Asunto(s)
Dimetilfumarato , Industria Farmacéutica/legislación & jurisprudencia , Medicamentos Genéricos , Fructosa/análogos & derivados , Guanina , Patentes como Asunto/legislación & jurisprudencia , Fentermina , Dimetilfumarato/economía , Combinación de Medicamentos , Industria Farmacéutica/economía , Industria Farmacéutica/tendencias , Medicamentos Genéricos/economía , Fructosa/economía , Guanina/economía , Humanos , Fentermina/economíaRESUMEN
OBJECTIVE: This study aims to see whether patients in a real-world setting taking topiramate for varied indications experience significant weight loss. METHODS: This was a retrospective cohort study from the Veterans Affairs San Diego Healthcare System. Patients were new topiramate users between January 1, 2000 and December 31, 2013 with body mass index > 25 kg/m(2) and medication possession ratio > 0.5. Primary outcome determined if topiramate users experienced significant changes in weight and body mass index. Secondary outcome analyzed predictive factors associated with 5% weight loss using logistic regression models. Patients were followed up 1 year post index date. RESULTS: A total of 767 patients were included in the final analysis. Patients lost an average of 5.6 lbs (216.1 lbs preweight vs. 210.5 lbs postweight) at an average follow-up of 7.8 months. A total of 43.2% (92/213) of females lost 5% of their body weight compared to 29.4% (163/554) of males. Females (odds ratio 1.73; 95% confidence interval 1.21-2.48; p = 0.003), topiramate indication other than headache, and adherent patients (odds ratio 1.78; 95% confidence interval 1.28-2.49; p = 0.001) were more likely to lose 5% of body weight. CONCLUSION: Topiramate should be considered with higher priority in overweight and obese patients for nonweight loss indications for dual benefit.
Asunto(s)
Fármacos Antiobesidad/uso terapéutico , Anticonvulsivantes/uso terapéutico , Fructosa/análogos & derivados , Obesidad/tratamiento farmacológico , Pérdida de Peso/efectos de los fármacos , Adulto , Anciano , Fármacos Antiobesidad/economía , Anticonvulsivantes/economía , Índice de Masa Corporal , Femenino , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Topiramato , Estados Unidos , United States Department of Veterans Affairs , VeteranosRESUMEN
BACKGROUND: Evidence of the cost and effects of interventions for reducing the global burden of migraine remains scarce. Our objective was to estimate the population-level cost-effectiveness of evidence-based migraine interventions and their contributions towards reducing current burden in low- and middle-income countries. METHODS: Using a standard WHO approach to cost-effectiveness analysis (CHOICE), we modelled core set intervention strategies for migraine, taking account of coverage and efficacy as well as non-adherence. The setting was primary health care including pharmacies. We modelled 26 intervention strategies implemented during 10 years. These included first-line acute and prophylactic drugs, and the expected consequences of adding consumer-education and provider-training. Total population-level costs and effectiveness (healthy life years [HLY] gained) were combined to form average and incremental cost-effectiveness ratios. We executed runs of the model for the general populations of China, India, Russia and Zambia. RESULTS: Of the strategies considered, acute treatment of attacks with acetylsalicylic acid (ASA) was by far the most cost-effective and generated a HLY for less than US$ 100. Adding educational actions increased annual costs by 1-2 US cents per capita of the population. Cost-effectiveness ratios then became slightly less favourable but still less than US$ 100 per HLY gained for ASA. An incremental cost of > US$ 10,000 would have to be paid per extra HLY by adding a triptan in a stepped-care treatment paradigm. For prophylaxis, amitriptyline was more cost-effective than propranolol or topiramate. CONCLUSIONS: Self-management with simple analgesics was by far the most cost-effective strategy for migraine treatment in low- and middle-income countries and represents a highly efficient use of health resources. Consumer education and provider training are expected to accelerate progress towards desired levels of coverage and adherence, cost relatively little to implement, and can therefore be considered also economically attractive. Evidence-based interventions for migraine should have as much a claim on scarce health resources as those for other chronic, non-communicable conditions that impose a significant burden on societies.
