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1.
BMC Health Serv Res ; 24(1): 562, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38693514

RESUMO

BACKGROUND: This study aimed to examine the reporting quality of existing economic evaluations for negotiated glucose-lowering drugs (GLDs) included in China National Reimbursement Drug List (NRDL) using the Consolidated Health Economic Evaluation Reporting Standards 2013 (CHEERS 2013). METHODS: We performed a systematic literature research through 7 databases to identify published economic evaluations for GLDs included in the China NRDL up to March 2021. Reporting quality of identified studies was assessed by two independent reviewers based on the CHEERS checklist. The Kruskal-Wallis test and Mann-Whitney U test were performed to examine the association between reporting quality and characteristics of the identified studies. RESULTS: We have identified 24 studies, which evaluated six GLDs types. The average score rate of the included studies was 77.41% (SD:13.23%, Range 47.62%-91.67%). Among all the required reporting items, characterizing heterogeneity (score rate = 4.17%) was the least satisfied item. Among six parts of CHEERS, results part scored least at 0.55 (score rate = 54.79%) because of the incompleteness of characterizing uncertainty. Results from the Kruskal-Wallis test and Mann-Whitney U test showed that model choice, journal type, type of economic evaluations, and study perspective were associated with the reporting quality of the studies. CONCLUSIONS: There remains room to improve the reporting quality of economic evaluations for GLDs in NRDL. Checklists such as CHEERS should be widely used to improve the reporting quality of economic researches in China.


Assuntos
Hipoglicemiantes , China , Humanos , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Análise Custo-Benefício , Mecanismo de Reembolso/normas , Negociação
2.
J Diabetes ; 16(5): e13553, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38664882

RESUMO

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 numéricos
3.
Artif Intell Med ; 151: 102868, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38632030

RESUMO

Proper insulin management is vital for maintaining stable blood sugar levels and preventing complications associated with diabetes. However, the soaring costs of insulin present significant challenges to ensuring affordable management. This paper conducts a comprehensive review of current literature on the application of machine learning (ML) in insulin management for diabetes patients, particularly focusing on enhancing affordability and accessibility within the United States. The review encompasses various facets of insulin management, including dosage calculation and response, prediction of blood glucose and insulin sensitivity, initial insulin estimation, resistance prediction, treatment adherence, complications, hypoglycemia prediction, and lifestyle modifications. Additionally, the study identifies key limitations in the utilization of ML within the insulin management literature and suggests future research directions aimed at furthering accessible and affordable insulin treatments. These proposed directions include exploring insurance coverage, optimizing insulin type selection, assessing the impact of biosimilar insulin and market competition, considering mental health factors, evaluating insulin delivery options, addressing cost-related issues affecting insulin usage and adherence, and selecting appropriate patient cost-sharing programs. By examining the potential of ML in addressing insulin management affordability and accessibility, this work aims to envision improved and cost-effective insulin management practices. It not only highlights existing research gaps but also offers insights into future directions, guiding the development of innovative solutions that have the potential to revolutionize insulin management and benefit patients reliant on this life-saving treatment.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Insulina , Aprendizado de Máquina , Humanos , Glicemia/metabolismo , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Hipoglicemiantes/economia , Insulina/economia , Insulina/metabolismo , Insulina/uso terapêutico
4.
Indian J Pharmacol ; 56(2): 97-104, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38687313

RESUMO

OBJECTIVES: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs. MATERIALS AND METHODS: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range). RESULTS: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001). CONCLUSION: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines.


Assuntos
Hipoglicemiantes , Índia , Humanos , Estudos Retrospectivos , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/economia , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Hipolipemiantes/economia , Hipolipemiantes/uso terapêutico , Fatores de Risco de Doenças Cardíacas , Custos de Medicamentos , Hipertensão/tratamento farmacológico , Hipertensão/economia , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/economia , Dislipidemias/tratamento farmacológico , Dislipidemias/economia , Anti-Hipertensivos/economia , Anti-Hipertensivos/uso terapêutico , Custos e Análise de Custo
5.
Curr Med Res Opin ; 40(5): 765-772, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38533582

RESUMO

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 adversos
6.
Diabet Med ; 41(6): e15304, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38421806

RESUMO

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.


