RESUMO
OBJECTIVES: This study was conducted to assess financial protection and equity in the healthcare financing system among slum dwellers with type 2 diabetes (T2D) in Iran in 2022. DESIGN: Cross-sectional study. SETTING: Primary care centres in Iran were selected from slums. PARTICIPANTS: Our study included 400 participants with T2D using a systematic random sampling method. Patients were included if they lived in slums for at least five consecutive years, were over 18 years old and did not have intellectual disabilities. PRIMARY AND SECONDARY MEASURES: A self-report questionnaire was used to assess cost-coping strategies vis-à-vis T2D expenditures and factors influencing them, as well as forgone care among slum dwellers. RESULTS: Of the 400 patients who participated, 53.8% were female. Among the participants, 27.8% were illiterate, but 30.3% could read and write. 75.8% had income below 40 million Rial. There was an association between age, education, income, basic insurance, supplemental insurance and cost-coping strategies (p<0.001). 88.2% of those with first university degree used health insurance and 34% of illiterate people used personal savings. 79.8% of people with income over 4 million Rial reported using insurance to cope with healthcare costs while 55% of those with income under 4 million Rial reported using personal savings and a combination of health insurance and personal savings to cope with healthcare costs. As a result of binary logistic regression, illiterate people (adjusted OR=16, 95% CI 3.65 to 70.17), individuals with low income (OR 5.024, 95% CI 2.42 to 10.41) and people without supplemental insurance (OR 1.885, 95% CI 0.03 to 0.37) are more likely to use other forms of cost-coping strategies than health insurance. CONCLUSIONS: As a result of insufficient use of insurance, cost-coping strategies used by slum dwellers vis-à-vis T2D expenditures do not protect them from financial risks. Expanding universal health coverage and providing supplemental insurance for those with T2D living in slums are recommended. Iran Health Insurance should adequately cover the costs of T2D care for slum dwellers so that they do not need to use alternative strategies.
Assuntos
Diabetes Mellitus Tipo 2, Áreas de Pobreza, Humanos, Feminino, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Estudos Transversais, Masculino, Irã (Geográfico), Pessoa de Meia-Idade, Adulto, Financiamento da Assistência à Saúde, Gastos em Saúde/estatística & dados numéricos, Idoso, Seguro Saúde/economia, Seguro Saúde/estatística & dados numéricos, Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To present the results of a cost analysis of remote consultations (teleconsultations) compared to in-person consultations for patients with type 2 diabetes, in the Brazilian public healthcare system (SUS) in the city of Joinville, Santa Catarina (SC). In addition to the costs from the local manager's perspective, the article also presents estimates from the patient's perspective, based on the transportation costs associated with each type of consultation. METHOD: Data were collected from 246 consultations, both remote and in-person, between 2021 and 2023, in the context of a randomized clinical trial on the impact of teleconsultation carried out in the city of Joinville, SC. Teleconsultations were carried out at Primary Health Units (PHU) and in-person consultations at the Specialized Health Center. The consultation costs were calculate by the method time and activity-based costing (TDABC), and for the estimate of transportation costs data was collected directly from the research participants . The mean costs and time required to carry out each type of consultation in different scenarios and perspectives were analyzed and compared descriptively. RESULTS: Considering only the local SUS manager's perspective, the costs for carrying out a teleconsultation were 4.5% higher than for an in-person consultation. However, when considering the transportation costs associated with each patient, the estimated value of the in-person consultation becomes 7.7% higher and, in the case of consultations in other municipalities, 15% higher than the teleconsultation. CONCLUSION: The results demonstrate that the incorporation of teleconsultation within the SUS can bring economic advantages depending on the perspective and scenario considered, in addition to being a strategy with the potential to increase access to specialized care in the public network.
Assuntos
Diabetes Mellitus Tipo 2, Consulta Remota, Humanos, Consulta Remota/economia, Consulta Remota/métodos, Brasil, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Programas Nacionais de Saúde/economia, Masculino, Custos e Análise de Custo, Feminino, Custos de Cuidados de Saúde/estatística & dados numéricos, Análise Custo-BenefícioRESUMO
BACKGROUND: Prediabetes management is a priority for policymakers globally, to avoid/delay type 2 diabetes (T2D) and reduce severe, costly health consequences. Countries moving from low to middle income are most at risk from the T2D "epidemic" and may find implementing preventative measures challenging; yet prevention has largely been evaluated in developed countries. METHODS: Markov cohort simulations explored costs and benefits of various prediabetes management approaches, expressed as "savings" to the public health care system, for three countries with high prediabetes prevalence and contrasting economic status (Poland, Saudi Arabia, Vietnam). Two scenarios were compared up to 15 y: "inaction" (no prediabetes intervention) and "intervention" with metformin extended release (ER), intensive lifestyle change (ILC), ILC with metformin (ER), or ILC with metformin (ER) "titration." RESULTS: T2D was the highest-cost health state at all time horizons due to resource use, and inaction produced the highest T2D costs, ranging from 9% to 34% of total health care resource costs. All interventions reduced T2D versus inaction, the most effective being ILC + metformin (ER) "titration" (39% reduction at 5 y). Metformin (ER) was the only strategy that produced net saving across the time horizon; however, relative total health care system costs of other interventions vs inaction declined over time up to 15 y. Viet Nam was most sensitive to cost and parameter changes via a one-way sensitivity analysis. CONCLUSIONS: Metformin (ER) and lifestyle interventions for prediabetes offer promise for reducing T2D incidence. Metformin (ER) could reduce T2D patient numbers and health care costs, given concerns regarding adherence in the context of funding/reimbursement challenges for lifestyle interventions.