Asunto(s)
Cumplimiento de la Medicación , Trastornos Migrañosos/tratamiento farmacológico , Modelos Económicos , Amitriptilina/economía , Amitriptilina/uso terapéutico , China , Análisis Costo-Beneficio , Fructosa/análogos & derivados , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Renta , India , Trastornos Migrañosos/economía , Propranolol/economía , Propranolol/uso terapéutico , Federación de Rusia , Autocuidado , Topiramato , Resultado del Tratamiento , ZambiaRESUMEN
BACKGROUND: Phase 3 clinical trial results reveal that Qsymia is a clinically effective long-term treatment for obesity, but whether this treatment is cost-effective compared to a diet and lifestyle intervention has yet to be explored. OBJECTIVE: To quantify the incremental cost-effectiveness of Qsymia (phentermine and topiramate extended-release) for health-related quality of life improvements. STUDY DESIGN AND METHODS: Estimates are based on cost and quality of life outcomes from a 56-week, multicenter, placebo-controlled, phase 3 clinical trial undertaken in 93 health centers in the US. Participants were overweight and obese adults (aged 18-70 years) with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidemia, diabetes or pre-diabetes or abdominal obesity). The intervention was diet and lifestyle advice plus the recommended dose of Qsymia (phentermine 7.5 mg plus topiramate 46.0 mg) vs. control, which included diet and lifestyle advice plus placebo. The study was from the payer perspective. Costs included the prescription cost, medication cost offsets and physician appointment costs. Effectiveness was measured in terms of quality-adjusted life years gained (QALYs). The main outcome measure was incremental cost per QALY gained of the intervention relative to control. RESULTS: Our base-case model, in which participants take Qsymia for 1 year with benefits linearly decaying over the subsequent 2 years, generates an incremental cost-effectiveness ratio (ICER) of $48,340 per QALY gained. Using the base-case assumptions, probabilistic sensitivity analyses reveal that the ICER is below $50,000 per QALY in 54 % of simulations. However, results are highly dependent on the extent to which benefits are maintained post medication cessation. If benefits persist for only 1 year post cessation, the ICER increases to $74,480. CONCLUSION: Although base-case results suggest that Qsymia is cost-effective, this result hinges on the time on Qsymia and the extent to which benefits are maintained post medication cessation. This should be an area of future research.
Asunto(s)
Fármacos Antiobesidad/economía , Costos de los Medicamentos , Fructosa/análogos & derivados , Obesidad/tratamiento farmacológico , Fentermina/economía , Pérdida de Peso/efectos de los fármacos , Fármacos Antiobesidad/administración & dosificación , Fármacos Antiobesidad/uso terapéutico , Ensayos Clínicos Fase III como Asunto , Análisis Costo-Beneficio , Combinación de Medicamentos , Fructosa/administración & dosificación , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Obesidad/economía , Fentermina/administración & dosificación , Fentermina/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Epilepsy is a common health problem which carries a huge medical social psychological and economic impact for a developing country. The aim of this hospital-based study was to get an insight into the effectiveness and tolerability of low cost antiepileptic drugs (AEDs) in Bangladeshi people with epilepsy. METHODS: This retrospective chart review was done from hospital records in weekly Epilepsy outdoor clinic of Department of Neurology, Dhaka Medical College Hospital (DMCH) from October 1998 to February 2013. A total of 854 epilepsy patients met the eligibility criteria (had a complete record of two years of follow up data) from hospital database. A checklist was used to take demographics (age and gender), epilepsy treatment and adverse event related data. At least two years of follow up data were considered for analysis. RESULTS: Out of 854 patients selected, majority of the patients attending outdoor clinic were >11-30 years age group (55.2%) with a mean age of 20.3 ± 9 years and with a male (53%) predominance. Focal epilepsy were more common (53%), among whom secondary generalized epilepsy was the most frequent diagnosis (67%) followed by complex partial seizure (21%). Among those with Idiopathic Generalized Epilepsy (46%), generalized tonic clonic seizure was encountered in 74% and absence seizure was observed in 13%. The number of patients on monotherapy and dual AED therapy were 67% and 24% respectively and polytherapy (i.e. >3 AEDs) was used only in 9%. CBZ (67%) was the most frequently prescribed AED, followed by VPA (43%), PHB (17%), and PHT (8%). CBZ was prescribed in 37% patients as monotherapy followed by VPA in 21% and PHB in 8% patients. Newer generation drugs eg lemotrigine and topiramate were used only as add on therapy in combination with CBZ and VPA in only 2% patients. The treatment retention rates over the follow up period for the AEDs in monotherapy varied between 86 and 91% and were highest for CBZ, followed by VPA. Most of the combination regimens had a treatment retention rate of 100%. The effectiveness of AED in terms of reduction of seizure frequency was highest for PHT (100%) and PHB (98%) followed by CBZ (96%) and VPA (95%). PHB and PHT were the cheapest of all AEDs (42 I$ and 56 I$/ year respectively). The costs of VPA and CBZ were two times and LTG and TOP were six to eight times higher. Adverse drug reaction (ADR) were observed among 140 (24.5%) of those with monotherapy. PHT (64%) was the most common drug to cause ADR, CBZ was at the bottom of the list to cause adverse effect (11.6%). VPA and PHB caused weight gain commonly. Adjustment of drug dose or withdrawal due to ADRs was necessary in 39% with PHT and 26% with PHB. CONCLUSION: Though PHT and PHB are cheapest and efficacious among all, CBZ and VPA are less costly, effective and well tolerated drug for seizure control in context of Bangladesh.
