[Budget impact analysis of viscosupplementation for non-surgical treatment of knee osteoarthritis]. / Análise do impacto orçamentário da viscossuplementação no tratamento não cirúrgico da osteoartrite de joelho.

Knee osteoarthritis affects 3.8% of the world population and manifests as pain, edema, stiffness, and reduced joint function, impacting the patient's quality of life. Treatment consists of the pharmacological, non-pharmacological, and surgical modalities. Viscosupplementation (intraarticular hyaluronate) has been proposed to relieve symptoms and potentially postpone surgery. This study estimated the budget impact of the association of this drug and non-surgical treatment (standard treatment) from the perspective of the Brazilian Unified National Health System. Based on the assumption that 5% of patients proceed to treatment and on the direct costs of the pharmacological and non-pharmacological modalities, the authors calculated the reference and alternative scenarios that compared the different treatment options in a three-year timeline. The principal analysis estimated an incremental budget impact of approximately BRL 126 million (U$ 32 million) for one vial of hyaluronate a year and BRL 252 million (USD 64 million) for two vials a year. Diacerein, an oral chondroprotector, assessed as an alternative, showed a budget impact of BRL 334 million (USD 86 million) in relation to standard treatment, representing a 24% cost increase compared to two vials a year of hyaluronate, making it less economically advantageous. Viscosupplementation can provide better quality of life for patients, reduce costs for the health system, and optimize the flow of care in health services. The estimates presented in this study can assist administrators in the best use of resources and thus in decision-making on the technology's incorporation.

A osteoartrite de joelho afeta cerca de 3,8% da população mundial e se manifesta por dor, edema, rigidez e redução da função articular, impactando na qualidade de vida do paciente. O tratamento consiste na modalidade farmacológica, não farmacológica e cirúrgica. A viscossuplementação (ácido hialurônico intra-articular) se propõe a oferecer alívio dos sintomas e a possibilidade de adiamento da cirurgia. Este estudo estimou o impacto orçamentário entre a associação desse medicamento e o tratamento não cirúrgico (tratamento padrão), sob a perspectiva do Sistema Único de Saúde. Com base no pressuposto de que 5% dos portadores da doença seguem para tratamento e nos custos diretos das modalidades: farmacológica e não farmacológica foram calculados os cenários de referência e alternativos que compararam as diferentes opções de tratamento para um horizonte temporal de três anos. A análise principal estimou um impacto orçamentário incremental de aproximadamente R$ 126 milhões (1 ampola anual) e R$ 252 milhões (2 ampolas anuais). Já a diacereína, um condroprotetor oral, avaliada como uma opção alternativa, mostrou um impacto de R$ 334 milhões no orçamento em relação ao tratamento padrão, o que proporciona um aumento de 24% no custo em relação ao uso de 2 ampolas anuais de ácido hialurônico, tornando-a economicamente menos vantajosa. A viscossuplementação pode proporcionar maior qualidade de vida ao paciente, redução de custos para o sistema e otimização do fluxo de atendimento nas unidades de saúde. As estimativas apresentadas neste estudo podem auxiliar o gestor quanto à melhor utilização dos recursos financeiros e consequente tomada de decisão quanto à incorporação da tecnologia.