Assuntos
Análise Custo-Benefício , Diabetes Mellitus Tipo 1 , Hipoglicemia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Humanos , Hipoglicemia/economia , Hipoglicemia/terapia , Masculino , Feminino , Adulto , Diabetes Mellitus Tipo 1/terapia , Diabetes Mellitus Tipo 1/economia , Pessoa de Meia-Idade , Educação de Pacientes como Assunto/economia , Glicemia/metabolismo , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico
7.
Value Health Reg Issues ; 41: 108-113, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38320441

RESUMO

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/economia
8.
J Manag Care Spec Pharm ; 30(2): 112-117, 2024 Feb 03.
Artigo em Inglês | MEDLINE | ID: mdl-38308630

RESUMO

BACKGROUND: Insulin affordability is a huge concern for patients with diabetes in the United States. On March 30, 2020, Utah signed House Bill 207 into law, aimed at capping copayments for insulin at $30 for a 30-day supply. The bill was enacted on January 1, 2021. OBJECTIVE: To assess patient basal insulin adherence, out-of-pocket costs, health plan costs, total costs on insulin, and hemoglobin A1c (A1c) in prepolicy vs postpolicy periods. METHODS: This study is a retrospective analysis using data from a regional health plan in Utah from October 1, 2019, to September 30, 2021. Inclusion criteria were fully enrolled members of all ages, under commercial insurance, with at least 1 fill for any type of insulin in both the preperiod and the postperiod. Adherence was measured by proportion of days covered (PDC). Paired t-tests and Wilcoxon sign rank tests were conducted to compare the health and economic outcomes. RESULTS: Out of 24,150 commercially insured individuals, a total of 244 patients were included. Across all 244 patients, there was a significant decline in monthly median out-of-pocket costs of insulin by 58.5% (P < 0.001), whereas the monthly median health plan costs of insulin increased by 22.0% (P < 0.001). The total monthly costs of insulin (the sum of out-of-pocket and health plan costs) were unchanged (P = 0.115). Only 74 patients with enough basal insulin fills in both periods were included in the analysis for PDC changes. PDC change was not statistically significant (P = 0.43). Among the 74 patients with PDC calculations, 29 patients had A1c recorded in both periods. The change in A1c was not statistically significant (P = 0.23). CONCLUSIONS: An insulin copayment max of $30 in Utah demonstrated lower patient out-of-pocket costs, subsidized by the health plan. PDC did not change, and HbA1c did not improve. An assessment of a longer period and on a larger population is needed.


Assuntos
Diabetes Mellitus Tipo 2 , Insulina , Humanos , Hemoglobinas Glicadas , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina/economia , Insulina/uso terapêutico , Adesão à Medicação , Políticas , Estudos Retrospectivos , Estados Unidos , Utah
9.
Diabetes Technol Ther ; 26(5): 324-334, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38215206

RESUMO

Background: Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). Methods: A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. Results: A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. Conclusion: MM780G is a cost-effective option for people with T1D managed in a Singapore setting.


Assuntos
Automonitorização da Glicemia , Análise Custo-Benefício , Diabetes Mellitus Tipo 1 , Hipoglicemiantes , Sistemas de Infusão de Insulina , Anos de Vida Ajustados por Qualidade de Vida , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/economia , Diabetes Mellitus Tipo 1/sangue , Singapura , Hipoglicemiantes/economia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Sistemas de Infusão de Insulina/economia , Masculino , Feminino , Automonitorização da Glicemia/economia , Insulina/administração & dosagem , Insulina/economia , Insulina/uso terapêutico , Adulto , Glicemia/análise , Hemoglobinas Glicadas/análise , Pessoa de Meia-Idade
10.
Front Public Health ; 11: 1201818, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37744474

RESUMO

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/métodos
11.
JAMA ; 330(7): 650-657, 2023 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-37505513

RESUMO

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 Tempo
12.
Adv Ther ; 40(5): 2015-2037, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36928495

