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2.
Value Health ; 23(4): 461-470, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32327163

RESUMO

OBJECTIVES: Biologic disease-modifying antirheumatic drugs (bDMARDs) are prescribed sequentially in the treatment of rheumatoid arthritis (RA). Healthcare decision makers continue to debate their use, mainly because of their high costs. Our aim was to perform an economic evaluation for France of bDMARD sequences for treatment of moderate-to-severe RA after inadequate response or intolerance to conventional DMARDs (eg, methotrexate). METHODS: A discretely integrated condition event simulation was developed to track the course of patients from first bDMARD through switches to further lines in a sequence. The model included 11 events, 91 conditions, and 21 controlling equations. Inputs were obtained from a meta-analysis of clinical trials, a French registry, national drug lists, and databases. Survival, time with minimal activity, quality-adjusted life-years (QALYs), and total costs were output. Structural and probabilistic sensitivity analyses were conducted. RESULTS: Sequences starting with etanercept biosimilars (ETB) cost less, with ETB-abatacept-infliximab the least expensive: the mean lifetime discounted total cost was €116 912 per patient, with a mean of 11.166 QALYs. Most other strategies were dominated or led to small QALY gains (0.0008-0.0329). Only ETB-tocilizumab-abatacept made it onto the efficiency frontier, but at €955 778 per QALY gained. These results were confirmed in several scenarios and uncertainty analyses. CONCLUSION: Given minor differences in QALYs gained between bDMARD sequences with large cost differences, starting with biosimilars was more efficient than starting with branded products. Our model and findings should provide French and other decision makers with useful tools to address the challenges of comparing sequences of treatments for RA.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Metotrexato/administração & dosagem , Modelos Econômicos , Antirreumáticos/economia , Artrite Reumatoide/economia , Artrite Reumatoide/fisiopatologia , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Análise Custo-Benefício , França , Humanos , Metotrexato/efeitos adversos , Metotrexato/economia , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença
3.
JAMA Netw Open ; 3(4): e202739, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32286656

RESUMO

Importance: The 2019 federal Ending the HIV Epidemic initiative requires a vast expansion of access to antiretroviral therapy (ART) and preexposure prophylaxis (PrEP) for HIV treatment and prevention. However, high prices for ART and PrEP can reduce their affordability and use. Medicare covers 1 in 4 persons living with HIV, and the Medicare Part D drug benefit imposes complicated cost-sharing between patients and other stakeholders. Objective: To determine how the Medicare Part D design distributes the cost burden for ART and PrEP between patients, insurance plans, manufacturers, and Medicare. Design and Setting: Nationwide cross-sectional analyses of first quarter 2019 Medicare formulary and pricing files for 3326 Part D plans were performed. These files contain drug benefit data, including prices and cost-sharing requirements. Main Outcomes and Measures: For 18 ART and 2 PrEP regimens, the out-of-pocket costs for patients and the cost borne by plans, manufacturers, and Medicare were projected for 1 year of treatment or prevention under a 2019 standard Medicare Part D insurance plan. Analyses assumed that patients used the ART or PrEP regimen and no other medications. Results: In 2019, ART prices ranged from $24 010 to $46 770 annually (median price, $35 780), with patients projected to pay 9% to 14% of the cost ($3270-$4350), insurance plans 18% to 24% ($5340-$8450), manufacturers 6% to 11% ($2370-$2750), and Medicare 53% to 67% ($12 770-$31 270). The price of PrEP was $20 570 annually, with patients contributing 15% ($2990), insurance plans 22% ($4570), manufacturers 13% ($2750), and Medicare 50% ($10 260). For beneficiaries with low-income subsidies that cover all patient cost-sharing, Medicare would assume 67% to 76% of ART costs and 65% of PrEP costs. Conclusions and Relevance: Medicare Part D mandates universal ART and PrEP coverage, but high prices (>$35 000 annually for ART and>$20 000 annually for PrEP) and the design of Part D can jeopardize affordability for patients and place most of the cost burden on taxpayers. Under a standard Medicare Part D benefit, patients pay $3000 to $4000 out-of-pocket yearly, unless they qualify for low-income subsidies, and half to two-thirds of the cost of ART and PrEP is borne by Medicare rather than insurance plans or manufacturers. To end the HIV epidemic by 2030, it appears that policies must address both high drug prices and revamp Medicare Part D cost-sharing.


