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1.
BMC Health Serv Res ; 22(1): 837, 2022 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-35765055

RESUMO

OBJECTIVE: We aimed to evaluate the cost-effectiveness of voretigene neparvovec (VN) compared with standard of care (SoC) for patients with inherited retinal disease (IRD) caused by a biallelic RPE65-mutation. VN is a live, non-replicating adeno-associated virus serotype 2 (AAV2). SoC is best supportive care provided to patients with visual impairment. Patients under SoC may experience progressive vision loss leading to complete blindness. METHODS: We adapted a previously published Markov cohort model for IRD. An annual cycle length, life-long time horizon, discount rate of 3% for cost and health outcomes, and Swiss health system perspective were used. Data from a randomised controlled phase III trial of VN versus SoC (ClinicalTrials.gov: NCT00999609) were used to estimate transitions between health states in the first year, after which VN patients were assumed to remain for 39 subsequent years in the health state they were in at the end of the first year. After the 40th year for VN patients and 1st year for SoC patients, visual decline was modelled based on observational data on the natural progression of the disease. Quality-adjusted life years (QALYs) were calculated based on an external study which elicited clinicians' EQ-5D-5L-based utility estimates for IRD patients with a RPE65-mutation. Costs (Swiss Francs (CHF), year 2018-2019) included drug acquisition/ administration, adverse events, testing for sufficient viable retinal cells, and healthcare-related costs of blindness. Societal costs of blindness were added in a complementary analysis. Robustness of the model results were tested in sensitivity and scenario analyses. RESULTS: For the base-case, VN resulted in incremental costs per patient of CHF 764'402 (VN: CHF 901'654, SoC: CHF 137'252), incremental blindness-free years of 7.67 (VN: 28.32, SoC: 20.65) and incremental QALYs of 6.73 (VN: 18.35, SoC: 11.62), leading to an incremental cost-effectiveness ratio of CHF 113'526 per QALY gained. In probabilistic sensitivity analysis, the cost-effectiveness of VN was better than CHF 100,000 per QALY gained in 41% of iterations. For the scenario analysis in which a societal perspective was adopted and for which a 50% work-related productivity loss from blindness was assumed, incremental costs of CHF 423,837 and an ICER of CHF 62'947 per QALY gained were produced. The scenario assuming VN treatment effect lasts for 20 years produced an ICER of CHF 156'171 per QALY gained, whereas assuming a life-long VN treatment effect resulted in an ICER of CHF 96'384 per QALY gained. CONCLUSION: The incremental cost-effectiveness ratio of VN compared to the SoC was estimated to be CHF 113'526 and CHF 62'947 per QALY gained, respectively, from a Swiss healthcare system, and societal perspective assuming a 50% productivity loss.


Assuntos
Terapia Genética , Doenças Retinianas , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Humanos , Cadeias de Markov , Mutação , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças Retinianas/economia , Doenças Retinianas/genética , Doenças Retinianas/terapia , Suíça
2.
Ophthalmol Retina ; 5(6): 496-502, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33588067

RESUMO

PURPOSE: To use electronic health record (EHR) time logs to calculate the complete cost profiles of routine pars plana vitrectomy surgery. DESIGN: Economic analysis. PARTICIPANTS: Patients undergoing elective vitrectomy procedures (Current Procedural Terminology codes 67040, 67041, and 67042) at Vanderbilt University Medical Center in fiscal year 2019. METHODS: Process flow mapping for routine vitrectomy surgery was used to define the operative episode. De-identified time logs were sourced from an internal perioperative data warehouse to calculate procedure-level durations. The costs of materials and overhead were calculated from internal financial management software. Costs per minute for space, equipment, and personnel were based on internal figures. These inputs were used for a time-driven activity-based costing (TDABC) analysis. MAIN OUTCOME MEASURES: Complete cost profile of routine pars plana vitrectomy surgery. RESULTS: Cost analysis of routine vitrectomy surgery resulted in a total cost of $7169.79 per patient, which was $2053.85 more than the maximum Medicare reimbursement for the equivalent episode, $5115.93. Vitrectomy cases do not break even unless the case duration is fewer than 26.81 minutes, overhead is reduced by 53.78%, or reimbursement is increased by 40.15%. Reimbursement does not compensate for variable costs alone for cases lasting longer than 55.09 minutes. In the cohort used here, 68% of cases are completely unprofitable, with increasing losses directly proportional to the length of the case. CONCLUSIONS: This analysis showed that true costs for routine vitrectomy procedures are significantly more than the maximum allowable Medicare reimbursement. Academic ophthalmology departments may benefit from more accurate costing approaches using existing EHR data. These approaches may be informative for policy discussion regarding appropriate reimbursement.


