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1.
BJGP Open ; 2021 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-33495164

RESUMEN

BACKGROUND: Oral nutritional supplements (ONS) are recommended for patients at risk of malnutrition or malnourished. Appropriate ONS prescribing requires regular monitoring to assess its continued requirement. Previous research identified long-term ONS prescriptions (>6 months) without review, with 70% of these influenced by social factors. AIM: To investigate the characteristics of ONS long-term users in Ireland and the determinants of larger volumes of ONS dispensing. DESIGN AND SETTING: Secondary analysis of anonymous dispensed pharmacy claims data of patients dispensed standard ONS for 12 consecutive months in 2018 (n=912). METHOD: Factors showing significant (P<0.05) univariate associations with above the median consumption of ONS units were entered into a multivariable model. RESULTS: Median age was 76 (range 18-101) years, with 66.9% of the sample being ≥65 years. Almost 70% of our sample was on polypharmacy (45.6%;≥5 medications) or excessive polypharmacy (21.5%;≥10 medications). Younger age and being on polypharmacy for drugs having an effect on the central nervous system (CNS) were significantly associated with being dispensed more ONS units in univariate and multivariate analysis. Those patients in the age range 18-44 were 2.5 fold more likely to be prescribed more ONS units (OR 2.5; 95% CI 1.5-4.25;P<0.001). Patients using CNS drugs or on CNS polypharmacy were more likely to be prescribed more ONS units (ORs 1.24 and 2.35; 95% CI 0.86-1.41 and 1.25-4.41 respectively; P=0.029). CONCLUSION: Older age and polypharmacy characterise long-term ONS users in this study. Younger age and CNS medication polypharmacy are predictors of more ONS units prescribed over a year.

2.
Value Health ; 23(11): 1423-1426, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-33127011

RESUMEN

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 , Infecciones por Coronavirus/tratamiento farmacológico , Economía Farmacéutica , Humanos , Neumonía Viral/tratamiento farmacológico , Calidad de Vida , Resultado del Tratamiento , Privación de Tratamiento
3.
BMJ Open ; 10(6): e035087, 2020 06 28.
Artículo en Inglés | MEDLINE | ID: mdl-32595137

RESUMEN

OBJECTIVE: Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN: Non-randomised pilot study. SETTING: Primary care in Ireland. PARTICIPANTS: Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. INTERVENTION: A pharmacist joined the practice team for 6 months (10 hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education. OUTCOME MEASURES: Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ≥65 years) with polypharmacy using patient questionnaires, before and 6 weeks after medication review by the pharmacist. RESULTS: Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57 000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. CONCLUSIONS: This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.

4.
Eur J Health Econ ; 21(6): 895-901, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32232603

RESUMEN

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.

5.
Clin Nutr ESPEN ; 36: 116-127, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-32220354

RESUMEN

BACKGROUND & AIMS: Malnutrition or undernutrition, arising from a deficiency of energy and protein intake, occurs commonly among community-dwelling individuals in developed countries. Once identified, malnutrition can be effectively treated in the majority of cases with dietary advice and the prescription of oral nutritional supplements (ONS) for patients who can eat and drink orally. However, previous research has reported inadequate screening and treatment of malnutrition in the community. The aim of this qualitative study was to explore general practitioners' (GPs) experiences and opinions on the management of malnutrition and the prescription of ONS in the primary care/community setting in Ireland. METHODS: Sixteen semi-structured interviews including chart stimulated recalls (CSR) were conducted with GPs. The interviews and CSRs explored, among others, the following domains; barriers and facilitators in the management of malnutrition, ONS prescribing in the primary care/community setting, and future directions in the management of malnutrition and ONS prescribing. Recorded interviews were transcribed and analysed following a generic qualitative approach with inductive thematic analysis using NVIVO 12 to facilitate data management. RESULTS: Three main themes were identified. Theme 1: 'Malnutrition is a secondary concern', encapsulating the idea that the identification of malnutrition is usually secondary to other clinical issues or disease rather than an independent clinical outcome. This theme also includes the idea that obesity is viewed as a dominant nutritional issue for GPs. Theme 2: 'Responsibility for malnutrition and ONS management in the community', highlighting that GPs feel they do not know who is responsible for the management of malnutrition in the community setting and expressed their need for more support from other healthcare professionals (HCPs) to effectively monitor and treat malnutrition. Theme 3: 'Reluctance to prescribe ONS', emerging from the GPs reported lack of knowledge to prescribe the appropriate ONS, their concern that ONS will replace the patient's meals and the costs associated with the prescription of ONS. CONCLUSIONS: GPs in Ireland do not routinely screen for malnutrition in their clinics as they feel unsupported in treating and managing malnutrition in the community due to limited or no dietetic service availability and time constraints. GPs also view malnutrition as a secondary concern to disease management and prioritise referral to dietetic services for patients with overweight and obesity. GPs reported that they have insufficient knowledge to change or discontinue ONS prescriptions. This study demonstrates that there is a clear need for primary care training in malnutrition identification, treatment and management and more community dietetic services are needed in order to support GPs and deliver high quality care to patients.