Assuntos
Diabetes Mellitus Tipo 2, Hipoglicemiantes, Cadeias de Markov, Metformina, Estado Pré-Diabético, Humanos, Estado Pré-Diabético/economia, Estado Pré-Diabético/terapia, Estado Pré-Diabético/epidemiologia, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/epidemiologia, Diabetes Mellitus Tipo 2/prevenção & controle, Metformina/uso terapêutico, Metformina/economia, Vietnã/epidemiologia, Hipoglicemiantes/uso terapêutico, Hipoglicemiantes/economia, Arábia Saudita/epidemiologia, Análise Custo-Benefício, Redução de Custos, Masculino, Feminino, Pessoa de Meia-Idade, Estilo de Vida, Custos de Cuidados de Saúde/estatística & dados numéricosRESUMO
AIMS: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness. Our aim was to evaluate the cost-effectiveness of at-home skin temperature monitoring to help prevent diabetes-related foot ulcer recurrence. MATERIALS AND METHODS: Multicenter randomized controlled trial. We randomized 304 persons at high diabetes-related foot ulcer risk to either usual foot care plus daily at-home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost-effectiveness based on foot care costs and quality-adjusted life years (QALY) during 18 months follow-up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost-effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness-to-pay/accept levels up to 100,000. RESULTS: The intervention had a 45% probability of being cost-effective at a willingness-to-accept of 50,000 per QALY lost. This resulted from (non-significantly) lower foot care costs in the intervention group (6067 vs. 7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non-significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). CONCLUSIONS: At-home skin temperature monitoring for diabetes-related foot ulcer prevention compared with usual care is at best equally cost-effective. The intervention resulted in cost-savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self-monitoring burdens.
Assuntos
Análise Custo-Benefício, Pé Diabético, Anos de Vida Ajustados por Qualidade de Vida, Humanos, Pé Diabético/prevenção & controle, Pé Diabético/economia, Pé Diabético/etiologia, Pé Diabético/terapia, Feminino, Masculino, Pessoa de Meia-Idade, Seguimentos, Idoso, Temperatura Cutânea, Recidiva, Prevenção Secundária/economia, Prevenção Secundária/métodos, Diabetes Mellitus Tipo 2/complicações, Diabetes Mellitus Tipo 2/economia, Prognóstico, Custos de Cuidados de Saúde/estatística & dados numéricosRESUMO
OBJECTIVE: While there are some recommendations about early insulin therapy in newly diagnosed Type 2 Diabetes Mellitus (T2DM) patients, there is not sufficient evidence on this strategy's cost-effectiveness. This study compared early insulin therapy versus oral anti-diabetic drugs (OADs) for managing T2DMusing a cost-effectiveness analysis approach in Iran. METHODS: In this economic evaluation, a decision analytic model was designed. The target population was newly diagnosed type 2 diabetic patients, and the study was carried out from the perspective of Iran's healthcare system with a one-year time horizon. Basal insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, and Thiazolidinediones (TZDs) were compared in this evaluation. The main outcome for assessing the effectiveness of each intervention was the reduction in the occurrence of diabetes complications. Strategies were compared using the incremental cost-effectiveness ratio (ICER), and deterministic and probabilistic sensitivity analyses were carried out. RESULTS: The DPP-4 inhibitors strategy was the dominant strategy with the highest effectiveness and the lowest cost. Early insulin therapy was dominated (ICER: $-53,703.18), meaning that it was not cost-effective. The sensitivity analyses consistently affirmed the robustness of the base case findings. The probabilistic sensitivity analysis indicated probabilities of 77%, 22%, and 1% for DPP-4 inhibitors, TZDs strategies, and early insulin therapy, respectively, in terms of being cost-effective. CONCLUSION: In terms of cost-effectiveness, early insulin therapy was not cost-effective compared to OADs for managing newly diagnosed T2DM patients. Future studies in this regard, utilizing more comprehensive evidence, can yield more accurate results.
Assuntos
Análise Custo-Benefício, Diabetes Mellitus Tipo 2, Hipoglicemiantes, Insulina, Humanos, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, Hipoglicemiantes/economia, Hipoglicemiantes/administração & dosagem, Hipoglicemiantes/uso terapêutico, Hipoglicemiantes/efeitos adversos, Insulina/administração & dosagem, Insulina/economia, Insulina/uso terapêutico, Insulina/efeitos adversos, Irã (Geográfico), Administração Oral, Masculino, Feminino, Pessoa de Meia-Idade, Inibidores da Dipeptidil Peptidase IV/economia, Inibidores da Dipeptidil Peptidase IV/administração & dosagem, Inibidores da Dipeptidil Peptidase IV/uso terapêutico, Inibidores da Dipeptidil Peptidase IV/efeitos adversosRESUMO
OBJECTIVES: The real-world ARISE study demonstrated initiation of fixed-ratio combination insulin degludec and aspart (IDegAsp) led to improvements in people achieving key glycemic control targets compared with prior therapies in Australia and India. This study evaluated the short-term cost-effectiveness of IDegAsp in these countries, in terms of the cost per patient achieving these targets. METHODS: A model was developed to evaluate the cost of control (treatment costs divided by the proportion of patients achieving each target) of IDegAsp versus prior therapies received in ARISE for 2 endpoints: glycated hemoglobin (HbA1c) <7.0%, and HbA1c less than a predefined individual treatment target. Costs, expressed from a healthcare payer perspective, were captured in 2022 Australian dollars (AUD) and 2022 Indian rupees (INR). RESULTS: The number of patients needed to treat to bring one to endpoints of HbA1c <7.0% and less than an individualized target with IDegAsp was 51% and 87% lower, respectively, than with prior therapies in Australia, and 52% and 66% lower, respectively, versus prior therapies in India. Cost of control was AUD 2449 higher and AUD 64 863 lower with IDegAsp versus prior therapies for endpoints of HbA1c <7.0% and less than an individualized target, respectively, in Australia and INR 211 142 and INR 537 490 lower with IDegAsp compared with prior therapies in India. CONCLUSIONS: IDegAsp was estimated to be cost-effective versus prior therapies when considering an individualized HbA1c target in Australia, and when considering an individualized HbA1c target and HbA1c <7.0% in India.
