Medicines In Spain Research Articles

HPR98 Examining Reimbursement and Pricing Decisions of Oncohematological Medicines in Spain

HPR98 Examining Reimbursement and Pricing Decisions of Oncohematological Medicines in Spain

Deliberative processes in health technology assessment of medicines: the case of Spain.

Spain incorporated in 2020 changes in its health technology assessment (HTA), pricing, and reimbursement system for medicines including publishing reports, development of networks of experts, or consultation with stakeholders. Despite these changes, it is unclear how deliberative frameworks are applied and the process has been criticized for not being sufficiently transparent. This study analyses the level of implementation of deliberative processes in HTA for medicines in Spain. We review the grey literature and summarize the Spanish HTA, pricing, and reimbursement process of medicines. We apply the deliberative processes for HTA checklist, developed to assess the overall context of the deliberative process, and identify the stakeholders involved and type of involvement following the framework for evidence-informed deliberative processes, a framework for benefit package design that aims to optimize the legitimacy of decision making. In the Spanish HTA, pricing, and reimbursement process deliberation takes place in order to exchange viewpoints and reach common ground, mainly during the prioritization, assessment, and appraisal steps. It is closed to the public, not clearly summarized in published documents and limited to the Ministry of Health, the regulatory agency, other Ministries, and experts with mostly clinical and/or pharmaceutical background. The views of stakeholders are only represented through consultation. Communication is the most commonly used form of stakeholder engagement. Despite improvements in transparency of the Spanish HTA process for evaluating medicines, aspects related to stakeholder involvement and implementation of deliberative frameworks need further attention in order to achieve further legitimacy of the process.

The availability of medicines in Spain

The availability of medicines in Spain

P28 Evidence-Informed Deliberative Process for Health Technology Assessment in Spain

To identify any gaps when applying evidence-informed deliberative frameworks in the health technology assessment (HTA) process for medicines in Spain.

Off-label pediatric medicines in Spain

Since 2009, the use of off-label and unlicensed drugs has been regulated in Spain. In pediatrics, this exceptional use is more common than in other medical specialties. It varies from 10% to 90% of all prescriptions in children. This variability is due to differences in methodology, classification and sources of information used, and also to the different pediatrics subspecialties. In addition, the knowledge of several pediatricians on this issue is limited and more than half do not comply with the law, in many cases due to ignorance. However, the use of off-label and unlicensed drugs is legal and necessary. The Medicines Committee of the Spanish Association of Pediatrics (CM-AEP) considers that it is necessary to improve the existing information on medicines in the pediatric population. Therefore, the CM-AEP works out a document where suggestions and actions are proposed to achieve it, because children’s health deserves it.

Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?

BackgroundThe economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. ObjectiveThe objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. MethodsNarrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. ResultsSpain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. ConclusionsPoor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.

Evaluation of new medicines in Spain and comparison with other European countries

ObjectiveTo compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany. MethodFor each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions. ResultsResults are presented as a summary of the HTA landscape for P&R of new medicines in each country. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA. ConclusionsBased on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions.

Análisis de la evolución en el acceso a los medicamentos huérfanos en España

ObjectiveTo assess the access to orphan medicines in Spain, focusing on those with an active “orphan” designation, as of 31st December 2017; and for those orphan medicines in the Spanish market, estimate the time between being assigned a National Code (NC) by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and being approved for launch. MethodWe used the European Commission's Public Register of orphan medicines to identify the orphan medicines authorised by the European Medicines Agency (EMA), as of 31 December 2017, while we sourced expired orphan indications from the EMA's website. Dates when NCs were assigned were sourced from the AEMPS, and commercialisation dates from Bot PLUS. A descriptive analysis of the study variables was done. The quantitative variables were described using means and medians, as well as standard deviations and ranges. The qualitative variables were described according to absolute and relative frequencies. The comparison of results was performed by parametric and non-parametric contrasts according to the applicability, at a 5% significance level. ResultsThe EMA has approved 100 orphan medicines (with designation as of 31/12/2017) between 2002-2017. Eighty-six have a NC assigned by the AEMPS. Fifty-four have been launched in Spain (representing 54% of the full sample; 63% with NC). For the 53 orphan drugs with launch date in Spain, the median time between receiving its NC and its launch is 13.4 months (standard deviation: 17.0; minimum: 2.1; maximum: 91,7). The median time is 12.4 months and 14.0 months for those medicines launched in Spain between 2002-2013 and 2014-2017 respectively (p = 0.46). This difference is not statistically significant, which is what could be expected given the low numbers of orphan medicines in the “population”. ConclusionComplex factors determine the access to orphan drugs in Europe. The centralised procedure to obtain marketing authorisation at European level is a success. However, access is more limited, given the complexities of the evaluation of the available evidence for pricing and reimbursement decisions. It is therefore necessary to implement new policies that reduce inequalities in access and help achieve sustainable healthcare systems. To achieve this, they will need to offer the possibility of allowing earlier access, and using payment by results when there is high uncertainty.