Asunto(s)
Anticonvulsivantes/uso terapéutico , Epilepsias Parciales/tratamiento farmacológico , Epilepsia Generalizada/tratamiento farmacológico , Convulsiones/tratamiento farmacológico , Adolescente , Adulto , Anticonvulsivantes/economía , Bangladesh , Carbamazepina/economía , Carbamazepina/uso terapéutico , Niño , Combinación de Medicamentos , Epilepsias Parciales/economía , Epilepsias Parciales/fisiopatología , Epilepsia Generalizada/economía , Epilepsia Generalizada/fisiopatología , Femenino , Estudios de Seguimiento , Fructosa/análogos & derivados , Fructosa/economía , Fructosa/uso terapéutico , Hospitales de Enseñanza , Humanos , Masculino , Persona de Mediana Edad , Fenobarbital/economía , Fenobarbital/uso terapéutico , Fenitoína/economía , Fenitoína/uso terapéutico , Prohibitinas , Estudios Retrospectivos , Convulsiones/economía , Convulsiones/fisiopatología , Topiramato , Resultado del Tratamiento , Ácido Valproico/economía , Ácido Valproico/uso terapéuticoRESUMEN
OBJECTIVE: To compare the efficacy and clinical benefit of 2 paradigms of migraine prevention using pre-emptive frovatriptan and daily topiramate. The study compares the paradigms of pre-emptive use of frovatriptan, a drug approved for acute migraine, and the daily use of topiramate, a Federal Drug Administration-approved and -accepted standard for migraine prophylaxis. BACKGROUND: Traditionally, preventive treatment of migraine required daily medication. However, recent studies suggest that pre-emptive prophylaxis may be beneficial to those migraineurs who can predict an attack of migraine based on premonitory symptoms and treat during that phase. METHODS: A total of 76 adult subjects with a diagnosis of migraine were screened for the study. During a 1-month baseline period, subjects demonstrated through a daily diary that they predicted at least 50% of migraine attacks during the premonitory phase and treated with their usual medication. Of these, 55 were randomized to either Group A (daily topiramate) or Group B (frovatriptan during premonitory symptoms); 44 completed the study. The treatment period lasted 2 months. The subjects answered the Migraine-Specific Quality of Life Questionnaire at randomization, and at Weeks 4 and 8. The revised Patient Perception of Migraine Questionnaire was answered 24 hours after taking frovatriptan (Group A, for break-through headaches; Group B, treatment during premonitory symptoms). RESULTS: The number of migraine attacks and headache days per month decreased significantly from baseline for both Groups A and B. Subjects in Group A had considerably more adverse events leading to study withdrawal than in Group B (18% vs 4%). Though this study was not powered to directly compare the efficacy of the 2 drugs, topiramate showed superiority over frovatriptan at Month 2 in reduction of headache days, which was a secondary end point in the study (P = .036). CONCLUSIONS: This pilot study demonstrated that statistical benefit for reduction of headache days over baseline for both pre-emptive frovatriptan and daily topiramate. Subjects utilizing pre-emptive frovatriptan experienced fewer adverse events leading to study withdrawal. Subjects utilizing daily topiramate had fewer headache days at Month 2.
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Carbazoles/administración & dosificación , Fructosa/análogos & derivados , Trastornos Migrañosos/prevención & control , Fármacos Neuroprotectores/administración & dosificación , Triptaminas/administración & dosificación , Adolescente , Adulto , Carbazoles/economía , Costos y Análisis de Costo , Esquema de Medicación , Femenino , Estudios de Seguimiento , Fructosa/administración & dosificación , Fructosa/economía , Humanos , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/economía , Trastornos Migrañosos/psicología , Fármacos Neuroprotectores/economía , Percepción del Dolor/efectos de los fármacos , Satisfacción del Paciente , Proyectos Piloto , Calidad de Vida , Agonistas de Receptores de Serotonina/economía , Método Simple Ciego , Encuestas y Cuestionarios , Factores de Tiempo , Topiramato , Resultado del Tratamiento , Triptaminas/economía , Adulto JovenRESUMEN
The aim of the present study was to evaluate the suitability of low-cost carbon sources for bacteriocin production by Leuconostoc mesenteroides strain E131. For this purpose, inexpensive sugars derived from a sugar refinery plant (glucose, fructose and sucrose) as well as waste molasses were utilized as carbon sources in submerged shake-flask experiments and the kinetic response of the microorganism was evaluated. Interestingly, in the case of molasses, non-negligible decolorization-detoxification (up to â¼27%) of the residue was performed together with the production of bacteriocin. In all instances the initial concentration of sugars employed was adjusted at 20 and 30 g/L, therefore the effect of both the nature and the initial quantity of sugar upon the growth of the microorganism was assessed. All media proved to be suitable for both biomass and bacteriocin production by L. mesenteroides, whereas variable quantities of lactate, acetate and ethanol were detected into the medium. Employment of fructose, sucrose or molasses as carbon sources resulted in the accumulation of mannitol (in some cases in significant quantities) into the medium; remarkable portion thus of the available or released fructose acted as electron acceptor instead of carbon source by the microorganism. The highest bacteriocin production achieved (=640 AU/mL) was obtained when initial glucose at 30 g/L was used as substrate. Finally, utilization of waste molasses as carbon source by L. mesenteroides resulted in satisfactory bacteriocin production (up to 320 AU/mL) besides the decolorization of the residue.