Assuntos
Análise Custo-Benefício, Combinação de Medicamentos, Hemoglobinas Glicadas, Hipoglicemiantes, Insulina de Ação Prolongada, Humanos, Austrália, Índia, Insulina de Ação Prolongada/uso terapêutico, Insulina de Ação Prolongada/economia, Insulina de Ação Prolongada/administração & dosagem, Análise Custo-Benefício/métodos, Hemoglobinas Glicadas/análise, Hipoglicemiantes/economia, Hipoglicemiantes/uso terapêutico, Hipoglicemiantes/administração & dosagem, Masculino, Feminino, Pessoa de Meia-Idade, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economiaRESUMO
OBJECTIVES: This study aimed to assess the cost-effectiveness of weight-management pharmacotherapies approved by Canada Health, i.e., orlistat, naltrexone 32 mg/bupropion 360 mg (NB-32), liraglutide 3.0 mg and semaglutide 2.4 mg as compared to the current standard of care (SoC). METHODS: Analyses were conducted using a cohort with a mean starting age 50 years, body mass index (BMI) 37.5 kg/m2, and 27.6% having type 2 diabetes. Using treatment-specific changes in surrogate endpoints from the STEP trials (BMI, glycemic, blood pressure, lipids), besides a network meta-analysis, the occurrence of weight-related complications, costs, and quality-adjusted life-years (QALYs) were projected over lifetime. RESULTS: From a societal perspective, at a willingness-to-pay (WTP) threshold of CAD 50 000 per QALY, semaglutide 2.4 mg was the most cost-effective treatment, at an incremental cost-utility ratio (ICUR) of CAD 31 243 and CAD 29 014 per QALY gained versus the next best alternative, i.e., orlistat, and SoC, respectively. Semaglutide 2.4 mg extendedly dominated other pharmacotherapies such as NB-32 or liraglutide 3.0 mg and remained cost-effective both under a public and private payer perspective. Results were robust to sensitivity analyses varying post-treatment catch-up rates, longer treatment durations and using real-world cohort characteristics. Semaglutide 2.4 mg was the preferred intervention, with a likelihood of 70% at a WTP threshold of CAD 50 000 per QALY gained. However, when the modeled benefits of weight-loss on cancer, mortality, cardiovascular disease (CVD) or osteoarthritis surgeries were removed simultaneously, orlistat emerged as the best value for money compared with SoC, with an ICUR of CAD 35 723 per QALY gained. CONCLUSION: Semaglutide 2.4 mg was the most cost-effective treatment alternative compared with D&E or orlistat alone, and extendedly dominated other pharmacotherapies such as NB-32 or liraglutide 3.0 mg. Results were sensitive to the inclusion of the combined benefits of mortality, cancer, CVD, and knee osteoarthritis.
Assuntos
Fármacos Antiobesidade, Análise Custo-Benefício, Obesidade, Orlistate, Humanos, Canadá, Pessoa de Meia-Idade, Obesidade/tratamento farmacológico, Obesidade/economia, Feminino, Fármacos Antiobesidade/uso terapêutico, Fármacos Antiobesidade/economia, Masculino, Orlistate/uso terapêutico, Anos de Vida Ajustados por Qualidade de Vida, Liraglutida/uso terapêutico, Liraglutida/economia, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, Bupropiona/uso terapêutico, Bupropiona/economia, Naltrexona/uso terapêutico, Naltrexona/economia, Peptídeos Semelhantes ao Glucagon/uso terapêutico, Peptídeos Semelhantes ao Glucagon/economiaRESUMO
Antecedentes y objetivos Estudios previos que cuantifican el coste de la diabetes tipo 2 (DM2) muestran resultados muy dispares. Nos planteamos definir el perfil del paciente con DM2 en Andalucía, analizar el uso de recursos sanitarios y, cuantificar su coste económico en el año 2022. Pacientes y métodos Estudio multicéntrico, transversal y descriptivo; 385 pacientes con DM2 de toda Andalucía (IC 95%; error: 5%). Datos analizados: edad, sexo, asistencia a consultas de Atención Primaria (AP), de enfermería, de urgencias y de especialidades hospitalarias; consumo de fármacos en general y antidiabéticos en particular, tiras de glucemia, pruebas complementarias y días de ingreso hospitalario. Resultados Edad media: 70,7 ± 12,44 años; 53,6% hombres. Contactos asistenciales: médico de AP: 8,36 ± 4,69; enfermería: 7,17 ± 12; consultas hospitalarias: 2,31 ± 2,38; urgencias: 1,71 ± 2,89. Días de ingreso hospitalario: 2,26 ± 6,46. Analíticas: 3,79 ± 5,45 y 2,17 ± 3,47 Rx. Fármacos consumidos: 9,20 ± 3,94 (1,76 ± 0,90 antidiabéticos). Tiras glucemia: 184 ± 488. Coste anual: 5.171,05 /paciente/año (2.228,36 por ingresos hospitalarios, 1.702,87 por fármacos y 1.239,82 por asistencias y pruebas complementarias). Conclusiones El andaluz con DM2 tiene 71 años de edad, consume 10 fármacos diferentes y trata su DM2 con doble terapia. Tiene 20 asistencias/año (75% en AP), cuatro análisis, dos Rx y precisa dos días de ingreso hospitalario. Los costes sanitarios directos superan los 5.000 /año. Lo que supone 41,66% del presupuesto de la Consejería de Salud y triplica el gasto medio por habitante (AU)
