RESUMO
BACKGROUND: Understanding the economic value of deucravacitinib and apremilast could assist treatment decision-making for patients with moderate to severe plaque psoriasis. OBJECTIVE: This study compared the cost per response (CPR) for US patients initiating deucravacitinib versus apremilast for moderate to severe plaque psoriasis. METHODS: A CPR model using pharmacy and administration costs was developed from a US payer perspective. Response was defined as a 75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at weeks 16 and 24. Long-term response was defined as the cumulative benefit over 52 weeks, measured as area under the curve; subsequent treatment was included. Scenario analyses explored varying the efficacy measure or choices of subsequent treatments and limiting discontinuation. RESULTS: The CPR for deucravacitinib versus apremilast was lower at 16 weeks (difference: -$3796 [95% confidence interval (CI): -$6140 to -$1659]) and 24 weeks (difference: -$12,784 [95% CI: -$16,674 to -$9369]). At 52 weeks, the cost per cumulative benefit was lower for patients who initiated deucravacitinib, regardless of initial treatment period duration (16 or 24 weeks). CONCLUSIONS: Scenario analyses found mainly consistent results. This study showed that the CPR is lower when initiating deucravacitinib versus apremilast in moderate to severe plaque psoriasis.
Assuntos
Análise Custo-Benefício , Psoríase , Índice de Gravidade de Doença , Talidomida , Humanos , Psoríase/tratamento farmacológico , Psoríase/economia , Estados Unidos , Talidomida/análogos & derivados , Talidomida/economia , Talidomida/uso terapêutico , Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Resultado do Tratamento , Custos de Medicamentos , Masculino , FemininoRESUMO
BACKGROUND: Survival outcomes for multiple myeloma have improved dramatically since the introduction of novel therapeutic agents. While these drugs are highly effective in improving survival outcomes and quality of life in patients with multiple myeloma, they come at a significant cost. We assessed the cost-effectiveness of bortezomib-based triplet or quadruplet drug regimens in isolation and followed by autologous hematopoietic stem cell transplantation (AHSCT) for the treatment of newly diagnosed multiple myeloma (NDMM) in the Indian context. METHODS: A Markov model was developed to assess the health and economic outcomes of novel drug regimens with and without AHSCT for the treatment of NDMM in India. We estimated the lifetime quality-adjusted life-years (QALYs) and costs in each scenario. The incremental cost-effectiveness ratios (ICERs) were computed and compared against the current willingness-to-pay threshold of a one-time per capita gross domestic product of â¹146,890 (US$1,927.70) for India. Parameter uncertainty was assessed through Monte Carlo probabilistic sensitivity analysis. RESULTS: Among seven treatment sequences, the VCd (bortezomib, cyclophosphamide, dexamethasone) alone arm has the lowest cost and health benefits as compared to four treatment sequences, namely VTd (bortezomib, thalidomide, dexamethasone) alone, VRd (bortezomib, lenalidomide, dexamethasone) alone, VRd plus AHSCT and DVRd (Daratumumab, bortezomib, lenalidomide, dexamethasone) plus AHSCT. It was found that VTd plus AHSCT and VCd plus AHSCT arms were extendedly dominated (ED) by combination of two alternative treatments. Among the five non-dominated strategies, VRd has a lowest incremental cost of â¹ 2,20,093 (US$2,888) per QALY gained compared to VTd alone followed by VRd plus AHSCT [â¹3,14,530 (US$4,128) per QALY gained] in comparison to VRd alone. None of the novel treatment sequences were found to be cost-effective at the current WTP threshold of â¹1,46,890 (US$1,927.7). CONCLUSION: At the current WTP threshold of one-time per capita GDP (â¹ 146,890) of India, VRd alone and VRd plus AHSCT has 38.1% and 6.9% probability to be cost-effective, respectively. Reduction in current reimbursement rates of novel drugs, namely VRd, lenalidomide, and pomalidomide plus dexamethasone under national insurance program and societal cost of transplant by 50%, would make VRd plus AHSCT and VTd plus AHSCT cost-effective at an incremental cost of â¹40,671 (US$34) and â¹97,639 (US$1,281) per QALY gained, respectively.