6.
Med Decis Making ; 40(2): 144-155, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-32009545

RESUMEN

Economic evaluation is an important element of the decision making process for the reimbursement of drugs. Heterogeneity can be considered an explained variation in clinical or economic outcomes based on the clinical and sociodemographic characteristics of patients. However, to our knowledge, the relationship between price negotiations and population heterogeneity has not been considered in the literature to date. If a company offers a conditional discount that is dependent on obtaining reimbursement in 2 subgroups or indications, an interaction is generated between groups that should be accounted for in economic evaluations. Critically, where the drug has 2 indications but is only cost-effective in 1 indication at the full price (herein "indication 1"), the cost savings realized from implementation of the discount in indication 1 can be used to offset the incremental cost of extending reimbursement to indication 2 at the discounted price. This reduces the incremental cost-effectiveness ratio and increases the probability of positive reimbursement compared to a stratified approach. Given the additional complexity that this introduces, we introduce a framework deemed the "hybrid approach" to guide the economic assessment. We present 2 worked examples. We show that failure to account for the interaction can lead to inaccurate conclusions regarding a drug's cost effectiveness and that adoption of strategic behavior could theoretically increase the reimbursement price of drugs. By adopting this framework, cost-effective interventions are identified that may have been previously misclassified as not being cost-effective and vice versa. Recognition of the interaction in the literature by pharmaceutical companies may influence the forms of discounts offered to decision makers. Therefore, we expect this research to have far-reaching effects on medical decision making.

7.
Value Health ; 23(1): 52-60, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31952674

RESUMEN

BACKGROUND: Many high cost treatments for advanced melanoma have become available in recent years. National health technology assessment agencies have raised concerns regarding uncertainty in their clinical and cost-effectiveness. OBJECTIVE: The aim of this systematic review is to identify economic evaluations of treatments for advanced melanoma and review model assumptions, outcomes, and quality as preparation for a health technology assessment. METHODS: A search of Embase, MEDLINE, EconLit, and the Cochrane Database was conducted. Only studies using decision-analytic models were included. Two authors independently completed full-text review and data extraction. RESULTS: Fifteen studies were identified. There were major differences in the structural assumptions underpinning the models. There was general agreement in study conclusions, although the predicted costs and quality-adjusted life years for each treatment varied. BRAF monotherapy (vemurafenib, dabrafenib) or BRAF/MEK combination therapy (BRAF monotherapy with cobimetinib or trametinib) has not been shown to be cost-effective in any jurisdiction. PD-1 inhibitors (pembrolizumab, nivolumab) are consistently found to be cost-effective compared with ipilimumab, although their cost-effectiveness compared with chemotherapy is not established. Combination therapy with nivolumab and ipilimumab is unlikely to be cost-effective in any setting. One study including all agents found that none of the new treatments were cost-effective relative to chemotherapy. Publication of the study in a health economics journal is associated with better reporting of and higher-quality assessment than those published in clinical journals. CONCLUSION: Despite differences in model structures and assumptions, the conclusions of most included studies were consistent. Health technology assessment has a key role in maximizing value from high-cost innovative treatments. Consideration should be given to divestment from BRAF/MEK inhibitors and ipilimumab in favor of reimbursement of PD-1 inhibitors.


