RESUMEN
BACKGROUND AND OBJECTIVE: In Ireland, similar to other jurisdictions, health technology assessment (HTA) is used to inform the health payer's drug reimbursement decisions. These HTAs are conducted by the National Centre for Pharmacoeconomics (NCPE). In 2009, the NCPE introduced the Rapid Review process to identify drugs that do not require further assessment in the form of the previously established full HTA process. METHODS: A retrospective analysis of all Rapid Reviews submitted to the NCPE from 2010 to 2019, inclusive, was conducted. Rapid Review recommendation was recorded (i.e. full HTA required or not required). For those submitted from 2012 to 2019, additional data relating to the drug, economic and clinical evidence-related factors were collected. Multivariable logistic regression methods were used to model the relationship between these factors and the likelihood of requiring a full HTA. An exploratory analysis estimated the additional NCPE appraisal time that would have been required to evaluate all drugs, had the Rapid Review process not been established. RESULTS: Of the 446 Rapid Reviews submitted, approximately half (49.6%) were deemed to require a full HTA. Drugs for cancer indications, drugs designated first-in-class status, and high-cost drugs were positively and significantly associated with the likelihood of requiring a full HTA. No significant association was found for drugs for orphan indications when factors relating to cost and clinical evidence were included in the model. Without the Rapid Review process, an estimated additional 15,631 NCPE appraisal days would have been required to evaluate all drugs submitted over the 10-year period. CONCLUSIONS: This is the first study to use data uniquely available to the NCPE to evaluate factors associated with the requirement for a full HTA following a Rapid Review. The process has reduced the NCPE appraisal time required to evaluate all submissions over the study period. The NCPE's Rapid Review process allows for appropriate resource prioritisation within a national HTA agency.
Asunto(s)
Economía Farmacéutica , Evaluación de la Tecnología Biomédica , Costos de los Medicamentos , Humanos , Organizaciones , Estudios Retrospectivos , Evaluación de la Tecnología Biomédica/métodosRESUMEN
This study aims to estimate the theoretical excess expenditure that would be incurred by the Irish state-payer, should drugs be reimbursed at their original asking ("list") price rather than at a price at which the drug is considered cost-effective. In Ireland, all new drugs are evaluated by the National Centre for Pharmacoeconomics. For this study, drugs that were submitted by pharmaceutical companies from 2012 to 2017 and considered not cost-effective at list price were reviewed. A total of 43 such drugs met our inclusion criteria, and their pharmacoeconomic evaluations were further assessed. The price at which the drug could be considered cost-effective (cost-effective price) at the upper cost-effectiveness threshold used in Ireland ( 45 000/quality adjusted life-year) was estimated for 18 drugs with an available cost-effectiveness model. Then, for each drug, the list price and cost-effective price (both per unit) were both individually applied to 1 year of national real-world drug utilization data. This allowed the estimation of the expected expenditures under the assumptions of list price paid and cost-effective price paid. The resulting theoretical excess expenditure, the expenditure at list price minus the expenditure at the cost-effective price, was estimated to be 108.2 million. This estimate is theoretical because of the confidentiality of actual drug prices. The estimation is calculated using the list price and likely overestimates the actual excess expenditure, which would reduce to zero if cost-effective prices are agreed. Nevertheless, this estimate illustrates the importance of a process to assess the value of new drugs so that potential excess drug expenditure is identified.
Asunto(s)
Análisis Costo-Beneficio/métodos , Costos de la Atención en Salud/estadística & datos numéricos , Resultado del Tratamiento , Análisis Costo-Beneficio/estadística & datos numéricos , Utilización de Medicamentos/normas , Utilización de Medicamentos/estadística & datos numéricos , Costos de la Atención en Salud/normas , Humanos , Irlanda , Programas Nacionales de Salud/economía , Programas Nacionales de Salud/normas , Programas Nacionales de Salud/estadística & datos numéricosRESUMEN
It is expected that the coronavirus disease 2019 (COVID-19) pandemic will leave large deficits in the budgets of many jurisdictions. Funding for other treatments, in particular new treatments, may become more constrained than previously expected. Therefore, a robust health technology assessment (HTA) system is vital. Many clinical trials carried out during the pandemic may have been temporarily halted, while others may have had to change their protocols. Even trials that continue as normal may experience external changes as other aspects of the healthcare service may not be available to the patients in the trial, or the patients themselves may contract COVID-19. Consequently, many limitations are likely to arise in the provision of robust HTAs, which could have profound consequences on the availability of new treatments. Therefore, the National Centre for Pharmacoeconomics Review Group wishes to discuss these issues and make recommendations for applicants submitting to HTA agencies, in ample time for these HTAs to be prepared and assessed. We discuss how the pandemic may affect the estimation of the treatment effect, costs, life-years, utilities, discontinuation rates, and methods of evidence synthesis and extrapolation. In particular, we note that trials conducted during the pandemic will be subject to a higher degree of uncertainty than before. It is vital that applicants clearly identify any parameters that may be affected by the pandemic. These parameters will require considerably more scenario and sensitivity analyses to account for this increase in uncertainty.