Assuntos
Antirreumáticos/economia , Antirreumáticos/uso terapêutico , Custo Compartilhado de Seguro/economia , Infecções por HIV/tratamento farmacológico , Custos de Cuidados de Saúde/estatística & dados numéricos , Medicare Part D/economia , Profilaxia Pré-Exposição/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Custo Compartilhado de Seguro/estatística & dados numéricos , Estudos Transversais , Feminino , Humanos , Masculino , Medicare Part D/estatística & dados numéricos , Pessoa de Meia-Idade , Profilaxia Pré-Exposição/estatística & dados numéricos , Estados Unidos
4.
Arthritis Rheumatol ; 72(7): 1067-1071, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32253823

RESUMO

OBJECTIVE: To compare uptake in the ordering of biosimilars at a Veterans Affairs Medical Center (VAMC) to that at an academic medical center, where institutional incentives for infused medications differ. METHODS: We performed a cross-sectional study of medical record data and estimated institutional financial incentives at 2 medical centers in Philadelphia: 1) the University of Pennsylvania Health System (UPHS), and 2) the local VAMC. All ordering events for filgrastim or infliximab products were quantified over time and stratified according to product (biosimilar versus reference product) and center. Financial incentives to the institutions over time were determined based on actual drug costs for the VAMC and average sales prices (ASPs) and Medicare Part B reimbursement rates for UPHS. RESULTS: There were 15,761 infusions of infliximab at UPHS, of which 99% were for the reference product. There was a sharper decline in the use of reference products at the VAMC; 62% of the 446 infliximab infusions ordered at the VAMC were for the reference product. ASPs were consistently lower for biosimilar infliximab products, but the estimated institutional financial incentives remained similar over time for biosimilar and reference infliximab at UPHS. At the VAMC, the costs for 100-mg vials of reference infliximab and infliximab-abda were $623.48 and $115.58, respectively: a $507.90 (81%) savings per vial. CONCLUSION: The uptake of infliximab biosimilars has been slow at an academic medical center compared to a nearby VAMC, where financial savings are realized by the institution from its use. Slow adoption of biosimilar medications may impact the rates of decline in costs.


Assuntos
Centros Médicos Acadêmicos , Antirreumáticos/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Filgrastim/uso terapêutico , Fármacos Hematológicos/uso terapêutico , Infliximab/uso terapêutico , United States Department of Veterans Affairs , Antirreumáticos/economia , Medicamentos Biossimilares/economia , Redução de Custos , Custos de Medicamentos , Filgrastim/economia , Gastroenterologia , Fármacos Hematológicos/economia , Humanos , Infliximab/economia , Infusões Intravenosas , Medicare Part B , Motivação , Philadelphia , Polietilenoglicóis/economia , Polietilenoglicóis/uso terapêutico , Mecanismo de Reembolso , Reumatologia , Estados Unidos
5.
Adv Ther ; 37(5): 2098-2115, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32141018

RESUMO

INTRODUCTION: We compared treatment switch patterns and healthcare costs among biologic-naive patients with psoriatic arthritis (PsA) who initiated apremilast or biologics. METHODS: A 1:2 propensity score match was used to adjust administrative claims data for adults initiating apremilast or biologics from January 1, 2014, to September 30, 2016, for possible selection bias. Patients had at least 12 months of pre- and post-index continuous enrollment in the Optum Clinformatics™ Data Mart database. Outcomes included switch frequency, days to switch, adherence on index treatment, and healthcare costs (total and per patient per month). Switch rate was defined as the proportion of patients who switched to a new treatment after initiation of the index treatment, and days to switch was calculated as the days between initiation of the index treatment and initiation of the new treatment. Adherence was calculated using the proportion of days covered and the medication possession ratio. The t test and chi-square, Kaplan-Meier, and Wilcoxon rank-sum tests were used to evaluate differences between the cohorts. RESULTS: Patient characteristics and switch rates were similar between the matched apremilast (n = 170) and biologic (n = 327) cohorts. After matching, patient characteristics were similar between the matched cohorts. The 12-month switch rates were similar for patients initiating apremilast versus those on biologics (17.7% vs. 25.1%, P = 0.06). This trend was similar at 6 months (7.7% vs. 13.2%, P = 0.07) and 18 months (24.4% vs. 29.3%, P = 0.33). Regardless of treatment switching, 12-month total healthcare costs were lower with apremilast versus biologics (all: $28,423 vs. $41,178, P < 0.0001; switched: $39,803 vs. $51,517, P = 0.0040; did not switch: $25,984 vs. $37,717, P < 0.0001). CONCLUSIONS: Biologic-naive patients with PsA who initiated apremilast had switch rates similar to biologic users and significantly lower healthcare costs, regardless of treatment switching.


Assuntos
Anti-Inflamatórios não Esteroides/economia , Antirreumáticos/economia , Artrite Psoriásica/tratamento farmacológico , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Talidomida/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/economia , Artrite Psoriásica/epidemiologia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Talidomida/economia , Talidomida/uso terapêutico , Estados Unidos/epidemiologia
6.
Medicine (Baltimore) ; 99(3): e16635, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32011430