Asunto(s)
Antineoplásicos/economía , Antineoplásicos/uso terapéutico , Costos de los Medicamentos , Asignación de Recursos para la Atención de Salud/economía , Política de Salud/economía , Melanoma/tratamiento farmacológico , Melanoma/economía , Neoplasias Cutáneas/tratamiento farmacológico , Neoplasias Cutáneas/economía , Evaluación de la Tecnología Biomédica/economía , Antineoplásicos/efectos adversos , Análisis Costo-Beneficio , Humanos , Melanoma/patología , Modelos Económicos , Terapia Molecular Dirigida/economía , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Neoplasias Cutáneas/patología , Factores de Tiempo , Resultado del Tratamiento
8.
Pharmacoeconomics ; 38(2): 217-231, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31761996

RESUMEN

BACKGROUND: Differing methodological requirements and decision-making criteria are recognised as barriers to transferability of cost-effectiveness analysis (CEA) across jurisdictions. OBJECTIVE: We assessed the generic and specific transferability of published CEAs of systemic treatments for advanced melanoma to the Irish setting. METHODS: CEAs of treatments for melanoma were identified by systematic review. Transferability to the Irish setting was assessed using the EUnetHTA transferability tool for Economic Evaluation. We present a narrative discussion comparing the differences in key parameter inputs and the likely impact of these differences on the model outcomes and the reimbursement recommendation. Transferability is considered within the context of the Irish cost-effectiveness threshold, using the net monetary benefit (NMB) framework. RESULTS: No published CEAs (n = 15) aligned with the Irish reference case for CEA. Changes to key parameters were unlikely to change the conclusions of the CEA when the cost-effectiveness threshold was considered. Ten studies (19 pairwise comparisons) were compared with findings by the National Centre for Pharmacoeconomics (NCPE) using NMB. Without accounting for differences in the cost-effectiveness threshold, there was alignment between the study conclusions and NCPE recommendations in 73.7% cases. When the Irish cost-effectiveness threshold was applied in the estimation of NMB, there was agreement in 89.5% of cases. CONCLUSIONS: Alignment in methodological requirements for CEA is important to facilitate joint health technology assessment (HTA) by regional collaborations in Europe. When parameter inputs are not exactly aligned, conclusions may still be comparable across jurisdictions. For international joint procurement initiatives, determining and implementing joint decision rules may be more important than trying to align rules regarding methodological and parameter inputs.

9.
Clin Nutr ; 2020 Dec 23.
Artículo en Inglés | MEDLINE | ID: mdl-33422348

RESUMEN

BACKGROUND & AIMS: Understanding how older adults perceive their nutritional needs and malnutrition risk is important to inform strategies to improve prevention and management of the condition. This scoping review aimed to identify, characterize and summarize the findings from studies analysing community-dwelling older adults' opinions and perceptions towards their nutritional needs and malnutrition risk. METHODS: An electronic literature search was carried out using three databases, Pubmed, Embase, and CINAHL up to January 2020. Articles were reviewed following PRISMA guidelines. RESULTS: A total of 16,190 records were identified and reviewed with 15 studies being included, all of which were conducted in high income countries. Common conceptual categories that were identified included; older community-dwelling adults consider that a healthy diet for them is the same as that recommended for the general population, consisting of fruits, vegetables, reduced fat and reduced sugar. Weight loss was seen as a positive outcome and a normal component of the ageing process. Lack of appetite was identified by participants in the majority of studies as a barrier to food intake. CONCLUSIONS: This review shows how older community-dwelling adults, with a high risk of malnutrition, follow dietary public health recommendations for the general population and have a greater awareness of the risks of overweight. The implementation of nutritional guidelines that consider the nutritional needs of all older adults and education of non-dietetic community healthcare professionals on providing appropriate nutritional advice to this population are warranted.

10.
Pharmacoecon Open ; 3(4): 583-589, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31073976

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.

11.
PLoS One ; 12(12): e0190147, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-29284064

RESUMEN

BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. RESULTS: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. CONCLUSIONS: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.


