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1.
There are marked differences between countries with regard to reimbursement decision-making, yet few studies have tried to understand this process and its consequences by a detailed analysis of the local context and decision-making structure. This article describes reimbursement decision-making and subsequent prescribing patterns of new pharmaceuticals by means of a case study on glitazones in treatment of type 2 diabetes mellitus patients in Denmark. The study shows that institutional arrangements, providing the context in which evidence is used, are highly important for understanding the reimbursement decision-making process. In particular the Danish Medicines Agency (DMA) has shaped the decision to reimburse glitazones on the basis of physician-mediated requests of individual patients. Relatively few patients have been prescribed glitazones since their introduction in 2000, suggesting that individual reimbursement may be an effective instrument in controlling overall expenditure of selected pharmaceuticals, although in the case of glitazones this has likely been achieved at the expense of equality in access to the products. The discussion focuses on the generalizability of the findings to both other pharmaceuticals in the individual reimbursement scheme in Denmark, and to other countries that are trying to balance the need to control overall pharmaceutical care expenditure with the need to secure equality in access to new drugs with therapeutic added value.  相似文献   

2.
OBJECTIVE: To determine if a pre-assessment can be used to establish whether cost-effectiveness results would meet the actual information needs of Dutch healthcare decision makers. METHODS: Two recent studies in rehabilitation medicine served as study material. Based on Wholey, a limited pre-assessment was performed in which the potential impact of cost-effectiveness analysis (CEA) results on intended users' decision making was assessed. Desk research and semi-structured interviews with several intended users of CEA results were performed. These included general practitioners, representatives of health insurance companies, the Health Care Insurance Board (CvZ), and medical guidelines committees. RESULTS: In day-to-day decision making of the interviewed decision makers, a cost-effectiveness criterion seemed to be of limited importance. Instead, results from clinical effectiveness studies and budget impact studies appeared to be sufficient. CvZ, however, preferred relative cost-effectiveness to be a criterion for inclusion in future reimbursement guidelines. In both cases the limited pre-assessments changed the expectations of the investigators regarding decision-making impact of an economic evaluation. CONCLUSION: This study revealed that the use of CEA results for Dutch micro- and meso-level healthcare decision making is not self-evident. The main purpose of CEA results is to support health policy making and planning at a macroeconomic level. Pre-assessment can be a valuable tool in designing a CEA to support the actual information needs of the decision makers.  相似文献   

3.
Public decision makers face demands to invest in applied research in order to accelerate the adoption of new genetic tests. However, such an investment is profitable only if the results gained from further investigations have a significant impact on health care practice. An upper limit for the value of additional information aimed at improving the basis for reimbursement decisions is given by the expected value of perfect information (EVPI). This study illustrates the significance of the concept of EVPI on the basis of a probabilistic cost-effectiveness model of screening for hereditary hemochromatosis among German men. In the present example, population-based screening can barely be recommended at threshold values of 50,000 or 100,000?Euro per life year gained and also the value of additional research which might cause this decision to be overturned is small: At the mentioned threshold values, the EVPI in the German public health care system was ca. 500,000 and 2,200,000?Euro, respectively. An analysis of EVPI by individual parameters or groups of parameters shows that additional research about adherence to preventive phlebotomy could potentially provide the highest benefit. The potential value of further research also depends on methodological assumptions regarding the decision maker's time horizon as well as on scenarios with an impact on the number of affected patients and the cost-effectiveness of screening.  相似文献   