RESUMO

OBJECTIVE: This study aimed to explore the cost-effectiveness of etanercept plus methotrexate (ETN+MTX) compared to triple disease-modifying anti-rheumatic drugs (DMARDs) in treating Chinese rheumatoid arthritis (RA) patients. METHODS: The 134 Chinese RA patients who were about to initiate ETN+MTX or triple DMARDs therapy based on treat-to-target strategy were consecutively recruited and categorized into ETN+MTX group (N = 49) or triple DMARDs group (N = 85). Treatment efficacy was assessed at month 3 (M3)/M6/M9/M12 after initiation of treatment. Also, 1-year treatment cost was evaluated, and cost-effectiveness analysis and sensitivity analysis were conducted. RESULTS: RA patients in ETN+MTX group exhibited similar disease activity and quality of life at each time point while elevated 28-joint disease activity score based on erythrocyte sedimentation rate (DAS28-ESR) change (M0-M12) and low disease activity rate compared with triple DMARDs group. For 1-year treatment cost, ETN+MTX required increased drug cost, decreased other medical cost, and finally elevated total cost compared with triple DMARDs. Meanwhile, compared to triple DMARDs, ETN+MTX produced an additional quality-adjusted life year (QALY) of 0.015, resulting in an incremental cost-effectiveness ratio (ICER) of ¥2,939,506.7 per QALY that was 53.1 folds of gross domestic product (GDP) per capita in China. More interestingly, sensitivity analysis revealed that the ETN price had to be reduced at least by 71.3% before ETN+MTX became cost-effectiveness compared to triple DMARDs. CONCLUSION: ETN+MTX is less cost-effective in treating Chinese RA patients compared with triple DMARDs.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Etanercepte/uso terapêutico , Metotrexato/uso terapêutico , Adulto , Idoso , Antirreumáticos/administração & dosagem , Antirreumáticos/economia , Sedimentação Sanguínea , China , Análise Custo-Benefício , Quimioterapia Combinada , Etanercepte/administração & dosagem , Etanercepte/economia , Feminino , Gastos em Saúde , Humanos , Masculino , Metotrexato/administração & dosagem , Metotrexato/economia , Pessoa de Meia-Idade , Qualidade de Vida , Indução de Remissão , Índice de Gravidade de Doença
7.
Ann Rheum Dis ; 79(6): 685-699, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31969328

RESUMO

OBJECTIVES: To provide an update of the European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) management recommendations to account for the most recent developments in the field. METHODS: An international task force considered new evidence supporting or contradicting previous recommendations and novel therapies and strategic insights based on two systematic literature searches on efficacy and safety of disease-modifying antirheumatic drugs (DMARDs) since the last update (2016) until 2019. A predefined voting process was applied, current levels of evidence and strengths of recommendation were assigned and participants ultimately voted independently on their level of agreement with each of the items. RESULTS: The task force agreed on 5 overarching principles and 12 recommendations concerning use of conventional synthetic (cs) DMARDs (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GCs); biological (b) DMARDs (tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, sarilumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, filgotinib, upadacitinib). Guidance on monotherapy, combination therapy, treatment strategies (treat-to-target) and tapering on sustained clinical remission is provided. Cost and sequencing of b/tsDMARDs are addressed. Initially, MTX plus GCs and upon insufficient response to this therapy within 3 to 6 months, stratification according to risk factors is recommended. With poor prognostic factors (presence of autoantibodies, high disease activity, early erosions or failure of two csDMARDs), any bDMARD or JAK inhibitor should be added to the csDMARD. If this fails, any other bDMARD (from another or the same class) or tsDMARD is recommended. On sustained remission, DMARDs may be tapered, but not be stopped. Levels of evidence and levels of agreement were mostly high. CONCLUSIONS: These updated EULAR recommendations provide consensus on the management of RA with respect to benefit, safety, preferences and cost.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Sociedades Médicas , Medicamentos Sintéticos/uso terapêutico , Antirreumáticos/economia , Produtos Biológicos/economia , Consenso , Quimioterapia Combinada , Europa (Continente) , Humanos , Inibidores de Janus Quinases/uso terapêutico , Medicamentos Sintéticos/economia , Revisões Sistemáticas como Assunto , Fator de Necrose Tumoral alfa/antagonistas & inibidores
9.
PLoS One ; 15(1): e0226754, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31895926

RESUMO

OBJECTIVE: Recent guideline updates have suggested de-escalating DMARDs when patients with rheumatoid arthritis achieve remission or low disease activity. We aim to evaluate whether it is cost-effective to de-escalate the biological form of DMARDs (bDMARDs). METHODS: Using a Markov model, we performed a cost-utility analysis for RA patients on bDMARD treatment. We compared continuing treatment (standard care) to a tapering approach (i.e., an immediate 50% dose reduction), withdrawal (i.e., an immediate 100% dose reduction) and tapering followed by withdrawal of bDMARDs. The parametrization is based on a comprehensive literature review. Results were computed for 30 years with a cycle length of three months. We applied the payer's perspective for Germany and conducted deterministic and probabilistic sensitivity analyses. RESULTS: Tapering or withdrawing bDMARD treatment resulted in ICERs of €526,254 (incr. costs -78,845, incr. QALYs -0.1498) or €216,879 (incr. costs -€121,691, incr. QALYs -0.5611) compared to standard care. Tapering followed by withdrawal resulted in a loss of 0.4354 QALYs and savings of €107,969 per patient, with an ICER of €247,987. Deterministic sensitivity analysis revealed that our results remained largely unaffected by parameter changes. Probabilistic sensitivity analysis suggests that tapering, withdrawal and tapering followed by withdrawal were dominant in 39.8%, 28.2% and 29.0% of 10,000 iterations. CONCLUSION: Our findings suggest that de-escalating bDMARDs in patients with RA may result in high cost savings but also a decrease in quality of life compared to standard care. If decision makers choose to implement de-escalation in daily practice, our results suggest the tapering approach.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/economia , Terapia Biológica/economia , Análise Custo-Benefício , Qualidade de Vida , Suspensão de Tratamento/economia , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/patologia , Terapia Biológica/métodos , Estudos de Coortes , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão
10.
J Manag Care Spec Pharm ; 26(2): 211-220, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31823689