Asunto(s)
Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/economía , Costos de los Medicamentos , Europa (Continente) , Humanos
12.
Pharmacoeconomics ; 35(11): 1177-1185, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28770453

RESUMEN

BACKGROUND: In Ireland, all new drugs for which reimbursement by the healthcare payer is sought undergo a health technology assessment by the National Centre for Pharmacoeconomics. The National Centre for Pharmacoeconomics estimate expected value of perfect information but not partial expected value of perfect information (owing to computational expense associated with typical methodologies). OBJECTIVE: The objective of this study was to examine the feasibility and utility of estimating partial expected value of perfect information via a computationally efficient, non-parametric regression approach. METHODS: This was a retrospective analysis of evaluations on drugs for cancer that had been submitted to the National Centre for Pharmacoeconomics (January 2010 to December 2014 inclusive). Drugs were excluded if cost effective at the submitted price. Drugs were excluded if concerns existed regarding the validity of the applicants' submission or if cost-effectiveness model functionality did not allow required modifications to be made. For each included drug (n = 14), value of information was estimated at the final reimbursement price, at a threshold equivalent to the incremental cost-effectiveness ratio at that price. The expected value of perfect information was estimated from probabilistic analysis. Partial expected value of perfect information was estimated via a non-parametric approach. Input parameters with a population value at least €1 million were identified as potential targets for research. RESULTS: All partial estimates were determined within minutes. Thirty parameters (across nine models) each had a value of at least €1 million. These were categorised. Collectively, survival analysis parameters were valued at €19.32 million, health state utility parameters at €15.81 million and parameters associated with the cost of treating adverse effects at €6.64 million. Those associated with drug acquisition costs and with the cost of care were valued at €6.51 million and €5.71 million, respectively. CONCLUSION: This research demonstrates that the estimation of partial expected value of perfect information via this computationally inexpensive approach could be considered feasible as part of the health technology assessment process for reimbursement purposes within the Irish healthcare system. It might be a useful tool in prioritising future research to decrease decision uncertainty.


Asunto(s)
Antineoplásicos/uso terapéutico , Toma de Decisiones , Neoplasias/tratamiento farmacológico , Mecanismo de Reembolso/economía , Antineoplásicos/economía , Análisis Costo-Beneficio , Costos de los Medicamentos , Economía Farmacéutica , Estudios de Factibilidad , Humanos , Irlanda , Neoplasias/economía , Estudios Retrospectivos , Estadísticas no Paramétricas , Evaluación de la Tecnología Biomédica , Incertidumbre
13.
Front Pharmacol ; 7: 305, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-27733828

RESUMEN

Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative. Secondly, MAPPs will result in new medicines on the market with limited evidence about their effectiveness and safety. Additional data are to be collected after approval. Consequently, adaptive pathways may increase the risk of exposing patients to ineffective or unsafe medicines. We have already seen medicines approved conventionally that subsequently proved ineffective or unsafe amongst a wider, more co-morbid population as well as medicines that could have been considered for approval under MAPPs but subsequently proved ineffective or unsafe in Phase III trials and were never licensed. Thirdly, MAPPs also put high demands on payers. Routine collection of patient level data is difficult with high transaction costs. It is not clear who will fund these. Other challenges for payers include shifts in the risk governance framework, implications for evaluation and HTA, increased complexity of setting prices, difficulty with ensuring equity in the allocation of resources, definition of responsibility and liability and implementation of stratified use. Exit strategies also need to be agreed in advance, including price reductions, rebates, or reimbursement withdrawals when price premiums are not justified. These issues and concerns will be discussed in detail including potential ways forward.

14.
Pharmacoeconomics ; 34(12): 1267-1276, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27473640

RESUMEN

BACKGROUND: In Ireland, all new drugs are considered for a formal pharmacoeconomic evaluation (PE) prior to a reimbursement decision. All evaluations are conducted by the National Centre for Pharmacoeconomics (NCPE). The objectives of this study were to describe the evaluation process and to examine the movement of drugs through the process. METHODS: The movement of all drugs submitted to the NCPE (from January 2010 to December 2015 inclusive) was investigated. RESULTS: A total of 230 Rapid Review submissions (each pertaining to one drug for one indication) were made. The Rapid Review process determines the requirement for a full PE. A full PE was deemed unnecessary in 108 cases (47 %). A positive reimbursement recommendation was made in 100 of these (a price reductions was advised in 25 cases and a recommendation to restrict/monitor usage was made in 35). The requirement for a full PE was recognised in 122 cases (53 %). In 12, subsequent payer-led price negotiations negated the requirement for a full PE, and reimbursement was recommended. In 24 cases, a timely full submission was not made; cost effectiveness could not be established. Fifteen interventions are currently going through the submission process. To date, 71 full PEs have been completed by the NCPE. Reimbursement was recommended in 19 and was not recommended in eight. Reimbursement was not recommended 'at the submitted price' in 44. Of these, reimbursement was subsequently approved in 34 (77 %) following price negotiations. To date, negotiations are on-going in a further six cases. In all, negotiations have been informed by the NCPE. A negative recommendation was reached in the remaining four. CONCLUSIONS: Over the study period, the NCPE evaluated 230 drugs for which reimbursement was sought. In total, a positive reimbursement recommendation has been made in 165 cases (72 % of all drugs submitted, or 79 % when drugs currently undergoing the process are excluded). A price reduction was deemed necessary in 71 (43 %) of the 165 cases, and a recommendation to restrict/monitor usage was made in 35 cases (21 %).


