BackgroundPharmaceutical companies design clinical development programs to generate the data that they believe will support reimbursement for the experimental compound.ObjectiveThe objective of the study was to present a process for using multicriteria decision analysis (MCDA) by a pharmaceutical company to estimate the probability of a positive recommendation for reimbursement for a new drug given drug and environmental attributes.MethodsThe MCDA process included 1) selection of decisions makers who were representative of those making reimbursement decisions in a specific country; 2) two pre-workshop questionnaires to identify the most important attributes and their relative importance for a positive recommendation for a new drug; 3) a 1-day workshop during which participants undertook three tasks: i) they agreed on a final list of decision attributes and their importance weights, ii) they developed level descriptions for these attributes and mapped each attribute level to a value function, and iii) they developed profiles for hypothetical products ‘just likely to be reimbursed’; and 4) use of the data from the workshop to develop a prediction algorithm based on a logistic regression analysis. The MCDA process is illustrated using case studies for three countries, the United Kingdom, Germany, and Spain. The extent to which the prediction algorithms for each country captured the decision processes for the workshop participants in our case studies was tested using a post-meeting questionnaire that asked the participants to make recommendations for a set of hypothetical products.ResultsThe data collected in the case study workshops resulted in a prediction algorithm: 1) for the United Kingdom, the probability of a positive recommendation for different ranges of cost-effectiveness ratios; 2) for Spain, the probability of a positive recommendation at the national and regional levels; and 3) for Germany, the probability of a determination of clinical benefit. The results from the post-meeting questionnaire revealed a high predictive value for the algorithm developed using MCDA.ConclusionsPrediction algorithms developed using MCDA could be used by pharmaceutical companies when designing their clinical development programs to estimate the likelihood of a favourable reimbursement recommendation for different product profiles and for different positions in the treatment pathway.
A519reimbursable drugs, has abolished the requirement, highlighting the potential practical difficulties in obtaining such prices. One country (Switzerland) has recently proposed amendments to its IRP methodology to focus on discounted rather than listed prices. ConClusions: IRP is increasing as a core market access risk globally, with the knock-on implications of low prices or price cuts in one country into other countries becoming a more tangible and complex threat. IRP is increasing both in terms of geographic scope and also in terms of the precise method of use. The shift from using manufacturing prices towards discounted prices, and the increasing transparency over net prices, represent a significant ongoing threat, and the practical implications are wide-ranging. It has the counter-productive effective of rendering pharmaceutical companies less willing and likely to engage in discounts.
OBJECTIVES: According to the Swedish Healthcare Act, any decisions for prioritisation in health care should be based on three principles; the principle of human dignity, the principle of need and solidarity, and the principle of cost-effectiveness. The principle of human dignity is superior to the two other principles and the cost-effectiveness principle is subordinate to the other two. The Swedish Dental and Pharmaceutical Benefits Agency (TLV) must prioritise accordingly when assessing whether a pharmaceutical should belong to the reimbursement system. This study aims to investigate the importance of economic evaluations in decisions for admission of pharmaceuticals to the reimbursement scheme. METHODS: A review of all TLV decisions regarding admission to the reimbursement system dated January 2011 to March 2012 was conducted. The information extracted included e.g. decision outcome, type of economic evaluation employed and considered medical need. Subsequently, the reasons behind the decisions were analysed. RESULTS: A total of 100 individual decisions for reimbursement were assessed. The vast majority of the 69 decisions leading to general reimbursement were made based on the result of an economic evaluation and a great medical need was the second most important reason. All of the eight negative decisions referred to the inability of the product to be considered a cost-effective alternative. The main reasons behind the 23 decisions for restricted reimbursement were a great medical need and that the product was cost-effective alternative for a specific subgroup.Hence, it appears that the principle for cost-effectiveness is considered more important than the principle of human dignity as medical need was the second most common reason for general reimbursement. CONCLUSIONS: The principle for cost-effectiveness appears to be the most important principle in decisions around a pharmaceutical's admission to the reimbursement system, although the principal's subordinate position to the principle of human dignity and the principle of need and solidarity.
The national government is repositioning the Community Pharmacies (CP) in the national health service, through definition of different: mix of services, relation with other health care actors, and range of objectives to achieve. Considering the contextual factors, the paper aims at analyzing the managerial implication for CP. For this purpose the CPs' director strategic attitude and the structure of the information system are investigated. METHODS: The paper is based on literature review and on a survey conducted among a national sample of 695 community pharmacies (CP). Data were collected through a questionnaire organized in both open questions and closed questions (Likert scale 1-7). Data were analyzed according to descriptive statistics to support the qualitative study approach. The SPSS program was used. RESULTS: Respondents have limited awareness of the different actions that the national and regional contexts implement regard to the CP. Although, the mix of services provided is heterogeneous and not widely consistent with the aims of the government reform (2009 law decree), there is a positive willingness to extent the professional role. Increasing the mix of services provided is perceived a strategic action (mϭ5,09), services are delivered even if the contribution to the CP's revenues is very low (mϭ2,62). The information system allows the monitoring of the overall financial results (mϭ5,33), while its relevance decreases with regard to the CP's cost structure (mϭ4,5) and to the specific service/business area's contribution to the general results (mϭ4,18). CONCLUSIONS: The study suggests that CP's directors haven't developed an effective strategic orientation yet. The actual information system is not able to support them to manage the changes. As long as CPs' director develop a strategic orientation, they could act as agent of change.
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