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1.
J Parkinsons Dis ; 10(4): 1535-1539, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32597817

RESUMO

Combined catechol-O-methyl-transferase-inhibition and Levodopa-Carbidopa intestinal gel (LCIG) infusion has the potential to reduce LCIG daily dose and the costs of this therapy. In this retrospective analysis, we report on Parkinson's disease (PD) patients on LCIG with concomitant Opicapone. In 11 patients, the introduction of Opicapone led to LCIG daily dose being reduced by 24.8% (p = 0.05) without any significant worsening of dyskinesia. Three patients withdrew from Opicapone due to side effects or inefficacy. LCIG daily dose reduction could lead to cost savings of £142,820.63/year in the United Kingdom while maintaining clinical care.


Assuntos
Carbidopa , Inibidores de Catecol O-Metiltransferase , Redução de Custos , Atenção à Saúde/economia , Agonistas de Dopamina , Levodopa , Oxidiazóis , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia , Idoso , Carbidopa/administração & dosagem , Carbidopa/economia , Inibidores de Catecol O-Metiltransferase/administração & dosagem , Inibidores de Catecol O-Metiltransferase/economia , Agonistas de Dopamina/administração & dosagem , Agonistas de Dopamina/economia , Combinação de Medicamentos , Feminino , Géis , Humanos , Bombas de Infusão Implantáveis , Infusões Parenterais , Levodopa/administração & dosagem , Levodopa/economia , Masculino , Pessoa de Meia-Idade , Oxidiazóis/administração & dosagem , Oxidiazóis/economia , Estudos Retrospectivos
2.
J Med Econ ; 22(3): 215-225, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30484353

RESUMO

AIMS: To carry out a cost-utility analysis comparing the cost-effectiveness of levodopa carbidopa intestinal gel (LCIG) with standard of care (SOC) in patients with advanced Parkinson's Disease (aPD) unsuitable for apomorphine or deep brain stimulation (DBS). LCIG is the only treatment option in this small, but clinically important, population. METHODS: A Markov model with 25 disease states based on disease stage and off-time status plus death. Patients enter the model with aPD spending >50% of their waking day in the off-state. Patients progress through the model in 6-monthly cycles for 20 years to approximate lifetime treatment and capture long-term costs and effects of therapy. Inputs are based on LCIG clinical trials for clinical outcomes and health state utilities, the literature for health state transitions and use UK-based input data wherever possible (drug costs, disease/adverse event management costs, discontinuation rates, mortality rates). LIMITATIONS: Data collection can be challenging in this small, elderly population with advanced disease, therefore some model inputs were estimated, rather than collected directly. It was assumed that a reduction in off-time was the only benefit after the first year of treatment with LCIG; this is a conservative approach, since there may be additional clinical benefits. RESULTS: There is a considerable incremental gain in quality adjusted life years (QALYs) for patients treated with LCIG of 1.26 QALY with an associated incremental cost-effectiveness ratio (ICER) of £52,110. If the impact on caregivers is included, the ICER reduces to £47,266. CONCLUSIONS: In cases where there is an orphan population, with no alternative treatment options, HTA assessments have a broader decision-making framework and the ICER is interpreted in this context. In the setting of a very small population, with considerable unmet need, LCIG represents value for money, as reflected by funding approval across the UK.


Assuntos
Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Carbidopa/economia , Carbidopa/uso terapêutico , Levodopa/economia , Levodopa/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/efeitos adversos , Carbidopa/administração & dosagem , Carbidopa/efeitos adversos , Análise Custo-Benefício , Combinação de Medicamentos , Géis/administração & dosagem , Gastos em Saúde , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Nível de Saúde , Humanos , Bombas de Infusão Implantáveis , Levodopa/administração & dosagem , Levodopa/efeitos adversos , Cadeias de Markov , Modelos Econométricos , Anos de Vida Ajustados por Qualidade de Vida , Escócia , Índice de Gravidade de Doença , País de Gales
3.
Zh Nevrol Psikhiatr Im S S Korsakova ; 117(6. Vyp. 2): 96-100, 2017.
Artigo em Russo | MEDLINE | ID: mdl-28980620