RESUMO

BACKGROUND: Rheumatoid arthritis (RA) is a chronic disease that requires long-term treatment to improve or maintain stable disease activity. Tumor necrosis factor inhibitors (TNFi), a class of biologic disease-modifying antirheumatic drugs (bDMARD), are effective at treating symptoms and inhibiting joint progression. Although treatment changes are not recommended in patients with stable disease, health plans have recently enacted formulary changes with higher copayments that could disrupt patient access to TNFis. OBJECTIVE: To assess the association of formulary copayment changes with real-world treatment patterns, treatment effectiveness, and health care costs among bDMARD-naive patients with RA receiving the TNFi etanercept. METHODS: This retrospective observational cohort analysis used the IBM Watson Health MarketScan Commercial Claims and Encounters Database. Adult patients with RA with 6 months of stable etanercept use (no refill gap ≥ 45 days) from January 1, 2013, through December 31, 2015, were selected and the index date was set to the first fill date after the stable-use period. Average etanercept copayment was calculated at the drug-plan level. Copayment change was defined as a monthly increase of at least $40 to account for copayment changes attributable to etanercept wholesale acquisition costs between 2014 and 2015. This amount also corresponded to the 90th percentile of average plan-level changes in etanercept copayments in the database, representing an average change in copayment by a payer. Patients were followed ≥ 12 months before and after the index date to track etanercept treatment changes and ≥ 12 months after a treatment change to track costs after etanercept copayment changes. Etanercept persistence, bDMARD switching, refill gaps, and treatment effectiveness (using a validated effectiveness algorithm) were described for patients with or without copayment change during the 12 months post-index or postchange. We also assessed the mean total of all-cause and RA-related expenditure during the 12-month post-index (or postchange) period. RESULTS: 1,970 stable patients met study inclusion criteria (mean [standard deviation] age: 50.3 [9.5] years; 77.8% female) and were evaluated. Of these, 133 (6.8%) patients had a copayment change ≥$40 during follow-up. Overall, most patients (60.3%) persisted on etanercept for the 12-month follow-up period, while 13.0% switched from etanercept, and 8.1% discontinued (refill gap of ≥ 45 days). Nearly half (48.0%) of all patients were considered effectively treated according to a validated algorithm. Compared with patients without a copayment change, those with a copayment change were more likely to switch biologics (19.5% vs. 12.6%; P = 0.021). Although statistical significance was not reached, patients with a copayment change were less likely to be persistent (54.1% vs. 60.7%; P = 0.135), and less likely to be effectively treated (42.1% vs. 48.4%; P = 0.161) than patients without a copayment change. All-cause and RA-related expenditures at baseline and post-copayment change were similar between patients with and without a copayment change. CONCLUSIONS: Changing formulary copayment of etanercept was associated with higher switching without difference in costs or health care utilization between copayment and no copayment change groups. DISCLOSURES: This study was sponsored by Amgen. Bonafede, Manjelievskaia, and Lopez-Gonzalez are employees of IBM Watson Health, which received funding from Amgen to conduct this study. Oko-osi, Collier, and Stolshek are employees and shareholders of Amgen. Gharaibeh was an employee of Amgen at the time of study execution and manuscript drafting. The authors have no other relationships that present a potential conflict of interest. Data pertaining to this study were presented in a poster at the 2018 ACR/ARHP Annual Meeting; October 19-24, 2018; Chicago, IL.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Dedutíveis e Cosseguros/economia , Etanercepte/administração & dosagem , Adolescente , Adulto , Antirreumáticos/economia , Artrite Reumatoide/economia , Estudos de Coortes , Infecções por Coronavirus/tratamento farmacológico , Etanercepte/economia , Feminino , Formulários Farmacêuticos como Assunto , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Inibidores do Fator de Necrose Tumoral/administração & dosagem , Inibidores do Fator de Necrose Tumoral/economia , Adulto Jovem
11.
Arthritis Rheumatol ; 72(2): 234-241, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31609057

