Cost and Effectiveness of Therapy for Wet Age-Related Macular Degeneration in Routine Clinical Practice

Studnička, Jan; Říhová, Barbora; Rencová, E; Rozsíval, P; Dubská, Z; Chrapek, O; Kolář, Petr; Kandrnal, Vít; Demlová, Regina; Pitrová, S; Řehák, J

doi:10.1159/000350802

Cited by 9 publications

(4 citation statements)

References 21 publications

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“…Therefore, these studies might not be able to provide relevant information for decision-makers (Payet et al 2008). Studies conducted under clinical practice conditions, such as Phase IV, pragmatic clinical trials and observational studies, which are aimed to assess the effectiveness of treatments, could be of great value in order to confirm the efficacy results obtained in RCTs (Alban et al 1997;AMCP 2016;Bastida et al 2010;CADTH 2017;Capri et al 2001;CES 2004;Fukuda 2016;Heintz et al 2016;Infarmed 1998; L€ a€ akkeiden Hintalautakunta 2017; Payet et al 2008;PHARMAC 2015;SMC, 2017;Studni cka et al 2013).…”

Section: Discussionmentioning

confidence: 99%

An analysis of the effectiveness outcomes of economic studies evaluating ophthalmic drugs: a systematic review

Ribeiro

Marques

Alves

et al. 2020

Acta Ophthalmologica

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Purpose: To characterize the effectiveness measures of cost-effectiveness studies (CES) of ophthalmic drugs. Methods: A systematic review was conducted in PubMed/Embase until October 2019. Cost-effectiveness studies (CES) evaluating ophthalmic drugs were included. Sources of effectiveness measures were extracted. Data on study design and study outcomes were extracted from sources of effectiveness measures. The adequacy of the sample size of the clinical studies used as sources of effectiveness measures was assessed. If CES have retrieved effectiveness data from multiple sources, the appropriateness of the method to combine the results was analysed. Results: Forty-five CES were included. Thirty-one (68.9%) retrieved their effectiveness measures from experimental studies, five (11.1%) from observational studies and nine (20%) from other type of data sources. Eight (17.8%) CES used data from a primary outcome of a study as an effectiveness measure, eight (17.8%) used data from secondary outcomes, seven (15.6%) used data from the both primary and secondary outcomes and for 22 (48.9%) it was not possible to identify the outcomes used. From the 23 (51.1%) CES based on a single clinical study, three (6.7%) included data from clinical studies which had an adequate sample size to detect significant differences in the clinical outcomes used as effectiveness measures. From the 17 (37.8%) CES based on multiple clinical studies, only one (2.2%) used and/or reported an adequate method of quantitative synthesis (metaanalysis). Conclusion: A considerable number of CES in ophthalmology were not based on clinical studies with adequate sample sizes and report results from effectiveness measures not assessed as primary outcomes.

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Section: Discussionmentioning

confidence: 99%

An analysis of the effectiveness outcomes of economic studies evaluating ophthalmic drugs: a systematic review

Ribeiro

Marques

Alves

et al. 2020

Acta Ophthalmologica

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“…Closer to clinics, a comparative cost-effectiveness of therapy for age-related macular degeneration has been performed between Verteporfin (a ribonucleic acid aptamer targeting the vascular endothelium growth factor (VEGF) from Novartis Pharma AG) and Ranibizumab (a monoclonal antibody targeting a wider diversity of VEGF isoforms from Genentech Inc). It was found that the treatment cost with the aptamer was half that of the monoclonal antibody [104]. The difference is not as striking as could be expected, but an emerging consensus suggests that the costs should be slightly lower.…”

Section: Comparative Advantages In Using Aptamers Over Antibodiesmentioning

confidence: 95%

Diagnostic and Therapeutic Value of Aptamers in Envenomation Cases

Ascoët

Waard

2020

IJMS

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It is now more than a century since Albert Calmette from the Institut Pasteur changed the world of envenomation by demonstrating that antibodies raised against animal venoms have the ability to treat human victims of previously fatal bites or stings. Moreover, the research initiated at that time effectively launched the discipline of toxicology, first leading to the search for toxic venom components, followed by the demonstration of venoms that also contained compounds of therapeutic value. Interest from pharmaceutical companies to treat envenomation is, however, declining, mainly for economic reasons, and hence, the World Health Organization has reclassified this public health issue to be a highest priority concern. While the production, storage, and safety of antivenom sera suffer from major inconveniences, alternative chemical and technological approaches to the problem of envenomation need to be considered that bypass the use of antibodies for toxin neutralization. Herein, we review an emerging strategy that relies on the use of aptamers and discuss how close—or otherwise—we are to finding a viable alternative to the use of antibodies for the therapy of human envenomation.