La osteoartritis de rodilla afecta a cerca de un 3,8% de la población mundial y se manifiesta por dolor, edema, rigidez y reducción de la función articular, impactando en la calidad de vida del paciente. El tratamiento consiste en la modalidad farmacológica, no farmacológica y quirúrgica. La viscosuplementación (ácido hialurónico intraarticular) se propone ofrecer un alivio de los síntomas y la posibilidad de un aplazamiento de la cirugía. Este estudio estimó el impacto presupuestario entre la asociación de este medicamento y el tratamiento no quirúrgico (tratamiento estándar), desde la perspectiva del Sistema Único de Salud. Basándonos en el supuesto de que un 5% de los portadores de la enfermedad siguen el tratamiento y en los costos directos de las modalidades tanto farmacológica, como no farmacológica, se calcularon los escenarios de referencia y alternativos que compararon las diferentes opciones de tratamiento para un horizonte temporal de tres años. El análisis principal estimó un impacto presupuestario incremental de aproximadamente BRL 126 millones (1 ampolla anual) y BRL 252 millones (2 ampollas anuales). En el caso de la diacereína, un condroprotector oral, evaluado como una opción alternativa, mostró un impacto de BRL 334 millones en el presupuesto, respecto al tratamiento estándar, lo que proporciona un aumento de un 24% en el costo, en relación con el uso de 2 ampollas anuales de ácido hialurónico, haciéndola económicamente menos ventajosa. La viscosuplementación puede proporcionar mayor calidad de vida al paciente, reducción de costes para el sistema y la optimización del flujo de atención en las unidades de salud. Las estimaciones presentadas en este estudio pueden ayudar al gestor en lo referente a una mejor utilización de los recursos financieros y, consecuentemente, en la toma de decisiones respecto a la incorporación de tecnología.

Análise do impacto orçamentário da viscossuplementação no tratamento não cirúrgico da osteoartrite de joelho / Budget impact analysis of viscosupplementation for non-surgical treatment of knee osteoarthritis / Análisis del impacto presupuestario de la viscosuplementación en el tratamiento no quirúrgico de la osteoartritis de rodilla

Resumo: A osteoartrite de joelho afeta cerca de 3,8% da população mundial e se manifesta por dor, edema, rigidez e redução da função articular, impactando na qualidade de vida do paciente. O tratamento consiste na modalidade farmacológica, não farmacológica e cirúrgica. A viscossuplementação (ácido hialurônico intra-articular) se propõe a oferecer alívio dos sintomas e a possibilidade de adiamento da cirurgia. Este estudo estimou o impacto orçamentário entre a associação desse medicamento e o tratamento não cirúrgico (tratamento padrão), sob a perspectiva do Sistema Único de Saúde. Com base no pressuposto de que 5% dos portadores da doença seguem para tratamento e nos custos diretos das modalidades: farmacológica e não farmacológica foram calculados os cenários de referência e alternativos que compararam as diferentes opções de tratamento para um horizonte temporal de três anos. A análise principal estimou um impacto orçamentário incremental de aproximadamente R$ 126 milhões (1 ampola anual) e R$ 252 milhões (2 ampolas anuais). Já a diacereína, um condroprotetor oral, avaliada como uma opção alternativa, mostrou um impacto de R$ 334 milhões no orçamento em relação ao tratamento padrão, o que proporciona um aumento de 24% no custo em relação ao uso de 2 ampolas anuais de ácido hialurônico, tornando-a economicamente menos vantajosa. A viscossuplementação pode proporcionar maior qualidade de vida ao paciente, redução de custos para o sistema e otimização do fluxo de atendimento nas unidades de saúde. As estimativas apresentadas neste estudo podem auxiliar o gestor quanto à melhor utilização dos recursos financeiros e consequente tomada de decisão quanto à incorporação da tecnologia.

Abstract: Knee osteoarthritis affects 3.8% of the world population and manifests as pain, edema, stiffness, and reduced joint function, impacting the patient's quality of life. Treatment consists of the pharmacological, non-pharmacological, and surgical modalities. Viscosupplementation (intraarticular hyaluronate) has been proposed to relieve symptoms and potentially postpone surgery. This study estimated the budget impact of the association of this drug and non-surgical treatment (standard treatment) from the perspective of the Brazilian Unified National Health System. Based on the assumption that 5% of patients proceed to treatment and on the direct costs of the pharmacological and non-pharmacological modalities, the authors calculated the reference and alternative scenarios that compared the different treatment options in a three-year timeline. The principal analysis estimated an incremental budget impact of approximately BRL 126 million (U$ 32 million) for one vial of hyaluronate a year and BRL 252 million (USD 64 million) for two vials a year. Diacerein, an oral chondroprotector, assessed as an alternative, showed a budget impact of BRL 334 million (USD 86 million) in relation to standard treatment, representing a 24% cost increase compared to two vials a year of hyaluronate, making it less economically advantageous. Viscosupplementation can provide better quality of life for patients, reduce costs for the health system, and optimize the flow of care in health services. The estimates presented in this study can assist administrators in the best use of resources and thus in decision-making on the technology's incorporation.