Assuntos
Registros Eletrônicos de Saúde/estatística & dados numéricos , Custos de Cuidados de Saúde/estatística & dados numéricos , Medicare/economia , Doenças Retinianas/cirurgia , Vitrectomia/economia , Humanos , Doenças Retinianas/economia , Estudos Retrospectivos , Estados Unidos
3.
Retina ; 41(8): 1754-1761, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-33315816

RESUMO

PURPOSE: To report trends of intravitreal corticosteroid use and explore the relationship between career experience, reported industry payments, and prescribing habits. METHODS: A retrospective review of ophthalmologists who administered intravitreal dexamethasone implants (DEX) and triamcinolone acetonide (TA) injections between August 2013 and December 2017. RESULTS: A total of 1,070 US ophthalmologists were reimbursed by Medicare for 522,804 DEX injections and 2.6 million TA injections. There was a significant positive trend in the number of DEX (P = 0.01), but not TA, injections per year. Mid-career and late-career physicians performed significantly greater total injections on average compared with early-career physicians (both P < 0.001). Early-career physicians performed a greater proportion of DEX injections than late-career physicians (P = 0.006). Industry payments were positively associated with the proportion of DEX used and inversely correlated with the proportion of TA administered (P < 0.001). On multivariate analysis, years in practice, number of payments, and total value of payments were significantly associated with the number of DEX injections administered (all P < 0.001). CONCLUSION: From 2013 to 2017, the use of DEX increased, whereas TA use remained stable. There was a positive association between DEX use and physician-industry interactions, which may be explained by seniority and experience. This study does not define a causal relationship.


Assuntos
Dexametasona/administração & dosagem , Medicare , Oftalmologistas/estatística & dados numéricos , Doenças Retinianas/diagnóstico por imagem , Triancinolona Acetonida/administração & dosagem , Adulto , Feminino , Seguimentos , Glucocorticoides/administração & dosagem , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Doenças Retinianas/economia , Estudos Retrospectivos , Estados Unidos , Adulto Jovem
5.
BMC Public Health ; 19(1): 1252, 2019 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-31510981

RESUMO

BACKGROUND: Antiangiogenic therapy has proved to be an important therapeutic tool for many retinal vascular diseases; however, its availability is limited in developing countries. This study sought to describe the bevacizumab vial sharing process and to evaluate the impact of this repackaging system on the costs incurred in a Brazilian public hospital. METHOD: This retrospective study compared the number and costs of intravitreal antiangiogenic injections approved via court order in the first year of the study (2015) to the number and costs of the bevacizumab injections provided through the use of vial sharing in the second year of the study (2016). Vial sharing consists of the traditional process used to repackage bevacizumab; in this case, however, the drug samples used were the residual volume from the preparation of bevacizumab for oncology patients. The hospital adhered to the guidelines established by the Brazilian Health Surveillance Agency (ANVISA). RESULTS: In the first year of the study and using medication obtained through court orders, 550 intravitreal injections were performed in the ophthalmology ambulatory care center. Based on local pricing tables, the total cost of the medication was BRL$1,036,056.25 (USD$267,546.58), and the average cost of each application was BRL$1883.74 (USD$486.45). In the second year of the study, 1081 intravitreal applications were performed at the same hospital using doses obtained through bevacizumab vial sharing. The total cost was BRL$21,942.49 (USD$5663.30) and the per-unit cost was BRL$20.30, or USD$5.23 (a savings of 97.88%). CONCLUSION: This study found that bevacizumab vial sharing led to a significant reduction in public health care costs associated with antiangiogenic treatment and increased the availability of the drug to public health care patients. These results can be extrapolated to other types of drugs and health care systems.