Background and objectives Previous studies that quantify the cost of type 2 diabetes (DM2) show very different results. We set out to define the profile of the patient with DM2 in Andalusia, analyze the use of health resources and quantify their economic cost during 2022. Patients and methods Multicenter, cross-sectional and descriptive study. Three hundred and eighty-five patients with DM2 from Andalusia (confidence level: 95%; error: 5%). Data analyzed: age, sex, attendance at primary care (PC), nursing, emergency and hospital specialty consultations; consumption of drugs in general and antidiabetics in particular, blood glucose strips, complementary tests and hospitalization days. Results Mean age: 70.7 ± 12.44 years; 53.6% men. Care contacts: PC physician: 8.36 ± 4.69; nursing: 7.17 ± 12; hospital visits: 2.31 ± 2.38; emergencies: 1.71 ± 2.89; hospitalization days: 2.26 ± 6.46. Laboratory tests: 3.79 ± 5.45 and 2.17 ± 3.47 Rx. Drugs consumed: 9.20 ± 3.94 (1.76 ± 0.90 antidiabetics). Blood glucose strips: 184 ± 488. Annual cost: 5171.05 /patient/year (2228.36 for hospital admissions, 1702.87 for drugs and 1239.82 for assistance and complementary tests). Conclusions The DM2 Andalusian is 71 years old, consumes 10 different drugs and treats DM2 with double therapy. He has been 20 attendances/year (75% in PC), 4 analyses, 2 X-rays and requires 2 days of hospitalization. Direct healthcare costs goes over 5000 /year. This represents 41.66% of the budget of the Andalusian Ministry of Health and triples the average cost per habitant (AU)
Assuntos
Humanos, Masculino, Feminino, Pessoa de Meia-Idade, Idoso, Idoso de 80 Anos ou mais, Diabetes Mellitus Tipo 2/economia, Custos de Medicamentos/estatística & dados numéricos, Efeitos Psicossociais da Doença, Estudos Transversais, EspanhaRESUMO
Objective: To systematically estimate and compare the effectiveness and cost-effectiveness of the glucagon-like peptide-1 receptor agonists (GLP-1RAs) approved in China and to quantify the relationship between the burden of diabetic comorbidities and glycosylated hemoglobin (HbA1c) or body mass index (BMI). Methods: To estimate the costs (US dollars, USD) and quality-adjusted life years (QALY) for six GLP-1RAs (exenatide, loxenatide, lixisenatide, dulaglutide, semaglutide, and liraglutide) combined with metformin in the treatment of patients with type 2 diabetes mellitus (T2DM) which is inadequately controlled on metformin from the Chinese healthcare system perspective, a discrete event microsimulation cost-effectiveness model based on the Chinese Hong Kong Integrated Modeling and Evaluation (CHIME) simulation model was developed. A cohort of 30,000 Chinese patients was established, and one-way sensitivity analysis and probabilistic sensitivity analysis (PSA) with 50,000 iterations were conducted considering parameter uncertainty. Scenario analysis was conducted considering the impacts of research time limits. A network meta-analysis was conducted to compare the effects of six GLP-1RAs on HbA1c, BMI, systolic blood pressure, and diastolic blood pressure. The incremental net monetary benefit (INMB) between therapies was used to evaluate the cost-effectiveness. China's per capita GDP in 2021 was used as the willingness-to-pay threshold. A generalized linear model was used to quantify the relationship between the burden of diabetic comorbidities and HbA1c or BMI. Results: During a lifetime, the cost for a patient ranged from USD 42,092 with loxenatide to USD 47,026 with liraglutide, while the QALY gained ranged from 12.50 with dulaglutide to 12.65 with loxenatide. Compared to exenatide, the INMB of each drug from highest to lowest were: loxenatide (USD 1,124), dulaglutide (USD -1,418), lixisenatide (USD -1,713), semaglutide (USD -4,298), and liraglutide (USD -4,672). Loxenatide was better than the other GLP-1RAs in the base-case analysis. Sensitivity and scenario analysis results were consistent with the base-case analysis. Overall, the price of GLP-1RAs most affected the results. Medications with effective control of HbA1c or BMI were associated with a significantly smaller disease burden (p < 0.05). Conclusion: Loxenatide combined with metformin was identified as the most economical choice, while the long-term health benefits of patients taking the six GLP-1RAs are approximate.
Assuntos
Diabetes Mellitus Tipo 2, Peptídeo 1 Semelhante ao Glucagon, Receptor do Peptídeo Semelhante ao Glucagon 1, Hemoglobinas Glicadas, Hipoglicemiantes, Metformina, Humanos, Índice de Massa Corporal, Comorbidade, Efeitos Psicossociais da Doença, Análise Custo-Benefício, Análise de Custo-Efetividade, Diabetes Mellitus Tipo 2/sangue, Diabetes Mellitus Tipo 2/diagnóstico, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, População do Leste Asiático, Exenatida, Peptídeo 1 Semelhante ao Glucagon/análogos & derivados, Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas, Hemoglobinas Glicadas/análise, Hipoglicemiantes/economia, Hipoglicemiantes/uso terapêutico, Liraglutida, Anos de Vida Ajustados por Qualidade de Vida, Resultado do Tratamento, Quimioterapia Combinada, Simulação por Computador, Controle Glicêmico/métodosRESUMO
Importance: Glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive. Objective: To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity. Evidence Review: The annual US Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity. Findings: On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval. Conclusions and Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.