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Bortezomib , Análise Custo-Benefício , Transplante de Células-Tronco Hematopoéticas , Cadeias de Markov , Mieloma Múltiplo , Anos de Vida Ajustados por Qualidade de Vida , Mieloma Múltiplo/tratamento farmacológico , Humanos , Índia , Transplante de Células-Tronco Hematopoéticas/economia , Bortezomib/uso terapêutico , Bortezomib/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Dexametasona/uso terapêutico , Dexametasona/economia , Dexametasona/administração & dosagem , Masculino , Feminino , Lenalidomida/uso terapêutico , Pessoa de Meia-Idade , Ciclofosfamida/uso terapêutico , Ciclofosfamida/economia , Talidomida/economia , Talidomida/uso terapêutico , Talidomida/análogos & derivados , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Anticorpos MonoclonaisRESUMO
PURPOSE OF REVIEW: Based on personal experiences, recommendations for physicians treating patients with multiple myeloma (MM) in low- and middle-income countries (LMICs) are proposed. RECOMMENDATIONS: (1) Implement strategies to keep the patient in the best possible condition for the longest time, in addition to focusing on ways to avoid financial toxicity; (2) if lenalidomide is unavailable, start treatment with thalidomide and dexamethasone, include, if possible, bortezomib; (3) conduct an outpatient-based autologous stem cell transplantation (ASCT) in all eligible patients; (4) use thalidomide as post-ASCT maintenance treatment if lenalidomide is unavailable for the standard risk patients; (5) monitor monoclonal proteins with serum protein electrophoresis and free light chain measurements; (6) employ novel drugs in cases of relapsed or refractory disease; and (7) do not forget supportive therapy. The therapeutic recommendations to treat patients with MM are somewhat different for physicians working in LMICs, compared with those treating patients in high-income countries. These are relevant since more than 50% of the inhabitants of the world live in LMICs, thus indicating that the vast majority of patients with MM are being treated in resource-constrained settings. As time goes by, physicians may acquire the ability to analyze and express their feelings and experiences about topics in the practice of medicine in which they could have learned lessons (1). Since 1980, we have been treating patients with multiple myeloma (MM); to date, we have been personally involved in the study and treatment of more than 300 patients with this disease (2). Having gained experience dealing with MM patients in underprivileged circumstances, such as those prevailing in our country: México, having explored different ideas, treatments, and methods, and being aware of the financial implications which may impact our selection of therapeutic strategies and recommendations, we felt that it was appropriate to share in this article some of these ideas with practitioners around the world who are involved in the treatment of patients with MM in low- and middle-income countries (LMICs).
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Mieloma Múltiplo/terapia , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Bortezomib/economia , Bortezomib/uso terapêutico , Países em Desenvolvimento , Dexametasona/economia , Dexametasona/uso terapêutico , Humanos , Imunossupressores/economia , Imunossupressores/uso terapêutico , Mieloma Múltiplo/diagnóstico , Mieloma Múltiplo/economia , Pobreza , Transplante de Células-Tronco/economia , Talidomida/economia , Talidomida/uso terapêuticoRESUMO
Plaque psoriasis is a chronic disease requiring long-term therapy. However, long-term real-world treatment patterns and costs are not well characterized. This study examined treatment patterns and healthcare costs among patients newly initiating a biologic or apremilast for moderate-to-severe plaque psoriasis. Included patients had ?1 prescription for secukinumab, ixekizumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018, no prior use of the index medication, and continuous enrolment 12 months pre-index and 24 months post-index. Treatment adherence, non-persistence, discontinuation, switching, use of combination therapy, and re-initiation were assessed at 12, 18, and 24 -months post-index. In addition, total and psoriasis-related healthcare costs were evaluated at 24 months. A total of 7,773 patients with 24-month follow-up were included. Overall, adherence was low (21.3%-33.5%) and non-persistence was high (58.4%-86.5%) over 24 months. Discontinuation (38.4%-51.3%), switching (29.7%-52.6%), combination therapy (27.6%-42.9%), and re-initiation of the index medication (19.3%-44.5%) were common. Healthcare costs were high and mostly contributed by psoriasis treatment. Therefore, maintaining disease control on long-term therapy is still challenging for many patients.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Custos de Cuidados de Saúde , Psoríase/tratamento farmacológico , Psoríase/economia , Talidomida/análogos & derivados , Adulto , Assistência Ambulatorial/economia , Honorários Farmacêuticos , Feminino , Hospitalização/economia , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Talidomida/economia , Talidomida/uso terapêuticoRESUMO
OBJECTIVES: To compare treatment patterns and costs among psoriasis patients with and without metabolic conditions newly initiating a biologic or apremilast. METHODS: Adult patients included had ≥1 prescription for secukinumab, adalimumab, ustekinumab, etanercept, or apremilast between 01/01/2015 and 08/31/2018 (date of first prescription was index date) and no index drug use in the 12-months pre-index, and continuous enrollment in the 12-month pre-index and 24-month post-index periods. Patients were divided into mutually exclusive treatment cohorts and stratified by their pre-index metabolic condition status. Treatment patterns (adherence, non-persistence, switching, discontinuation, use of combination therapy, and re-initiation) and healthcare costs were compared. RESULTS: Overall, 7773 patients were included; 47.5-56.7% had a metabolic condition. Except for the apremilast group, patients with metabolic conditions had higher discontinuation (secukinumab: 50.6% vs. 43.7%; adalimumab*: 53.9% vs. 48.7%; ustekinumab*: 41.9% vs. 35.1%; etanercept: 42.8% vs. 41.2%; apremilast: 43.1% vs. 46.1%) and switching (secukinumab: 48.1% vs. 41.2%; adalimumab*: 47.8% vs. 41.9%; ustekinumab*: 34.5% vs. 25.3%; etanercept*: 53.6% vs. 51.5%; apremilast: 45.8% vs. 44.6%) than patients without (*p < .05). Patients with metabolic conditions incurred significantly higher costs. CONCLUSION: Many psoriasis patients initiating biologics or apremilast had metabolic conditions. These patients had higher discontinuation and switching, and significantly higher healthcare costs.