Asunto(s)
Comités Consultivos , Infecciones por Coronavirus , Pandemias , Neumonía Viral , Evaluación de la Tecnología Biomédica , Betacoronavirus , Presupuestos , COVID-19 , Infecciones por Coronavirus/tratamiento farmacológico , Economía Farmacéutica , Humanos , Neumonía Viral/tratamiento farmacológico , Calidad de Vida , SARS-CoV-2 , Resultado del Tratamiento , Privación de TratamientoRESUMEN
BACKGROUND: The National Centre for Pharmacoeconomics (NCPE) is a National HTA Agency in Ireland responsible for assessment of comparative clinical effectiveness, cost-effectiveness and potential budget impact of drugs on behalf of the Health Service Executive. This research aims to assess if the budget impact models submitted to the NCPE have accurate predicted utilisation, assess if the models are consistent in the parameters included, and determine if probabilistic sensitivity analyses would aid the characterization of uncertainty. METHODS: A retrospective analysis of budget impact models that had been submitted (January 2010-December 2017 inclusive) to the NCPE was performed. The input parameters in the budget impact model were recorded. For each drug, annual realised utilisation was compared with what had been predicted by the respective budget impact model. A probabilistic sensitivity analysis was also performed on each model. RESULTS: A total of 12 models were included; each model pertained to one drug for one indication. Of the 12 models, six underpredicted and six overpredicted the annual realised utilisation. There were a range of different parameters included in each of the budget impact models. A probabilistic sensitivity analysis did not improve the characterization of uncertainty. CONCLUSION: This research has demonstrated that budget impact models submitted to a national HTA agency have limited accuracy in predicting realised utilisation, and there is inconsistency among the parameters included. An electronic budget impact template for applicants has been developed, as a more systematic approach, for their submissions to the NCPE.
Asunto(s)
Presupuestos , Economía Farmacéutica , Modelos Económicos , Análisis Costo-Beneficio , Utilización de Medicamentos/economía , Humanos , Irlanda , Mecanismo de Reembolso/economía , Estudios RetrospectivosRESUMEN
BACKGROUND: The National Centre for Pharmacoeconomics (NCPE) is commissioned by the Corporate Pharmaceutical Unit of the Health Service Executive (HSE-CPU) to assess the evidence for the comparative effectiveness and cost effectiveness of drugs for use by patients in Ireland. All new drugs are required to undergo rapid review (RR) appraisal by the NCPE. Following this, high-cost drugs or those predicted to have a significant budget impact then undergo a full health technology assessment (HTA) appraisal by the NCPE. OBJECTIVE: The objective of this paper was to quantify each stage of the timeline from marketing authorisation (MA) to completion of HTA appraisal and explore the association between submission features and the time to appraise RRs and HTAs. METHODS: All RRs and HTAs submitted to the NCPE (2015-2017 inclusive) were included in the dataset. Several dates and features of each submission were also listed for the purpose of analysis. RESULTS: A total of 158 RR and 49 HTA appraisals were completed by the NCPE between 2015 and 2017. The median time from MA to submission of RR was 59 days; the median time to appraise RR was 31.5 days. Only 49% of RRs appraised (2015-2017 inclusive) were recommended for HTA. The median time from RR decision to submission of HTA was 115 days, and the median time taken by the NCPE to appraise an HTA was 131 days. CONCLUSION: This paper identifies which stages of the process make a substantial contribution to the HTA timeline. Time to submission of RR varied widely between submissions, with only a few companies choosing to submit prior to an MA being granted. The average RR appraisal time was in line with the 4-week timeframe set out in a 2016 agreement. The time to appraise an HTA was longer than the 90-day timeframe.