RESUMO

AIM: To assess the cost-efficiency of the fixed levodopa/carbidopa/entacapone combination and the free combination of levodopa/carbidopa with rasagiline. MATERIAL AND METHODS: An analysis was performed using the Markov model including three clinical states: duration of off-time ≤25%, duration of off-time >25% and fatal outcome. Costs of the drugs were calculated based on the results of auctions for 2016 by IMS Health data. RESULTS: In basic variant (drugs containing levodopa, 5-times a day), costs of treatment with the fixed levodopa/carbidopa/entacapone combination were 2.45 times higher than with rasagiline + levodopa/carbidopa. When taking levodopa drugs 3 times a day, costs of treatment with levodopa/carbidopa/entacapone were 1.53 times higher. Costs of treatment with rasagiline in combination with levodopa/carbidopa were lower by 10.4% even in the least beneficial variant of sensitivity analysis (maximal cost of rasagiline, maximal cost of levodopa/carbidopa and minimal cost of the fixed levodopa/carbidopa/entacapone combination). In basic variant, the cost-efficiency of treatment with rasagiline in combination with levodopa/carbidopa at the advanced stage of Parkinson's disease was 281.4 thousand roubles/QALY. CONCLUSION: Rasagiline in combination with levodopa/carbidopa is clinically and economically expedient for treatment of patients at the advanced stage of Parkinson's disease because of the reduction of costs compared to the fixed levodopa/carbidopa/entacapone combination.


Assuntos
Farmacoeconomia , Doença de Parkinson , Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Carbidopa/economia , Carbidopa/uso terapêutico , Catecóis/economia , Catecóis/uso terapêutico , Terapia Combinada , Quimioterapia Combinada , Humanos , Levodopa/economia , Levodopa/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia
4.
J Med Econ ; 20(11): 1207-1215, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28895769

RESUMO

BACKGROUND: Parkinson's disease (PD) is an incurable, progressive neurological condition, with symptoms impacting movement, walking, and posture that eventually become severely disabling. Advanced PD (aPD) has a significant impact on quality-of-life (QoL) for patients and their caregivers/families. Levodopa/carbidopa intestinal gel (LCIG) is indicated for the treatment of advanced levodopa-responsive PD with severe motor fluctuations and hyper-/dyskinesia when available combinations of therapy have not given satisfactory results. AIMS: To determine the cost-effectiveness of LCIG vs standard of care (SoC) for the treatment of aPD patients. METHODS: A Markov model was used to evaluate LCIG vs SoC in a hypothetical cohort of 100 aPD patients with severe motor fluctuations from an Irish healthcare perspective. Model health states were defined by Hoehn & Yahr (H&Y) scale-combined with amount of time in OFF-time-and death. SoC comprised of standard oral therapy ± subcutaneous apomorphine infusion and standard follow-up visits. Clinical efficacy, utilities, and transition probabilities were derived from published studies. Resource use was estimated from individual patient-level data from Adelphi 2012 UK dataset, using Irish costs, where possible. Time horizon was 20 years. Costs and outcomes were discounted at 4%. Both one-way and probabilistic sensitivity analyses were conducted. RESULTS: The incremental cost-effectiveness ratio for LCIG vs SOC was €26,944/quality adjusted life year (QALY) (total costs and QALYs for LCIG vs SoC: €537,687 vs €514,037 and 4.37 vs 3.49, respectively). LCIG is cost-effective at a payer threshold of €45,000. The model was most sensitive to health state costs. CONCLUSION: LCIG is a cost-effective treatment option compared with SoC in patients with aPD.


Assuntos
Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/economia , Carbidopa/administração & dosagem , Carbidopa/economia , Levodopa/administração & dosagem , Levodopa/economia , Doença de Parkinson/tratamento farmacológico , Antiparkinsonianos/uso terapêutico , Carbidopa/uso terapêutico , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Géis , Gastos em Saúde , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Irlanda , Levodopa/uso terapêutico , Masculino , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida
6.
J Med Econ ; 18(2): 155-65, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25348011