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Fármacos Dermatológicos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Psoríase/tratamento farmacológico , Adalimumab/economia , Adalimumab/uso terapêutico , Adulto , Bases de Dados Factuais , Fármacos Dermatológicos/economia , Etanercepte/economia , Etanercepte/uso terapêutico , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Psoríase/economia , Estudos Retrospectivos , Talidomida/análogos & derivados , Talidomida/economia , Talidomida/uso terapêutico , Resultado do Tratamento , Ustekinumab/economia , Ustekinumab/uso terapêuticoRESUMO
Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.
Assuntos
Betametasona/análogos & derivados , Produtos Biológicos/administração & dosagem , Calcitriol/análogos & derivados , Fármacos Dermatológicos/administração & dosagem , Psoríase/tratamento farmacológico , Administração Cutânea , Aerossóis , Betametasona/administração & dosagem , Betametasona/efeitos adversos , Betametasona/economia , Produtos Biológicos/efeitos adversos , Produtos Biológicos/economia , Calcitriol/administração & dosagem , Calcitriol/efeitos adversos , Calcitriol/economia , Análise Custo-Benefício , Fármacos Dermatológicos/efeitos adversos , Fármacos Dermatológicos/economia , Combinação de Medicamentos , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/economia , Quimioterapia Combinada/métodos , Humanos , Psoríase/diagnóstico , Psoríase/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Talidomida/administração & dosagem , Talidomida/efeitos adversos , Talidomida/análogos & derivados , Talidomida/economia , Resultado do TratamentoRESUMO
Aim: Treatment switching and healthcare costs were compared among biologic-naive psoriasis patients initiating apremilast or biologics with ≥12 months pre-/post-index continuous enrollment in Optum Clinformatics™ Data Mart. Methods: After propensity score matching, switch rates (new therapy post-index) and days between index and switch were assessed. Total and per-patient per-month costs by service type were assessed. Results: Apremilast initiators (n = 533) were matched and compared with biologic initiators (n = 955). Twelve-month cumulative switch rates and days to switch were similar. Apremilast initiators had significantly lower total healthcare costs than biologic initiators; apremilast switchers and nonswitchers had significantly lower per-patient per-month costs than biologic switchers and nonswitchers, driven mainly by reduced outpatient pharmacy costs. Conclusion: Apremilast initiators had lower healthcare costs even with treatment switching.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Produtos Biológicos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Inibidores da Fosfodiesterase 4/uso terapêutico , Psoríase/tratamento farmacológico , Talidomida/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/economia , Produtos Biológicos/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Fosfodiesterase 4/economia , Pontuação de Propensão , Estudos Retrospectivos , Talidomida/economia , Talidomida/uso terapêutico , Resultado do Tratamento , Troca de TratamentoRESUMO
BACKGROUND: In Québec, targeted biologic therapies for moderate to severe plaque psoriasis are restricted to patients who have not responded to phototherapy or conventional systemic treatment, primarily due to high drug costs. Apremilast, an oral treatment for plaque psoriasis, was added to the Québec provincial health insurance plan (Régie de l'assurance maladie du Québec; RAMQ) formulary in 2015, making this the only province in Canada with public drug plan reimbursement for apremilast. OBJECTIVES: The aim of this study is to describe patients' characteristics, treatment patterns, healthcare resource utilization (HCRU), and associated costs and to measure real-world budget impact of using apremilast before biologics in plaque psoriasis. METHODS: This study was performed using RAMQ drug claims and medical services data. Patients diagnosed with psoriasis between January 2015 and December 2017 were identified. Medical services and prescription claims were categorized as all-cause and psoriasis-related. Using RAMQ database estimates, a 3-year budget impact analysis was developed comparing treatment cost with and without the addition of apremilast to the formulary. RESULTS: In all, 540 patients were identified (apremilast: n = 92; biologics: n = 448). Comorbidity burden and treatment persistence and adherence were comparable between apremilast and biologic users. The year following the index date, all-cause HCRU was lower for apremilast versus biologic users (CAN$19 763 vs CAN$28 025; P < .01), mainly driven by drug cost. Using apremilast before biologics resulted in an estimated RAMQ net savings of CAN$49 290 (2015), CAN$746 856 (2016), and CAN$1 216 512 (2017), and a total savings of CAN$2 012 658 since apremilast's addition to the formulary. CONCLUSION: Adding apremilast to the drug formulary of other Canadian provinces could result in significant healthcare savings.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Psoríase/tratamento farmacológico , Talidomida/análogos & derivados , Adulto , Idoso , Anti-Inflamatórios não Esteroides/economia , Uso de Medicamentos/economia , Uso de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Psoríase/economia , Psoríase/epidemiologia , Quebeque/epidemiologia , Estudos Retrospectivos , Talidomida/economia , Talidomida/uso terapêutico , Adulto JovemRESUMO