Assuntos
Inibidores da Angiogênese/economia , Bevacizumab/economia , Custos de Medicamentos , Doenças Retinianas/tratamento farmacológico , Doenças Retinianas/economia , Idoso , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/uso terapêutico , Brasil , Análise Custo-Benefício , Feminino , Custos de Cuidados de Saúde , Humanos , Injeções Intravítreas/economia , Pessoa de Meia-Idade , Estudos Retrospectivos
6.
Ophthalmol Retina ; 3(1): 16-26, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30935655

RESUMO

PURPOSE: A comparison of anti-vascular endothelial growth factor (anti-VEGF) medication use across multiple countries. CLINICAL RELEVANCE: Anti-VEGF medication use is now considered first-line treatment for numerous retinal diseases globally. Exploring medication choices, costs within each healthcare system, policy challenges, emerging treatments, and patient access all provide insight into a newly recognized and major public health issue. METHODS: All data presented in this review are available through the published English literature in PubMed, non-peer-reviewed trade publications, and reported surveys. The following search terms were used: anti-VEGF OR bevacizumab OR ranibizumab OR aflibercept OR pegaptanib OR conbercept AND trends OR survey OR cost OR patterns OR preference. Countries with large populations and available data included the United States, United Kingdom, China, India, Korea, Singapore, and Australia. Population and economic statistics were obtained from published reports from the World Bank, World Health Organization, and Commonwealth Fund. RESULTS: Anti-VEGF medication use and costs are significant aspects of patient and healthcare system expenditures in each nation and may have an especially large potential economic burden in India and China. Bevacizumab use comprises the majority of anti-VEGF medication use in the United States and Singapore, although aflibercept use is growing rapidly. Paradoxically, data demonstrate that there is a significant trend in medication choice toward ranibizumab and aflibercept among practice settings outside of the United States, such as the United Kingdom, China, South Korea, and Australia. The price of anti-VEGF medications ranged from US $30 (ziv-aflibercept) to US $1950 (ranibizumab and aflibercept). Ranibizumab's price ranged from US $240 in India to US $1950 in the United States. Conbercept in China costs approximately US $1150 per dose. CONCLUSIONS: Outside of the United States, many nations are using a majority of more expensive anti-VEGF medications, which may lead to increased costs and decreased access. Increasing the availability of safely compounded anti-VEGF medications will likely improve access, create patient/provider choice, and decrease relative healthcare costs for the growing burden of retinal diseases globally.


Assuntos
Custos de Medicamentos/estatística & dados numéricos , Saúde Pública/economia , Ranibizumab/administração & dosagem , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Doenças Retinianas/tratamento farmacológico , Inibidores da Angiogênese/administração & dosagem , Ásia Ocidental , Análise Custo-Benefício , Humanos , Injeções Intravítreas , Doenças Retinianas/economia , Reino Unido , Estados Unidos , Fatores de Crescimento do Endotélio Vascular/antagonistas & inibidores
7.
Value Health ; 22(2): 161-167, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30711060

RESUMO

OBJECTIVE: The gene therapy voretigene neparvovec (VN) is the first Food and Drug Administration-approved treatment for vision loss owing to the ultra-rare RPE65-mediated inherited retinal disorders. We modeled the cost-utility of VN compared with standard of care (SoC). STUDY DESIGN: A 2-state Markov model, alive and dead, with a lifetime horizon. METHODS: Visual acuity (VA) and visual field (VF) were tracked to model quality-adjusted life-years (QALYs). VN led to an improvement in VA and VF that we assumed was maintained for 10 years followed by a 10-year waning period. The cost of VN was $850 000, and other direct medical costs for depression and trauma were included for a US healthcare system perspective. A modified societal perspective also included direct nonmedical costs and indirect costs. RESULTS: VN provided an additional 1.3 QALYs over the remaining lifetime of an individual. The average total lifetime direct medical cost for individuals treated with VN was $1 039 000 compared with $213 400 for SoC, leading to an incremental cost-effectiveness ratio (ICER) of $643 800/QALY from the US healthcare system perspective. Direct nonmedical costs totalled $1 070 900 for VN and $1 203 300 for SoC, and indirect costs totalled $405 400 for VN and $482 900 for SoC, leading to an ICER of $480 100/QALY from the modified societal perspective. CONCLUSIONS: At the current price, VN was unlikely to reach traditional cost-effectiveness standards compared with SoC. VN has important implications for both development and pricing of future gene therapies; therefore clinical and economic analyses must be carefully considered.