Asunto(s)
Economía Farmacéutica , Preparaciones Farmacéuticas/economía , Salud Pública/economía , Mecanismo de Reembolso , Análisis Costo-Beneficio , Costos y Análisis de Costo , Toma de Decisiones , Política de Salud , Humanos , Irlanda
15.
Pharmacoeconomics ; 34(9): 925-37, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27034245

RESUMEN

BACKGROUND: Decisions on reimbursement of health interventions in many jurisdictions are informed by health technology assessments (HTAs). Historically, the focus of these has often been cost effectiveness or cost utility, while other criteria were considered informally. More recently, there has been an increasing interest in the formal incorporation of additional criteria using multi-criteria decision analysis. Such an approach has not yet formally been part of decision-making policy in Ireland. OBJECTIVE: The objective of this analysis is to demonstrate that cost effectiveness is not the only criterion influencing reimbursement decisions in Ireland. Furthermore, the aim is to reveal criteria that may have informally influenced reimbursement decisions in the past. METHODS: A list of potential criteria was identified based on the literature, national guidelines and experience of the national HTA agency. Information on each of these criteria was sought for every assessment conducted in Ireland up to July 2015. A logistic regression was fitted to the data to identify influential parameters. Model selection was performed using the Bolasso method. RESULTS: Thirteen criteria were considered in the analysis. Two members of the HTA review team assessed the performance of the interventions against these criteria. Model selection suggests that the incremental cost-effectiveness ratio and quality of evidence could be important drivers of reimbursement recommendations in Ireland. Less important drivers suggested include the year of assessment, the level of uncertainty, as well as safety and tolerability. CONCLUSION: The analysis demonstrates that recommendations for or against the reimbursement of technologies in Ireland are not only driven by cost effectiveness. This highlights the need for more formal inclusion of criteria in the process, to improve transparency and ensure consistency.


Asunto(s)
Toma de Decisiones , Técnicas de Apoyo para la Decisión , Mecanismo de Reembolso , Evaluación de la Tecnología Biomédica/métodos , Tecnología Biomédica/economía , Análisis Costo-Beneficio , Humanos , Irlanda , Modelos Logísticos , Modelos Económicos , Formulación de Políticas , Estudios Retrospectivos , Incertidumbre
16.
Expert Rev Clin Pharmacol ; 8(1): 77-94, 2015 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25487078

RESUMEN

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.


Asunto(s)
Prestación de Atención de Salud/métodos , Descubrimiento de Drogas/métodos , Revisión de la Utilización de Medicamentos/métodos , Preparaciones Farmacéuticas/administración & dosificación , Ensayos Clínicos Fase III como Asunto , Industria Farmacéutica/métodos , Humanos
17.
BMC Med ; 11: 179, 2013 Aug 13.
Artículo en Inglés | MEDLINE | ID: mdl-23941275

RESUMEN

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.


Asunto(s)
Prestación de Atención de Salud/métodos , Atención al Paciente/métodos , Medicina de Precisión/métodos , Prestación de Atención de Salud/tendencias , Estudios de Factibilidad , Predicción , Humanos , Atención al Paciente/tendencias , Farmacogenética/métodos , Farmacogenética/tendencias , Medicina de Precisión/tendencias
18.
Front Pharmacol ; 4: 39, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23717279

RESUMEN

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. OBJECTIVE: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. METHODOLOGY: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. RESULTS: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