BACKGROUND: Several new treatment options have been approved for relapsed and/or refractory multiple myeloma (RRMM). In this systematic review, associations of the efficacy of each approved regimen with adverse events (AEs) and the total cost per cycle were compared with a Bayesian network meta-analysis (NMA) of phase 3 randomized controlled trials (RCTs). METHODS: Scopus, Cochrane, PubMed Publisher, and Web of Science were searched from January 1999 to July 2018 for phase 3 RCTs of regimens (approved by the US Food and Drug Administration) used in RRMM. The relative ranking of agents was assessed with surface under the cumulative ranking (SUCRA) probabilities. The primary efficacy, safety, and cost outcomes were progression-free survival with the regimen, grade 3 to 4 AEs, and the total cost per cycle (regimen cost plus average cost of managing AEs). RESULTS: Fifteen studies including 7718 patients and evaluating 14 different regimens were identified. Daratumumab, lenalidomide, and dexamethasone were ranked highest for reducing progression (hazard ratio, 0.13; 95% credible interval, 0.09-0.19; SUCRA, 1) but carried the highest probability of total cost per cycle ($41,420; 95% Credible Interval [CrCl], $58,665-$78,041; SUCRA, 0.02). Panobinostat, bortezomib, and dexamethasone were the least effective and least safe (SUCRA, 0.24), whereas bortezomib, thalidomide, and dexamethasone emerged as least effective with the highest total cost per cycle (SUCRA, 0.33). Carfilzomib and dexamethasone emerged as the winner when this regimen was considered in terms of efficacy and safety (SUCRA, 0.61) and efficacy and total cost per cycle (SUCRA, 0.60). CONCLUSIONS: The results of this NMA can provide additional guidance for the decision-making process when one is choosing the most appropriate regimen for RRMM.
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Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Teorema de Bayes , Bortezomib/administração & dosagem , Bortezomib/economia , Ensaios Clínicos Fase III como Assunto , Dexametasona/administração & dosagem , Dexametasona/economia , Custos de Medicamentos , Humanos , Lenalidomida/administração & dosagem , Lenalidomida/economia , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/patologia , Oligopeptídeos/administração & dosagem , Oligopeptídeos/economia , Intervalo Livre de Progressão , Ensaios Clínicos Controlados Aleatórios como Assunto , Talidomida/administração & dosagem , Talidomida/economia , Resultado do TratamentoRESUMO
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.
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects an estimated 30% of psoriasis patients who use systemic therapy. Symptoms of PsA, such as joint swelling and tenderness, can be painful and disabling and may worsen quality of life. PsA can also impart a substantial economic burden. Treatment for moderate to severe PsA often involves the use of systemic oral medications (e.g., conventional systemic treatments such as methotrexate or targeted systemic treatments such as apremilast) or biologic therapy given by injection or infusion. Because PsA symptoms and responses to treatment can vary, patients may switch treatments over time. More research is needed to better understand how switching treatments affects healthcare costs among patients starting treatment with apremilast or a biologic for PsA. This study compared treatment switching and healthcare costs among patients with PsA who had never been treated with a biologic and who started treatment with apremilast or a biologic for PsA. Rates of treatment switching at 12 months were similar for patients starting treatment with apremilast versus those starting a biologic. Patients starting treatment with apremilast had significantly lower total healthcare costs compared with those starting a biologic, even if they later switched to a biologic. Healthcare costs calculated per patient per month (PPPM) were also lower with apremilast versus biologics, driven by lower PPPM pharmacy costs. These findings suggest that starting treatment with apremilast may be an effective and cost-effective strategy for managing PsA, even for patients who later switch to a biologic.