RESUMO

BACKGROUND: Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting ∼ 5.2 million people worldwide. Continuous subcutaneous apomorphine (CSAI) represents an alternative treatment option for advanced PD with motor fluctuation. The purpose of this analysis was to estimate the cost-effectiveness of CSAI compared with Levodopa/carbidopa intestinal gel (LCIG), Deep-Brain-Stimulation (DBS) and Standard-of-care (SOC). METHODS: A multi-country Markov-Model to simulate the long-term consequences, disease progression (Hoehn & Yahr stages 3-5, percentage of waking-time in the OFF-state), complications, and adverse events was developed. Monte-Carlo simulation accounted for uncertainty. Probabilities were derived from RCT and open-label studies. Costs were estimated from the UK and German healthcare provider's perspective. QALYs, life-years (LYs), and costs were projected over a life-time horizon. RESULTS: UK lifetime costs associated with CSAI amounts to £78,251.49 and generates 2.85 QALYs and 6.28 LYs (€104,500.08, 2.92 QALYs and 6.49 LYs for Germany). Costs associated with LCIG are £130,011.34, achieves 3.06 QALYs and 6.93 LYs (€175,004.43, 3.18 QALYs and 7.18 LYs for Germany). The incremental-cost per QALY gained (ICER) was £244,684.69 (€272,914.58). Costs for DBS are £87,730.22, associated with 2.75 QALYs and 6.38 LYs (€105,737.08, 2.85 QALYs and 6.61 LYs for Germany). CSAI dominates DBS. SOC associated UK costs are £76,793.49; 2.62 QALYs and 5.76 LYs were reached (€90,011.91, 2.73 QALYs and 6 LYs for Germany). CONCLUSIONS: From a health economic perspective, CSAI is a cost-effective therapy and could be seen as an alternative treatment to LCIG or DBS for patients with advanced PD.


Assuntos
Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Apomorfina/economia , Apomorfina/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Carbidopa/economia , Carbidopa/uso terapêutico , Análise Custo-Benefício , Estimulação Encefálica Profunda/economia , Esquema de Medicação , Géis , Alemanha , Humanos , Injeções Subcutâneas , Levodopa/economia , Levodopa/uso terapêutico , Cadeias de Markov , Modelos Econométricos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida
7.
Artigo em Russo | MEDLINE | ID: mdl-25614914

RESUMO

The application of levodopa/carbidopa intestinal gel (LCIG), which provides the more reliable control of the disease and decrease in progression rates compared to standard treatment, is a variant of treatment of severe forms of Parkinson's disease. An analysis of pharmacoeconomic aspects of LCIG use in foreign countries has shown that this treatment significantly improves expectancy of patients and reduces the costs of professional care. The approximate threshold values of costs per 1 QALY recommended for reimbursement of intervention costs are £30,000 in the United Kingdom and €50,000 in Sweden. In respect to intervention, LCIG can be regarded as an acceptable drug.


Assuntos
Antiparkinsonianos/uso terapêutico , Carbidopa/uso terapêutico , Análise Custo-Benefício , Levodopa/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Antiparkinsonianos/economia , Carbidopa/economia , Europa (Continente) , Humanos , Levodopa/economia
8.
J Med Econ ; 16(2): 191-201, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23035627

RESUMO

OBJECTIVE: To perform a comparative long-term analysis of the associated healthcare costs for the therapeutic options in advanced Parkinson's Disease (PD): deep brain stimulation (DBS), continuous duodenal levodopa-carbidopa infusion (CDLCI), and continuous subcutaneous apomorphine infusion (CSAI). METHODS: Resource use associated with the pre-treatment period, procedure, and follow-up was assessed for the three therapies from the perspective of the Spanish national healthcare system. Resources consumption was measured with a Healthcare Resources Questionnaire (at nine advanced PD centres). Unit costs (Euro-Spain 2010) were applied to measure resource use to obtain the average total cost for each therapy over 5 years. RESULTS: Mean cumulative 5-year cost per patient was significantly lower with DBS (€88,014) vs CSAI (€141,393) and CDLCI (€233,986) (p < 0.0001). DBS was associated with the lowest cumulative costs from year 2, with a yearly average cost of €17,603 vs €46,797 for CDLCI (p = 0.001) and €28,279 for CSAI (p = 0.008). For every patient treated annually with CDLCI, two could be treated with DBS (or €29,194 could be saved) and for every patient treated with CSAI, €10,676 could be saved with DBS. The initial DBS investment (32.2% of the total 5-year costs) was offset by decreases in anti-Parkinsonian drugs and follow-up costs. CDLCI and CSAI required constant drug use (i.e., levodopa and carbidopa for CDLCI, apomorphine for CSAI), representing ∼95% of their total 5-year cost. LIMITATIONS: All costs were based on a questionnaire, not on actual clinical data. The study is not a cost-effectiveness analysis as there is a lack of comparable outcomes data. An expert panel was used due to the complexity and variability in the treatment of advanced PD. The sample size was relatively small. CONCLUSIONS: Overall, DBS requires less use of health resources than CDLCI or CSAI in advanced PD patients, mostly pharmacological. The initial DBS investment was offset at year 2 by reductions in the ongoing consumption of anti-Parkinsonian medication. For every patient treated annually with CDLCI or CSAI, substantial cost savings could be made with DBS.