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Bacteriocinas/biosíntesis , Fructosa/farmacología , Glucosa/farmacología , Leuconostoc/crecimiento & desarrollo , Sacarosa/farmacología , Edulcorantes/farmacología , Bacteriocinas/economía , Medios de Cultivo/economía , Medios de Cultivo/farmacología , Fructosa/economía , Glucosa/economía , Melaza , Sacarosa/economía , Edulcorantes/economíaAsunto(s)
Anticonvulsivantes/economía , Aprobación de Drogas/legislación & jurisprudencia , Industria Farmacéutica/legislación & jurisprudencia , Fructosa/análogos & derivados , Trastornos Mentales/tratamiento farmacológico , Uso Fuera de lo Indicado/legislación & jurisprudencia , Aprobación de Drogas/economía , Industria Farmacéutica/economía , Fructosa/economía , Humanos , Mercadotecnía/economía , Mercadotecnía/legislación & jurisprudencia , Trastornos Mentales/economía , Uso Fuera de lo Indicado/economía , Topiramato , Estados UnidosRESUMEN
Topiramate is known to be efficacious in migraine prophylaxis, but its optimal dose has not been systematically studied in the Asian population. Here, we show that a fixed low dose of topiramate 25 mg/day is efficacious in migraine prophylaxis and also attest to advantages in terms of medication cost savings and more favourable side effect profile.
Asunto(s)
Pueblo Asiatico , Fructosa/análogos & derivados , Trastornos Migrañosos/prevención & control , Adolescente , Adulto , Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/efectos adversos , Anticonvulsivantes/economía , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Costos de los Medicamentos/estadística & datos numéricos , Femenino , Fructosa/administración & dosificación , Fructosa/efectos adversos , Fructosa/economía , Humanos , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/etnología , Evaluación de Resultado en la Atención de Salud , Parestesia/inducido químicamente , Proyectos Piloto , Singapur , Topiramato , Resultado del Tratamiento , Adulto JovenRESUMEN
Lennox-Gastaut syndrome (LGS) is a catastrophic childhood form of epilepsy. The syndrome is characterized by mental impairment, frequent seizures of multiple types that are particularly resistant to treatment, and high rates of seizure-related injury. With the introduction of newer, but more costly, antiepileptic drugs (AEDs), it is important that decision makers are able to assess their value in the management of this rare and difficult-to-treat condition. To evaluate the cost effectiveness, from the UK NHS perspective, of rufinamide in patients with LGS. An individual patient-simulation model was developed to estimate the total treatment-related costs and clinical benefits of rufinamide compared with topiramate and lamotrigine over a 3-year time horizon. The model examines the treatment scenarios of adding rufinamide, lamotrigine or topiramate to older AEDs (standard therapy), or standard therapy alone within a primary-care or community setting. Three placebo-controlled clinical trials of adjunctive AED treatment for children with LGS were analysed. There are no head-to-head comparator studies. Between 98 and 139 patients were randomized in each study and the mean age in each study was 10, 11 and 14 years. A mixed-treatment comparison using a random-effects model was carried out on the number of patients in each response category, using the placebo arms of the respective trials. The primary outcome measure was the percentage of successfully treated patients, defined as >50% reduction in the frequency of total seizures and drop attacks. The hypothesis being tested was formulated after data collection. Costs ( pound, year 2006/07 values) of patient monitoring, switching treatments, hospitalization due to seizure, treatment of adverse effects, and personal and social services were included in the analysis. Results of 10,000 Monte Carlo simulations were bootstrapped to conduct probabilistic sensitivity analysis. Over 3 years, adjunctive rufinamide resulted in higher total costs than topiramate and lamotrigine; however, with more patients being treated successfully, this leads to acceptable incremental cost-effectiveness ratios. If society is prepared to pay at least 250 pounds for a 1% increase in the number of successfully treated LGS patients, in terms of a 50% reduction in the frequency of drop attacks, the probability of the treatment with rufinamide being cost effective is >80%. This cost-effectiveness analysis suggests that rufinamide results in more LGS patients being treated successfully at a reasonable cost from a UK NHS perspective.
