Pharmaceutical Budget Research Articles

A methodological review of national and transnational pharmaceutical budget impact analysis guidelines for new drug submissions.

IntroductionBudget impact analysis (BIA) in health care, sometimes referred to as resource impact, is the financial change in the use of health resources associated with adding a new drug to a formulary or the adoption of a new health technology. Several national and transnational organizations worldwide have updated their BIA guidelines in the past 4 years. The aim of the present review was to provide a comprehensive list of the key recommendations of BIA guidelines from different countries that may be of interest for those who wish to build or to update BIA guidelines.MethodsNational and transnational BIA guidelines were searched in databases including MEDLINE, EMBASE, Cochrane, EconLit, CINAHL, Business Source Premier, HealthSTAR, and the gray literature including regulatory agency websites. Data were reviewed and abstracted based on key elements in a standard BIA model (analytical model structure, input and data sources, and reporting format).ResultsEight national (Australia, UK, Belgium, Ireland, France, Poland, Brazil, and Canada) and one transnational (International Society for Pharmacoeconomics and Outcomes Research) BIA guidelines were included in this review, and a comprehensive list of BIA recommendations was identified. The review showed that certain recommendations such as patient population assessment, drug-related direct costs, discounting, and disaggregated results were common across the various jurisdictions. BIA guidelines differed from each other in terms of the number and scope of recommendations, the terminology used (eg, the definition of comparators or cost offsets) and the direction of the recommendations (ie, to include or not to include with respect to such items as off-label indications, indirect costs, clinical outcomes, and resource utilization).ConclusionWhile there was a common purpose for all of the BIA guidelines that were identified, substantial differences did occur in the specific recommendations. The pharmaceutical financing system structure might explain why guidelines from the UK, Australia, and Canada have more country-specific recommendations. The desire to be consistent with adopted economic evaluation assumptions might be another reason for some observed differences between countries. Further research is required to assess the source of the heterogeneity between BIA recommendations are identified in different guidelines.

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review.

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

Biosimilars And Reference Biotechnologic Drugs: Comparison Of The Biosimilars’ Effect On Reference Drug’s Price For EU, USA And Turkey

The use of biotechnology-derived products has increased over the last years. In this regard, biosimilars are considered as an alternative to decrease the total biologic drugs cost for countries. To investigate biosimilars cost saving effect on pharmaceutical budget, our research question was based on whether there are considerable price differences between between biosimilar and reference biotechnological product. Considering the probable price differences between biosimilar and reference drug, substitution of biosimilars with reference drugs are expected to result in relatively lower price differences compared to price differences between generic and original conventional drugs. In this regard, in this study, it was aimed to analyze the price differences between biosimilar and reference biotechnology drugs in Europe, USA and Turkey. A systematic literature review was performed by using keywords of ¨Biosimilars Pricing Europe¨, ¨Biosimilars Pricing USA¨ and ¨Biosimilars Pricing Turkey¨ in Pubmed. For Turkey, there was lack of literature with these keywords. Therefore an analysis was made using the local prices of biosimilar drugs whose reference products are also being reimbursed in Turkey. In light of the systematic literature review, the price differences between biosimilar and reference drugs were changed between 0.51% and -38% in Europe. Price differences were found to be between +0.53% and -39.60% in Turkey. As the first biosimilar drug in USA was registered in April 2015, there was lack of literature based on real data with the keywords used in this study. But the price differences assumptions for USA were close to the numbers observed in studies based on EU markets. Although the price difference between biosimilar and reference biotechnological product is relatively lower compared to the conventional drugs, which can be up to 80%, price differences in EU countries, with only by the competition of biosimilar and biotechnology drugs, cost savings could be more than 10 billion $.

Budget Impact Of Newly Approved Drugs By The Sicilian Drug Formulary Committee: An Introductive Analysis

The Italian National Health Service (INHS) is highly decentralized and Regions are responsible for planning healthcare services and allocating financial resources. Local autonomy implies stronger financial accountability leading to different economic strategies across regions. The Sicilian Drug Formulary Committee (SDFC) must approve drugs before hospital use at regional level and drug companies must present a specific dossier for the approval. Budget impact is a critical information for decision makers, therefore the aim of this study is to perform a pharmaceutical budget impact analysis (BIA) of drugs dispensed by the Sicilian Healthcare System (SHS) after one year from their approval. From 1st January 2013 to 1st April 2016, all approved 117-drugs, for which dossiers were presented to SDFC, were identified and stratified according to the Anatomical Therapeutic Chemical (ATC) classification. To perform the BIA, the following data were considered: the main indication of use for an average adult patient (i.e. average body weight of 70kg or body surface of 1.8m2), treatment duration of 12 months, the highest drugs’ strength, ex-factory prices. The average annual cost per patient was then multiplied for the eligible cohort as estimated in the drug dossier presented by the manufacturers. The BIA showed that in the first year from approval, drugs were associated with a total estimated annual pharmaceutical cost of € 500.9 million in charge of the SHS. The highest total expenditures were observed in three drug classes: respiratory system (ATC R) = €215,021,396 (494,782 patients), antineoplastic and immunomodulating agents (ATC L) = €177,185,744 (7,028 patients) and alimentary tract and metabolism (ATC A) = €47,335,649 (68,360 patients). In the past three years, the SDFC approved drugs accounted for €500 million for one year treatment at steady state. Further analyses and monitoring are needed to validate the estimation.