Assuntos
Antiparkinsonianos/economia , Estimulação Encefálica Profunda/economia , Recursos em Saúde/economia , Doença de Parkinson/terapia , Carbidopa/economia , Custos e Análise de Custo/métodos , Recursos em Saúde/estatística & dados numéricos , Humanos , Levodopa/economia , Doença de Parkinson/economia , Índice de Gravidade de Doença , Espanha , Inquéritos e Questionários
9.
J Med Econ ; 14(5): 584-93, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21728911

RESUMO

OBJECTIVE: Evaluation of cost-effectiveness of levodopa/carbidopa intestinal gel (LCIG), compared to standard care (SC) in patients with advanced Parkinson's disease (aPD) in the UK. DESIGN: Markov model to quantify costs and outcomes associated with LCIG versus SC in aPD patients at Hoehn and Yahr (H&Y) stages 3, 4 or 5 experiencing >50% OFF time per day. Time horizon was lifetime, LCIG treatment was assumed to last maximal 5 years after which patients revert to SC. Model comprised 12 aPD health states according to H&Y status and daily time spent in OFF state. Cost analyses are reported from a UK NHS and Personal Social Services perspective. Uncertainties were assessed through one-way sensitivity analyses. COMPARATORS: LCIG, providing patients with continuous dopaminergic stimulation to maximise functional ON time during the day and SC, defined as medically determined best available oral medication. MAIN OUTCOME MEASURES: Cost-effectiveness, based on quality adjusted life years gained, presented as an incremental cost-effectiveness ratio. RESULTS: Lifetime analysis yields an incremental cost per QALY of £36,024 for LCIG compared to SC (incremental cost £39,644, QALY gain 1.1). Results were sensitive to time on treatment, health state on treatment initiation, and estimates of long term benefit (OWSA results from £32,127 to £66,421 per QALY). Findings must be considered in the context of the study limitations which were mainly due to data availability constraints. CONCLUSIONS: LCIG is an effective treatment, reducing OFF time and improving quality of life in advanced PD. It provides value for money in levodopa-responsive aPD patients with severe motor fluctuations when no other treatment options are effective or suitable. Given LCIG is an orphan drug, it is reasonable to suggest that it may be considered cost-effective in the UK setting. However, further research is needed to complete current data gaps and increase robustness of the model.


Assuntos
Antiparkinsonianos/economia , Carbidopa/economia , Géis/economia , Levodopa/economia , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/fisiopatologia , Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/uso terapêutico , Carbidopa/administração & dosagem , Carbidopa/uso terapêutico , Análise Custo-Benefício , Humanos , Levodopa/administração & dosagem , Levodopa/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Reino Unido
10.
J Neurol ; 258(9): 1649-56, 2011 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-21442463

RESUMO

It was previously thought that the prevalence of Parkinson's disease (PD) in developing countries, and in particular sub-Saharan Africa (SSA), was lower than the rest of the world. The Hai PD prevalence project [1] diagnosed 32 patients (the majority previously undiagnosed and untreated) with PD from a population of 161,000, giving age standardised prevalence rates of 64 (men) and 20 (women)/100,000, respectively. Subsequently, drug treatment has been commenced for all surviving patients with annual follow up. The aim of the study was to document response to treatment, development of side effects, progression of disease and feasibility and sustainability of supplying medication to patients in rural Tanzania. Eleven patients died before the start of medication, and a further four during follow up. One patient moved away from the study area. At the end of 3 years of treatment, 16 patients were surviving. Only one stopped medication due to side effects (dyskinesia). At 3 years, 9/16 experienced wearing off and a further three had dyskinesias. Non motor symptoms were a problem at initial assessment [2] and continued to be a problem for many of the patients. We have shown that it is possible to find, treat and follow up patients with PD in a rural sub-Saharan African setting. Availability of affordable medication locally is a major issue. Acknowledging that movement disorders and neurological diseases in general are an issue in this setting is important to drive education and training, and for allocation of funding from health care providers in SSA.