Assuntos
Alelos , Análise Custo-Benefício , Terapia Genética/economia , Doenças Retinianas/economia , Doenças Retinianas/terapia , cis-trans-Isomerases/economia , Adolescente , Adulto , Idoso , Análise Custo-Benefício/métodos , Feminino , Terapia Genética/métodos , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Doenças Retinianas/genética , Transtornos da Visão/economia , Transtornos da Visão/genética , Transtornos da Visão/terapia , Adulto Jovem , cis-trans-Isomerases/administração & dosagem , cis-trans-Isomerases/genética
8.
JAMA Ophthalmol ; 136(5): 524-531, 2018 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-29800250

RESUMO

Importance: Examining costs and consequences of different low-vision (LV) programs provides important information about resources needed to expand treatment options efficiently. Objective: To examine the costs and consequences of LV rehabilitation or basic LV services. Design, Setting, and Participants: The US Department of Veterans Affairs (VA) Low Vision Intervention Trial (LOVIT) II was conducted from September 27, 2010, to July 31, 2014, at 9 VA facilities and included 323 veterans with macular diseases and a best-corrected distance visual acuity of 20/50 to 20/200. Veterans were randomized to receive basic LV services that provided LV devices without therapy, or LV rehabilitation that added a therapist to LV services who provided instruction and homework on using LV devices, eccentric viewing, and environmental modification. We compared costs and consequences between these groups. Interventions: Low-vision devices without therapy and LV devices with therapy. Main Outcomes and Measures: Costs of providing basic LV services or LV rehabilitation were assessed. We measured consequences as changes in functional visual ability from baseline to follow-up 4 months after randomization using the VA Low Vision Visual Functioning Questionnaire. Visual ability was measured in dimensionless log odds units (logits). Results: Of 323 randomized patients, the mean (SD) age was 80 (10.5) years, 314 (97.2%) were men, and 292 (90.4%) were white. One hundred sixty (49.5%) received basic LV services and 163 (50.1%) received LV rehabilitation. The mean (SD) total direct health care costs per patient were similar between patients who were randomized to receive basic LV services ($1662 [$671]) or LV rehabilitation ($1788 [$864]) (basic LV services, $126 lower; 95% CI, $299 lower to $35 higher; P = .15). However, basic LV services required less time and had lower transportation costs. Patients receiving LV rehabilitation had greater improvements in overall visual ability, reading ability, visual information processing, and visual motor skill scores.


Assuntos
Análise Custo-Benefício , Doenças Retinianas/reabilitação , Baixa Visão/economia , Baixa Visão/reabilitação , Pessoas com Deficiência Visual/reabilitação , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Feminino , Custos de Cuidados de Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Qualidade de Vida , Doenças Retinianas/economia , Inquéritos e Questionários , Estados Unidos , United States Department of Veterans Affairs , Veteranos , Acuidade Visual
9.
BMC Ophthalmol ; 18(1): 64, 2018 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-29486762

RESUMO

BACKGROUND: To compare anti-VEGF treatments for macular disease in terms of costs and clinical outcomes. METHODS: We identified patients suffering from macular disease and treated either with aflibercept, ranibizumab or both at the largest public eye clinic in Switzerland between January 1st and December 31st 2016 who were insured in one of the two participating health insurance companies. Clinical data were extracted from the electronic health record system. The health insurers provided the health claim costs for the ophthalmologic care and the total health care costs of each patient in the observation period. Using multivariate regression models, we assessed the monthly ophthalmologic and the monthly total costs of patients with no history of switching (ranibizumab vs. aflibercept), patients with a history of switching from ranibizumab to aflibercept, patients switching during the observation period and a miscellaneous group. We examined baseline differences in age, proportion of males, visual acuity (letters), central retinal thickness (CRT) and treatment history before entering the study. We investigated treatment intensity and compared the changes in letters and CRT. RESULTS: The analysis involved 488 eyes (361 patients), 182 on ranibizumab treatment, and 63 on aflibercept treatment, 160 eyes with a history of switching from ranibizumab to aflibercept, and 45 switchers during follow-up and 38 eyes of the miscellaneous group. Compared to ranibizumab, monthly costs of ophthalmologic treatment were slightly higher for aflibercept treatment + 175.0 CHF (95%CI: 1.5 CHF to 348.3 CHF; p = 0.048) as were the total monthly costs + 581.0 CHF (95%CI: 159.5 CHF to 1002.4 CHF; p = 0.007). Compared to ranibizumab, the monthly treatment intensity with aflibercept was similar (+ 0.057 injections/month (95%CI -0.023 to 0.137; p = 0.162), corresponding to a projected annual number of 5.4 injections for ranibizumab vs. 6.1 injections for aflibercept. During follow-up, visus dropped by 0.7 letters with ranibizumab and increased by 0.6 letters with aflibercept (p = 0.243). CRT dropped by - 14.9 µm with ranibizumab and by - 19.5 µm with aflibercept (p = 0.708). The monthly costs of all other groups examined were higher. CONCLUSION: These real-life data show that aflibercept treatment is equally expensive, and clinical outcomes between the two drugs are similar.