Assuntos
Diabetes Mellitus Tipo 2, Aprovação de Drogas, Medicamentos Genéricos, Receptor do Peptídeo Semelhante ao Glucagon 1, Hipoglicemiantes, Patentes como Assunto, Humanos, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, Aprovação de Drogas/legislação & jurisprudência, Medicamentos Genéricos/economia, Medicamentos Genéricos/uso terapêutico, Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas, Preparações Farmacêuticas/economia, Hipoglicemiantes/economia, Hipoglicemiantes/uso terapêutico, Patentes como Assunto/legislação & jurisprudência, Estados Unidos, Equivalência Terapêutica, Comércio, Competição Econômica/economia, Competição Econômica/legislação & jurisprudência, Fatores de TempoRESUMO
OBJECTIVES: The purpose of this study was to explore social determinants of health (SDoH), and disease severity as predictors of sleep quality in persons with both Obstructive Sleep Apnea (OSA) and type 2 diabetes (T2D). METHODS: Disease severity was measured by Apnea-Hypopnea Index [(AHI) ≥ 5] and HbA1c for glycemic control. SDoH included subjective and objective financial hardship, race, sex, marital status, education, and age. Sleep quality was measured by Pittsburgh Sleep Quality Index (PSQI). RESULTS: The sample (N = 209) was middle-aged (57.6 ± 10.0); 66% White and 34% African American; and 54% men and 46% women. Participants carried a high burden of disease (mean AHI = 20.7 ± 18.1, mean HbA1c = 7.9% ± 1.7%). Disease severity was not significantly associated with sleep quality (all p >.05). Worse sleep quality was associated with both worse subjective (b = -1.54, p = .015) and objective (b = 2.58, p <.001) financial hardship. Characteristics significantly associated with both subjective and objective financial hardship included being African American, female, ≤ 2 years post high school, and of younger ages (all p < .01).Discussion: Financial hardship is a more important predictor of sleep quality than disease severity, age, sex, race, marital status, and educational attainment, in patients with OSA and T2D.
Assuntos
Diabetes Mellitus Tipo 2, Estresse Financeiro, Apneia Obstrutiva do Sono, Qualidade do Sono, Determinantes Sociais da Saúde, Feminino, Humanos, Masculino, Pessoa de Meia-Idade, Diabetes Mellitus Tipo 2/complicações, Diabetes Mellitus Tipo 2/economia, Estresse Financeiro/economia, Hemoglobinas Glicadas, Polissonografia, Apneia Obstrutiva do Sono/complicações, Apneia Obstrutiva do Sono/economia, Índice de Gravidade de Doença, Determinantes Sociais da Saúde/economiaRESUMO
OBJECTIVE: To analyse the cost-effectiveness of multicomponent interventions designed to improve outcomes in type 2 diabetes mellitus (T2DM) in primary care in the Canary Islands, Spain, within the INDICA randomised clinical trial, from the public health system perspective. DESIGN: An economic evaluation was conducted for the within-trial period (2 years) comparing the four arms of the INDICA study. SETTING: Primary care in the Canary Islands, Spain. PARTICIPANTS: 2334 patients with T2DM without complications were included. INTERVENTIONS: Interventions for patients (PTI), for primary care professionals (PFI), for both (combined intervention arm for patients and professionals, CBI) and usual care (UC) as a control group. OUTCOMES: The main outcome was the incremental cost per quality-adjusted life-years (QALY). Only the intervention and the healthcare costs were included. ANALYSIS: Multilevel models were used to estimate results, and to measure the size and significance of incremental changes. Missed values were treated by means of multiple imputations procedure. RESULTS: There were no differences between arms in terms of costs (p=0.093), while some differences were observed in terms of QALYs after 2 years of follow-up (p=0.028). PFI and CBI arms were dominated by the other two arms, PTI and UC. The differences between the PTI and the UC arms were very small in terms of QALYs, but significant in terms of healthcare costs (p=0.045). The total cost of the PTI arm (2571, 95% CI 2317 to 2826) was lower than the cost in the UC arm (2750, 95% CI 2506 to 2995), but this difference did not reach statistical significance. Base case estimates of the incremental cost per QALY indicate that the PTI strategy was the cost-effective option. CONCLUSIONS: The INDICA intervention designed for patients with T2DM and families is likely to be cost-effective from the public healthcare perspective. A cost-effectiveness model should explore this in the long term. TRIAL REGISTRATION NUMBER: NCT01657227.