RESUMEN
BACKGROUND: In Ireland, health technology assessment (HTA) submissions for orphan drugs or drugs for rare diseases have increased in recent years but have not been explicitly analysed. All evaluations are conducted by the National Centre for Pharmacoeconomics (NCPE). OBJECTIVES: The objectives of this study were to ascertain the number of orphan drug submissions to the NCPE and determine how these drugs proceeded through the NCPE critical evaluation process compared with non-orphan drug submissions. METHODS: This was a retrospective analysis of applicant rapid review submissions made to the NCPE from January 2012 to December 2017 inclusive. Drugs were categorised according to the following definitions: orphan (non-cancer) drug, orphan (cancer) drug and ultra-orphan drug. In each of the three categories, the outcome of rapid review appraisal, and where relevant, the outcome of the subsequent HTA was recorded. RESULTS: During the period of study, 280 rapid review submissions were made to the NCPE, of which 21 were for orphan (non-cancer) drugs, 24 were for orphan (cancer) and ten were for ultra-orphan drugs. After rapid review, 44%, 78% and 100% of orphan (non-cancer) drugs, orphan (cancer) drugs and ultra-orphan products, respectively, were recommended for full HTA. When the outcome of the rapid review process was compared between orphan drugs and non-orphan drugs, a statistically significant difference was detected in the proportion of rapid reviews for which the outcome was 'HTA recommended' (Pearson's Chi-squared test; p = 0.04). CONCLUSIONS: The number of submissions to the NCPE for orphan drugs has increased in recent years. The rapid review and HTA process in Ireland plays a role in supporting the reimbursement decision-making process for orphan drugs in a similar manner to the process established for non-orphan drugs. However, the outcome of the reimbursement process for orphan drugs versus non-orphan drugs (in terms of access for patients) has yet to be quantified.
RESUMEN
Acute herpes zoster and its complication post herpetic neuralgia represent a significant challenge to primary care physicians in their care of an ageing population of patients. This was a cross-sectional observational study by means of a quantitative survey of 1,000 general practitioners registered in Ireland exploring the frequency of diagnosis, methods of treatment and cost of AHZ and PHN in primary care. We recorded an 18% response rate (n = 184) with an 83% completion rate (n = 152/184). 80% of cases of AHZ occurred in patients aged 50 years or more with 81% of study participants encountering cases at a rate of 1-3 patients per month. Famciclovir (37%) and valaciclovir (36%) were the most commonly prescribed antiviral agents. Mild opioids (32%) were the most common analgesic agents used for first line AHZ pain, and pregabalin (37%) the most commonly prescribed analgesic agent for second line AHZ pain. Pregabalin was also the most commonly prescribed analgesic for both first and second line PHN pain (29% and 24%, respectively). The mean per-case direct cost (medication and GP visits) of treating AHZ and PHN in primary care was 195 (range 153-236) and 201 (range 140-313), respectively. Based on national sentinel data the estimated annual direct costs of treating AHZ and PHN in primary care is 2,278,196 (range 1,793,399-2, 763,445). The treatment of AHZ and PHN represents both a significant care and cost burden on primary care resources in Ireland in keeping with other European based studies.