RESUMO

OBJECTIVE: Billions of public dollars are spent each year on biologic disease-modifying antirheumatic drugs (DMARDs), but the drivers of recent increases in biologic DMARD spending are unclear. This study was undertaken to characterize changes in total spending and unit prices for biologic DMARDs in Medicare and Medicaid programs and quantified the major sources of these spending increases. METHODS: We accessed drug spending data from years 2012-2016, covering all Medicare Part B (fee-for-service), Medicare Part D, and Medicaid enrollees. After calculating 5-year changes in total spending and unit prices for each biologic DMARD as well as in aggregate, we performed standard decomposition analyses to isolate 4 sources of spending growth: drug prices, uptake (number of recipients), treatment intensity (mean number of doses per claim), and treatment duration (annual number of claims per recipient), both excluding and including time-varying rebates. RESULTS: From 2012 to 2016, annual spending on public-payer claims for the 10 biologic DMARDs included in this study more than doubled ($3.8 billion to $8.6 billion), with median drug price increases of 51% in Medicare Part D (mean 54%) and 8% in Medicare Part B (mean 21%). With adjustment for general inflation, unit price increases alone accounted for 57% of the 5-year, $3.0 billion spending increase in Part D, while 37% of the spending increase was from increased uptake. Accounting for time-varying rebates, prices were still responsible for 54% of increased spending. Unit prices and spending were lower under Medicaid than under Medicare Part D, though temporal trends and contributors were similar. CONCLUSION: Postmarket drug price changes alone account for the majority of the recent spending growth in biologic DMARDs. Policy interventions targeting price increases, particularly those under Medicare Part D plans, may help mitigate financial burdens for public payers and biologic DMARD recipients.


Assuntos
Antirreumáticos/economia , Produtos Biológicos/economia , Comércio , Gastos em Saúde , Medicaid/economia , Medicare/economia , Humanos , Estados Unidos
12.
J Med Econ ; 23(1): 1-9, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31589081

RESUMO

Aims: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease involving multiple organs systems and places a significant economic burden on SLE patients. There is a literature gap regarding the standard of care and economic burden in SLE patients, their families, and society. This study assessed medication use patterns among SLE patients and generated the annual and total economic burden associated with the illness.Materials and methods: Adult patients with ≥2 medical claims on different dates for SLE diagnoses were identified from 01 January 2013 to 31 December 2015 using two large administrative claims databases representative of the commercially insured US population. Patient demographics and clinical characteristics during 1-year pre-SLE diagnosis were assessed. Outcomes including the proportion of patients who used SLE medications and annual costs were assessed 1-year post-SLE diagnosis. Total costs related to SLE were extrapolated to the US population to estimate the economic burden based on SLE prevalence.Results: A total of 30,086 SLE patients were identified. The most common baseline comorbidities were hypertension and infections. Corticosteroids and hydroxychloroquine were the most common SLE medications. Biologics utilization was minimal. SLE patients had, on average, 26.0 physician visits, 23.7 prescription claims, 1.7 inpatient admissions, and 2.0 hospital days per patient 1-year post-SLE diagnosis. Annual all-cause median costs among all SLE patients were $8712 per patient per year. Total costs ranged between $1.4-1.6 and $2.8-3.2 billion per year, depending on prevalence estimates.Conclusions: Our findings indicate a nominal use of biologics (∼2%) among SLE patients; despite belimumab being one of the few approved treatments for SLE in the USA. These data reveal an unmet need for availability of advanced SLE therapy, and future studies are warranted concerning the underlying causes. SLE is also associated with a substantial economic burden of ≤3.2 billion per year. These findings may assist in future planning and resource allocation.


Assuntos
Corticosteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Hidroxicloroquina/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Lúpus Eritematoso Sistêmico/economia , Corticosteroides/economia , Fatores Etários , Antirreumáticos/economia , Comorbidade , Efeitos Psicossociais da Doença , Feminino , Gastos em Saúde/estatística & dados numéricos , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Hidroxicloroquina/economia , Revisão da Utilização de Seguros , Masculino , Modelos Econométricos , Características de Residência , Estudos Retrospectivos , Fatores Sexuais , Fatores Socioeconômicos , Estados Unidos
13.
Arthritis Care Res (Hoboken) ; 72(3): 334-342, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-30629813

RESUMO

OBJECTIVE: To determine whether intensive combinations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDS) achieve similar clinical benefits more cheaply than high-cost biologics such as tumor necrosis factor inhibitors (TNFi) in patients with active rheumatoid arthritis (RA) whose illness has failed to respond to methotrexate and another DMARD. METHODS: We used within-trial cost-effectiveness and cost-utility analyses from health and social care and 2 societal perspectives. Participants were recruited into an open-label, 12-month, pragmatic, randomized, multicenter, 2-arm, noninferiority trial in 24 rheumatology clinics in England and Wales. Costs were linked with the Health Assessment Questionnaire (HAQ; primary outcome) and quality-adjusted life years derived from 2 measures (Short-Form 36 health survey and EuroQol 5-domain 3-level instrument). RESULTS: In total, 205 participants were recruited, 104 in the csDMARD arm and 101 in the TNFi arm. Participants in the csDMARD arm with poor response at 6 months were offered TNFi; 46 participants (44%) switched. Relevant cost and outcome data were available for 93% of participants at 6-month follow-up and for 91-92% of participants at 12-month follow-up. The csDMARD arm had significantly lower total costs from all perspectives (6-month health and social care adjusted mean difference -£3,615 [95% confidence interval (95% CI) -4,104, -3,182]; 12-month health and social care adjusted mean difference -£1,930 [95% CI -2,599, -1,301]). The HAQ score showed benefit to the csDMARD arm at 12 months (-0.16 [95% CI -0.32, -0.01]); other outcomes/follow-ups showed no differences. CONCLUSION: Starting treatment with csDMARDs, rather than TNFi, achieves similar outcomes at significantly lower costs. Patients with active RA and who meet the National Institute for Health and Care Excellence criteria for expensive biologics can be treated with combinations of intensive csDMARDs in a cost-effective manner.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/economia , Idoso , Antirreumáticos/uso terapêutico , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores do Fator de Necrose Tumoral/uso terapêutico
14.
Pharmacoeconomics ; 38(1): 39-56, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31452079