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/epidemiologiaRESUMO
Aims: The aim of this study was to conduct a cost-effectiveness analysis, as well as a budget impact analysis, on the use of apremilast for the treatment of adult patients with psoriatic arthritis (PsA), within the Italian National Health Service (NHS).Methods: A Markov state transition cohort model, which was adapted to the Italian context, was used to compare the costs of the currently available treatments and of the patients' quality of life with two alternative treatment sequences, with or without apremilast as pre-biologic therapy. Moreover, a budget impact model was developed based on the population of patients treated for PsA in Italy, who can be eligible for treatment with apremilast. The eligible population was represented by adult patients with PsA who had an inadequate response to or were intolerant to previous disease-modifying antirheumatic drugs (DMARDs), for the approved indication, and for the treatment studied in the economic analytic model.Results: This cost-effectiveness analysis estimated that the strategy of using apremilast before biologic therapy is cost-effective, with an incremental cost-effectiveness ratio of 32,263.00 per QALY gained which is slightly over the normal threshold found in other Italian economic studies, which usually considers a 40-year-period. Conversely, the budget impact analysis was conducted over 3 years, and it led to an estimated annual saving of 1.6 million, 4.6 million and 5.5 million in the first, second and third year of apremilast commercialization, respectively, for a total saving of 11.75 million in 3 years.Limitations: Limitations of this analysis include the absence of head-to-head trials comparing therapies included in the economic model, the lack of comparative long-term data on treatment efficacy, and the assumption of complete independence between the considered response rates to therapy.Conclusion: The use of apremilast as a first option before the use of biologic agents may represent a cost-effective treatment strategy for patients with PsA who fail to respond to, or are intolerant to, previous DMARD therapy. In addition, based on a budget impact perspective, the use of apremilast may lead to cost savings to the Italian healthcare system.
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Anti-Inflamatórios não Esteroides/economia , Artrite Psoriásica/tratamento farmacológico , Orçamentos , Talidomida/análogos & derivados , Análise Custo-Benefício , Humanos , Itália , Cadeias de Markov , Qualidade de Vida , Inquéritos e Questionários , Talidomida/economiaRESUMO
Aims: The aim of this study was to conduct a cost-effectiveness analysis, as well as a budget impact analysis, on the use of apremilast for the treatment of adult patients with moderate-to-severe plaque psoriasis (defined as a psoriasis area severity index [PASI] ≥ 10), who failed to respond to, had a contraindication to, or were intolerant to other systemic therapies, within the Italian National Health Service (NHS).Materials and methods: A Markov state-transition cohort model adapted to the Italian context was used to compare the costs of the currently available treatments and of the patients' quality of life with two alternative treatment sequences, with or without apremilast as pre-biologic therapy. Moreover, a budget impact model was developed based on the population of patients treated for psoriasis in Italy, who would be eligible for treatment with apremilast.Results: Over 5 years, the cost-effectiveness analysis showed that the strategy of using apremilast before biologic therapy was dominant compared with the sequence of biologic treatments without apremilast. In addition, it is important to underline that the use of apremilast slightly increases the quality-adjusted life years gained over 5 years. Furthermore, within the budget impact analysis, the strategy including apremilast would lead to a saving of 16 million within 3 years. Savings would mainly be related to a reduction in pharmaceutical spending, hospital admissions and other drug administration-related costs.Conclusion: These models proved to be robust to variation in parameters and it suggested that the use of apremilast would lead to savings to the Italian healthcare system with potential benefits in terms of patients' quality of life.
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/economia , Psoríase/tratamento farmacológico , Talidomida/análogos & derivados , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Itália , Pessoa de Meia-Idade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , Talidomida/administração & dosagem , Talidomida/economiaRESUMO
Elderly patients are a group with a high frequency of psoriasis. Their disease burden has negative impacts on their quality of life. While there is a clear need to treat these patients, there are challenges in doing so. This work seeks to define the challenges that exist in treating elderly Medicare patients, as well as to provide treatment suggestions for providers to follow if they encounter one or more of these challenges. Providers face the following challenges when creating treatment plants for elderly patients with psoriasis: difficulty in obtaining drug coverage through Medicare, increased medical comorbidities, and polypharmacy. Providers aim for regimens that are affordable, safe, and efficacious, but it is not always clear how to achieve this combination, especially in elderly Medicare patients. This work is relevant in that it aims to explain the logistical roadblocks posed by Medicare coverage and provide solutions for commonly encountered issues in the treatment of a disabling and common disease in a high-risk population. Specifically, alternative treatment options to biologics and small-molecule inhibitors are discussed and include topical therapies, phototherapy, methotrexate, acitretin, and cyclosporine and for psoriatic arthritis include corticosteroids and leflunomide. The specific risks and benefits of these therapies in the elderly population are provided, allowing providers to make patient-specific decisions about optimal regimens.