Asunto(s)
Antivirales , Herpes Zóster , Neuralgia Posherpética , Atención Primaria de Salud , Enfermedad Aguda , Anciano , Antivirales/economía , Antivirales/uso terapéutico , Estudios Transversales , Costos de la Atención en Salud/estadística & datos numéricos , Herpes Zóster/diagnóstico , Herpes Zóster/tratamiento farmacológico , Herpes Zóster/economía , Herpes Zóster/epidemiología , Humanos , Irlanda/epidemiología , Persona de Mediana Edad , Neuralgia Posherpética/diagnóstico , Neuralgia Posherpética/tratamiento farmacológico , Neuralgia Posherpética/economía , Neuralgia Posherpética/epidemiología , Atención Primaria de Salud/economía , Atención Primaria de Salud/estadística & datos numéricosRESUMEN
AIMS: Prevention of cardiovascular disease and heart failure (HF) in a cost-effective manner is a public health goal. This work aims to assess the cost-effectiveness of the St Vincent's Screening TO Prevent Heart Failure (STOP-HF) intervention. METHODS AND RESULTS: This is a substudy of 1054 participants with cardiovascular risk factors [median age 65.8 years, interquartile range (IQR) 57.8:72.4, with 4.3 years, IQR 3.4:5.2, follow-up]. Annual natriuretic peptide-based screening was performed, with collaborative cardiovascular care between specialist physicians and general practitioners provided to patients with BNP levels >50 pg/mL. Analysis of cost per case prevented and cost-effectiveness per quality-adjusted life year (QALY) gained was performed. The primary clinical endpoint of LV dysfunction (LVD) with or without HF was reduced in intervention patients [odds ratio (OR) 0.60; 95% confidence interval (CI) 0.38-0.94; P = 0.026]. There were 157 deaths and/or emergency hospitalizations for major adverse cardiac events (MACE) in the control group vs. 102 in the intervention group (OR 0.68; 95% CI 0.49-0.93; P = 0.01). The cost per case of LVD/HF prevented was 9683 (sensitivity range -843 to 20 210), whereas the cost per MACE prevented was 3471 (sensitivity range -302 to 7245). Cardiovascular hospitalization savings offset increased outpatient and primary care costs. The cost per QALY gain was 1104 and the intervention has an 88% probability of being cost-effective at a willingness to pay threshold of 30 000. CONCLUSION: Among patients with cardiovascular risk factors, natriuretic peptide-based screening and collaborative care reduced LVD, HF, and MACE, and has a high probability of being cost-effective. TRIAL REGISTRATION: NCT00921960.
Asunto(s)
Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/economía , Péptido Natriurético Encefálico/sangre , Anciano , Análisis Costo-Beneficio , Femenino , Costos de la Atención en Salud , Insuficiencia Cardíaca/prevención & control , Hospitalización/economía , Humanos , Masculino , Persona de Mediana Edad , Grupo de Atención al Paciente , Estudios Prospectivos , Años de Vida Ajustados por Calidad de Vida , Factores de Riesgo , Disfunción Ventricular Izquierda/sangre , Disfunción Ventricular Izquierda/economía , Disfunción Ventricular Izquierda/prevención & controlRESUMEN
AIMS: The aim was to describe the utilization of antidiabetic agents, in terms of persistence and regimen change, in the management of a cohort of newly treated type 2 diabetes patients and to investigate associated socio-demographic and treatment factors. METHODS: A population-based retrospective cohort study was conducted using the national pharmacy claims database in Ireland. Subjects were analyzed for persistence and regimen change. Cox proportional hazards regression examined associations of socio-demographic and treatment factors on treatment patterns. Hazard ratios (HR) and 95% CIs are presented. RESULTS: A total of 20947 subjects were identified in the study over a 2 year period. Most were initiated on metformin (76%) or sulphonylureas (22%) and 77% were persistent with therapy 12 months after initiation. The likelihood of non-persistence was significantly lower in the youngest (40-49 years) age groups (reference 60-69 years) (HR 1.62, 95% CI 1.42, 1.84) and those on sulphonylureas (HR 1.49, 95% CI 1.36, 1.64). The likelihood of receiving a regimen change was significantly lower in the older (80+ years) age groups (HR 0.63, 95% CI 0.56, 0.71), females (HR 0.91, 95% CI 0.86, 0.95), and those with pre-existing CVD (1 vs. 0 CVD medicines) (HR 0.82, 95% CI 0.74, 0.90), and higher in those on sulphonylureas (HR 1.83, 95% CI 1.73, 1.94). CONCLUSIONS: Type of treatment, pre-existing CVD and demographic factors are shown to be associated with the observed treatment patterns. Guideline recommended agents were widely used on treatment initiation though a substantial minority were not initiated on the recommended first line agent. Use of guideline recommended agents was not as evident during treatment progression. Further optimization of initial and subsequent antidiabetic agent prescribing may be possible.