19.
Pharmacoeconomics ; 30(10): 941-59, 2012 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-22667458

RESUMEN

BACKGROUND: The National Centre for Pharmacoeconomics, in collaboration with the Health Services Executive, considers the cost effectiveness of all new medicines introduced into Ireland. Health Technology Assessments (HTAs) are conducted in accordance with the existing agreed Irish HTA guidelines. These guidelines do not specify a formal analysis of value of information (VOI). OBJECTIVE: The aim of this study was to demonstrate the benefits of using VOI analysis in decreasing decision uncertainty and to examine the viability of applying these techniques as part of the formal HTA process for reimbursement purposes within the Irish healthcare system. METHOD: The evaluation was conducted from the Irish health payer perspective. A lifetime model evaluated the cost effectiveness of rivaroxaban, dabigatran etexilate and enoxaparin sodium for the prophylaxis of venous thromboembolism after total hip replacement. The expected value of perfect information (EVPI) was determined directly from the probabilistic analysis (PSA). Population-level EVPI (PEVPI) was determined by scaling up the EVPI according to the decision incidence. The expected value of perfect parameter information (EVPPI) was calculated for the three model parameter subsets: probabilities, preference weights and direct medical costs. RESULTS: In the base-case analysis, rivaroxaban dominated both dabigatran etexilate and enoxaparin sodium. PSA indicated that rivaroxaban had the highest probability of being the most cost-effective strategy over a threshold range of &U20AC;0-&U20AC;100 000 per QALY. At a threshold of &U20AC;45 000 per QALY, the probability that rivaroxaban was the most cost-effective strategy was 67%. At a threshold of &U20AC;45 000 per QALY, assuming a 10-year decision time horizon, the PEVPI was &U20AC;11.96 million and the direct medical costs subset had the highest EVPPI value (&U20AC;9.00 million at a population level). In order to decrease uncertainty, a more detailed costing study was undertaken. In the subsequent analysis, rivaroxaban continued to dominate both comparators. In the PSA, rivaroxaban continued to have the highest probability of being optimal over the threshold range &U20AC;0-&U20AC;100 000 per QALY. At &U20AC;45 000 per QALY, the probability that rivaroxaban was the most cost-effective strategy increased to 80%. At &U20AC;45 000 per QALY, the 10-year PEVPI decreased to &U20AC;3.58 million and the population value associated with the direct medical costs fell to &U20AC;1.72 million. CONCLUSION: This increase in probability of cost effectiveness, coupled with a substantially reduced potential opportunity loss could influence a decision maker's confidence in making a reimbursement decision. On discussions with the decision maker we now intend to incorporate the use of VOI into our HTA process.


Asunto(s)
Anticoagulantes/economía , Artroplastia de Reemplazo de Cadera/métodos , Modelos Económicos , Tromboembolia Venosa/prevención & control , Anticoagulantes/uso terapéutico , Artroplastia de Reemplazo de Cadera/economía , Bencimidazoles/economía , Bencimidazoles/uso terapéutico , Análisis Costo-Beneficio , Dabigatrán , Toma de Decisiones , Enoxaparina/economía , Enoxaparina/uso terapéutico , Guías como Asunto , Costos de la Atención en Salud , Humanos , Irlanda , Morfolinas/economía , Morfolinas/uso terapéutico , Piridinas/economía , Piridinas/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán , Evaluación de la Tecnología Biomédica , Tiofenos/economía , Tiofenos/uso terapéutico , Factores de Tiempo , Tromboembolia Venosa/economía , Tromboembolia Venosa/etiología
20.
Pharmacoeconomics ; 27(10): 829-46, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-19803538

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.


Asunto(s)
Anticoagulantes/economía , Bencimidazoles/economía , Enoxaparina/economía , Morfolinas/economía , Piridinas/economía , Tiofenos/economía , Anticoagulantes/uso terapéutico , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Cadera/métodos , Artroplastia de Reemplazo de Rodilla/economía , Artroplastia de Reemplazo de Rodilla/métodos , Bencimidazoles/uso terapéutico , Análisis Costo-Beneficio , Dabigatrán , Árboles de Decisión , Enoxaparina/uso terapéutico , Fibrinolíticos/economía , Fibrinolíticos/uso terapéutico , Humanos , Irlanda , Modelos Económicos , Método de Montecarlo , Morfolinas/uso terapéutico , Piridinas/uso terapéutico , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán , Tiofenos/uso terapéutico , Tromboembolia Venosa/economía , Tromboembolia Venosa/prevención & control
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