4.
5.
ObjectivesIn January 2009, the National Institute for Health and Care Excellence introduced supplementary guidance for end-of-life (EoL) treatments, which allowed treatments with an incremental cost-effectiveness ratio over the regular threshold (£20 000-£30 000) to be recommended, if they satisfied the EoL criteria. The aims of this study were (1) to systematically review 10 years of EoL supplementary guidance implementation and explore how it could be improved, and (2) to create a framework for incorporating the uncertainty relating to EoL criteria satisfaction into model-based cost-effectiveness analyses for decision making.MethodsAll appraisals between January 2009 and 2019 were screened for EoL discussions. Data were extracted on the EoL criteria and cost-effectiveness assessment details. Additionally, a quantitative method was developed to include the EoL criteria satisfaction uncertainty into model-based cost-effectiveness analyses. A stylized example was created to provide a case study for the inclusion of EoL criteria satisfaction uncertainty.ResultsAn EoL discussion was identified in 35% of appraisals, 57% of which led to a positive EoL decision. Only 5.7% of technologies with positive EoL decisions were not recommended, versus 43.8% of technologies with negative EoL decisions. EoL criteria assessment was often reported insufficiently and evaluated inconsistently and nontransparently. A total of 54.9% of EoL decisions were made while at least 1 criterion was surrounded by considerable uncertainty. By applying the proposed quantitative method, this EoL criteria satisfaction uncertainty was accounted for in decision making. The stylized example demonstrated that the impact of EoL criteria satisfaction uncertainty can be substantial enough to reverse the reimbursement decision.ConclusionsTo improve consistency/transparency and correct reimbursement decisions’ likelihood, new guidelines on the implementation of the EoL criteria are needed.  相似文献   

6.
Pharmaceutical pricing and reimbursement in Finland   总被引:1,自引:0,他引:1  
The cornerstones of social security within the Finnish health care system are public health care and an insurance system covering drug costs in outpatient care and the services of the private health care sector. The reimbursement system is two-tiered, so that when a wholesales price is approved for a drug, it automatically enters the basic reimbursement category. The acceptance of a medicine into the higher reimbursement categories for serious and long-term illnesses involves a separate legislative process. Compared with OECD countries, the degree of reimbursement is low. The price decision is mainly based on international price comparisons, the price of corresponding products on the market, and the funds the reimbursement system has at its disposal. Since 1998, a pharmacoeconomic justification has been mandatory for all new chemical entities. The wholesales prices fall below the EU average. A committee deliberating a reform of the reimbursement system is expected to deliver its report during the summer of 2001.  相似文献   

7.
Authorities in a number of countries rely increasingly on cost-effectiveness analysis to determine reimbursement status or clinical guidance for pharmaceuticals. This study compared the use of health economic evidence across five reimbursement committees (Australia, Ontario and British Columbia in Canada, Finland, and France) and one clinical guidance committee (England and Wales). Health economic evidence was found to support decision making, although cost-effectiveness is less important in some identifiable situations. Since the relative importance of cost-effectiveness varies, it will be difficult to implement a single explicit threshold. Further research may make patterns of decision making, distributional concerns, and the importance of different criteria more transparent, which would help to narrow the gap between the theory and practice of health economic evaluations. While the use of health economic evidence and the outcome of decision making are similar across committees, there is presently only limited knowledge to what extent prescribing patterns are influenced by decisions.  相似文献   

8.
The cornerstones of social security within the Finnish health care system are public health care and an insurance system covering drug costs in outpatient care and the services of the private health care sector. The reimbursement system is two-tiered, so that when a wholesales price is approved for a drug, it automatically enters the basic reimbursement category. The acceptance of a medicine into the higher reimbursement categories for serious and long-term illnesses involves a separate legislative process. Compared with OECD countries, the degree of reimbursement is low. The price decision is mainly based on international price comparisons, the price of corresponding products on the market, and the funds the reimbursement system has at its disposal. Since 1998, a pharmacoeconomic justification has been mandatory for all new chemical entities. The wholesales prices fall below the EU average. A committee deliberating a reform of the reimbursement system is expected to deliver its report during the summer of 2001.  相似文献   