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Sustitución de Medicamentos , Hipoglucemiantes/uso terapéutico , Pautas de la Práctica en Medicina , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Bases de Datos Farmacéuticas , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiología , Esquema de Medicación , Quimioterapia Combinada , Femenino , Adhesión a Directriz , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Irlanda/epidemiología , Modelos Logísticos , Masculino , Metformina/uso terapéutico , Persona de Mediana Edad , Oportunidad Relativa , Guías de Práctica Clínica como Asunto , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Compuestos de Sulfonilurea/uso terapéutico , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Organised colorectal cancer screening is likely to be cost-effective, but cost-effectiveness results alone may not help policy makers to make decisions about programme feasibility or service providers to plan programme delivery. For these purposes, estimates of the impact on the health services of actually introducing screening in the target population would be helpful. However, these types of analyses are rarely reported. As an illustration of such an approach, we estimated annual health service resource requirements and health outcomes over the first decade of a population-based colorectal cancer screening programme in Ireland. METHODS: A Markov state-transition model of colorectal neoplasia natural history was used. Three core screening scenarios were considered: (a) flexible sigmoidoscopy (FSIG) once at age 60, (b) biennial guaiac-based faecal occult blood tests (gFOBT) at 55-74 years, and (c) biennial faecal immunochemical tests (FIT) at 55-74 years. Three alternative FIT roll-out scenarios were also investigated relating to age-restricted screening (55-64 years) and staggered age-based roll-out across the 55-74 age group. Parameter estimates were derived from literature review, existing screening programmes, and expert opinion. Results were expressed in relation to the 2008 population (4.4 million people, of whom 700,800 were aged 55-74). RESULTS: FIT-based screening would deliver the greatest health benefits, averting 164 colorectal cancer cases and 272 deaths in year 10 of the programme. Capacity would be required for 11,095-14,820 diagnostic and surveillance colonoscopies annually, compared to 381-1,053 with FSIG-based, and 967-1,300 with gFOBT-based, screening. With FIT, in year 10, these colonoscopies would result in 62 hospital admissions for abdominal bleeding, 27 bowel perforations and one death. Resource requirements for pathology, diagnostic radiology, radiotherapy and colorectal resection were highest for FIT. Estimates depended on screening uptake. Alternative FIT roll-out scenarios had lower resource requirements. CONCLUSIONS: While FIT-based screening would quite quickly generate attractive health outcomes, it has heavy resource requirements. These could impact on the feasibility of a programme based on this screening modality. Staggered age-based roll-out would allow time to increase endoscopy capacity to meet programme requirements. Resource modelling of this type complements conventional cost-effectiveness analyses and can help inform policy making and service planning.
Asunto(s)
Neoplasias Colorrectales/diagnóstico , Planificación en Salud Comunitaria , Detección Precoz del Cáncer/economía , Tamizaje Masivo , Factores de Edad , Anciano , Neoplasias Colorrectales/prevención & control , Costos y Análisis de Costo , Toma de Decisiones , Estudios de Factibilidad , Femenino , Recursos en Salud , Humanos , Irlanda , Masculino , Cadenas de Markov , Tamizaje Masivo/economía , Persona de Mediana Edad , Modelos Estadísticos , Evaluación de Programas y Proyectos de SaludRESUMEN
BACKGROUND: There are concerns that proton pump inhibitors (PPI) are being over prescribed in both primary and secondary care. This study aims to establish potential cost savings in a community drug scheme for a one year period according to published clinical and cost-effective guidelines for PPI prescribing. METHODS: Retrospective population-based cohort study in the Republic of Ireland using the Health Services Executive (HSE) Primary Care Reimbursement Services (PCRS) pharmacy claims database. The HSE-PCRS scheme is means tested and provides free health care including medications to approximately 30% of the Irish population. Prescription items are WHO ATC coded and details of every drug dispensed and claimants' demographic data are available. Potential cost savings (net ingredient cost) were estimated according to UK NICE clinical guidelines for all HSE-PCRS claimants on PPI therapy for ≥3 consecutive months starting in 2007 with a one year follow up (n=167,747). Five scenarios were evaluated; (i) change to PPI initiation (cheapest brand); and after 3 months (ii) therapeutic switching (cheaper brand/generic equivalent); (iii) dose reduction (maintenance therapy); (iv) therapeutic switching and dose reduction and (v) therapeutic substitution (H2 antagonist). RESULTS: Total net ingredient cost was 88,153,174 for claimants on PPI therapy during 2007. The estimated costing savings for each of the five scenarios in a one year period were: (i) 36,943,348 (42% reduction); (ii) 29,568,475 (34%); (iii) 21,289,322 (24%); (iv) 40,505,013 (46%); (v) 34,991,569 (40%). CONCLUSION: There are opportunities for substantial cost savings in relation to PPI prescribing if implementation of clinical guidelines in terms of generic substitution and step-down therapy is implemented on a national basis.