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Anticonvulsivantes/economía , Análisis Costo-Beneficio/estadística & datos numéricos , Epilepsia Tipo Ausencia/economía , Discapacidad Intelectual/economía , Triazoles/economía , Adolescente , Adulto , Anticonvulsivantes/uso terapéutico , Niño , Preescolar , Simulación por Computador , Epilepsia Tipo Ausencia/tratamiento farmacológico , Fructosa/análogos & derivados , Fructosa/economía , Fructosa/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Lactante , Discapacidad Intelectual/tratamiento farmacológico , Lamotrigina , Modelos Económicos , Ensayos Clínicos Controlados Aleatorios como Asunto , Síndrome , Factores de Tiempo , Topiramato , Resultado del Tratamiento , Triazinas/economía , Triazinas/uso terapéutico , Triazoles/uso terapéutico , Reino UnidoRESUMEN
PURPOSE: To estimate the cost-effectiveness of rufinamide relative to topiramate and lamotrigine as adjunctive treatment for children with Lennox-Gastaut Syndrome (LGS). METHODS: A Markov decision analytic model was developed to estimate the incremental cost-effectiveness ratio over a three-year time horizon in patients with LGS uncontrolled by up to three antiepileptic drugs. Utilities were assigned to health states, defined according to a patient's response to treatment (> or =75%, > or =50% and <75%, and <50% reduction in tonic-atonic [drop attack] seizure frequency and death). Efficacy and safety estimates were made using indirect/mixed-treatment comparisons of data obtained from published literature. Outcomes included costs and quality-adjusted life-years (QALYs), allowing the incremental cost-effectiveness ratio to be estimated as cost per QALY gained. RESULTS: Over three years, the total cumulative costs for rufinamide, topiramate, and lamotrigine were pound24,992, pound23,360, and pound21,783, respectively. Rufinamide resulted in an incremental QALY gain of 0.079 relative to topiramate and 0.021 relative to lamotrigine. The incremental costs of rufinamide were pound1632 and pound3209, relative to topiramate and lamotrigine, resulting in an incremental cost per QALY gained of pound20,538 and pound154,831, respectively. CONCLUSIONS: Considering the underlying assumptions, this current economic evaluation demonstrates that rufinamide is likely to be a cost-effective alternative to topiramate as adjunctive treatment for children with LGS in the UK. In addition, when compared to lamotrigine, which is an inexpensive treatment, rufinamide should be considered as a cost-effective alternative due to the importance of patient choice and equity of access in such a rare and devastating condition.
Asunto(s)
Anticonvulsivantes/economía , Anticonvulsivantes/uso terapéutico , Análisis Costo-Beneficio/economía , Utilización de Medicamentos/estadística & datos numéricos , Epilepsia/tratamiento farmacológico , Epilepsia/economía , Niño , Intervalos de Confianza , Estudios de Seguimiento , Fructosa/análogos & derivados , Fructosa/economía , Fructosa/uso terapéutico , Estado de Salud , Humanos , Lamotrigina , Cadenas de Markov , Calidad de Vida , Sensibilidad y Especificidad , Topiramato , Triazinas/economía , Triazinas/uso terapéutico , Triazoles/economía , Triazoles/uso terapéutico , Reino UnidoRESUMEN
In the US, it is estimated that up to 10% of men and 25% of women, particularly those aged 25-55 years, experience debilitating migraines, such that the condition presents an enormous economic burden for patients, health systems, employers and society. Migraine headache is a particularly prevalent condition associated with major reductions in patients' quality of life. From a payer perspective, the implementation of relevant programmes of migraine prophylaxis is highly desirable. Consistent evidence exists, from several randomized, controlled studies, of the efficacy of amitriptyline, divalproex sodium, propranolol, timolol and topiramate in migraine prophylaxis. Considering resource utilization, various studies suggest that migraine prophylaxis with antiepileptics, antidepressants, beta-blockers or calcium channel antagonists markedly reduces triptan use and visits to physician offices and emergency departments (EDs), without compromising quality of care or treatment outcomes. Over recent years, the effects of topiramate in reducing resource utilization in patients with migraine have been relatively widely studied. In US claims database analyses involving >4000 patients with migraine, topiramate significantly reduced triptan use by up to 20% in the 12-month period after starting treatment. Reductions were also noted in the numbers of ED visits, diagnostic procedures, hospital admissions and migraine-related hospitalization days. These long-term benefits of topiramate manifested without any increase in overall headache-related costs. Furthermore, in detailed modelling analyses based on UK and US data, topiramate-induced savings in acute medical services were estimated to offset about one-quarter of the monthly per patient cost of the topiramate regimen, which was shown to be a dominant cost-effective intervention relative to no preventive therapy: cost-effectiveness ratios were calculated as pound 5728 per quality-adjusted life-year (QALY) [2005 costings] and $US10 888 per QALY (2002 costings), respectively. Overall, there is a need to improve quality of care in migraine, and prophylactic therapy appears to be an effective option, particularly with respect to decreasing resource use and improving productivity. For both health-plan payers and employers, topiramate appears to be a cost-effective intervention for preventing migraine.