9.
The societal and individual costs of Alzheimer's disease are significant, worldwide. As the world ages, these costs are increasing rapidly, while health systems face finite budgets. As a result, many regulators and payers will require or at least consider phase III cost-effectiveness data (in addition to safety and efficacy data) for drug approval and reimbursement, increasing the risks and costs of drug development. Incorporating pharmacoeconomic studies in phase III clinical trials for Alzheimer's disease presents a number of challenges. We propose several specific suggestions to improve the design of pharmacoeconomic studies in phase III clinical trials. We propose that acute episodes of care are key outcome measures for pharmacoeconomic studies. To improve the possibility of detecting a pharmacoeconomic impact in phase III, we suggest several strategies including; study designs for enrichment of pharmacoeconomic outcomes that include co-morbidity of patients; reducing variability of care that can affect pharmacoeconomic outcomes through standardized care management; employing administrative claims data to better capture meaningful pharmacoeconomic data; and extending clinical trials in open label follow-up periods in which pharmacoeconomic data are captured electronically by administrative claims. Specific aspects of power analysis for pharmacoeconomic studies are presented. The particular pharmacoeconomic challenges caused by the use of biomarkers in clinical trials, the increasing use of multinational studies, and the pharmacoeconomic challenges presented by biologicals in development for Alzheimer's disease are discussed. In summary, since we are entering an era in which pharmacoeconomic studies will be essential in drug development for supporting regulatory approval, payor reimbursement and integration of new therapies into clinical care, we must consider the design and incorporation of pharmacoeconomic studies in phase III clinical trials more seriously and more creatively.  相似文献   

10.

Background

Value-based pricing (VBP), whereby prices are set according to the perceived benefits offered to the consumer at a time when costs and benefits are characterized by considerable uncertainty and are then reviewed ex post, is a much discussed topic in pharmaceutical reimbursement. It is usually combined with coverage with evidence development (CED), a tool in which manufacturers are granted temporary reimbursement but are required to collect and submit additional health economic data at review. Many countries, including the UK, are signalling shifts in this direction. Several countries, including Sweden, have already adopted this approach and offer good insight into the benefits and pitfalls in actual practice.

Objective

To describe VBP reimbursement decision making using CED in actual practice in Sweden.

Methods

Decision making by The Dental and Pharmaceutical Benefits Agency (TLV) in Sweden was reviewed using a case study of continuous intraduodenal infusion of levodopa/carbidopa (Duodopa®) in the treatment of advanced Parkinson’s disease (PD) with severe motor fluctuations.

Results

The manufacturer of Duodopa® applied for reimbursement in late 2003. While the proper economic data were not included in the submission, TLV granted reimbursement until early 2005 to provide time for the manufacturer to submit a formal economic evaluation. The re-submission with economic data was considered inadequate to judge cost effectiveness, so TLV granted an additional extension of reimbursement until August 2007, at which time conclusive data were expected. The manufacturer initiated a 3-year, prospective health economic study and a formal economic model. Data from a pre-planned interim analysis of the data were loaded into the model and the cost-effectiveness ratio was the basis of the next re-submission. TLV concluded that the data were suitable for making a definite decision and that the drug was not cost effective, deciding to discontinue reimbursement for any new patients (current patients were unaffected). The manufacturer continued to collect data and to improve the economic model and re-submitted in 2008. New data and the improved model resulted in reduced uncertainty and a lower cost-effectiveness ratio in the range of Swedish kronor (SEK)430 000 per QALY gained in the base-case analysis, ranging up to SEK900 000 in the most conservative sensitivity analysis, resulting in reimbursement being granted.

Discussion

The case of Duodopa® provides excellent insight into VBP reimbursement decision making in combination with CED and ex post review in actual practice. Publicly available decisions document the rigorous, time-consuming process (four iterations were required before a final decision could be reached). The data generated as part of the risk-sharing agreement proved correct the initial decision to grant limited coverage despite lack of economic data. Access was provided to 100 patients while evidence was generated.