Assuntos
Artrite Psoriásica/tratamento farmacológico , Fármacos Dermatológicos/administração & dosagem , Psoríase/tratamento farmacológico , Idoso , Artrite Psoriásica/economia , Artrite Psoriásica/patologia , Produtos Biológicos/administração & dosagem , Produtos Biológicos/economia , Fármacos Dermatológicos/economia , Humanos , Medicare/economia , Fototerapia/métodos , Psoríase/economia , Psoríase/patologia , Qualidade de Vida , Índice de Gravidade de Doença , Talidomida/administração & dosagem , Talidomida/análogos & derivados , Talidomida/economia , Estados UnidosRESUMO
In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in 2012. The reason for rejection was the lack of comparative effectiveness studies proving that LEN was more effective than thalidomide (THAL), a strictly controlled drug regulated by Federal law 10.651/2003 and dispensed to patients (at no costs) through public health system units and hospitals. ANVISA unexplained retreat on the LEN approval for marketing was an unquestionable triumph of the lobbying that ensued the denial, at the forefront of which were politicians, Congress members, patient organizations and medical societies. Two randomized (phase III) trials and three observational (case-control and population-based cohort) compared the effectiveness of THAL- versus LEN-based therapies in MM. Overall, these studies showed no difference in efficacy between LEN- and THAL-based therapies. LEN caused less neuropathy, and more severe hematologic adverse effects. It is much costlier than THAL, and substitution of THAL by LEN shall raise considerably public healthcare costs in Brazil.
Assuntos
Inibidores da Angiogênese/administração & dosagem , Controle de Medicamentos e Entorpecentes , Lenalidomida/administração & dosagem , Talidomida/administração & dosagem , Inibidores da Angiogênese/efeitos adversos , Inibidores da Angiogênese/economia , Brasil , Análise Custo-Benefício , Custos de Medicamentos , Humanos , Lenalidomida/efeitos adversos , Lenalidomida/economia , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/economia , Síndromes Mielodisplásicas/tratamento farmacológico , Síndromes Mielodisplásicas/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Talidomida/efeitos adversos , Talidomida/economia , Resultado do TratamentoRESUMO
Abstract In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in 2012. The reason for rejection was the lack of comparative effectiveness studies proving that LEN was more effective than thalidomide (THAL), a strictly controlled drug regulated by Federal law 10.651/2003 and dispensed to patients (at no costs) through public health system units and hospitals. ANVISA unexplained retreat on the LEN approval for marketing was an unquestionable triumph of the lobbying that ensued the denial, at the forefront of which were politicians, Congress members, patient organizations and medical societies. Two randomized (phase III) trials and three observational (case-control and population-based cohort) compared the effectiveness of THAL- versus LEN-based therapies in MM. Overall, these studies showed no difference in efficacy between LEN- and THAL-based therapies. LEN caused less neuropathy, and more severe hematologic adverse effects. It is much costlier than THAL, and substitution of THAL by LEN shall raise considerably public healthcare costs in Brazil.
Resumo A Agência Nacional de Vigilância Sanitária (ANVISA) aprovou em abril de 2017 a lenalidomida (LEN) para o mieloma múltiplo (MM) e síndrome mielodisplásica. A ANVISA havia negado o registro em 2010, e indeferido um recurso apresentado em 2012. O motivo do indeferimento foi a falta de estudos comparativos de efetividade demonstrando que LEN era mais eficaz do que a talidomida (TAL), um medicamento rigorosamente controlado pela lei federal 10.651/2003 e dispensado gratuitamente a pacientes através de unidades de saúde e hospitais públicos. O recuo não explicado da ANVISA em relação ao registro da LEN foi um inquestionável triunfo do lobby que sucedeu a recusa inicial do registro, a frente do qual estavam políticos, membros do Congresso, associações de pacientes e sociedades médicas. Dois ensaios randomizados (fase III) e três estudos observacionais (caso-controle e coorte de base populacional) compararam a efetividade de terapias para o MM com TAL- e com LEN. Em conjunto, esses estudos mostraram que não havia diferenças quanto a eficácia de tratamentos com LEN- e aqueles com TAL. A LEN causou menos neuropatias, e efeitos adversos hematológicos mais graves. Ela é muito mais cara do que a TAL, e a substituição da TAL pela LEN aumentará muito os custos da assistência pública à saúde no Brasil.