Asunto(s)
Costo de Enfermedad , Eficiencia , Trastornos Migrañosos/prevención & control , Adulto , Costos y Análisis de Costo , Bases de Datos Factuales , Femenino , Fructosa/análogos & derivados , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Masculino , Trastornos Migrañosos/economía , Trastornos Migrañosos/epidemiología , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Topiramato , Reino Unido/epidemiología , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVES: To explore the effects of generic substitution of the antiepileptic drug (AED) topiramate (Topamax) in Canada; to convert observed Canadian costs into the settings of France, Germany, Italy, and the United Kingdom (UK); and to forecast the economic impact of generic topiramate entry in these four European countries. DESIGN AND METHODS: Health claims from Régie de l'assurance maladie du Québec (RAMQ) plan (1/2006-9/2008) and IMS Health data (1998-2008) were used. Patients with epilepsy and > or = 2 topiramate dispensings were selected. An open-cohort design was used to classify observation into mutually-exclusive periods of branded versus generic use of topiramate. Canadian healthcare utilization and costs (2007 CAN$/person-year) were compared between periods using multivariate models. Annualized per-patient costs (2007 euro or 2007 pound sterling/person-year) were converted using Canadian utilization rates, European prices and service-use ratios. Non-parametric bootstrap served to assess statistical significance of cost differences. Topiramate market was forecasted following generic entry (09/2009-09/2010) using autoregressive models based on the European experience. The economic impact of generic topiramate entry was estimated for each country. RESULTS: A total of 1164 patients (mean age: 39.8 years, 61.7% female) were observed for 2.6 years on average. After covariates adjustment, generic-use periods were associated with increased pharmacy dispensings (other AEDs: +0.95/person-year, non-AEDs: +12.28/person-year, p < 0.001), hospitalizations ( + 0.08/person-year, p = 0.015), and lengths of hospital stays (+0.51 days/person-year, p < 0.001). Adjusted costs, excluding topiramate, were CAN$1060/person-year higher during generic use (p = 0.005). Converted per-patient costs excluding topiramate were significantly higher for generic relative to brand periods in all European countries (adjusted cost differences per person-year: 706-815 euro, p < 0.001 for all comparisons). System-wide costs would increase from 3.5 to 24.4% one year after generic entry. LIMITATIONS: Study limitations include the absence of indirect costs, possible claim inaccuracies, and IMS data limitations. CONCLUSIONS: Higher health costs were projected for G4 European countries from the Canadian experience following the generic entry of topiramate.
Asunto(s)
Medicamentos Genéricos/economía , Medicamentos Genéricos/uso terapéutico , Unión Europea/economía , Fructosa/análogos & derivados , Adolescente , Adulto , Anciano , Anticonvulsivantes/economía , Anticonvulsivantes/uso terapéutico , Canadá , Niño , Preescolar , Europa (Continente) , Femenino , Predicción , Fructosa/economía , Fructosa/uso terapéutico , Costos de la Atención en Salud , Recursos en Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Topiramato , Adulto JovenRESUMEN
OBJECTIVE: To investigate clinical and economic consequences following generic substitution of one vs multiple generics of topiramate (Topamax; Ortho-McNeil Neurologics, Titusville, NJ). METHODS: Medical and pharmacy claims data of Régie de l'Assurance-Maladie du Québec from January 2006 to October 2007 were used. Patients with epilepsy treated with topiramate were selected. An open-cohort design was used to classify the observation period into periods of brand, single-generic, and multiple-generic use. One-year generic-switch and switchback-to-brand rates were estimated using Kaplan-Meier methodology. Medical resource utilization and costs were compared among the three periods using multivariate regression analysis. RESULTS: In total, 948 patients were observed during 1,105 person-years of brand use, 233 person-years of single-generic use, and 92 person-years of multiple-generic use. A total of 23% of generic users received at least two different generic versions. Compared to brand use, multiple-generic use was associated with higher utilization of other prescription drugs (incidence rate ratio [IRR] = 1.27, 95% confidence interval [CI] = 1.24-1.31), higher hospitalization rates (0.48 vs 0.83 visit/person-year, IRR = 1.65, 95% CI = 1.28-2.13), and longer hospital stays (2.6 vs 3.9 days/person-year, IRR = 1.43, 95% CI = 1.27-1.60), but the effect was less pronounced in single-generic use (hospitalization: IRR = 1.08, 95% CI = 0.88-1.34, length of stay: IRR = 1.12, 95% CI = 1.03-1.23). The risk of head injury or fracture was nearly three times higher (hazard ratio = 2.84, 95% CI = 1.24-6.48) following a generic-to-generic switch compared to brand use. The total annualized health care cost per patient was higher in the multiple-generic than brand periods by C$1,716 (cost ratio = 1.21, p = 0.0420). CONCLUSION: Multiple-generic substitution of topiramate was significantly associated with negative outcomes, such as hospitalizations and injuries, and increased health care costs.