Assuntos
Antiparkinsonianos/efeitos adversos , Carbidopa/efeitos adversos , Levodopa/efeitos adversos , Doença de Parkinson/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiparkinsonianos/economia , Carbidopa/economia , Estudos de Coortes , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/economia , Discinesia Induzida por Medicamentos/epidemiologia , Feminino , Seguimentos , Humanos , Levodopa/economia , Masculino , Pessoa de Meia-Idade , Doença de Parkinson/economia , Doença de Parkinson/mortalidade , Prevalência , Estudos Retrospectivos , Tanzânia/epidemiologia
11.
CNS Drugs ; 25(1): 53-66, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21128694

RESUMO

BACKGROUND: Suboptimal adherence to long-term therapies is common and may potentially have adverse consequences on patient outcomes and healthcare costs. OBJECTIVE: To assess the association between adherence to levodopa/carbidopa/entacapone therapy and healthcare utilization and costs in patients with Parkinson's disease. METHODS: A retrospective historical cohort study, conducted in the US, using a health insurance claims database, with data spanning from 1 January 2000 to 31 December 2005. Subjects included patients with Parkinson's disease who were treated with levodopa (L), carbidopa (C) and entacapone (E) either as separate tablets (LC + E) or as a single-tablet formulation (LCE). The association between satisfactory adherence (defined as 'proportion of days covered' for LCE or LC + E during 1-year follow-up ≥80%) and healthcare utilization and costs was examined using multivariate regression to control for pretreatment adherence to LC and other patient characteristics. RESULTS: Compared with unsatisfactory adherence (n = 598), satisfactory adherence (n = 617) was associated with 39% fewer Parkinson's disease-related hospitalizations (95% CI 20, 54; p < 0.001), 47% lower all-cause inpatient costs (95% CI 18, 65; p = 0.004) and 18% lower all-cause total costs (95% CI 11, 24; p < 0.001). On an adjusted basis, all-cause total costs were $US3508 less for those with satisfactory versus unsatisfactory adherence. In both the LC + E and LCE groups, satisfactory adherence was associated with significant reductions in all-cause hospitalizations (39% and 46%, respectively), and all-cause total costs (10% and 31%, respectively). The association between adherence and total healthcare costs was stronger for patients receiving LCE. CONCLUSIONS: Better adherence to levodopa/carbidopa/entacapone therapy is associated with lower healthcare utilization and costs. Non-adherence to LCE is associated with a greater increase in costs than non-adherence to LC + E. Efforts should be made to ensure adherence to both therapies.


Assuntos
Antiparkinsonianos/administração & dosagem , Atenção à Saúde/estatística & dados numéricos , Doença de Parkinson/tratamento farmacológico , Cooperação do Paciente , Antiparkinsonianos/economia , Carbidopa/administração & dosagem , Carbidopa/economia , Catecóis/administração & dosagem , Catecóis/economia , Estudos de Coortes , Atenção à Saúde/economia , Custos de Cuidados de Saúde , Humanos , Levodopa/administração & dosagem , Levodopa/economia , Nitrilas/administração & dosagem , Nitrilas/economia , Doença de Parkinson/economia , Estudos Retrospectivos
12.
Appl Health Econ Health Policy ; 8(6): 377-86, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-21043539