Multi-Indication Pricing: Nice in Theory but Can it Work in Practice?

For medicines with different valued indications (uses), multi-indication pricing implies charging different prices for different uses. In this article, we assess how multi-indication pricing could help achieve overall strategic objectives of pricing controls, summarise its advantages and disadvantages (vs. uniform pricing) and estimate the hypothetical impact on prices of moving towards multi-indication pricing for specific oncologic medicines in Spain. International experience shows that multi-indication pricing can be implemented in real practice, and indeed a few initiatives are currently in use, albeit mostly applied indirectly through confidential pricing agreements that offer a way to discriminate prices across countries without altering list prices. However, some more sophisticated systems are in place in Italy, and more recently in Spain, where the objective is to monitor usage per patient/indication, and ultimately pay for outcomes. Based on the existing experience, we also outline six conditions required for multi-indication pricing. Multi-indication pricing is a useful tool to determine the relative prices of a drug for multiple (different-valued) indications, but by itself will not offer the 'solution' to what the absolute price should be. That will be driven, among other things, by cost-effectiveness thresholds, if they exist. Overall, we argue multi-indication pricing is nice in theory and it could work in practice, although changes in the manner in which medicines are priced, procured and monitored in clinical practice need to be applied.

La subasta de medicamentos en Andalucía. Cuestiones controvertidas y perspectivas de futuro

El procedimiento de subasta de medicamentos establecido en la Comunidad Autónoma de Andalucía en el año 2011 como medida de ahorro del gasto farmacéutico ha sido duramente criticado tanto por el Gobierno de la nación que ha interpuestos varios recursos ante el TC por invasión competencial, como por los laboratorios farmacéuticos españoles cuyos intereses se han visto duramente perjudicados con el sistema andaluz. Sin embargo, el TC ha venido a avalar la constitucionalidad de la medida y parece que las últimas noticias apuntan a que se pueda convertir en una medida modelo para el resto de Comunidades Autónomas. De ahí, el interés en realizar este análisis jurídico sobre un tema de máxima actualidad y poder identificar los pros y contras de esta medida andaluza que si bien surge con un carácter claramente coyuntural –motivado por la crisis económica-, su reciente respaldo por el TC podría convertirla en una medida estructural en la dispensación de la prestación farmacéutica en nuestro país.

Analysis of Spanish generic medicines retail market: recommendations to enhance long-term sustainability

The use of generic medicines in Spain is traditionally low compared to other European countries, despite efforts of the Spanish government in the past. This paper provides a perspective on the Spanish generic medicines retail market and how the current policy environment may affect the long-term sustainability. The Spanish government’s focus on prices of generic medicines (e.g., mandatory price cuts, reference price set at the lowest level) have made them amongst the lowest in Europe. In our opinion, this combination of continuous pressure on prices and limited diffusion of generic medicines may undermine the long-term sustainability of the Spanish generic medicines retail market. The unique experience in Spain shows the impact of demand-side policies on the use of generic medicines. Because a sustainable generic medicines retail market is important to maintain future competition in the off-patent medicines market, this perspective paper rounds off with recommendations to increase its sustainability.

Paying for Formerly Free Medicines in Spain After 1 Year of Co-Payment: Changes in the Number of Dispensed Prescriptions

After more than three decades of free medicines for the elderly in Spain, in the context of heavy austerity reforms of public financing, a set of cost-sharing reforms on pharmaceutical prescriptions with regional variants have been established in Spain since July 2012. The purpose of this analysis is to present the first attempt to provide accurate estimates of the overall impact at the regional level of these cost-sharing reforms. We estimated the impact of the reforms on the quantity of dispensed medicines during the first 14 months. We estimated 17 autoregressive integrated moving average (ARIMA) time series models of the monthly number of prescriptions dispensed in pharmacies for the period January 2003-May 2012 in each one of the 17 regions (Autonomous Communities) of Spain. We calculated dynamic forecasts for the horizon June 2012-July 2013 in order to estimate the counterfactual (number of prescriptions that would had been observed without the intervention), and we estimated the impact of cost-sharing changes as the difference between the observed number of accumulated prescriptions at 3, 6, 12, and 14 months and the number predicted by our time-series models (in percentages). During the last decade the number of dispensed prescriptions has experienced rapid and continuous increases. In the first 14 months after the co-payment reform, the total number of prescriptions decreased dramatically, by more than 20% in Catalunya, Valencia, and Galicia, by more than 15% in nine other regions, and by more than 10% in 15 of the 17 Spanish regions. The results of our model suggest that the new co-payment caused an abrupt shift in the mean level of the time series. No shift in trend has been detected; the previous positive trend remains unchanged in most of the Autonomous Communities. After decades of unsuccessfully trying to reduce drug spending in the Spanish National Health System through actions on prices and on prescribers, the co-payment established in mid-2012 led to a dramatic reduction in the use of drugs. The health effects of this reduction are not known.