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Traumatismos Craneocerebrales/epidemiología , Medicamentos Genéricos/administración & dosificación , Epilepsia/tratamiento farmacológico , Epilepsia/epidemiología , Fracturas Óseas/epidemiología , Fructosa/análogos & derivados , Adulto , Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/efectos adversos , Anticonvulsivantes/economía , Enfermedad Crónica/tratamiento farmacológico , Estudios de Cohortes , Comorbilidad , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Costos de los Medicamentos/estadística & datos numéricos , Costos de los Medicamentos/tendencias , Utilización de Medicamentos/economía , Medicamentos Genéricos/efectos adversos , Medicamentos Genéricos/economía , Femenino , Fructosa/administración & dosificación , Fructosa/efectos adversos , Fructosa/economía , Planes de Asistencia Médica para Empleados/economía , Costos de la Atención en Salud/estadística & datos numéricos , Costos de la Atención en Salud/tendencias , Hospitalización/estadística & datos numéricos , Humanos , Reembolso de Seguro de Salud/economía , Masculino , Aceptación de la Atención de Salud , Modelos de Riesgos Proporcionales , Quebec , Estudios Retrospectivos , Factores de Riesgo , TopiramatoRESUMEN
Topiramate is one of several antiepileptic drugs that are used in the prevention of migraine, but the only one licensed for use in the UK. Topiramate has an extensive evidence base provided by double-blind, placebo-controlled trials to show that it is a safe, effective and well tolerated drug in the management of migraine. It has also been shown to have a role in the management of chronic migraine, which represents a challenge to primary care clinicians as well as headache specialists. Studies have demonstrated that topiramate can also be effective in preventing migraine in childhood and adolescence, although this is unlicensed in the UK. It has been shown in models both in the US and the UK to offer a cost benefit when direct and indirect costs are evaluated by reducing work loss, improving quality of life and reducing the use of increasingly scarce health resources.
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Anticonvulsivantes/uso terapéutico , Fructosa/análogos & derivados , Trastornos Migrañosos/prevención & control , Anticonvulsivantes/economía , Interacciones Farmacológicas , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Calidad de Vida , Topiramato , Resultado del TratamientoRESUMEN
Topiramate (Topamax) is a structurally novel broad-spectrum antiepileptic drug (AED) with established efficacy as monotherapy or adjunctive therapy in the treatment of adult and paediatric patients with generalised tonic-clonic seizures, partial seizures with or without generalised seizures, and seizures associated with Lennox-Gastaut syndrome. The incidence and severity of many adverse events, including CNS-related events, may be reduced through the use of slow titration to effective and well tolerated dosages. It is associated with few clinically significant interactions with other drugs, is effective when used with other AEDs, is not associated with drug-induced weight gain and, at lower dosages, does not interfere with the effectiveness of oral contraceptives. Therefore, topiramate is a valuable option as monotherapy or adjunctive therapy in the treatment of epilepsy in adult and paediatric patients.
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Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/uso terapéutico , Epilepsia/tratamiento farmacológico , Fructosa/análogos & derivados , Animales , Anticonvulsivantes/efectos adversos , Anticonvulsivantes/economía , Anticonvulsivantes/farmacocinética , Anticonvulsivantes/farmacología , Fructosa/administración & dosificación , Fructosa/efectos adversos , Fructosa/economía , Fructosa/farmacocinética , Fructosa/farmacología , Fructosa/uso terapéutico , Humanos , TopiramatoRESUMEN
Migraine is a common disorder with a relatively high burden of disease from the perspective of both society and the individual patient. Optimizing the use of prophylactic treatment may decrease the frequency and severity of attacks thus reducing the burden of disease. In this regard, topiramate has been found to be as effective as propranolol in the prevention of migraine attacks. In the present study, a cost-minimization analysis was performed. Monthly preventive medication cost and price per migraine attack reduced were used as measures. In comparison with propranolol and flunarizine, topiramate was identified as being the most costly option for migraine prophylaxis with a monthly drug cost of USD 24.97-45.04 as compared with propranolol (USD 1.72-6.87) and flunarizine (USD 6.09-12.18). Current treatment options would appear to offer better value for money in achieving effective migraine prophylaxis unless additional benefits can be identified for topiramate in this patient group.