Assuntos
Inibidores da Angiogênese/economia , Custos de Cuidados de Saúde , Ranibizumab/economia , Proteínas Recombinantes de Fusão/economia , Doenças Retinianas/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/uso terapêutico , Feminino , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Ranibizumab/uso terapêutico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Doenças Retinianas/economia , Acuidade Visual
10.
Asia Pac J Ophthalmol (Phila) ; 6(6): 561-568, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28971631

RESUMO

During the past decade, drugs that inhibit the actions of vascular endothelial growth factor (VEGF) have become standard-of-care treatment for a variety of chorioretinal vascular conditions. The off-label, intravitreal use of ziv-aflibercept (Zaltrap) has provided clinicians with an additional cost-effective drug. The commercial preparation of ziv-aflibercept contains the same aflibercept (VEGF-trap) molecule as Eylea but has a much higher osmolarity (1000 mOsm/kg vs 300 mOsm/kg). Initial concerns regarding cytotoxicity and long-term safety of intravitreal ziv-aflibercept have been largely negated after a series of publications failed to identify adverse ocular and systemic side effects. Both treatment-naive and anti-VEGF‒resistant cases of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and choroidal neovascular membrane (CNVM) may respond as well to ziv-aflibercept as to aflibercept. A higher dose of ziv-aflibercept (2 mg in 0.08 mL) does not cause any adverse effects during short-term follow-up period (1 month). Data from various sources suggest that ziv-aflibercept may be as cost effective as bevacizumab, thereby making it an attractive treatment option in low- and middle-income countries. However, problems with off-label use, compounding, and counterfeiting limit its availability in many countries. Data from prospective, randomized, multicenter clinical trials are still required to convince physicians and regulatory bodies of its clinical efficacy and potential as early therapy.


Assuntos
Neovascularização de Coroide/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/economia , Proteínas Recombinantes de Fusão/uso terapêutico , Doenças Retinianas/tratamento farmacológico , Neovascularização de Coroide/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Humanos , Receptores de Fatores de Crescimento do Endotélio Vascular/química , Proteínas Recombinantes de Fusão/química , Doenças Retinianas/economia , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
11.
Retina ; 36(10): 1958-63, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-27465574

RESUMO

BACKGROUND: Throughout medicine, the cost of various treatments has been increasingly studied with the result that certain management guidelines might be reevaluated in their context. Cost-utility is a term referring to the expense of preventing the loss of quality of life, quantified in dollars per quality-adjusted life year. In 2002, the American Academy of Ophthalmology published hydroxychloroquine screening recommendations which were revised in 2011. The purpose of this report is to estimate the cost-utility of these recommendations. METHODS: A hypothetical care model of screening for hydroxychloroquine retinopathy was formulated. The costs of screening components were calculated using 2016 Medicare fee schedules from the Centers for Medicare and Medicaid Services. RESULTS: The cost-utility of screening for hydroxychloroquine retinopathy with the 2011 American Academy of Ophthalmology guidelines was found to vary from 33,155 to 344,172 dollars per quality-adjusted life year depending on the type and number of objective screening tests chosen, practice setting, and the duration of hydroxychloroquine use. Screening had a more favorable cost-utility when the more sensitive and specific diagnostics were used, and for patients with an increased risk of toxicity. CONCLUSION: American Academy of Ophthalmology guidelines have a wide-ranging cost-utility. Prudent clinical judgment of risk stratification and tests chosen is necessary to optimize cost-utility without compromising the efficacy of screening.