Asunto(s)
Guías de Práctica Clínica como Asunto , Inhibidores de la Bomba de Protones/economía , Adolescente , Adulto , Anciano , Ahorro de Costo/economía , Ahorro de Costo/métodos , Bases de Datos Factuales , Costos de los Medicamentos , Sustitución de Medicamentos/economía , Sustitución de Medicamentos/normas , Femenino , Humanos , Irlanda , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/economía , Pautas de la Práctica en Medicina/estadística & datos numéricos , Inhibidores de la Bomba de Protones/administración & dosificación , Inhibidores de la Bomba de Protones/uso terapéutico , Estudios Retrospectivos , Adulto JovenRESUMEN
BACKGROUND: The majority of pharmaceutical expenditure in Ireland occurs in the community for services provided by general practitioners and pharmacists. In the current national and international economic climate, it is anticipated that demand on these services will continue to grow. OBJECTIVE: The aim of this article was to examine trends in expenditure of pharmaceuticals on the Community Drugs Schemes from 2005 to 2010, and to examine the impact of cost-containment interventions on expenditures that were introduced at this time and affected the pricing mechanism for pharmaceuticals in Ireland. METHODS: Prescription data were analyzed using an Irish national prescription claims database according to drug category, that is, generic, patent, and off patent for the 2 largest schemes; the publicly funded General Medical Services (GMS) Scheme and copayment Drugs Payment (DP) Scheme. Segmented regression analysis of interrupted time series was used to analyze the effects of the interventions on expenditure. RESULTS: An increase in expenditure was noted across all schemes up to 2009 and declined thereafter to the end of the study period (October 2010). Significant reductions in expenditure were noted after introduction of a 20% price cut to patent-expired products (off patents) (P < 0.001). In July 2009, pharmacy and wholesale margins were reduced, resulting in significant reductions in expenditure for patented (GMS Scheme: P < 0.05 and DP Scheme: P < 0.001) and generic (DP Scheme only: P < 0.01) products. Significant reductions in expenditure were noted for off-patent products on the GMS Scheme at this time (P < 0.01). No significant reductions in expenditure were noted for off patents after a 15% price reduction in January 2009. An additional 40% price reduction in February 2010 resulted in significant reductions in expenditure for off-patent products on both the GMS (P < 0.01) and DP Scheme (P < 0.05). CONCLUSIONS: Results from this study, based on a section of the total population of Ireland during a 6-year period, indicate that reductions in the wholesale margin and pharmacy markup had the largest impact on reducing pharmaceutical expenditure during the study period.
Asunto(s)
Control de Costos/organización & administración , Bases de Datos Factuales/estadística & datos numéricos , Gastos en Salud/estadística & datos numéricos , Revisión de Utilización de Seguros/estadística & datos numéricos , Medicamentos bajo Prescripción/economía , Medicina Estatal/economía , Costos y Análisis de Costo , Costos de los Medicamentos/tendencias , Gastos en Salud/tendencias , Reembolso de Seguro de Salud/economía , Irlanda , Medicina Estatal/organización & administraciónRESUMEN
AIM: The aim of this article was to evaluate the influence of different demand-side measures to enhance the prescribing of generics in ambulatory care based on cross-national comparisons. METHODS: An observational retrospective study was conducted using administrative databases from across Europe, documenting changes in reimbursed utilization and expenditure of different proton pump inhibitors (PPIs) and statins between 2001 and 2007, alongside different reforms to enhance prescribing efficiency. Utilization was converted to defined daily doses (DDDs) and expenditures were converted to euros. Demand-side measures were collated under the '4 Es'--education, engineering, economics and enforcement--to enable comparisons on the nature and intensity of reforms between countries. RESULTS: There were considerable differences in the utilization of generics and patent-protected PPIs and statins among Western European countries. Decreased utilization of omeprazole and simvastatin, alongside increased utilization of esomeprazole, atorvastatin and rosuvastatin, was seen in countries with limited demand-side measures to counteract commercial pressures. Prescribing restrictions, or a combination of education, prescribing targets and financial incentives, had the greatest influence on enhancing the utilization of omeprazole and simvastatin. For example, there was a threefold reduction in the utilization of atorvastatin in Austria following prescribing restrictions. Multiple demand-side interventions generally had a greater influence than single interventions, with the impact appearing additive. Multiple interventions coupled with initiatives to lower prices of generics considerably enhanced prescribing efficiency. CONCLUSION: This cross-national study has demonstrated considerable variation in the utilization and expenditure of PPIs and statins across Europe, providing opportunities to further improve prescribing efficiency. The '4 Es' do provide an understandable methodology to document and compare the influence of different demand-side measures, with the influence varying by their extent and intensity. Further reforms are essential given current financial pressures. Consequently, further research will concentrate on the potential to develop a scoring system to help predict the possible impact of different demand-side measures on future utilization patterns.