Assuntos
Humanos , Talidomida/administração & dosagem , Inibidores da Angiogênese/administração & dosagem , Controle de Medicamentos e Entorpecentes , Lenalidomida/administração & dosagem , Talidomida/economia , Talidomida/efeitos adversos , Síndromes Mielodisplásicas/economia , Síndromes Mielodisplásicas/tratamento farmacológico , Brasil , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Custos de Medicamentos , Análise Custo-Benefício , Inibidores da Angiogênese , Inibidores da Angiogênese/efeitos adversos , Lenalidomida/economia , Lenalidomida/efeitos adversos , Mieloma Múltiplo/economia , Mieloma Múltiplo/tratamento farmacológicoRESUMO
Aim: To assess the cost-effectiveness of lenalidomide plus low dose dexamethasone (Rd) relative to bortezomib-contained therapy (BCT) for newly diagnosed multiple myeloma patients ineligible for stem cell transplantation (ndMM) in China. Materials & methods: A literature review was conducted to identify appropriate evidence for developing a cost-effectiveness model comparing Rd with BCT for lifetime health outcomes and direct medical costs in Chinese ndMM patients. Results: The estimated incremental cost-effectiveness ratio per gained quality-adjusted life years for Rd versus BCT was ¥49,793. The chance for Rd to be cost effective, under the cost-effectiveness thresholds of three-times the 2018 Chinese gross domestic goods per capita, was 90.8%. Conclusion: The cost-effectiveness of Rd relative to BCT for ndMM in Chinese patients is highly attractive.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/economia , Mieloma Múltiplo/economia , Transplante de Células-Tronco/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bortezomib/administração & dosagem , Bortezomib/economia , China , Terapia Combinada/economia , Análise Custo-Benefício , Dexametasona/uso terapêutico , Feminino , Humanos , Lenalidomida/administração & dosagem , Lenalidomida/economia , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/terapia , Estudos Observacionais como Assunto , Anos de Vida Ajustados por Qualidade de Vida , Transplante de Células-Tronco/métodos , Talidomida/administração & dosagem , Talidomida/economiaRESUMO
Aim: To compare monthly healthcare resource utilization (HRU) and costs among adult patients with multiple myeloma (MM) receiving second or subsequent line of treatment (LOT) with carfilzomib or pomalidomide as monotherapy or in combination with dexamethasone. Methods and materials: Adult MM patients who received carfilzomib or pomalidomide as second/subsequent LOT between 2006 and 2014 were selected from the MarketScan databases. LOT was determined using Medical/pharmacy claims using a published algorithm. For each patient, first LOT with carfilzomib or pomalidomide was defined as index LOT. Patients with first LOT as index LOT, who received other chemotherapy in combination with carfilzomib or pomalidomide, or who underwent stem cell transplant (STC) during index LOT were excluded. Monthly HRU and costs during index LOT were compared using inverse probability of treatment weights (IPTW) based on propensity scores for receipt of carfilzomib estimated by logistic regression with LOT, patient demographics, Charlson index, comorbidities, pre-index healthcare cost, and receipt of prior SCT as covariates. Results: After weighting, baseline characteristics were well balanced among 114 carfilzomib and 144 pomalidomide patients. Mean (95% CI) numbers of outpatient visits per month were 7.1 (5.2-8.0) with carfilzomib and 4.7 (3.9-6.1) with pomalidomide (p = 0.006). Otherwise, there were no statistically significant differences between the groups in mean monthly HRU and costs or median time to therapy discontinuation. Mean (95% CI) monthly total healthcare costs were $19,776 (15,322-27,748) with pomalidomide and $17,321 (12,412-21,874) with carfilzomib (p = 0.522). Limitations: Comparison of carfilzomib vs pomalidomide may be biased if there are unobserved factors not balanced by IPTW. The relatively small sample size limits the power of analyses to detect potential differences between treatment groups. Conclusions: Monthly HRU and costs are similar among patients with relapse or refractory MM patients receiving carfilzomib or pomalidomide as monotherapy or in combination with dexamethasone.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Dexametasona/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Oligopeptídeos/uso terapêutico , Talidomida/análogos & derivados , Fatores Etários , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Comorbidade , Dexametasona/administração & dosagem , Dexametasona/economia , Feminino , Gastos em Saúde/estatística & dados numéricos , Recursos em Saúde/economia , Humanos , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/economia , Oligopeptídeos/administração & dosagem , Oligopeptídeos/economia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Recidiva , Características de Residência , Fatores Sexuais , Talidomida/administração & dosagem , Talidomida/economia , Talidomida/uso terapêuticoRESUMO
OBJECTIVE: We provide a real-world overview of multiple myeloma (MM) treatment patterns, outcomes and healthcare resource use (HRU) in Portugal. METHODS: Data were collected retrospectively from consecutive patients diagnosed/treated at the Portuguese Oncology Institute of Porto (IPO-Porto) between 2012 and 2015. Primary objectives were progression-free survival (PFS) and overall survival (OS), with treatment patterns and HRU secondary. Analysis was by line of therapy (LOT), and post hoc by age (<65/≥65 years). RESULTS: 165, 73 and 32 patients received first, second and third LOTs respectively (N = 187). OS probabilities were 91.5%, 83.2% (<65 years) and 86.6%, 65.3% (≥65 years) at 12, 24 months respectively. PFS decreased from the start of each LOT for both age groups and was less for patients ≥65 years. Younger patients received more combination treatment (immunomodulatory drugs + proteasome inhibitors) and stem cell transplants, and had higher mean costs than older patients (81,213 vs. 36,864 where three LOTs were received). Cost drivers were medications, transplantations and hospitalisations. CONCLUSION: Our results suggest divergence between younger and older MM patients. Older patients had lower OS and PFS probabilities, HRU costs and fewer stem cell transplantations. The treatment patterns in each LOT may differ from other countries' findings, suggesting treatment heterogeneity.