RESUMO

INTRODUCTION: The objective of this systematic literature review was to evaluate the available literature concerning the clinical, economic, and patient-reported benefits of insulin pen platforms, including connected insulin pens/caps/sleeves and insulin platforms, as well as mobile apps capable of receiving near real-time insulin dosing information. METHODS: Medline and Embase databases and the Cochrane Library were searched for published literature between January 2015 and May 2021, and manual searches for conference abstracts from 2018 to May 2021 were performed. These searches were supplemented by internet searches for relevant literature and clinical trials. Study selection involved the population, intervention, comparator, outcomes, time frame, and study design outline. Included studies investigated connected insulin systems or connected caps/sleeves enabling pens to be connected, or apps able to connect to these systems, in individuals of all ages with type 1 or type 2 diabetes mellitus. RESULTS: Searches identified a total of 26 publications (mostly observational studies and conference abstracts) for inclusion, representing ten unique, predominantly small studies. Evidence in this field is still in its early stages, and only two randomized controlled trials met our inclusion criteria. Available results showed that connected insulin pens and their systems potentially helped reduce suboptimal insulin use and may therefore improve glycemic control. Satisfaction of people with diabetes with the technologies used was high, and economic benefits were noted. Features of effective connected insulin pen devices include simplicity of use and data upload/sharing, useful "point-of-care" alerts, and simple and understandable data presentation to facilitate more effective consultations. CONCLUSIONS: Connected insulin pen systems could be increasingly considered as part of routine clinical care for insulin-treated persons with diabetes who must manage the complexity of their daily insulin routine. Future research focusing on the way data obtained from these devices can be most effectively used alongside other information is urgently needed.


Digital health tools, like text message reminders and mobile apps, are being used more often to help people with diabetes improve their health in a way that works for them. For people who take insulin to treat their diabetes, what has been missing is a way to track insulin doses alongside other diabetes information in an app. Connected insulin pens, also called smart pens, are able to do this. In this article we have looked at the evidence available on the benefits of connected insulin pens. We found that while information on connected insulin pens is limited at the moment, what there is shows that using a connected insulin pen can help people remember to take their insulin and give themselves the right dose and that those who have used a connected insulin pen or related technology are happy with it. Useful features of connected insulin pens include being easy to use, having an alert function, and being able to share the insulin information with the user's doctor. Connected insulin pens may also reduce diabetes-related costs. Connected insulin pens are likely to become more common for people with diabetes who take insulin, but there is a need for more research on how best to use them to improve the treatment of people with diabetes.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Hipoglicemiantes , Insulina , Humanos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Insulina/administração & dosagem , Insulina/economia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/economia , Aplicativos Móveis , Sistemas Automatizados de Assistência Junto ao Leito , Injeções Subcutâneas , Análise Custo-Benefício
13.
Adv Ther ; 39(7): 3180-3198, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35553372

RESUMO

INTRODUCTION: Novel glucagon-like peptide-1 (GLP-1) receptor agonist oral semaglutide has demonstrated greater improvements in glycated hemoglobin (HbA1c) and body weight versus oral medications empagliflozin and sitagliptin, and injectable GLP-1 analog liraglutide, in the PIONEER clinical trial program. Based on these data, the present analysis aimed to evaluate the long-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin and liraglutide in Spain. METHODS: Outcomes were projected over patients' lifetimes using the IQVIA CORE Diabetes Model (v9.0), discounted at 3.0% annually. Cohort characteristics and treatment effects were sourced from PIONEER 2 and 4 for the comparisons of oral semaglutide 14 mg versus empagliflozin 25 mg and liraglutide 1.8 mg, respectively, and PIONEER 3 for oral semaglutide 7 and 14 mg versus sitagliptin 100 mg. Costs were accounted from a healthcare payer perspective in 2020 euros (EUR). Patients were assumed to receive initial therapies until HbA1c exceeded 7.5% and then treatment-intensified to basal insulin. RESULTS: Oral semaglutide 14 mg was associated with improvements in quality-adjusted life expectancy of 0.13, 0.19 and 0.06 quality-adjusted life years (QALYs) versus empagliflozin 25 mg, sitagliptin 100 mg and liraglutide 1.8 mg, respectively, with direct costs EUR 168 higher versus empagliflozin and EUR 236 and 1415 lower versus sitagliptin and liraglutide, respectively. Oral semaglutide 14 mg was associated with an incremental cost-effectiveness ratio (ICER) of EUR 1339 per QALY gained versus empagliflozin and was considered dominant (clinically superior and cost saving) versus sitagliptin and liraglutide. Additional analyses demonstrated that oral semaglutide 7 mg was associated with improvements of 0.11 QALYs and increased costs of EUR 226 versus sitagliptin and was therefore associated with an ICER of EUR 2011 per QALY gained. CONCLUSION: Oral semaglutide 14 mg was dominant versus sitagliptin and liraglutide, and cost-effective versus empagliflozin, for the treatment of type 2 diabetes in Spain.