Asunto(s)
Medicamentos Genéricos/uso terapéutico , Pautas de la Práctica en Medicina/normas , Garantía de la Calidad de Atención de Salud , Atención Ambulatoria , Bases de Datos Factuales , Costos de los Medicamentos , Medicamentos Genéricos/economía , Europa (Continente) , Reforma de la Atención de Salud , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/economía , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Pautas de la Práctica en Medicina/tendencias , Inhibidores de la Bomba de Protones/economía , Inhibidores de la Bomba de Protones/uso terapéutico , Estudios RetrospectivosRESUMEN
A record number of delegates from industry, academia and health policy convened at the 7th Annual Meeting of Health Technology Assessment International (HTAi) which was held in Dublin, Ireland in June 2010. The theme of this year's meeting was 'Maximizing the Value of HTA'. The scientific program covered a broad range of topics from coverage with evidence development to timeliness of conducting HTAs, early engagement with stakeholders, value of information analysis, patient involvement and international collaboration. There was also a lively social program with the conference dinner held at the Guinness Storehouse.
Asunto(s)
Cooperación Internacional , Participación del Paciente , Evaluación de la Tecnología Biomédica/organización & administración , Humanos , Factores de TiempoRESUMEN
In Ireland, expenditure on medicines in the community has increased over sixfold from 300 million euro in 1998 to 1.9 billion euro in 2008. The Health Service Executive has examined all aspects of the drugs supply chain in an attempt to obtain value for money. The 2006 agreement between the Health Service Executive and the Irish Pharmaceutical Healthcare Association resulted in a 35% reduction in the price of patent-expired medicines with estimated savings of 248 million euro. The agreement has been extended to 2012 providing a further 40% price reduction for those off-patent products. Reductions in wholesaler margins and pharmacy reimbursement will provide savings of 130 million euro per annum. Patient co-payment under the Drugs Payment Scheme increased to 120 euro per month and a new co-payment for medical card holders is to be introduced. Since September 2009, all new pharmaceutical products are considered for pharmacoeconomic assessment. Generic substitution and reference pricing are to be introduced in 2011.
Asunto(s)
Costos de los Medicamentos/tendencias , Economía Farmacéutica , Gastos en Salud/estadística & datos numéricos , Medicamentos bajo Prescripción/economía , Seguro de Costos Compartidos/economía , Medicamentos Genéricos/economía , Gastos en Salud/tendencias , Humanos , Irlanda , Programas Nacionales de Salud/economía , Mecanismo de Reembolso/economíaRESUMEN
To describe the pharmacoeconomic assessment process in Ireland and to provide examples of recent appraisals and the subsequent impact on pricing and reimbursement decisions. The pharmacoeconomic appraisals conducted by the National Centre for Pharmacoeconomics (NCPE) between September 2006 and February 2009 were reviewed. The NCPE recommendations and subsequent reimbursement decisions by the Health Service Executive (HSE) were recorded. Recommendations made by the NCPE were compared with those of UK agencies. The duration of the NCPE pharmacoeconomic process and the time from marketing authorization to reimbursement was estimated. The budget impact assessments from the pharmaceutical companies were reviewed and compared for consistency. The NCPE conducted 12 single technology appraisals during the study period. Eight of the medicines assessed were either recommended as a cost-effective use of resources or recommended with certain restrictions, and were funded by the HSE. Of the four medicines that were not considered cost effective, two were reimbursed after a price reduction was negotiated and the remaining two were not. The NCPE recommendations concurred with those of the UK agencies for the majority of appraisals, with the exception of sunitinib and lapatinib. The average duration of the NCPE process was 2.7 months. The average time from marketing authorization to reimbursement was 7 months. The review of budget impact assessments highlighted a high degree of variability between submissions. The findings of this review highlight the efficiency of the pharmacoeconomic process and the acceptance of the NCPE recommendations by the HSE for pricing and reimbursement decisions. NCPE recommendations broadly concurred with those of UK agencies for the majority of appraisals.