Social work and netnography: The case of Spain and generic drugs

In this study, we examine a key issue for the sustainability of our welfare state: the patterns of consumption of generic drugs, the Internet, and healthcare social work. Taking the online context (netnography) as an object of ethnographic analysis, we analyze climates of opinion in relation to the consumption of generic drugs. We identify and analyze the linguistic framing and social discrediting of generic drugs via misinformation and the creation of risk perception to curb the social acceptability and consumption of these medicines in Spain. Based on the results obtained, we provide strategies that can be used by healthcare social workers.

The creation of a new nutritional market in Spain: vitamins in the press (1917-1950)

To analyze the extent to which vitamins played a role in the strategy to create a new market of food, food-medicines, and medicines in Spain during the first half of the twentieth century. A study was made of references to vitamins in the years between 1917 and 1950 in the daily newspapers "ABC", "Heraldo de Madrid", "El Imparcial", "El Liberal" and "El Sol", published in Madrid, "La Vanguardia", published in Barcelona, and the weekly publication "Blanco y Negro". The starting date was selected as the year in which the first news of vitamins appeared. The year 1950 marked the end of the harshest stage of autarky imposed by Franco's regime. The news that appeared was classified in the following categories: scientific news, nutritional advice, advertising, economy, politics, anecdotes and metaphors. The advertisements that used vitamins as part of their marketing strategy are the most important section with over 50% of total references to the vitamin concept in almost all the newspapers. Scientific news on vitamins ranks second in importance. References to vitamins in the remaining categories were below 5%. Judging by the references which appear in the most important newspapers of the time vitamins represent a fundamental element in the creation of a new food product market in Spain in the first half of the twentieth century.

PHP10 Two Phases Study on the Perspective of Health Care Professionals on Current Mechanisms for Authorizing the Prescription of Specifically Controlled Medicines in Spain

PHP10 Two Phases Study on the Perspective of Health Care Professionals on Current Mechanisms for Authorizing the Prescription of Specifically Controlled Medicines in Spain

Information provided by generic and brand-name pharmaceutical manufacturers in response to a request

To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. Community pharmacy in Spain. A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.

Medicamentos genéricos en España: primera etapa

To analyse the evolution of the consumption of generic medicines in the first months of their existence in our country, and the additional savings that could have been achieved if they had been used to their full potential. In parallel, to analyse the supply of these products. Observational, retrospective study. The entire National Health Service. All medical prescriptions officially issued under the National Health System in Spain between October 1997 and December 1998. During this period generic medicines to the value of 1727 million pesetas (10.4 million euros) were consumed in our country. This was equivalent to 22.8 millions DDD of 18 different active principles. This figure represented 0.15% of the total consumption of pharmaceutical products in retail amount paid, and 0.17% in number of packages. The potential additional saving that could have been achieved was calculated at 13,227 million pesetas (79.5 million euros). The number of different kinds of generic medicines on sale in May 1999 was 67. The consumption of generic medicines in Spain is increasing steadily in absolute figures in this first stage of their existence. However, there is a long way to go before they reach their maximum potential. As such, the saving not achieved is still very substantial. Supply is also increasing steadily.

Drug utilization studies: a tool for determining the effectiveness of drug use.

To evaluate the quality of the consumption of medicines in Spain, its potential efficacy, and its evolution during the last years, an assessment of the 'intrinsic value' of the most sold pharmaceutical specialities (amounting to more than 50% of total pharmaceutical market) was carried out. A panel of five clinical pharmacologist classified medicines, according to their intrinsic value, in four groups: (i) 'high value' (41% of analyzed medicines in 1980); (ii) 'relative value' (12% in 1980); (iii) 'doubtful value' (3%); (iv) 'no value' (23%), and (v) 'unacceptable value' (21%). Drugs were also classified according to their expected potential of use; and three groups were formed: (i) 'high' (32%); (ii) 'relatively high' (14%), and (iii) 'reduced' (10%). A fourth group of 'not applicable' (44%) in this classification was formed with pharmaceuticals considered unvaluable or unacceptable in the first classification. The results of this study suggest that this kind of analysis may be a useful tool to evaluate the efficacy of drugs in the community, and to identify priorities and guidelines in the selection of drugs in each country.