Assuntos
Antimaláricos/efeitos adversos , Antirreumáticos/efeitos adversos , Análise Custo-Benefício , Técnicas de Diagnóstico Oftalmológico/economia , Hidroxicloroquina/efeitos adversos , Doenças Retinianas/diagnóstico , Doenças Retinianas/economia , Academias e Institutos/normas , Eletrorretinografia/economia , Feminino , Angiofluoresceinografia/economia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Oftalmologia/normas , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica , Anos de Vida Ajustados por Qualidade de Vida , Doenças Retinianas/induzido quimicamente , Sensibilidade e Especificidade , Tomografia de Coerência Óptica/economia , Estados Unidos
12.
Arch Soc Esp Oftalmol ; 91(6): 257-64, 2016 Jun.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-26920947

RESUMO

OBJECTIVE: To review the evidence on the cost-effectiveness of ocriplasmin as a treatment for vitreomacular traction (VMT), and to estimate the impact on the Spanish National Health System (NHS). MATERIAL AND METHODS: 1) Systematic review. The following databases were searched in January 2015: MEDLINE, PREMEDLINE, EMBASE, CRD, the Cochrane Library, and key websites. Selection criteria were: full economic evaluations that compared ocriplasmin with usual care ('watch and wait' and/or vitrectomy) in patients with VMT. The outcomes to extract were costs of the alternatives and the incremental cost-effectiveness ratio. Studies of budget impact analysis were also included. The methodological quality was assessed, and a narrative synthesis of the included studies was carried out. 2) Estimation of budget impact. The impact on the budget as a result of the introduction of ocriplasmin in the NHS was estimated, including data from different sources. RESULTS: Six studies were identified, none of them performed in Spain. The two best studies concluded that ocriplasmin is cost-effective in their respective countries (Canada and United Kingdom), but only in patients with certain conditions (without epiretinal membrane, for example). The results of the budget impact analysis are different between countries. The analysis for Spain showed that the introduction of ocriplasmin would mean a saving over 1 million Euros for the NHS in 5 years. CONCLUSIONS: The cost-effectiveness of ocriplasmin has not been demonstrated in Spain. However, good studies performed in other countries found that ocriplasmin is cost-effective in selected patients. Given the current prices in Spain, ocriplasmin could involve a saving for the Spanish NHS.


Assuntos
Fibrinolisina/economia , Fragmentos de Peptídeos/economia , Doenças Retinianas/tratamento farmacológico , Medicina Estatal/economia , Orçamentos , Análise Custo-Benefício , Método Duplo-Cego , Fibrinolisina/administração & dosagem , Fibrinolisina/uso terapêutico , Humanos , Injeções Intravítreas , Estudos Multicêntricos como Assunto , Fragmentos de Peptídeos/administração & dosagem , Fragmentos de Peptídeos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Doenças Retinianas/economia , Doenças Retinianas/etiologia , Doenças Retinianas/cirurgia , Perfurações Retinianas/tratamento farmacológico , Perfurações Retinianas/economia , Perfurações Retinianas/etiologia , Perfurações Retinianas/prevenção & controle , Espanha , Estresse Mecânico , Resultado do Tratamento , Vitrectomia/economia , Descolamento do Vítreo/complicações
13.
Dev Ophthalmol ; 55: 376-80, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26502165

RESUMO

The advent of anti-VEGF therapy for neovascular age-related macular degeneration and macular edema secondary to retinal vein occlusion and diabetes mellitus has prevented blindness in tens of thousands of people. However, the costs of these drugs are without precedent in ophthalmic drug therapeutics. An analysis of the financial implications of retinal drugs and the impact of the Food and Drug Administration on treatment of retinal disease must include not only an evaluation of the direct costs of the drugs and the costs associated with their administration, but also the cost savings which accrue from their clinical benefit. This chapter will discuss the financial and regulatory issues associated with retinal drugs.