Conclusions

Economic appraisal differs from clinical assessment, and decision makers benefit from analysis of naturalistic, actual practice data. Despite reviewing the initial trial-based, ‘piggy-back’ economic analysis, TLV was uncertain of the cost effectiveness in actual practice and deferred a final decision until observational data from the DAPHNE study became available. Second, acceptance of economic modelling and use of temporary reimbursement conditional on additional evidence development provide a mechanism for risk sharing between TLV and manufacturers, which enabled patient access to a drug with proven clinical benefit while necessary evidence to support claims of cost effectiveness could be generated.  相似文献   

11.
Introduction of the new Pharmaceutical Benefits Board (LFN; 1 October 2002) has markedly changed the principles of pricing and reimbursement of drugs in Sweden. The Board is required to make decisions based on information on cost-effectiveness, and pharmaceutical companies must submit economic evaluations when relevant as part of their applications for reimbursement. This study examined experience to date regarding the use of health-economic evaluations and cost-effectiveness information by the LFN. We also describe activities and the use of cost-effectiveness analysis by Swedish local formulary committees organized by the 21 county councils. It is concluded that economic evaluations have supported decision making by LFN, although cost-effectiveness seems to be of varying importance in different situations. While the use of health-economic evaluations and the outcome of decision making by LFN are similar to comparable committees in other countries, there is presently a gap in this sense between the LFN and Swedish local formulary committees. Coordinated decision making is much needed but may be difficult to implement as the perspective, expertise, and objectives of the two public authorities differ.  相似文献   

12.
When entering the market, orphan drugs are associated with substantial prices and a high degree of uncertainty regarding safety and effectiveness. This makes decision making about the reimbursement of these drugs a complex exercise. To advance on this, the Dutch government introduced a conditional reimbursement trajectory that requires a re-evaluation after four years. This article focuses on the origins, governance and outcomes of such a conditional reimbursement trajectory for orphan drugs. We find that the conditional reimbursement scheme is the result of years of discussion and returning public pressure about unequal access to expensive drugs. During the implementation of the scheme the actors involved went through a learning process about the regulation. Our analysis shows that previous collaborations or already existing organisational structures led to faster production of the required data on cost-effectiveness. However, cost-effectiveness evidence resulting from additional research seems to weigh less than political, judicial and ethical considerations in decision making on reimbursement of orphan drugs in the Netherlands.  相似文献   

13.
Allergic rhinitis, as a medical condition, merits attention because of its prevalence in the population as well as the substantial economic impact of treating it. By virtue of their efficacy and low adverse effect profile, intranasal corticosteroids have gained recognition by healthcare providers as the first-line therapy for allergic rhinitis. For managed care decision makers, the use of intranasal corticosteroids as the gold standard of treatment in allergic rhinitis makes comparative economic and humanistic (patient preference or health-related quality of life [HR-QOL]) data between the various intranasal corticosteroids increasingly important for formulary decisions.Although the equal efficacy and safety of intranasal corticosteroid products in the treatment of allergic rhinitis is well documented, research that compares the different economic and humanistic aspects of intranasal corticosteroid products is limited and less conclusive. In this article, we review published studies reporting pharmacoeconomic and humanistic analyses of intranasal corticosteroids in the treatment of allergic rhinitis and make recommendations for managed care decision makers in the selection of intranasal corticosteroids for allergic rhinitis. Based on inclusion/exclusion criteria, 15 pharmacoeconomic and 19 patient preference/HR-QOL studies were selected and reviewed.The literature reviewed does not provide evidence of the superiority of a single intranasal corticosteroid product with respect to pharmacoeconomic, patient preference, or HR-QOL considerations. This finding is primarily owing to the lack of published head-to-head studies comparing pharmacoeconomic or humanistic outcomes between the different intranasal corticosteroids. Without further head-to-head studies on intranasal corticosteroids for the treatment of allergic rhinitis, cost minimization results may be the best decision strategy for managed care organizations (MCOs). Ideally, the results of cost-effectiveness or cost-utility studies comparing the different intranasal corticosteroids should guide the final formulary decision. In the absence of such studies, pharmacoeconomic and humanistic outcomes data from studies reported in the literature should be included into a pharmacoeconomic model, which considers the prevalence of allergic rhinitis in the MCOs to guide formulary inclusion decisions. Managed care decision makers will increasingly need to request this information from drug manufacturers if an informed, evidence-based decision is to be made.  相似文献   