RESUMO

BACKGROUND/OBJECTIVE: Baricitinib is a selective and reversible Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor inhibitors (TNFis) and has been shown to improve multiple clinical and patient-reported outcomes. However, it is unclear what the budgetary impact would be for US commercial payers to add baricitinib to their formulary and how the efficacy of baricitinib compares to other disease-modifying antirheumatic drugs (DMARDs) with a similar indication. METHODS: A budget impact model (BIM) was developed for a hypothetical population of 1 million plan members that compared a world without and with baricitinib. A retrospective observational study was carried out to estimate market utilization of advanced therapies. Number needed to treat (NNT) and cost per additional responder were calculated for American College of Rheumatology (ACR) 20%/50%/70% improvement criteria (ACR20/50/70) response outcomes combining cost estimates from the BIM and efficacy values from a network meta-analysis (NMA). The model included costs related to drug acquisition and monitoring costs. RESULTS: Adding baricitinib would save a commercial payer $US169,742 for second-line therapy and $US135,471 for third-line therapy over a 2-year time horizon (all costs correspond to 2019 US dollars). Cost savings were driven by baricitinib drawing market share away from more expensive comparators. The NMA, based on nine studies, found no statistically significant differences in the median treatment difference between baricitinib and comparators except for versus a conventional synthetic DMARD (csDMARD), and thus NNT versus a csDMARD was similar. The cost per additional responder for baricitinib in patients with inadequate response to a TNFi was substantially lower than all other treatments for all three ACR response criteria at 12 weeks (ACR20: $US129,672; ACR50: $US237,732; ACR70: $US475,464), and among the lowest at 24 weeks (ACR20: $US167,811; ACR50: $US259,344; ACR70: $US570,557). CONCLUSIONS: Baricitinib, compared to other DMARDs, was a less expensive option (- $US0.01 incremental cost per member per month in second- and third-line therapy over a 2-year time horizon) with comparable efficacy in patients with inadequate response to TNFi. Adding baricitinib to formulary would likely be cost saving for US payers and expands treatment options for these patients.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/economia , Azetidinas/economia , Modelos Econômicos , Inibidores de Proteínas Quinases/economia , Sulfonamidas/economia , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Azetidinas/uso terapêutico , Análise Custo-Benefício , Humanos , Metanálise como Assunto , Inibidores de Proteínas Quinases/uso terapêutico , Estudos Retrospectivos , Índice de Gravidade de Doença , Sulfonamidas/uso terapêutico , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral/uso terapêutico
15.
Arthritis Care Res (Hoboken) ; 72(3): 343-352, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-30801951

RESUMO

OBJECTIVE: To systematically review the modeling approaches and quality of economic analyses comparing cycling tumor necrosis factor inhibitors (TNFi) to swapping to a therapy with a different mode of action in patients with rheumatoid arthritis whose initial TNFi failed. METHODS: We searched electronic databases, gray literature, and references of included publications until July 2017. Two reviewers independently screened citations. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Data regarding modeling methodology were extracted. RESULTS: We included 7 articles comprising 19 comparisons. Three studies scored ≥16 of 24 on the CHEERS checklist. Most models used a lifetime horizon, took a payer perspective, employed a 6-month cycle length, and measured treatment efficacy in terms of the American College of Rheumatology improvement criteria. We noted possible sources of bias in terms of transparency and study sponsorship. In the cost-utility comparisons, the median incremental cost-effectiveness ratio was US $70,332 per quality-adjusted life-year for swapping versus cycling strategies. Rituximab was more effective and less expensive than TNFi in 7 of 11 comparisons. Abatacept (intravenous) compared to TNFi was less cost-effective than rituximab. Common influential parameters in sensitivity analyses were the rituximab dosing schedule, assumptions regarding disease progression, and the estimation of utilities. CONCLUSION: Differences in the design, key assumptions, and model structure chosen had a major impact on the individual study conclusions. Despite the existence of multiple reporting standards, there continues to be a need for more uniformity in the methodology reported in economic evaluations of cycling versus swapping strategies after TNFi in patients with rheumatoid arthritis.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Modelos Econômicos , Antirreumáticos/economia , Artrite Reumatoide/economia , Humanos , Falha de Tratamento , Inibidores do Fator de Necrose Tumoral/uso terapêutico
16.
Int J Pharm ; 573: 118817, 2020 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-31678520

