo dezona) y severa (en casos muy seleccionados puedeconsiderarse la realización de una panfotocoagulación–PFC–). Los pacientes con retinopatía diabéticaproliferativa (RDP) serán tratados en los centroshospitalarios (PFC/fármacos antiangiogénicos/cirugía vítreorretiniana –CVR–) hasta que sea controladosu proceso. Se discute asimismo el tratamientodel edema macular (EM) diabético según sus característicasangiográficas y topográficas.Se hace hincapié en la importancia del control metabólicodel paciente (optimizar el control glucémico,de su hipertensión arterial y de la dislipemia) comotratamiento necesario y coadyuvante de su RD.Esta propuesta terapéutica ha sido ampliamente discutidapor retinólogos de los cuatro grandes hospitalesde Canarias por lo que se trata de un texto consensuadobasado en la bibliografía científica actual(AU)

We present general guidelines to help us with thetreatment of diabetic retinopathy (DR) at a timewhen numerous therapeutic alternatives have beendeveloped although their role has not yet been adequatelydefined. This protocol is not directed atexperienced retinologists but rather at general ophthalmologistswho require a practical and up to dateguide of a pathology as prevalent as RD.The different therapeutic options available, andtheir most accepted indications depending on thedegree of diabetic retinopathy that patients have, arereviewed. We propose what to do in cases of mild,moderate and severe non-proliferative diabetic retinopathyas well as in cases of proliferative diabeticretinopathy (panphotocoagulation/antiangiogenicdrugs/vitreorretinal surgery). The treatment of diabeticmacular edema depending on its angiographicand topographic characteristics is also discussed.The importance of metabolic control of thepatient is stressed (tight glycemic control, control of arterial hypertension and dyslipemia) in aidingthe treatment of diabetic retinopathy.This therapeutic proposal has been discussedwidely by retinologists from the four largest hospitalsin the Canary Islands, and is therefore an agreedtext based on recent scientific literature(AU)

Sensitivity and specificity of digital retinal imaging for screening diabetic retinopathy.

AIMS: To assess the effectiveness of a non-mydriatic digital camera (45 degrees -30 degrees photographs) compared with the reference method for screening diabetic retinopathy. METHODS: Type 1 and 2 diabetic patients (n = 773; 1546 eyes) underwent screening for diabetic retinopathy in a prospective observational study. Hospital-based non-mydriatic digital retinal imaging by a consultant specialist in retinal diseases was compared with slit-lamp biomicroscopy and indirect ophthalmoscopy through dilated pupils, as a gold standard, previously performed in a community health centre by another consultant specialist in retinal diseases. The main outcome measures were sensitivity and specificity of screening methods and prevalence of diabetic retinopathy. RESULTS: The prevalence of any form of diabetic retinopathy was 42.4% (n = 328); the prevalence of sight-threatening including macular oedema and proliferative retinopathy was 9.6% (n = 74). Sensitivity of detection of any diabetic retinopathy by digital imaging was 92% (95% confidence interval 90, 94). Specificity of detection of any diabetic retinopathy was 96% (95, 98). The predictive value of the negative tests was 94% and of a positive test 95%. For sight-threatening retinopathy digital imaging had a sensitivity of 100%. CONCLUSIONS: A high sensitivity and specificity are essential for an effective screening programme. These results confirm digital retinal imaging with a non-mydriatic camera as an effective option in community-based screening programmes for diabetic retinopathy.