Asunto(s)
Fructosa/análogos & derivados , Trastornos Migrañosos/economía , Trastornos Migrañosos/prevención & control , Fármacos Neuroprotectores/economía , Fármacos Neuroprotectores/uso terapéutico , Análisis Costo-Beneficio , Relación Dosis-Respuesta a Droga , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Metaanálisis como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , TopiramatoRESUMEN
OBJECTIVE: To evaluate the medical resource utilization and overall cost of care among patients treated with topiramate (TPM) for migraine prevention in a commercially insured population. Background.-Preventive migraine therapy with TPM significantly reduces the frequency of migraine attacks. Limited data exist on the real-world health care consumption associated with TPM therapy for migraine prevention. METHODS: Data were obtained from a large geographically diverse integrated medical and pharmacy claims database representative of the commercially insured population. The date of the first TPM claim between July 2000 and December 2003 was considered the index date. Patients needed at least 1 triptan prescription (Rx) claim during the 6-month preindex period, and > or =2 TPM Rx claims in the 12 months following index TPM Rx to be included in the analysis. Headache-related inpatient and outpatient resource use were compared: preindex vs postindex period 1 (months 1-6) and preindex vs postindex period 2 (months 7-12). Subgroup analyses were conducted based on the triptan consumption during the 6-month preindex period: Cohort L (low triptan users) with < or =36 triptan doses, and Cohort H (high triptan users) with >36 triptan doses. RESULTS: The sample included 2645 plan members (1778 patients in Cohort L, and 867 patients in Cohort H). TPM utilization was associated with significantly less triptan utilization in the first (34.8 quantity dispensed; 7.5% decrease) and second (30.2; 19.6% decrease) follow-up periods compared to the preindex period (37.6; both P < .0001). In postindex period 1, there was a 46% decrease in emergency department (ED) visits, 39% decrease in diagnostic procedures (eg, CT scans and MRIs), and a 33% decrease in hospital admission; physician office visits were unchanged. In postindex period 2, there was a 46% decrease in ED visits, 72% decrease in diagnostic procedures, 61% decrease in hospital admissions, and a 35% decrease in physician office visits. Decreases in resource use were observed in both cohorts L and H. Mean +/- SD total headache-related cost was $2118 +/- $3406 per patient in the preperiod, versus $2450 +/- $3318 in follow-up period 1 and $2009 +/- $3136 in follow-up period 2. CONCLUSION: In this sample of patients from a diverse set of health plans receiving TPM, significant decreases in resource use were observed within 6 months of TPM initiation, and this trend continued in follow-up period 2. Although there was an initial increase in total headache-related cost upon introduction of TPM (follow-up period 1), the cost in follow-up period 2 was lower than in the preindex period, suggesting that benefits of long-term treatment with TPM can be achieved without increasing total cost.
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Costo de Enfermedad , Fructosa/análogos & derivados , Trastornos Migrañosos/economía , Fármacos Neuroprotectores/economía , Adulto , Estudios de Cohortes , Costos y Análisis de Costo , Bases de Datos Factuales/estadística & datos numéricos , Relación Dosis-Respuesta a Droga , Femenino , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Revisión de Utilización de Seguros , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/prevención & control , Fármacos Neuroprotectores/uso terapéutico , Servicios Farmacéuticos/economía , Estudios Retrospectivos , TopiramatoRESUMEN
The results of an open prospective naturalistic study on the use of topiramate (topamax) in 92 patients with focal epilepsy are presented. The pharmacological remission with duration over one year was achieved in 47,8% of patients. In total, the percentage of remission and clinical improvement made up 68,5%. The positive changes were observed in drug-naive patients (during first monotherapy) and in patients who previously received ineffective therapy. In some cases of patients with resistant forms of epilepsy, pharmacological remission or significant improvement of the control over seizures was found. The topamax therapy substantially increased the quality of life of the patients. The cost of therapy was 3100-5200 rubles per month, mean costs for a one patient during one year--416,000 rubles. The marginal utility 237,000 rubles per each additional QALY was significantly lower than $20,000, the minimal threshold of cost-effectiveness for European countries.
Asunto(s)
Anticonvulsivantes/uso terapéutico , Costos de los Medicamentos/estadística & datos numéricos , Epilepsia/tratamiento farmacológico , Fructosa/análogos & derivados , Adulto , Anticonvulsivantes/administración & dosificación , Anticonvulsivantes/economía , Economía Farmacéutica , Epilepsia/economía , Femenino , Estudios de Seguimiento , Fructosa/administración & dosificación , Fructosa/economía , Fructosa/uso terapéutico , Humanos , Masculino , Estudios Prospectivos , Calidad de Vida , Inducción de Remisión , Topiramato , Resultado del TratamientoRESUMEN
The entrance of economics into the literature on obesity and diabetes has been instrumental in showing how people respond to incentives when maximizing their health. In this paper some of the roles that prices and policies have played in the surging obesity and diabetes rates across the world are addressed. The paper focuses on the possible role that prices of foods with high glycemic indexes play in determining blood sugar levels, and addresses the recent concern with high fructose corn syrup and genetically modified goods across the world. The possible links and implications suggest that future research in the area is urgently needed.