RESUMO

BACKGROUND: Value-based pricing (VBP), whereby prices are set according to the perceived benefits offered to the consumer at a time when costs and benefits are characterized by considerable uncertainty and are then reviewed ex post, is a much discussed topic in pharmaceutical reimbursement. It is usually combined with coverage with evidence development (CED), a tool in which manufacturers are granted temporary reimbursement but are required to collect and submit additional health economic data at review. Many countries, including the UK, are signalling shifts in this direction. Several countries, including Sweden, have already adopted this approach and offer good insight into the benefits and pitfalls in actual practice. OBJECTIVE: To describe VBP reimbursement decision making using CED in actual practice in Sweden. METHODS: Decision making by The Dental and Pharmaceutical Benefits Agency (TLV) in Sweden was reviewed using a case study of continuous intraduodenal infusion of levodopa/carbidopa (Duodopa®) in the treatment of advanced Parkinson's disease (PD) with severe motor fluctuations. RESULTS: The manufacturer of Duodopa® applied for reimbursement in late 2003. While the proper economic data were not included in the submission, TLV granted reimbursement until early 2005 to provide time for the manufacturer to submit a formal economic evaluation. The re-submission with economic data was considered inadequate to judge cost effectiveness, so TLV granted an additional extension of reimbursement until August 2007, at which time conclusive data were expected. The manufacturer initiated a 3-year, prospective health economic study and a formal economic model. Data from a pre-planned interim analysis of the data were loaded into the model and the cost-effectiveness ratio was the basis of the next re-submission. TLV concluded that the data were suitable for making a definite decision and that the drug was not cost effective, deciding to discontinue reimbursement for any new patients (current patients were unaffected). The manufacturer continued to collect data and to improve the economic model and re-submitted in 2008. New data and the improved model resulted in reduced uncertainty and a lower cost-effectiveness ratio in the range of Swedish kronor (SEK)430,000 per QALY gained in the base-case analysis, ranging up to SEK900,000 in the most conservative sensitivity analysis, resulting in reimbursement being granted. DISCUSSION: The case of Duodopa® provides excellent insight into VBP reimbursement decision making in combination with CED and ex post review in actual practice. Publicly available decisions document the rigorous, time-consuming process (four iterations were required before a final decision could be reached). The data generated as part of the risk-sharing agreement proved correct the initial decision to grant limited coverage despite lack of economic data. Access was provided to 100 patients while evidence was generated. CONCLUSIONS: Economic appraisal differs from clinical assessment, and decision makers benefit from analysis of naturalistic, actual practice data. Despite reviewing the initial trial-based, 'piggy-back' economic analysis, TLV was uncertain of the cost effectiveness in actual practice and deferred a final decision until observational data from the DAPHNE study became available. Second, acceptance of economic modelling and use of temporary reimbursement conditional on additional evidence development provide a mechanism for risk sharing between TLV and manufacturers, which enabled patient access to a drug with proven clinical benefit while necessary evidence to support claims of cost effectiveness could be generated.


Assuntos
Antiparkinsonianos/economia , Carbidopa/economia , Custos de Medicamentos , Levodopa/economia , Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/uso terapêutico , Carbidopa/administração & dosagem , Vias de Administração de Medicamentos , Combinação de Medicamentos , Duodeno , Órgãos Governamentais , Humanos , Levodopa/administração & dosagem , Modelos Econômicos , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia , Mecanismo de Reembolso/economia , Suécia , Resultado do Tratamento
13.
Clin Drug Investig ; 30(11): 789-98, 2010.
Artigo em Inglês | MEDLINE | ID: mdl-20818839

RESUMO

BACKGROUND: As Parkinson's disease (PD) progresses, patients and their families experience substantial health and economic burdens. Because motor fluctuations (also called 'off-time') are linked to poor quality of life and higher healthcare costs, minimizing off-time is an effective strategy for reducing costs associated with PD. OBJECTIVE: To assess the cost utility of rasagiline or entacapone as adjunctive therapies to levodopa versus levodopa/carbidopa/entacapone (LCE) versus standard levodopa monotherapy in patients with advanced PD and motor fluctuations in the US. METHODS: A 2-year stochastic Markov model was utilized to examine the cost effectiveness of treatments of advanced PD. The model assumed that patients transition health status every 4 months. Transition probabilities, including uncertainties, were estimated from clinical trial data. Medical costs, daily drug costs and utility weights were obtained from published literature. RESULTS: Over 2 years, all therapy options showed greater effectiveness than levodopa alone. Rasagiline+levodopa and LCE were cost saving from a payor perspective, while entacapone+levodopa was cost saving from a societal perspective. Mean benefits over 2 years were 0.12 (90% credibility interval [CI] 0.07, 0.18) additional quality-adjusted life-years (QALYs) for rasagiline+levodopa, entacapone+levodopa and LCE, 5.08 (90% CI 3.87, 6.28) additional months with

Assuntos
Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Custos de Medicamentos , Modelos Econômicos , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia , Antiparkinsonianos/administração & dosagem , Carbidopa/economia , Carbidopa/uso terapêutico , Catecóis/economia , Catecóis/uso terapêutico , Redução de Custos , Análise Custo-Benefício , Progressão da Doença , Esquema de Medicação , Quimioterapia Combinada , Humanos , Indanos/economia , Indanos/uso terapêutico , Levodopa/economia , Levodopa/uso terapêutico , Cadeias de Markov , Nitrilas/economia , Nitrilas/uso terapêutico , Doença de Parkinson/fisiopatologia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Processos Estocásticos , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
14.
Artigo em Russo | MEDLINE | ID: mdl-18833115

RESUMO

An open randomized study of pharmacoeconomic efficacy of stalevo in patients with Parkinson's disease with motor fluctuations was conducted. The results of the study revealed that the drug substantially reduced motor deficit, increased the "on"-period, decreased the duration and severity of the "off" period, improved the daily activity and quality of life of patients compared to standard therapy with an additional dosage of levodopa/DDC inhibitor. Despite the increase in cost, the use of stalevo in the treatment of Parkinson's disease with motor fluctuations is cost-effective in long-term (already after two years) management of patients.