Assuntos
Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Análise por Conglomerados, Análise Custo-Benefício, Humanos, Atenção Primária à Saúde, Qualidade de Vida, Anos de Vida Ajustados por Qualidade de Vida, EspanhaRESUMO
Importance: Bariatric surgery is recommended for patients with severe obesity (body mass index ≥40) and type 2 diabetes (T2D). However, the most cost-effective treatment remains unclear and may depend on the patient's T2D severity. Objective: To estimate the cost-effectiveness of medical therapy, sleeve gastrectomy (SG), and Roux-en-Y gastric bypass (RYGB) among patients with severe obesity and T2D, stratified by T2D severity. Design, Setting, and Participants: This economic evaluation used a microsimulation model to project health and cost outcomes of medical therapy, SG, and RYGB over 5 years. Time horizons varied between 10 and 30 years in sensitivity analyses. Model inputs were derived from clinical trials, large cohort studies, national databases, and published literature. Probabilistic sampling of model inputs accounted for parameter uncertainty. Estimates of US adults with severe obesity and T2D were derived from the National Health and Nutrition Examination Survey. Data analysis was performed from January 2020 to August 2021. Exposures: Medical therapy, SG, and RYGB. Main Outcomes and Measures: Quality-adjusted life-years (QALYs), costs (in 2020 US dollars), and incremental cost-effectiveness ratios (ICERs) were projected, with future cost and QALYs discounted 3.0% annually. A strategy was deemed cost-effective if the ICER was less than $100â¯000 per QALY. The preferred strategy resulted in the greatest number of QALYs gained while being cost-effective. Results: The model simulated 1000 cohorts of 10â¯000 patients, of whom 16% had mild T2D, 56% had moderate T2D, and 28% had severe T2D at baseline. The mean age of simulated patients was 54.6 years (95% CI, 54.2-55.0 years), 61.6% (95% CI, 60.1%-63.4%) were female, and 65.1% (95% CI, 63.6%-66.7%) were non-Hispanic White. Compared with medical therapy over 5 years, RYGB was associated with the most QALYs gained in the overall population (mean, 0.44 QALY; 95% CI, 0.21-0.86 QALY) and when stratified by baseline T2D severity: mild (mean, 0.59 QALY; 95% CI, 0.35-0.98 QALY), moderate (mean, 0.50 QALY; 95% CI, 0.25-0.88 QALY), and severe (mean, 0.30 QALY; 95% CI, 0.07-0.79 QALY). RYGB was the preferred strategy in the overall population (ICER, $46â¯877 per QALY; 83.0% probability preferred) and when stratified by baseline T2D severity: mild (ICER, $36â¯479 per QALY; 73.7% probability preferred), moderate (ICER, $37â¯056 per QALY; 85.6% probability preferred), and severe (ICER, $98â¯940 per QALY; 40.2% probability preferred). The cost-effectiveness of RYGB improved over a longer time horizon. Conclusions and Relevance: These findings suggest that the effectiveness and cost-effectiveness of bariatric surgery vary by baseline severity of T2D. Over a 5-year time horizon, RYGB is projected to be the preferred treatment strategy for patients with severe obesity regardless of baseline T2D severity.
Assuntos
Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Derivação Gástrica/economia, Custos de Cuidados de Saúde/estatística & dados numéricos, Obesidade Mórbida/economia, Obesidade Mórbida/cirurgia, Adulto, Análise Custo-Benefício, Diabetes Mellitus Tipo 2/epidemiologia, Feminino, Humanos, Masculino, Pessoa de Meia-Idade, Obesidade Mórbida/epidemiologia, Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: The primary objective was to develop a computerized culturally adapted health literacy intervention for older Hispanics with type 2 diabetes (T2D). Secondary objectives were to assess the usability and acceptability of the intervention by older Hispanics with T2D and clinical pharmacists providing comprehensive medication management (CMM). MATERIALS AND METHODS: The study occurred in three phases. During phase I, an integration approach (i.e., quantitative assessments, qualitative interviews) was used to develop the intervention and ensure cultural suitability. In phase II, the intervention was translated to Spanish and modified based on data obtained in phase I. During phase III, the intervention was tested for usability/acceptability. RESULTS: Thirty participants (25 older Hispanics with T2D, 5 clinical pharmacists) were included in the study. Five major themes emerged from qualitative interviews and were included in the intervention: 1) financial considerations, 2) polypharmacy, 3) social/family support, 4) access to medication/information, and 5) loneliness/sadness. Participants felt the computerized intervention developed was easy to use, culturally appropriate, and relevant to their needs. Pharmacists agreed the computerized intervention streamlined patient counseling, offered a tailored approach when conducting CMM, and could save them time. CONCLUSION: The ability to offer individualized patient counseling based on information gathered from the computerized intervention allows for precision counseling. Future studies are needed to determine the effectiveness of the developed computerized intervention on adherence and health outcomes.
Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico, Letramento em Saúde/organização & administração, Hispânico ou Latino, Conduta do Tratamento Medicamentoso/organização & administração, Educação de Pacientes como Assunto/organização & administração, Aculturação, Fatores Etários, Idoso, Idoso de 80 Anos ou mais, Instrução por Computador/economia, Instrução por Computador/métodos, Análise Custo-Benefício, Aconselhamento/economia, Aconselhamento/métodos, Diabetes Mellitus Tipo 2/sangue, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/etnologia, Feminino, Letramento em Saúde/economia, Letramento em Saúde/métodos, Letramento em Saúde/normas, Humanos, Masculino, Adesão à Medicação/etnologia, Conduta do Tratamento Medicamentoso/economia, Pessoa de Meia-Idade, Educação de Pacientes como Assunto/economia, Educação de Pacientes como Assunto/métodos, Farmacêuticos/organização & administração, Medicina de Precisão/economia, Medicina de Precisão/métodos, Relações Profissional-Paciente, Desenvolvimento de ProgramasRESUMO