Assuntos
Diabetes Mellitus Tipo 2 , Peptídeos Semelhantes ao Glucagon , Hipoglicemiantes , Administração Oral , Compostos Benzidrílicos/uso terapêutico , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/tratamento farmacológico , Peptídeos Semelhantes ao Glucagon/economia , Peptídeos Semelhantes ao Glucagon/uso terapêutico , Glucosídeos/uso terapêutico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Liraglutida/uso terapêutico , Fosfato de Sitagliptina/uso terapêutico , Espanha
14.
J Med Econ ; 25(1): 238-248, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35094622

RESUMO

OBJECTIVES: Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of rescue therapy, and choosing the most effective and cost-effective option will improve outcomes for patients and may reduce costs for healthcare payers. The present analysis aimed to compare costs and use of medical services with nasal glucagon and injectable glucagon in people with type 1 and 2 diabetes in Canada when used to treat severe hypoglycemic events when impaired consciousness precludes treatment with oral carbohydrates using an economic model, based on differences in the frequency of successful administration of the two interventions. METHODS: A decision tree model was prepared in Microsoft Excel to project outcomes with nasal glucagon and injectable glucagon. The model structure reflected real-world decision-making and treatment outcomes, based on Canada-specific sources. The model captured the use of glucagon, emergency medical services (EMS), emergency room, inpatient stay, and follow-up care. Costs were accounted for in 2019 Canadian dollars (CAD). RESULTS: Nasal glucagon was associated with reduced use of all medical services compared with injectable glucagon. EMS call outs were projected to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect, and combined costs of CAD 1,249, CAD 460, and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations. CONCLUSIONS: When a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Glucagon/administração & dosagem , Hipoglicemia , Canadá , Análise Custo-Benefício , Glucagon/economia , Custos de Cuidados de Saúde , Humanos , Hipoglicemia/tratamento farmacológico , Hipoglicemia/economia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/economia
15.
JAMA Netw Open ; 5(1): e2140371, 2022 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-35029667

RESUMO

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 22 788 diabetic patients included in the study, 20 245 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 (12 429 [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 Jovem
16.
J Manag Care Spec Pharm ; 28(1): 91-98, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34726499

RESUMO

The cost of diabetes care in the United States continues to rise, with insulin costs growing rapidly. Accessibility and affordability of these life-saving medications are concerns for providers and patients that need to be addressed. Availability of biosimilar insulin products may help address these issues by introducing additional competition to the insulin market, but they may also face adoption challenges from patients and health care providers alike. In addition, policymakers at state and federal levels are examining and addressing rising insulin costs through legislative and administrative actions. The purpose of this paper is to review the current US diabetes landscape, highlight the differences between biosimilar insulins and follow-on insulins and considerations for successful adoption of biosimilar insulins, and review the current policy landscape regarding rising insulin costs. DISCLOSURES: This Viewpoints article was supported by Sandoz, Inc. Wagner and Patel are employees of Sandoz, Inc. White was employed by Sandoz, Inc., at the time of this study.


Assuntos
Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina/economia , Insulina/uso terapêutico , Redução de Custos , Humanos , Seguro Saúde , Medicare , Formulação de Políticas , Estados Unidos
17.
PLoS One ; 16(12): e0261231, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34941883

RESUMO

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.