Assuntos
Antineoplásicos/uso terapêutico , Custos de Cuidados de Saúde , Fatores Imunológicos/uso terapêutico , Mieloma Múltiplo/terapia , Padrões de Prática Médica , Inibidores de Proteassoma/uso terapêutico , Transplante de Células-Tronco/estatística & dados numéricos , Fatores Etários , Idoso , Antineoplásicos/economia , Compostos de Boro/economia , Compostos de Boro/uso terapêutico , Bortezomib/economia , Bortezomib/uso terapêutico , Custos de Medicamentos/estatística & dados numéricos , Feminino , Glicina/análogos & derivados , Glicina/economia , Glicina/uso terapêutico , Recursos em Saúde/economia , Hospitalização/economia , Humanos , Fatores Imunológicos/economia , Lenalidomida/economia , Lenalidomida/uso terapêutico , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/economia , Portugal , Intervalo Livre de Progressão , Inibidores de Proteassoma/economia , Transplante de Células-Tronco/economia , Taxa de Sobrevida , Talidomida/economia , Talidomida/uso terapêuticoRESUMO
OBJECTIVE: This study compared real-world treatment patterns and healthcare costs among biologic-naive psoriasis patients initiating apremilast or biologics. METHODS: A retrospective cohort study was conducted using the Optum Clinformatics™ claims database. Patients with psoriasis were selected if they had initiated apremilast or biologics between January 1, 2014, and December 31, 2015; had 12 months of pre-index and post-index continuous enrollment in the database; and were biologic-naive. The index date was defined as the date of the first claim for apremilast or biologic, and occurred between January 1, 2014, and December 31, 2015. Treatment persistence was defined as continuous treatment without a > 60-day gap in therapy (discontinuation) or a switch to a different psoriasis treatment during the 12-month post-index period. Adherence was defined as a medication possession ratio (MPR) of ≥ 80% while persistent on the index treatment. Persistence-based MPR was defined as the number of days with the medication on hand measured during the patients' period of treatment persistence divided by the duration of the period of treatment persistence. Because patients were not randomized, apremilast patients were propensity score matched up to 1:2 to biologic patients to adjust for possible selection bias. Treatment persistence/adherence and all-cause healthcare costs were evaluated. Cost differences were determined using Wilcoxon rank-sum tests. RESULTS: In all, 343 biologic-naive patients initiating apremilast were matched to 680 biologic-naive patients initiating biologics. After matching, patient characteristics were similar between cohorts. Twelve-month treatment persistence was similar for biologic-naive patients initiating apremilast vs biologics (32.1% vs 33.2%; p = 0.7079). While persistent on therapy up to 12 months, per-patient per-month (PPPM) total healthcare costs were significantly lower among biologic-naive cohorts initiating apremilast vs biologics ($2,214 vs $5,184; p < 0.0001). Likewise, PPPM costs while persistent on therapy were significantly lower among patients initiating apremilast vs biologics, whether they switched treatments ($2,475 vs $4,422; p < 0.0001), remained persistent ($2,279 vs $3,883; p < 0.0001), or discontinued but did not switch treatments ($2,104 vs $6,294; p < 0.0001). LIMITATIONS: Data were limited to individuals with United Healthcare commercial and Medicare Advantage insurance plans, and may not be generalizable to psoriasis patients with other insurance or without health insurance coverage. CONCLUSION: Biologic-naive patients with similar patient characteristics receiving apremilast vs biologics had significantly lower PPPM costs, even when they switched to biologics during the 12-month post-index period. These results may be useful to payers and providers seeking to optimize psoriasis care while reducing healthcare costs.