Resumen: La osteoartritis de rodilla afecta a cerca de un 3,8% de la población mundial y se manifiesta por dolor, edema, rigidez y reducción de la función articular, impactando en la calidad de vida del paciente. El tratamiento consiste en la modalidad farmacológica, no farmacológica y quirúrgica. La viscosuplementación (ácido hialurónico intraarticular) se propone ofrecer un alivio de los síntomas y la posibilidad de un aplazamiento de la cirugía. Este estudio estimó el impacto presupuestario entre la asociación de este medicamento y el tratamiento no quirúrgico (tratamiento estándar), desde la perspectiva del Sistema Único de Salud. Basándonos en el supuesto de que un 5% de los portadores de la enfermedad siguen el tratamiento y en los costos directos de las modalidades tanto farmacológica, como no farmacológica, se calcularon los escenarios de referencia y alternativos que compararon las diferentes opciones de tratamiento para un horizonte temporal de tres años. El análisis principal estimó un impacto presupuestario incremental de aproximadamente BRL 126 millones (1 ampolla anual) y BRL 252 millones (2 ampollas anuales). En el caso de la diacereína, un condroprotector oral, evaluado como una opción alternativa, mostró un impacto de BRL 334 millones en el presupuesto, respecto al tratamiento estándar, lo que proporciona un aumento de un 24% en el costo, en relación con el uso de 2 ampollas anuales de ácido hialurónico, haciéndola económicamente menos ventajosa. La viscosuplementación puede proporcionar mayor calidad de vida al paciente, reducción de costes para el sistema y la optimización del flujo de atención en las unidades de salud. Las estimaciones presentadas en este estudio pueden ayudar al gestor en lo referente a una mejor utilización de los recursos financieros y, consecuentemente, en la toma de decisiones respecto a la incorporación de tecnología.

Long-Term Health and Economic Value of Improved Mobility among Older Adults in the United States.

BACKGROUND: Mobility impairments have substantial physical and mental health consequences, resulting in diminished quality of life. Most studies on the health economic consequences of mobility limitations focus on short-term implications. OBJECTIVES: To examine the long-term value of improving mobility in older adults. METHODS: Our six-step approach used clinical trial data to calibrate mobility improvements and estimate health economic outcomes using a microsimulation model. First, we measured improvement in steps per day calibrated with clinical trial data examining hylan G-F 20 viscosupplementation treatment. Second, we created a cohort of patients 51 years and older with osteoarthritis. In the third step, we estimated their baseline quality of life. Fourth, we translated steps-per-day improvements to changes in quality of life using estimates from the literature. Fifth, we calibrated quality of life in this cohort to match those in the trial. Last, we incorporated these data and parameters into The Health Economic Medical Innovation Simulation model to estimate how mobility improvements affect functional status limitations, medical expenditures, nursing home utilization, employment, and earnings between 2012 and 2030. RESULTS: In our sample of 12.6 million patients, 66.7% were female and 70% had a body mass index of more than 25 kg/m2. Our model predicted that a 554-step-per-day increase in mobility would reduce functional status limitations by 5.9%, total medical expenditures by 0.9%, and nursing home utilization by 2.8%, and increase employment by 2.9%, earnings by 10.3%, and monetized quality of life by 3.2% over this 18-year period. CONCLUSIONS: Interventions that improve mobility are likely to reduce long-run medical expenditures and nursing home utilization and increase employment.