Importance: Social determinants of health play a role in diabetes management and outcomes, including potentially life-threatening complications of severe hypoglycemia and diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar state (HHS). Although several person-level socioeconomic factors have been associated with these complications, the implications of area-level socioeconomic deprivation are unknown. Objective: To examine the association between area-level deprivation and the risks of experiencing emergency department visits or hospitalizations for hypoglycemic and hyperglycemic crises (ie, DKA or HHS). Design, Setting, and Participants: This cohort study used deidentified administrative claims data for privately insured individuals and Medicare Advantage beneficiaries across the US. The analysis included adults with diabetes who met the claims criteria for diabetes between January 1, 2016, and December 31, 2017. Data analyses were performed from November 17, 2020, to November 11, 2021. Exposures: Area deprivation index (ADI) was derived for each county for 2016 and 2017 using 17 county-level indicators from the American Community Survey. ADI values were applied to patients who were living in each county based on their index dates and were categorized according to county-level ADI quintile (with quintile 1 having the least deprivation and quintile 5 having the most deprivation). Main Outcomes and Measures: The numbers of emergency department visits or hospitalizations related to the primary diagnoses of hypoglycemia and DKA or HHS (ascertained using validated diagnosis codes in the first or primary position of emergency department or hospital claims) between 2016 and 2019 were calculated for each ADI quintile using negative binomial regression models and adjusted for patient age, sex, health plan type, comorbidities, glucose-lowering medication type, and percentage of White residents in the county. Results: The study population included 1â¯116â¯361 individuals (563 943 women [50.5%]), with a mean (SD) age of 64.9 (13.2) years. Of these patients, 343â¯726 (30.8%) resided in counties with the least deprivation (quintile 1) and 121â¯810 (10.9%) lived in counties with the most deprivation (quintile 5). Adjusted rates of severe hypoglycemia increased from 13.54 (95% CI, 12.91-14.17) per 1000 person-years in quintile 1 counties to 19.13 (95% CI, 17.62-20.63) per 1000 person-years in quintile 5 counties, corresponding to an incidence rate ratio of 1.41 (95% CI, 1.29-1.54; P < .001). Adjusted rates of DKA or HHS increased from 7.49 (95% CI, 6.96-8.02) per 1000 person-years in quintile 1 counties to 8.37 (95% CI, 7.50-9.23) per 1000 person-years in quintile 5 counties, corresponding to an incidence rate ratio of 1.12 (95% CI, 1.00-1.25; P = .049). Conclusions and Relevance: This study found that living in counties with a high area-level deprivation was associated with an increased risk of severe hypoglycemia and DKA or HHS. The concentration of these preventable events in areas of high deprivation signals the need for interventions that target the structural barriers to optimal diabetes management and health.
Assuntos
Diabetes Mellitus Tipo 1/complicações, Diabetes Mellitus Tipo 2/complicações, Hiperglicemia/epidemiologia, Hipoglicemia/epidemiologia, Privação Social, Adolescente, Adulto, Idoso, Diabetes Mellitus Tipo 1/economia, Diabetes Mellitus Tipo 2/economia, Feminino, Humanos, Hiperglicemia/etiologia, Hipoglicemia/etiologia, Incidência, Masculino, Pessoa de Meia-Idade, Fatores de Risco, Fatores Socioeconômicos, Estados Unidos/epidemiologia, Adulto JovemRESUMO
Importance: Increasing prices of antidiabetic medications in the US have raised substantial concerns about the effects of drug affordability on diabetes care. There has been little rigorous evidence comparing the experiences of patients with diabetes across different types of insurance coverage. Objective: To compare the utilization patterns and costs of prescription drugs to treat diabetes among low-income adults with Medicaid vs those with Marketplace insurance in Colorado during 2014 and 2015. Design, Setting, and Participants: This cross-sectional study included diabetic patients enrolled in Colorado Medicaid and Marketplace plans who were aged 19 to 64 years and had incomes between 75% and 200% of the federal poverty level during 2014 and 2015. Data analysis was conducted from September 2020 to April 2021. Exposures: Health insurance through Colorado Medicaid or Colorado's state-based Marketplace. Main Outcomes and Measures: Primary outcomes were drug utilization (prescription drug fills) and drug costs (total costs and out-of-pocket costs). The secondary outcome was months with an active prescription for noninsulin antidiabetic medications. An all payer claims database was combined with income data, and linear models were used to adjust for clinical and demographic confounders. Results: Of 22â¯788 diabetic patients included in the study, 20â¯245 were enrolled in Medicaid and 2543 in a Marketplace plan. Marketplace-eligible individuals were older (mean [SD] age, 52.12 [10.60] vs 47.70 [11.33] years), and Medicaid-eligible individuals were more likely to be female (12â¯429 [61.4%] vs 1413 [55.6%]). Medicaid-eligible patients were significantly more likely than Marketplace-eligible patients to fill prescriptions for dipeptidyl peptidase 4 inhibitors (adjusted difference, -3.7%; 95% CI, -5.3 to -2.1; P < .001) and sulfonylureas (adjusted difference, -6.6%; 95% CI, -8.9 to -4.3; P < .001). Overall rates of insulin use were similar in the 2 groups (adjusted difference, -2.3%; -5.1 to 0.5; P = .11). Out-of-pocket costs for noninsulin medications were 84.4% to 95.2% lower and total costs were 9.4% to 54.2% lower in Medicaid than in Marketplace plans. Out-of-pocket costs for insulin were 76.7% to 94.7% lower in Medicaid than in Marketplace plans, whereas differences in total insulin costs were mixed. The percentage of months of apparent active medication coverage was similar between the 2 groups for 4 of 5 drug classes examined, with Marketplace-eligible patients having a greater percentage of months than Medicaid-eligible patients for sulfonylureas (adjusted difference, 5.3%; 95% CI, 0.3%-10.4%; P = .04). Conclusions and Relevance: In this cross-sectional study, drug utilization across multiple drug classes was higher and drug costs were significantly lower for adults with diabetes enrolled in Medicaid than for those with subsidized Marketplace plans. Patients with Marketplace coverage had a similar percentage of months with an active prescription as patients with Medicaid coverage.