14.
Throughout Europe and in a number of other industrialized countries, the coming decades have been predicted to feature an increase in the proportion of patients who are elderly. This has led to considerable concern with respect to financing the health care system and has also increased the concerns about the efficiency of health care. Integrating ageing and efficiency issues, this paper examines the effects of age on the cost-effectiveness of medical interventions and its impact on decision making. First, at the clinical level, the relation between age and the cost-effectiveness of medical interventions is analysed. Second, at the population level, a framework is presented which allows researchers and decision makers to assess the impact of these effects on the decision-making process. It is shown that the allocation of health care resources at the macro-level is seriously impaired when age is ignored as a variable in cost-effectiveness analysis. Because clinical trials typically employ ‘young’ populations, when the data are extrapolated to the whole population the attractiveness of medical interventions in terms of cost-effectiveness may be considerably overestimated. Furthermore, the cost-effectiveness ratio may vary across countries or over time as a result of demographic or epidemiological variation. Economic evaluators should describe the impact of age, which should then be considered by decision makers to control for age effects.  相似文献   

15.
ObjectivesThrough the years, assessing the value for money or cost-effectiveness of treatments has become increasingly important. In this context, the price regulations have become stricter in Turkey in contrast to regulations on pharmacoeconomic (PE) assessments. Considering lack of guidelines on PE evaluations, an urgent need arises for pharmacoeconomic regulations in Turkey.MethodsIn this study, we conducted a scoping review on pharmacoeconomic guidelines with specific interest for Turkey's reference countries. Our search covered PubMed, Web of Science, and Cochrane databases, without date restriction. In addition, to provide further background for recommendations on pharmacoeconomic guidelines, a brief review of the Turkish medicines’ reimbursement system and those in reference countries was conducted, in the framework of the respective healthcare systems, explicitly considering the “Health Systems in Transition” series published by World Health Organization. The comparison tool and relevant databases of the International Society for Pharmacoeconomics and Outcomes Research were also reviewed.ResultsAfter selection, 6 relevant publications were included in this review. Regarding review on reimbursement regulations in reference countries, only Greece came out as having no formal PE guidelines.ConclusionsThe set of recommended PE guidelines for Turkey were therefore based on France, Portugal, Spain, and Italy's guidelines and literature data. Our recommended set of guidelines can form the basis for further discussion and help determining the final set for formal embedding in the Turkish regulatory procedure for reimbursement of drugs.Public Interest SummaryThrough the years, assessing the value for money or cost-effectiveness of treatments has become important. Therefore, the price regulations have become stricter in Turkey in contrast to regulations on pharmacoeconomic (PE) assessments. Since an urgent need arises for pharmacoeconomic regulations in Turkey, we conducted a scoping review on PE guidelines with specific interest for Turkey's reference countries. Our search covered three comprehensive databases. In addition, to conduct a widen research on country specific reimbursement systems and other relevant publications. After selection of articles, 6 relevant publications were included in this review. Since, only Greece came out as having no formal PE guidelines, the set of recommended PE guidelines for Turkey were therefore based on other four countries’ guidelines and literature data. Our recommended set of guidelines can form the basis for further discussion and help determining the final set for Turkish regulatory procedure for reimbursement of drugs.  相似文献   

16.
17.

Objectives

Reimbursement recommendations on (orphan) drugs are usually made at a national level and this can lead to variation in patient access to the same drug in different countries. We compared differences in patient access to ultra-orphan drugs between countries. Furthermore, we describe how reimbursed and non-reimbursed orphan drugs differ with respect to pharmacoeconomic properties.

Methods

We studied patient access to eight high-priced inpatient ultra-orphan drugs in nine countries. In addition, we determined whether differences with respect to cost per patient, budget impact and cost-effectiveness existed between orphan drugs with a positive and negative reimbursement status.