Asunto(s)
Economía Farmacéutica , Reembolso de Seguro de Salud/economía , Programas Nacionales de Salud/organización & administración , Medicamentos bajo Prescripción/economía , Análisis Costo-Beneficio/organización & administración , Costos de los Medicamentos , Sector de Atención de Salud/organización & administración , Humanos , Seguro de Servicios Farmacéuticos/economía , IrlandaRESUMEN
INTRODUCTION: European countries need to learn from each other to address unsustainable increases in pharmaceutical expenditures. OBJECTIVE: To assess the influence of the many supply and demand-side initiatives introduced across Europe to enhance prescribing efficiency in ambulatory care. As a result provide future guidance to countries. METHODS: Cross national retrospective observational study of utilization (DDDs - defined daily doses) and expenditure (Euros and local currency) of proton pump inhibitors (PPIs) and statins among 19 European countries and regions principally from 2001 to 2007. Demand-side measures categorized under the "4Es" - education engineering, economics, and enforcement. RESULTS: Instigating supply side initiatives to lower the price of generics combined with demand-side measures to enhance their prescribing is important to maximize prescribing efficiency. Just addressing one component will limit potential efficiency gains. The influence of demand-side reforms appears additive, with multiple initiatives typically having a greater influence on increasing prescribing efficiency than single measures apart from potentially "enforcement." There are also appreciable differences in expenditure (/1000 inhabitants/year) between countries. Countries that have not introduced multiple demand side measures to counteract commercial pressures to enhance the prescribing of generics have seen considerably higher expenditures than those that have instigated a range of measures. CONCLUSIONS: There are considerable opportunities for European countries to enhance their prescribing efficiency, with countries already learning from each other. The 4E methodology allows European countries to concisely capture the range of current demand-side measures and plan for the future knowing that initiatives can be additive to further enhance their prescribing efficiency.
RESUMEN
BACKGROUND: It has been estimated that major orthopaedic surgery has the highest risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) when compared with other surgery. Two new orally active anticoagulants have recently become licensed in Ireland for the primary prevention of venous thromboembolism in adult patients undergoing elective total hip replacement (THR) or total knee replacement (TKR). Rivaroxaban (Xarelto) is a direct factor Xa inhibitor and dabigatran etexilate (Pradaxa) is a prodrug of the active compound dabigatran, which inhibits thrombin. OBJECTIVE: To evaluate the cost effectiveness of rivaroxaban and dabigatran etexilate compared with enoxaparin sodium for the prophylaxis of venous thromboembolism in patients undergoing elective THR and TKR in the Irish healthcare setting. METHODS: The evaluation was conducted from the Irish health-payer perspective. A static decision-tree model was developed with a 180-day post-surgery time horizon. Separate models for the disease states THR and TKR were run to accommodate the different venous thromboembolism risks associated with each procedure. Outcome measures were QALYs and life-years gained (LYG). Costs were valued in euro, year 2008 values. One-way sensitivity analysis of all probabilities in the model was performed. A probabilistic sensitivity analysis using second-order Monte Carlo simulation was performed to determine the probability of cost effectiveness at euro 45,000 per QALY threshold. RESULTS: In the THR base-case model, rivaroxaban dominated both dabigatran etexilate and enoxaparin sodium. The incremental cost-effectiveness ratios for dabigatran etexilate relative to enoxaparin were euro 23,934 per LYG and euro 17,835 per QALY. In the TKR base-case model, rivaroxaban dominated both dabigatran etexilate and enoxaparin sodium. Dabigatran etexilate also dominated enoxaparin sodium. In the one-way sensitivity analysis, the THR model was robust to all but four probability variations; the TKR model was robust to all variations. At a cost-effectiveness threshold of euro 45,000 per QALY, the probability that rivaroxaban was the most cost-effective strategy after THR was 39%, followed by dabigatran etexilate at 32% and enoxaparin sodium at 29%. The probability that rivaroxaban was the most cost-effective strategy after TKR was 46%, followed by dabigatran etexilate at 30% and enoxaparin sodium at 24%. CONCLUSION: Base-case analysis indicates that when both rivaroxaban and dabigatran etexilate are compared with enoxaparin sodium, rivaroxaban is the less costly and more effective option after THR and TKR. Probabilistic sensitivity analysis indicates that rivaroxaban is the most cost-effective strategy at a cost-effectiveness threshold of euro 45,000 per QALY; however, there is uncertainty regarding this strategy being more cost effective than dabigatran etexilate when both are compared with enoxaparin sodium.