Assuntos
Diabetes Mellitus Tipo 2, Hipoglicemiantes, Cobertura do Seguro/economia, Medicaid/economia, Adulto, Colorado, Estudos Transversais, Diabetes Mellitus Tipo 2/tratamento farmacológico, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/epidemiologia, Custos de Medicamentos/estatística & dados numéricos, Feminino, Humanos, Hipoglicemiantes/economia, Hipoglicemiantes/uso terapêutico, Masculino, Pessoa de Meia-Idade, Pobreza, Honorários por Prescrição de Medicamentos/estatística & dados numéricos, Estados Unidos, Adulto JovemRESUMO
Introduction: diabetes is a leading cause of death, disability, and high healthcare costs, especially among patients with poor glycemic control. Providing decentralized diabetes care to patients in low-income countries remains a major challenge. We aimed to assess hemoglobin A1C (HbA1c) level of patients enrolled in primary-level non-communicable disease clinics of Rwamagana, Rwanda, and identify predictors associated with a) change in HbA1c level over a 6-month period or b) achieving HbA1c <7%. We also explored whether living in a community with a home-based care practitioner was associated with HbA1c-related outcomes. Methods: we conducted structured interviews and HbA1c testing among patients with type 2 diabetes at baseline and after six months. Multivariable linear regression and multivariable logistic regression were used. Results: hundred and thirty (130) participants enrolled at baseline, and 123 patients remained in the study after six months. At baseline, 26% of patients had HbA1c <7%. After 6-months, 37% of patients had HbA1c <7%. Factors correlated with the greatest improvements in HbA1c were having HbA1c >9% at baseline, while factors associated with having HbA1c <7% after six months included older age and having HbA1c <7% at baseline. We did not find significant associations between home-based care practitioners and improvement in HbA1c level or achieving HbA1c <7. Conclusion: the number of patients with well-controlled glycemia improved over time during this study but was still low overall. Care provided by home-based care practitioners was not associated with six-month HbA1c outcomes. Enhanced care is needed to achieve glycemia control in primary healthcare settings.
Assuntos
Países em Desenvolvimento, Diabetes Mellitus Tipo 2, Hemoglobinas Glicadas, Controle Glicêmico, Humanos, Glicemia/análise, Diabetes Mellitus Tipo 2/sangue, Diabetes Mellitus Tipo 2/complicações, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Hemoglobinas Glicadas/análise, Controle Glicêmico/economia, Controle Glicêmico/métodos, Estudos Prospectivos, Ruanda, Países em Desenvolvimento/economiaRESUMO
AIM: To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care. METHODS: An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon. Health-related quality of life (EQ-5D) and total healthcare costs were compared between the intervention and the usual care group within the trial period. The 'UKPDS Outcomes Model 2' was used to simulate post-trial lifetime costs, life expectancy and quality-adjusted life years (QALYs). RESULTS: No significant difference in health-related quality of life and costs was found between the two groups within the trial period. Professional-mode flash glucose monitoring yielded greater QALYs (0.03 [95% CI: 0.02, 0.04]) and a higher cost (A$3807 [95% CI: 3604, 4007]) compared with usual clinical care using a lifetime horizon under the trial-based monitoring frequency, considered not cost-effective (incremental cost-effectiveness ratio = A$120,228). The intervention becomes cost-effective if sensor price is reduced to lower than 50%, or monitoring frequency is decreased to once per year while maintaining the same treatment effect on HbA1c . CONCLUSIONS: Including professional-mode flash glucose monitoring every 3 months as part of a management plan for people with type 2 diabetes in general practice is not cost-effective, but could be if the sensor price or monitoring frequency can be reduced.
Assuntos
Automonitorização da Glicemia/métodos, Análise Custo-Benefício, Diabetes Mellitus Tipo 2/sangue, Medicina Geral, Idoso, Diabetes Mellitus Tipo 2/economia, Diabetes Mellitus Tipo 2/terapia, Feminino, Custos de Cuidados de Saúde, Humanos, Masculino, Pessoa de Meia-Idade, Monitorização Fisiológica, Qualidade de Vida, Anos de Vida Ajustados por Qualidade de Vida, VitóriaAssuntos
Consenso, Diabetes Mellitus Tipo 2/terapia, Educação de Pacientes como Assunto/métodos, Autogestão/educação, Autogestão/métodos, Complicações do Diabetes/diagnóstico, Complicações do Diabetes/terapia, Diabetes Mellitus Tipo 2/diagnóstico, Diabetes Mellitus Tipo 2/economia, Dietética, Humanos, Profissionais de Enfermagem, Terapia Nutricional, Equipe de Assistência ao Paciente, Farmacêuticos, Assistentes Médicos, Atenção Primária à Saúde/métodos, Estados UnidosRESUMO
INTRODUCTION: Few economic evaluations have assessed the cost-effectiveness of screening type-2 diabetes mellitus (T2DM) in different healthcare settings. This study aims to evaluate the value for money of various T2DM screening strategies in Vietnam. METHODS: A decision analytical model was constructed to compare costs and quality-adjusted life years (QALYs) of T2DM screening in different health care settings, including (1) screening at commune health station (CHS) and (2) screening at district health center (DHC), with no screening as the current practice. We further explored the costs and QALYs of different initial screening ages and different screening intervals. Cost and utility data were obtained by primary data collection in Vietnam. Incremental cost-effectiveness ratios were calculated from societal and payer perspectives, while uncertainty analysis was performed to explore parameter uncertainties. RESULTS: Annual T2DM screening at either CHS or DHC was cost-effective in Vietnam, from both societal and payer perspectives. Annual screening at CHS was found as the best screening strategy in terms of value for money. From a societal perspective, annual screening at CHS from initial age of 40 years was associated with 0.40 QALYs gained while saving US$ 186.21. Meanwhile, one-off screening was not cost-effective when screening for people younger than 35 years old at both CHS and DHC. CONCLUSIONS: T2DM screening should be included in the Vietnamese health benefits package, and annual screening at either CHS or DHC is recommended.