Assuntos
Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Carbidopa/economia , Carbidopa/uso terapêutico , Catecóis/economia , Catecóis/uso terapêutico , Levodopa/economia , Levodopa/uso terapêutico , Doença de Parkinson , Transtornos Psicomotores/complicações , Análise Custo-Benefício , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença de Parkinson/complicações , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia , Índice de Gravidade de Doença
15.
Curr Med Res Opin ; 21(7): 1005-14, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16004667

RESUMO

BACKGROUND AND METHODS: A Markov model was developed to evaluate the cost-effectiveness of levodopa/carbidopa/entacapone (LCE;Stalevo), in the treatment of patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (wearing-off). LCE, with or without other antiparkinsonian medications, was compared to UK standard care, comprising traditional levodopa/ dopa-decarboxylase inhibitor (DDCI) with other antiparkinsonian medications (e.g. selegiline or dopamine agonists) added as needed. The costs and outcomes of both treatments were projected over a period of 10 years from the perspective (a) of society as a whole and (b) of the UK National Health Service (NHS). Sensitivity analyses, including second-order Monte Carlo simulations, were performed to assess the confidence level of the primary results. RESULTS: Treatment with LCE produced an average gain of +1.04 quality-adjusted life-years (QALYs) per patient (2.57 vs. 1.53) in the base-case analysis (discount rate 3.5%). This gain was accompanied by a reduction in the total 10-year direct cost of care to society of 10198 pounds per patient ( approximately E14800). From the societal perspective, therefore, LCE was dominant, producing better clinical outcomes with lower costs. This dominance was reiterated in all sensitivity analyses of society-focused analysis, including a shortening of the time-frame to 5 years. Although treatment with LCE resulted in an increase in direct costs per patient of 3239 pounds (25756 pounds versus 22517 pounds) to the NHS over the 10-year period analysed, the incremental cost-effectiveness ratio (ICER) of LCE was only 3105 pounds per QALY gained (approximately E4500). All ICERs to the NHS remained below 3800 pounds per QALY gained in univariate sensitivity analyses applying different discount rates. When a shorter, 5-year, time-horizon was analysed, the NHS-related ICER for LCE was 6526 pounds per QALY gained. All these ICERs are within the range usually considered to indicate acceptable or highly acceptable cost effectiveness (defined as < 30000 pounds per QALY gained). The results of the Monte Carlo simulations indicated that the likelihood of LCE being either 'dominant' or more effective at an 'acceptable cost' from either the societal or the NHS perspective was high, exceeding 96% in the base-case sensitivity analysis, and was 93% even when all the uncertainties associated with the model were taken into consideration simultaneously. In particular, compared to standard care, the probability that LCE would provide better outcomes at a lower cost to society as a whole was 77% in the base-case sensitivity analysis and 72% in the scenario involving the highest degree of uncertainty. CONCLUSIONS: In the UK the use of LCE to treat PD patients with wearing-off is beneficial to individual patients and likely to offer money savings to society as a whole, compared with UK standard therapy. The added cost of the medication itself is exceeded by the savings made in other direct costs of PD, mainly those relating to social care or PD-related private expenditures.


Assuntos
Antiparkinsonianos/economia , Antiparkinsonianos/uso terapêutico , Carbidopa/economia , Carbidopa/uso terapêutico , Catecóis/economia , Catecóis/uso terapêutico , Levodopa/economia , Levodopa/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/economia , Adolescente , Adulto , Idoso , Criança , Análise Custo-Benefício , Combinação de Medicamentos , Custos de Medicamentos , Feminino , Humanos , Masculino , Cadeias de Markov , Pessoa de Meia-Idade , Reino Unido
16.
Artigo em Russo | MEDLINE | ID: mdl-15847322