Intra articular hyaluronic acid in the management of knee osteoarthritis: Pharmaco-economic study from the perspective of the national health insurance system.

INTRODUCTION: Pharmaco-economic data on the management of knee osteoarthritis (OA) with intra articular hyaluronic acid (IA HA) viscosupplementation is limited. We contrasted IA HA with non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Observational, prospective and multicenter study comparing treatments of knee OA costs and efficacy with either NSAIDs alone, or hyaluronic acid (Arthrum H 2%®), during a 6-month follow-up period. The investigators were pharmacists who recorded data on disease, drug consumption and healthcare circuit. Retrospectively, the 6-month period preceding inclusion was also studied, to ensure the comparability of groups. RESULTS: 199 patients were analyzed in a NSAIDs group and 202 in an IA HA group. Any of the WOMAC sub-scores and the EQ-5D Quality of Life index were significantly improved in the IA HA group (p<0.0001) at 3 and 6 months. Clinical results were therefore in favor of the IA HA group. The total drug expenses per 6-month period were comparable before and after inclusion, €96 and €98 for NSAIDs group vs €94 and €101 for IA HA group, which indicates no evidence of additional cost from IA HA. For the active part of the population, the incidence of sick leave was lower in the IA HA group, indicating a better maintenance of patient activity. The overall expense on 12 months (6 months before and 6 months after inclusion) for the national health insurance system was comparable for NSAIDs and IA HA groups: €528 and €526, respectively. The number of patients taking NSAIDs significantly decreased in IA HA group (from 100% at inclusion to 66% at 1-3 months and 44% at 4-6 months), but remained unchanged (100%) during the follow-up period, in NSAIDs group. CONCLUSION: Treatment with IA HA did not generate additional cost for the national health insurance and was associated with a functional improvement of knee osteoarthritis and Quality of Life. The cost-utility analysis was in favor of IA HA, with a gain of QALY equivalent to half a month, after the 6-month follow-up period comparing both treatments. The NSAIDs consumption was decreased in the IA HA group, resulting in an improved estimated benefit/risk ratio.

Knee Viscosupplementation: Cost-Effectiveness Analysis between Stabilized Hyaluronic Acid in a Single Injection versus Five Injections of Standard Hyaluronic Acid.

Given the wide difference in price per vial between various presentations of hyaluronic acid, this study seeks to compare the effectiveness and treatment cost of stabilized hyaluronic acid (NASHA) in a single injection with standard preparations of hyaluronic acid (HA) in five injections in osteoarthritis (OA) of the knee. Fifty-four patients with knee osteoarthritis (Kellgren-Lawrence Grade II and III) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score greater than 7, with a homogeneous distribution of age, sex, BMI, and duration of disease, were included in this study. Patients were randomized into two groups: Group I was treated with NASHA (Durolane®) and Group II with HA (Go-ON®). Patient's evolution was followed up at the 1st, 2nd, 4th, 8th, 12th, and 26th week after treatment. A statistically significant improvement in WOMAC score was observed for patients treated with NASHA versus those who received HA at Week 26. In addition, the need for analgesia was significantly reduced at Week 26 in the NASHA-treated group. Finally, the economic analysis showed an increased cost of overall treatment with HA injections. Our data support the use of the NASHA class of products in the treatment of knee OA.

[Cost-analysis of viscosupplementation treatment with hyaluronic acid in candidate knee replacement patients with osteoarhritis]. / Análisis de costes del tratamiento con viscosuplementación con ácido hialurónico estabilizado en pacientes con artrosis de rodilla candidatos a implantación de prótesis.