RESUMO

Transferosomes, also known as transfersomes, are ultradeformable vesicles for transdermal applications consisting of a lipid bilayer with phospholipids and an edge activator and an ethanol/aqueous core. Depending on the lipophilicity of the active substance, it can be encapsulated within the core or amongst the lipid bilayer. Compared to liposomes, transferosomes are able to reach intact deeper regions of the skin after topical administration delivering higher concentrations of active substances making them a successful drug delivery carrier for transdermal applications. Most transferosomes contain phosphatidylcholine (C18) as it is the most abundant lipid component of the cell membrane, and hence, it is highly tolerated for the skin, decreasing the risk of undesirable effects, such as hypersensitive reactions. The most common edge activators are surfactants such as sodium deoxycholate, Tween® 80 and Span® 80. Their chain length is optimal for intercalation within the C18 phospholipid bilayer. A wide variety of drugs has been successfully encapsulated within transferosomes such as phytocompounds like sinomenine or apigenin for rheumatoid arthritis and leukaemia respectively, small hydrophobic drugs but also macromolecules like insulin. The main factors to develop optimal transferosomal formulations (with high drug loading and nanometric size) are the optimal ratio between the main components as well as the critical process parameters for their manufacture. Application of quality by design (QbD), specifically design of experiments (DoE), is crucial to understand the interplay among all these factors not only during the preparation at lab scale but also in the scale-up process. Clinical trials of a licensed topical ketoprofen transferosomal gel have shown promising results in the alleviation of symptons in orthreothritis with non-severe skin and subcutaneous tissue disorders. However, the product was withdrawn from the market which probably was related to the higher cost of the medicine linked to the expensive manufacturing process required in the production of transferosomes compared to other conventional gel formulations. This example brings out the need for a careful formulation design to exploit the best properties of this drug delivery system as well as the development of manufacturing processes easily scalable at industrial level.


Assuntos
Portadores de Fármacos/química , Desenvolvimento de Medicamentos/métodos , Bicamadas Lipídicas/química , Fosfolipídeos/química , Pele/metabolismo , Administração Cutânea , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/economia , Antirreumáticos/administração & dosagem , Antirreumáticos/economia , Membrana Celular/metabolismo , Permeabilidade da Membrana Celular , Ensaios Clínicos como Assunto , Portadores de Fármacos/economia , Composição de Medicamentos/economia , Composição de Medicamentos/métodos , Desenvolvimento de Medicamentos/economia , Etanol/química , Humanos , Interações Hidrofóbicas e Hidrofílicas , Osteoartrite/tratamento farmacológico , Pele/citologia , Absorção Cutânea , Dermatopatias/tratamento farmacológico , Tensoativos/química , Água/química
17.
PLoS One ; 14(12): e0226287, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31830144

RESUMO

INTRODUCTION: Rheumatoid Arthritis (RA) is a highly prevalent autoimmune disease associated with joint inflammation and destruction. Treatment for RA, especially with biologic agents (biologics), improves patient functionality and quality of life and averts costly complications or disease progression. Cost of RA pharmaceutical treatment has rarely been reported on the basis of real-world, big data. This study reports on the real-world, big data RA pharmaceutical treatment cost in Greece. METHODS: The Business Intelligence database of the National Organization for Healthcare Services Provision (EOPYY) was used to identify and provide analytics on patients on treatment for RA. EOPYY is responsible for funding healthcare and pharmaceutical care services for approximately 95% of the population in the country. ICD-10 codes were applied to identify patients with RA and at least one reimbursed prescription between 1 June 2014 and 31 May 2015. RESULTS: 35,873 unique patients were recorded as undergoing treatment for RA. Total reimbursed treatment cost for the study period was €81,206,363.70, of which €52,732,142.18 (64.94%) was for treatment with biologics. Of that cost, €39,724,489.71 (48.32%) accounted for treatment with anti-TNFs and/or methotrexate/corticosteroids. CONCLUSION: Real world, big data analysis confirms that the major driver of RA pharmaceutical cost is, as expected, the cost of treatment with biologics. It is critical to be able to match this cost to the treatment outcome it produces to ensure an optimal, no-waste, evidence-based allocation of healthcare resources to need.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/economia , Big Data/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde/estatística & dados numéricos , Preparações Farmacêuticas/economia , Adolescente , Adulto , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Criança , Pré-Escolar , Feminino , Grécia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
18.
Arthritis Res Ther ; 21(1): 285, 2019 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-31831064