Results

Reimbursement status was available for 78 orphan drugs, of which 56 (72%) were positive. Large differences were observed between countries; while two countries had a positive status for two out of nine ultra-orphan drugs, four countries had positive status for all drugs it assessed. A number of drugs were reimbursed only after price negotiations and/or through specific orphan drug policies. The average cost per patient, budget impact and incremental cost-effectiveness ratios were lower for ultra-orphan drugs with a positive reimbursement status than for those with a negative status, although only cost-effectiveness ratios were statistically significant.

Conclusions

Large differences in patient access to ultra-orphan drugs were observed between countries. Future research should examine if similar findings can be seen in other countries and with other orphan drugs, and it should also determine which other factors play a role in reimbursement status of orphan drugs.  相似文献   

18.
From the perspective of a health system as a drug purchaser, it is becoming increasingly obvious that the traditional pharmacoeconomic cost-outcomes techniques of comparator drug evaluation are of limited application. The reason is that such approaches fail to address the information needs of drug purchasers. The key question that these evaluations should address is: If a new product is introduced to formulary, what will be the net impact on the costs of treatment of that disease or therapy area and on the outcomes profile of the treating population? It is on these criteria that claims made for lipid therapies should be judged. Issues that the traditional approach fails to address include: 1) the impact of budget constraints, 2) the determinants and impact of therapy switching, 3) the impact of poor compliance on claims for cost-effectiveness, and 4) the way in which more integrative approaches to treatment delivery might reinforce claims made for particular products. Guidelines are important in this process because they set out the informational requirements and analytical standards required of drug manufacturers making a submission to pharmacy and therapeutics committees. This paper identifies what may be considered to be the minimum informational requirements and suggests how a systems approach to drug evaluation could apply in the area of lipid therapy and the claims for competing products.  相似文献   

19.
《Value in health》2015,18(1):100-109
BackgroundThe conditional reimbursement policy for expensive medicines in The Netherlands requires data collection on actual use and cost-effectiveness after the initial decision to reimburse a drug. This introduces new sources of uncertainty (less important in a randomized controlled trial than in daily practice), which may affect priorities for further research.ObjectivesThis article focuses on determining the impact of including these uncertainties at the time a decision is made, and whether more complex models are always needed to address prioritization of additional research.MethodsWe constructed a typical decision model for chronic progressive diseases with four health states and parameters related to transition and exacerbation probabilities, costs, and utilities. Different scenarios are built on the basis of three additional uncertainties: persistence, compliance, and broadening of indication. Persistence refers to treatment duration. Compliance describes the fraction of treatment benefit obtained because of not taking the medication as prescribed. Broadening of indication reflects a shift in the severity distribution at treatment start. These uncertainties were parameterized in the model and included in the value-of-information analysis.ResultsThe most important parameters were transition probabilities. Broadening of indication had little impact on the overall uncertainty. Compliance and persistence were important when establishing priorities for further research. Major differences with respect to the reference scenario were due to the parameterization of compliance in the decision model.ConclusionsThe usual practice of modeling only randomized controlled trial data at the time the decision on conditional reimbursement is made can lead to wrong decisions. Additional uncertainties arising from outcomes studies should be anticipated at an early stage and included in the model because this can have a strong impact on the prioritization of further research.  相似文献   

20.
Pricing and reimbursement of new pharmaceuticals have been based until recently on the traditional clinical trial outcomes (efficacy, safety, and quality parameters) used for registration. Now we can distinguish various additional data requirements which relate to the use of the drug in real daily practice. The most important new data requirements are effectiveness, cost-effectiveness, and budgetary impact. A main question is how much the impact is of the various types of data in the pricing and reimbursement process. The objective of this contribution is to present a method for quantifying this type of uncertainty in order to develop a more solid pricing and reimbursement strategy for a new innovative drug. The concepts are illustrated for a new hypothetical antidepressant drug in The Netherlands. This method is based on the analytic hierarchy process (AHP) concept which measures decision makers' preferences for the critical success factors. This study shows that the AHP concept may be applied to the pricing and reimbursement environment. The method may be used to assess the pricing potential of a new drug, considering the various data requirements in the reimbursement process.  相似文献   

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