Assuntos
Controle de Medicamentos e Entorpecentes , Farmacoeconomia/legislação & jurisprudência , Custos de Cuidados de Saúde , Soluções Oftálmicas/economia , Preparações Farmacêuticas/economia , Doenças Retinianas/economia , Redução de Custos , Efeitos Psicossociais da Doença , Custos de Medicamentos , Humanos , Legislação de Medicamentos/economia , Doenças Retinianas/tratamento farmacológico , Estados Unidos , United States Food and Drug Administration
16.
Artigo em Inglês | MEDLINE | ID: mdl-25877395

RESUMO

The field of gene therapy for retinal blinding disorders is experiencing incredible momentum, justified by hopeful results in early stage clinical trials for inherited retinal degenerations. The premise of the use of the gene as a drug has come a long way, and may have found its niche in the treatment of retinal disease. Indeed, with only limited treatment options available for retinal indications, gene therapy has been proven feasible, safe, and effective and may lead to durable effects following a single injection. Here, we aim at putting into context the promise and potential, the technical, clinical, and economic boundaries limiting its application and development, and speculate on a future in which gene therapy is an integral component of ophthalmic clinical care.


Assuntos
Terapia Genética/tendências , Doenças Retinianas/terapia , Ensaios Clínicos como Assunto , Previsões , Terapia Genética/economia , Terapia Genética/métodos , Humanos , Degeneração Retiniana/economia , Degeneração Retiniana/genética , Degeneração Retiniana/terapia , Doenças Retinianas/economia , Doenças Retinianas/genética , Transgenes/genética , Resultado do Tratamento
18.
Ophthalmology ; 121(9): 1720-6, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24835758

RESUMO

OBJECTIVE: To evaluate cost-effectiveness and cost utilities for treatment options for vitreomacular adhesions (VMAs) and full-thickness macular holes (MHs). DESIGN: A Markov model of cost-effectiveness and utility. PARTICIPANTS: There were no participants. METHODS: Outcomes of published clinical trials (index studies) of surgical treatment of VMAs and MHs and a prospective, multicenter clinical trial of pharmaceutical vitreolysis with intravitreal ocriplasmin with saline control were used to generate a model for costs of treatment and visual benefits. All techniques were assumed to result in a 2.5-line visual benefit if anatomy was resolved. Markov analysis, with cost data from the Centers for Medicare and Medicaid Services, was used to calculate imputed costs for each primary treatment modality in a facility setting, with surgery performed in a hospital serving as the highest end of the range and nonfacility setting with surgery performed in an ambulatory surgery center serving as the lowest end of the range. MAIN OUTCOME MEASURES: Imputed costs of therapy, cost per line saved, cost per line-year saved, cost per quality-adjusted life years (QALYs). RESULTS: When pars plana vitrectomy (PPV) was selected as the primary procedure, the overall imputed cost ranged from $5802 to $7931. The cost per line was $2368 to $3237, the cost per line-year saved was $163 to $233 and the cost per QALY was $5444 to $7442. If intravitreal injection of ocriplasmin was the primary procedure, the overall imputed cost was $8767 to $10 977. The cost per line ranged from $3549 to $4456, the cost per line-year saved was $245 to $307, and the cost per QALY was between $8159 and $10 244. If intravitreal saline injection was used as a primary procedure, the overall imputed cost was $5828 to $8098. The cost per line was $2374 to $3299, the cost per line-year saved was $164 to $227, and the cost per QALY was $5458 to $7583. CONCLUSIONS: As a primary procedure, PPV was the most cost-effective therapy in this model. The other treatments had similar costs per QALY saved and compare favorably with costs of therapy for other retinal diseases.


Assuntos
Fibrinolisina/economia , Fibrinolíticos/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Doenças Retinianas/economia , Vitrectomia/economia , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Injeções Intravítreas , Cadeias de Markov , Fragmentos de Peptídeos , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de Vida , Doenças Retinianas/terapia , Perfurações Retinianas/terapia , Aderências Teciduais/terapia
19.
Am J Ophthalmol ; 155(3): 418-428.e1, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23218706