RESUMO

The efficacy of domestic drug tremonorm (levadopa-carbidopa) for Parkinson's disease (PD) treatment was studied. The treatment was conducted in neurological outpatient departments in several Moscow administrative regions and was administered to 142 PD patients, 15 being assigned to this drug for the first time and 127 being previously treated with other medications containing levadopa/carbidopa. A minimal effective dose (up to 500 mg) was selected for each patient and was not changed during 2 months. For patients previously switched to levadopa, the change for tremonorm has been done during 1 day if the dose of levadopa did not exceed 500 mg, and during 2 months in case a patient received over 500 mg per day. Modified Hoehn&Yahr scale, UPDRS, MMSE, PDQ-39 and other scales were used in complex evaluation of the disease stage. Positive effect of tremonorm was detected for 94 patients (66.2%), all of them continued tremonorm therapy after the end of the study. The most frequent side-effects proved to be dyspeptic symptoms. Tremonorm caused statistically significant positive changes in patient's movement scaled by UPDRS and the QL indexes in all PDQ-39 subscales. Positive changes in movement activity were accompanied by decrease of bradykinesia, tremor, better walking, writing and every day activity of PD patients. A change of nacom for tremonorm did not result in significant alteration of symptoms and Quality of Life indexes that suggest similar influence of these drugs on PD symptomatology. At the same time, a substantially lower price of tremonorm allows reducing of treatment costs.


Assuntos
Carbidopa/administração & dosagem , Levodopa/administração & dosagem , Doença de Parkinson/tratamento farmacológico , Carbidopa/efeitos adversos , Carbidopa/economia , Carbidopa/uso terapêutico , Interpretação Estatística de Dados , Combinação de Medicamentos , Dispepsia/induzido quimicamente , Humanos , Levodopa/efeitos adversos , Levodopa/economia , Levodopa/uso terapêutico , Entrevista Psiquiátrica Padronizada , Moscou , Pacientes Ambulatoriais , Doença de Parkinson/diagnóstico , Doença de Parkinson/economia , Qualidade de Vida , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
17.
Ann Pharmacother ; 32(9): 878-83, 1998 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-9762373

RESUMO

OBJECTIVE: To compare the costs of pharmacotherapy in patients with Parkinson's disease before and after converting from standard Sinemet to extended-release Sinemet CR. DESIGN: Investigators retrospectively reviewed records of patients converting from Sinemet to Sinemet CR for efficacy and total drug costs. Cost-effectiveness was evaluated retrospectively from data collected in prospective Sinemet CR efficacy trials. SETTING: Parkinson's disease clinic at a tertiary care university teaching hospital. PATIENTS: 100 patients with motor fluctuations who had undergone an initial 6-month course of Sinemet therapy, followed by a 6-month course of Sinemet CR. MAIN OUTCOME MEASURES: Total cost was measured as the cost of Sinemet formulations plus the costs of other antiparkinson medications. Differences in pre- and postconversion costs were compared by using the paired, two-tailed Student's t-test. A substudy of 39 patients on the cost-effectiveness of conversion measured the ratio of daily medication costs to the daily hours "on" without chorea. RESULTS: While total daily medication costs after conversion increased by 21%, patients experienced either a comparable or an improved degree of disease control with Sinemet CR. Patients who were also taking selegiline were able to decrease selegiline expense by 20%. The costs of other adjunctive medications did not differ significantly after conversion. The cost-effectiveness analysis revealed an increase in postconversion on time by 2.2 hours (p = 0.0001), accompanied by a $2.85 decrease in total cost per hour on without chorea (p = 0.11). CONCLUSIONS: Although Sinemet CR is more costly, it may be more cost-effective in patients with motor fluctuations. Some patients may be able to reduce adjunctive medications.


Assuntos
Antiparkinsonianos/administração & dosagem , Antiparkinsonianos/economia , Carbidopa/economia , Levodopa/economia , Transtornos dos Movimentos/economia , Doença de Parkinson/economia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiparkinsonianos/uso terapêutico , Carbidopa/administração & dosagem , Carbidopa/uso terapêutico , Análise Custo-Benefício , Preparações de Ação Retardada , Combinação de Medicamentos , Feminino , Humanos , Levodopa/administração & dosagem , Levodopa/uso terapêutico , Masculino , Pessoa de Meia-Idade , Transtornos dos Movimentos/complicações , Transtornos dos Movimentos/tratamento farmacológico , Transtornos dos Movimentos/fisiopatologia , Doença de Parkinson/complicações , Doença de Parkinson/tratamento farmacológico , Doença de Parkinson/fisiopatologia , Estudos Prospectivos
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