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“…Z jejich analýz je také patrné, jaký význam má dostatečná frekvence kontrol a zejména aplikací. Pokud jsou pacienti léčeni dostatečně intenzivně, lze se i v reálné klinické praxi přiblížit vynikajícím výsledkům léčby v klinických studiích [16,17,28].…”

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One-year follow-up outcomes of treatment of wet age-related macular degeneration with aflibercept

Ym¹,

Pencak

Stranak

et al. 2018

CSO

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Cíl: Zhodnotit výsledky roční terapie preparátem aflibercept u pacientů s nově diagnostikovanou vlhkou formou věkem podmíněné makulární degenerace (VPMD). Metodika: Retrospektivní vyhodnocení léčby 28 očí 28 pacientů průměrného věku 74,2 let, kteří byli léčeni preparátem aflibercept na Oftalmologické klinice Fakultní nemocnice Královské Vinohrady. Všichni pacienti byli léčeni dle souhrnu údajů o přípravku (SPC), tj. úvodními 3 injekcemi po měsíčních intervalech, následovaný 4 injekcemi každé 2 měsíce. Hodnotili jsme změnu nejlépe korigované zrakové ostrosti (BCVA) na Early Treatment of Diabetic Retinopathy Study (ETDRS) optotypech a změnu centrální retinální tloušťky (CRT) pomocí optické koherenční tomografie (OCT). Výsledky: Průměrná vstupní hodnota BCVA byla 61,5 písmen ETDRS optotypu. Po úvodních 3 injekcích se zlepšila BCVA na 70,5 písmen, po roce léčby pak došlo k lehkému poklesu na 68,1 písmen. Lepší nebo stejnou zrakovou ostrost mělo 25 očí (89,3 %), ke zhoršení došlo u 3 očí (10,7 %). CRT se snížila ze vstupní průměrné hodnoty 360,9 µm na 253,3 µm po úvodní fázi a na 233,8 µm po roce léčby. Bez známek aktivity onemocnění bylo na konci sledovacího období 25 očí (89,3 %). Nebyly zaznamenány žádné komplikace léčby. Závěr: V našem souboru potvrzujeme účinnost a bezpečnost preparátu aflibercept u pacientů s nově diagnostikovanou vlhkou formou VPMD. Dodržením fixního léčebného režimu lze i v reálné klinické praxi dosáhnout podobně vynikajících výsledků léčby jako v klinických studiích. Klíčová slova: aflibercept, anti-VEGF terapie, optická koherenční tomografie (OCT), vlhká forma VPMD SUMMARY ONE-YEAR FOLLOW-UP OUTCOMES OF THE TREATMENT OF WET AGE-RELATED MACULAR DEGENERATION WITH AFLIBERCEPT Purpose: To evaluate one-year follow-up outcomes of the treatment with aflibercept in patients with newly diagnosed wet age-related macular degeneration (AMD). Methods: It was a retrospective analysis of 28 eyes of 28 patients with an average age of 74,2 years, who were treated with aflibercept at the Department of Ophthalmology, University Hospital Královské Vinohrady in Prague. All patients were treated according to the SPC, it means initial 3 injections at monthly intervals, followed by 4 injections every 2 months. We evaluated the change in the best corrected visual acuity (BCVA) on Early Treatment of Diabetic Retinopathy Study (ETDRS) charts and the change in central retinal thickness (CRT) by the optical coherence tomography (OCT). Results: The mean input visual acuity was 61,5 letters of the ETDRS optotype. After the initial 3 injections the BCVA improved to 70,5 letters and after one year's treatment, it dropped slightly to 68,1 letters. Better or equal visual acuity had 25 eyes (89,3 %), with worsening in 3 eyes (10,7 %). CRT decreased from an entry average of 360,9 μm to 253,3 μm after the initial phase and to 233,8 μm after one year treatment. No signs of disease activity had 25 eyes (89,3 %) at the end of the follow-up period. There were no complications of the treatment. Conclusion: In our study, we confirm th...

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Cost and Effectiveness of Therapy for Wet Age-Related Macular Degeneration in Routine Clinical Practice

Cited by 9 publications

References 21 publications

An analysis of the effectiveness outcomes of economic studies evaluating ophthalmic drugs: a systematic review

An analysis of the effectiveness outcomes of economic studies evaluating ophthalmic drugs: a systematic review

Diagnostic and Therapeutic Value of Aptamers in Envenomation Cases

One-year follow-up outcomes of treatment of wet age-related macular degeneration with aflibercept

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