RESUMO

PURPOSE: To determine the impact of the revised academy guidelines on screening for hydroxychloroquine retinopathy. DESIGN: Retrospective, observational cohort study. METHODS: setting: Private practice of 29 doctors. study population: Total of 183 patients for follow-up and 36 patients for baseline screening. observation procedure: Review of charts, 10-2 visual fields (VFs), multifocal electroretinograms (mfERG), and spectral-domain optical coherence tomography (SD-OCT) images before and after the revised guidelines. main outcome measure: Rates of use of ancillary tests and clinical intervention, costs of screening, follow-up schedules, and comparative sensitivity of tests. RESULTS: New hydroxychloroquine toxicity was found in 2 of 183 returning patients (1.1%). Dosing above 6.5 mg/kg/d was found in 28 of 219 patients (12.8%), an underestimate because patient height, weight, and daily dose were not determined in 77 (35.1%), 84 (38.4%), and 59 (26.9%), respectively. In 10 of the 28 (35.7%), the dose was reduced, in 2 (7.1%) hydroxychloroquine was stopped, but in 16 (57.1%) no action was taken. The cost of screening rose 40%/patient after the revised guidelines. Fundus autofluorescence imaging was not used. No toxicity was detected by adding mfERG or SD-OCT. In no case was a 5-year period free of follow-up recommended after baseline screening in a low-risk patient. CONCLUSIONS: Detection of toxic daily dosing is a cost-effective way to reduce hydroxychloroquine toxicity, but height, weight, and daily dose were commonly not checked. The revised guidelines, emphasizing mfERG, SD-OCT, or FAF, raised screening cost without improving case detection. The recommended 5-year screening-free interval for low-risk patients after baseline examination was ignored.


Assuntos
Antirreumáticos/efeitos adversos , Técnicas de Diagnóstico Oftalmológico/normas , Hidroxicloroquina/efeitos adversos , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Retina/patologia , Doenças Retinianas/diagnóstico , Academias e Institutos/normas , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Artrite Reumatoide/tratamento farmacológico , Constituição Corporal , Análise Custo-Benefício , Técnicas de Diagnóstico Oftalmológico/economia , Monitoramento de Medicamentos , Eletrorretinografia/economia , Eletrorretinografia/normas , Feminino , Custos de Cuidados de Saúde , Humanos , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Masculino , Programas de Rastreamento/economia , Programas de Rastreamento/normas , Pessoa de Meia-Idade , Oftalmologia/economia , Oftalmologia/normas , Retina/efeitos dos fármacos , Doenças Retinianas/induzido quimicamente , Doenças Retinianas/economia , Estudos Retrospectivos , Tomografia de Coerência Óptica/economia , Tomografia de Coerência Óptica/normas , Estados Unidos , Campos Visuais , Adulto Jovem
20.
Curr Opin Ophthalmol ; 23(3): 163-74, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22487884

RESUMO

PURPOSE OF REVIEW: This analysis discusses the comparative effectiveness and cost-effectiveness of vitreoretinal interventions, measured in quality-adjusted life years (QALYs) and percentage patient value (PPV gain, or improvement in quality of life and/or length of life). The material is relevant since the Patient Protection and Affordable Care Act enacted by Congress with the support of the President has emphasized the critical importance of patient-based preferences. RECENT FINDINGS: The majority of preference-based, comparative effectiveness and cost-effectiveness vitreoretinal interventions assessed in the US healthcare literature are Value-Based Medicine analyses, thus comparable. These interventions confer a mean patient (human) value gain (improvement in quality of life) of 8.3% [SD 6.3%, 95% confidence interval (CI) + 2.6%]. The average cost-utility of these vitreoretinal interventions is US$23 026/QALY (SD US$24 508, 95% CI + US$8770). Most vitreoretinal interventions are very cost effective using a conventional US standard of US$50 000/QALY as the upper anchor for a very cost-effective intervention, and the World Health Organization of approximately US$142 200/QALY as the upper anchor for a cost-effective intervention. CONCLUSIONS: Most vitreoretinal interventions confer considerable patient value and are very cost effective. Further standardization across healthcare is needed in the preference-based, comparative and cost-utility (cost-effectiveness) arena. The metrics of PPV (percentage patient value) gain and US$/PPV (dollars expended per percentage patient value gain) or financial value gain may be more user-friendly than the QALY.


Assuntos
Pesquisa Comparativa da Efetividade , Custos de Cuidados de Saúde , Anos de Vida Ajustados por Qualidade de Vida , Doenças Retinianas/economia , Cirurgia Vitreorretiniana/economia , Análise Custo-Benefício , Medicina Baseada em Evidências , Humanos , Qualidade de Vida , Doenças Retinianas/cirurgia
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