Assuntos
Diabetes Mellitus Tipo 2/diagnóstico , Programas de Triagem Diagnóstica/economia , Centros Comunitários de Saúde/economia , Análise Custo-Benefício , Atenção à Saúde , Diabetes Mellitus Tipo 2/economia , Hospitais de Distrito/economia , Humanos , Hipoglicemiantes/economia , Programas de Rastreamento/economia , Anos de Vida Ajustados por Qualidade de Vida , Vietnã/epidemiologia
18.
Eur Rev Med Pharmacol Sci ; 25(22): 7058-7065, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34859870

RESUMO

OBJECTIVE: Diabetes mellitus is a chronic metabolic disease which has an adverse impact on the quality of patient's life, so patients often need to receive treatment for a long time. Selection of medications with high therapeutics effects and low cost is very important for patients to take medicine for a longer period of time. Sitagliptin is a drug which is widely used in clinics and can effectively control blood glucose level. This article explores the pharmacoeconomic value of Sitagliptin in the treatment of diabetes mellitus. PATIENTS AND METHODS: A total of 100 patients with diabetes mellitus treated were recruited in this study. The patients were randomly divided into 4 groups with 25 cases in each group. Patients in group A were treated with pioglitazone, group B with Sitagliptin, group C with metformin and group D with glimepiride. The cost of the drugs, the treatment results and adverse effects were compared. RESULTS: Compared with group A, C and D, the cost-effectiveness ratio of group B was low (p<0.05), and the therapeutic effect was high (p<0.05). In addition, the incidence of adverse reactions in group B was lower than that in group A, C and D (p<0.05). There was no significant difference in the levels of FPG, 2hPG and HbAlc in patients among the four groups before treatment (p>0.05). After treatment, the levels of FPG, 2hPG and HbAlc in group B were significantly lower than those in groups A, C and D (p<0.05). Finally, there was no significant difference in waist circumference and BMI among the four groups before treatment (p>0.05). After treatment, the waist circumference and BMI in group B were lower than those in groups A, C and D (p<0.05). CONCLUSIONS: The application of Sitagliptin in the treatment of diabetic patients can effectively enhance the therapeutic effect. The cost effectiveness is satisfactory, and the blood glucose level can be maintained at a stable state.


Assuntos
Diabetes Mellitus/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Fosfato de Sitagliptina/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Diabetes Mellitus/economia , Farmacoeconomia , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Hipoglicemiantes/economia , Masculino , Metformina/economia , Metformina/uso terapêutico , Pessoa de Meia-Idade , Pioglitazona/economia , Pioglitazona/uso terapêutico , Fosfato de Sitagliptina/efeitos adversos , Fosfato de Sitagliptina/economia , Compostos de Sulfonilureia/economia , Compostos de Sulfonilureia/uso terapêutico
20.
Lancet ; 398(10313): 1837-1850, 2021 11 13.
Artigo em Inglês | MEDLINE | ID: mdl-34774146

RESUMO

Type 1 diabetes is on the rise globally; however, the burden of mortality remains disproportionate in low-income and middle-income countries (LMICs). As 2021 marks 100 years since the discovery of insulin, we revisit progress, global burden of type 1 diabetes trends, and understanding of the pathogenesis and management practices related to the disease. Despite much progress, inequities in access and availability of insulin formulations persist and are reflected in differences in survival and morbidity patterns related to the disease. Some of these inequities have also been exacerbated by health-system challenges during the COVID-19 pandemic. There is a clear opportunity to improve access to insulin and related essential technologies for improved management of type 1 diabetes in LMICs, especially as a part of universal health coverage. These improvements will require concerted action and investments in human resources, community engagement, and education for the timely diagnosis and management of type 1 diabetes, as well as adequate health-care financing. Further research in LMICs, especially those in Africa, is needed to improve our understanding of the burden, risk factors, and implementation strategies for managing type 1 diabetes.


Assuntos
Países em Desenvolvimento , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/patologia , Diabetes Mellitus Tipo 1/terapia , Carga Global da Doença/tendências , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Adolescente , Criança , Pré-Escolar , Gerenciamento Clínico , História do Século XX , História do Século XXI , Humanos , Hipoglicemiantes/economia , Hipoglicemiantes/história , Insulina/economia , Insulina/história , Expectativa de Vida , Cobertura Universal do Seguro de Saúde
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