RESUMO

INTRODUCTION: Biosimilar infliximab has the potential for appreciable cost savings compared to its reference biologic, but dose escalation is common and increases costs. We compared frequency of dose escalation and associated Medicare-approved amount so as to determine the break-even point at which infliximab dose escalation would offset the cost savings of using a biosimilar, referent to alternatively using golimumab. METHODS: We studied Medicare enrollees with rheumatoid arthritis (RA) initiating infliximab or golimumab. Frequency of dose escalation was summarized descriptively over 18 months, as were Medicare-approved amounts for reimbursement. Analyses were repeated conditioning on high adherence (i.e., non-discontinuation, > 10-week gap). Multivariable-adjusted logistic regression and mixed models evaluated factors associated with infliximab dose escalation. RESULTS: A total of 5174 infliximab and 2843 golimumab initiators were observed. Dose escalation was rare for golimumab (5%) but common for infliximab (49%), and was even more common (72%) for infliximab among patients who persisted on treatment. Regardless of dose escalation, the adjusted least square mean dollar amounts were appreciably higher for golimumab ($28,146) than for infliximab ($21,216) and greater among persistent patients (cost difference $9269, favoring infliximab). Only when patients escalated infliximab to ≥ 8 mg/kg every 6 weeks was golimumab IV at break-even or less expensive. After controlling for multiple factors, physician ownership of the infusion center was associated with greater likelihood of infliximab dose escalation (odds ratio = 1.25, 95% CI 1.09-1.44). CONCLUSION: Despite frequent dose escalation with infliximab that often increase its dose by threefold or more, the savings from the current price of its biosimilar substantially offsets the costs of an alternative infused TNFi biologic for which no biosimilar is available.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Infliximab/uso terapêutico , Adulto , Anticorpos Monoclonais/economia , Antirreumáticos/economia , Antirreumáticos/uso terapêutico , Medicamentos Biossimilares/economia , Estudos de Coortes , Relação Dose-Resposta a Droga , Custos de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Infliximab/economia , Modelos Logísticos , Masculino , Medicaid/economia , Medicare/economia , Pessoa de Meia-Idade , Estados Unidos
19.
Adv Rheumatol ; 59(1): 48, 2019 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-31727164

RESUMO

BACKGROUND: Pharmaceutical Assistance (PA) is a dynamic and multidisciplinary process that aims to supply health systems, programs or services with quality medicines, enabling access and health care, in an efficient and timely manner. The objective of the study was to evaluate the profile of administrative processes for the treatment of PsA, identify the time elapsed in the flow of processes and its associated factors. METHODS: A cross-sectional study of medication requests for the treatment of PsA was carried out between November 2014 and December 2016. Linear regression was used to verify the factors associated with time to delivery. RESULTS: A total of 218 cases containing 250 drugs were analyzed. The median time between the medical appointment and the first dispensation was 66 days (interquartile range, 44-90). The State proceedings, which includes requesting the drug until the authorization of treatment, was the stage that most contributed to the total time spent. The factors associated with the longer time to delivery of medications were prescriptions coming from clinics and specialty centers, from dermatologists, non-authorized processes and non-persistent patients in the treatment in 12 months. CONCLUSION: The median time to receive medicines for the PsA treatment in Belo Horizonte health region after a medical prescription was higher than 2 months. The time between the solicitation of the medicines and the authorization of the treatment in the SUS (State administrative procedure) was the main component of the total time spent.


Assuntos
Antirreumáticos/provisão & distribução , Artrite Psoriásica/tratamento farmacológico , Custos de Medicamentos , Inibidores do Fator de Necrose Tumoral/provisão & distribução , Antirreumáticos/economia , Brasil , Estudos Transversais , Feminino , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde/economia , Reumatologistas/estatística & dados numéricos , Fatores de Tempo , Inibidores do Fator de Necrose Tumoral/economia
20.
Medicine (Baltimore) ; 98(48): e17750, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770193

RESUMO

The aim of this study was to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) (ABN + MTX) versus conventional disease-modifying anti-rheumatic drugs (cDMARDs) in rheumatoid arthritis (RA) patients.Forty-eight moderate to severe RA patients underwent ABN + MTX or cDMARDs treatment were consecutively enrolled and assigned to ABN + MTX group (n = 26) and control group (n = 22). Patients were followed up and their disease activity and quality of life (QoL) were evaluated at 3rd month, 6th month and 12th month after initiation of treatment. Treatment costs of 2 groups were calculated, then pharmacoeconomic analysis was performed.ABN + MTX increased drug cost and total cost while decreased indirect cost compared with cDMARDs after 12-month treatment. ABN + MTX group gained additional 0.22 quality-adjusted life years (QALY) and yielded an incremental cost-effectiveness ratio (ICER) of ¥104,293.6 per QALY after treatment. Sensitivity analysis reveals that rising ABN price by 20% produced an ICER of ¥130,403.6 per QALY, which was still lower than 3 times of the mean gross domestic product (GDP) per capita during the same period in China (¥165,960). Besides, ABN + MTX was more cost-effective in severe RA patients compared to moderate RA patients.ABN + MTX is cost-effective in treating moderate to severe RA patients compared with cDMARDs, although the total cost of ABN + MTX is relatively higher.


Assuntos
Antirreumáticos/economia , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/economia , Custos de Medicamentos/estatística & dados numéricos , Fragmentos Fc das Imunoglobulinas/economia , Metotrexato/economia , Receptores Tipo II do Fator de Necrose Tumoral/economia , Proteínas Recombinantes de Fusão/economia , Idoso , Antirreumáticos/administração & dosagem , Artrite Reumatoide/economia , Medicamentos Biossimilares/administração & dosagem , Análise Custo-Benefício , Quimioterapia Combinada/economia , Feminino , Humanos , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Masculino , Metotrexato/administração & dosagem , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Receptores Tipo II do Fator de Necrose Tumoral/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Índice de Gravidade de Doença , Resultado do Tratamento
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