A high percentage of knee osteoarthritis finally need a knee replacement. Previous treatments used including viscosupplementation with hyaluronic acid can delay the knee replacement. The objective of this study was to estimate the economic impact in the short, medium and long term of the knee replacement delay, by conducting a budget impact analysis of the incorporation of viscosupplementation to the treatment of knee osteoarthritis. From the data of patients treated at a specialized Knee Osteoarthritis Unit we built a discrete event simulation model that reproduced the progress of patients, as it could represent changes in the health status of an individual and their interaction with the system. The model allowed the number of prostheses and replacements performed each year to be calculated in a population including 1,000 patients each year according to the use of viscosupplementation. The budget impact analysis was estimated for 10 years by adding the cost of each treatment. A total of 224 patient candidates to receive a knee replacement were studied. The viscosupplementation use delayed the need to perform the knee replacement by 2.67 years The budgetary impact would lead to net savings during the 10 years. However, it is much greater in the earlier years. The sum of the savings in the first three years would be 36 million euros. The study concludes that the use of viscosupplementation reduced the economic burden of knee osteoarthritis in the health system as a result of delayed knee replacement. The simulation model enabled the economic impact in both the short and long term to be analysed.

Prospective randomized trial comparing the efficacy of single 6-ml injection of hylan G-F 20 and hyaluronic acid for primary knee arthritis: a preliminary study.

OBJECTIVE: To compare the efficacy of single 6-ml intraarticular injection between hylan G-F 20 and hyaluronic acid (HA) for knee osteoarthritis. MATERIAL AND METHOD: Thirty-two patients with primary knee arthritis, who were randomly received single intraarticular injection of 6-ml hylan G-F 20 (Synvisc) or HA (Hyalgan), were prospectively evaluated for clinical outcomes at a minimum 26-week follow-up. The parameters, including visual analog scale (VAS) during walking, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and Short-Form 36 (SF-36) questionnaires, were evaluated at pre-injection, then at 1 week, 4 weeks, 8 weeks, 12 weeks and 26 weeks, post-injection. RESULTS: There were 15 patients in both groups who were available for final follow-up with no statistical differences in demographic data, VAS during walking, WOMAC score and SF-36 score at pre-injection. There was no adverse event related to viscosupplementation using in is better than of both agents. At 26-week follow-up, patients in both groups had significantly improved VAS during walking (p < 0.01), WOMAC score (p < 0.01) and SF-36 (p < 0.05) with no statistical differences between groups. However the cost of hylan G-F 20 was much more expensive than that of HA (534 USD vs. 252 USD). CONCLUSION: A single intraarticular injection of both hylan G-F 20 and HA for primary knee arthritis had no adverse event related to 6-ml volume. At 26-week follow-up of the present preliminary study, both groups had similarly improved clinical outcomes post-injection. Further study in larger population is required. As the cost of hylan G-F 20 was 2 times higher than HA, a single 6-ml intraarticular injection of HA (Hyalgan) provided better cost-effectiveness than hylan G-F 20 (Synvisc).

The economic burden of osteoarthritis.

As the most common form of joint disease, osteoarthritis (OA) is associated with an extremely high economic burden. This burden is largely attributable to the effects of disability, comorbid disease, and the expense of treatment. Although typically associated with less severe effects on quality of life and per capita expenditures than rheumatoid arthritis, OA is nevertheless a more costly disease in economic terms because of its far higher prevalence. At the same time, the burden of OA is increasing. While direct and indirect per capita costs for OA have stabilized in recent years, the escalating prevalence of the disease-partly a function of the rapid increase in 2 major risk factors: aging and obesity-has led to much higher overall spending for OA. Approximately one-third of direct OA expenditures are allocated for medications, much of which goes toward pain-related agents. Hospitalization costs comprise nearly half of direct costs, although these expenditures are consumed by only 5% of OA patients who undergo knee or hip replacement surgery. However, while these surgeries are costly, they also appear to be quite cost-effective in the long term. Indirect costs for OA are also high, largely a result of work-related losses and home-care costs. Despite the need for wide-ranging and up-to-date data on the economics of OA treatment to clarify the most effective treatments and the best use of resources, this area of study has received insufficient research attention.