Drug Policy in Bulgaria

Bulgaria has a mixed public-private health care financing system. Health care is financed mainly from compulsory health insurance contributions and out-of-pocket payments. Out-of-pocket payments constitute a large share of the total health care expenditure (44.14% in 2014). The share of drugs expenditure for outpatient treatment was 42.3% of the total health care expenditure in 2014, covered mainly by private payments (78.6% of the total pharmaceutical expenditure). The drug policy is run by the Ministry of Health (MoH), the National Council on Prices and Reimbursement of Medicinal Products, and the Health Technology Assessment Commission. The MoH defines diseases for which the National Health Insurance Fund (NHIF) pays for medicines. The National Council on Prices and Reimbursement of Medicinal Products maintains a positive drug list (PDL) and sets drug prices. Health technology assessment was introduced in 2015 for medicinal products belonging to a new international nonproprietary name group. The PDL defines prescription medicines that are paid for by the NHIF, the MoH, and the health care establishments; exact patient co-payments and reimbursement levels; as well as the ceiling prices for drugs not covered by the NHIF, including over-the-counter medicines. The reimbursement level can be 100%, 75%, or up to 50%. The PDL is revised monthly in all cases except for price increase. Physicians are not assigned with pharmaceutical budgets, there is a brand prescribing practice, and the substitution of prescribed medicines by pharmacists is prohibited. Policies toward cost containment and effectiveness increase include introduction of a reference pricing system, obligation to the NHIF to conduct mandatory centralized bargaining of discounts for medicinal products included in the PDL, public tendering for medicines for hospital treatment, reduction of markup margins of wholesalers and retailers, patient co-payment, and the introduction of health technology assessment. Although most of the policies have been introduced since 2011, there is still weak evidence for improvement regarding cost containment and effectiveness.

Drug Policy in Poland

We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients’ share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e.g., level of reimbursement and risk-sharing scheme agreements). The Agency for Health Technology Assessment and Tariff System dossier is obligatory for reimbursement application and includes the analysis of clinical effectiveness, economic analysis (with the threshold of quality-adjusted life-year established as no more than 3 times the gross domestic product per capita), and the analysis of budget impact. In Poland, only a positive list of reimbursed drugs is published and it is updated every 2 months. The following levels of reimbursement are in use: 100%, 70%, 50%, and lump sum (about €0.8). The first reimbursement decision is given for a period of 2 years only, the second for 3 years, and the third for 5 years. There is no separate budget or special legal regulations for orphan drugs. Generic substitution of drugs is desired but not mandatory. Physicians are not assigned with pharmaceutical budgets. The access to real-world data is limited; the only registers available are for drugs used in drug programs.

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries.

Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries.Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country. Data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) in the years 2014 and 2015 were also collected for each country, along with data on the total pharmaceutical and total public health care budgets.Results: Our survey revealed that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries; the price of biosimilars was usually reduced compared with original drugs and specific price discounts were common. Substitution and interchangeability were generally allowed, although in most countries they were at the discretion of the physician after a clinical assessment. Original biologic drugs and the corresponding biosimilars were usually in the same homogeneous group, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the countries was the same and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta). The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between the countries, with the highest observed value for Slovakia and Hungary and the lowest—for Croatia.Conclusions: The requirements for the pricing and reimbursement of biosimilar products as well as the access of patients to biologic treatment do not differ significantly between the considered CEE countries. Biosimilar drugs significantly influence the reimbursement systems of these countries, and the expenditure on the reimbursement of biosimilars is increasing as they are becoming more accessible to patients.

Trends in medicines procurement by the Brazilian federal government from 2006 to 2013.

The costs of medicines pose a growing burden on healthcare systems worldwide. A comprehensive understanding of current procurement processes provides strong support for the development of effective policies. This study examined Brazilian Federal Government pharmaceutical procurement data provided by the Integrated System for the Administration of General Services (SIASG) database, from 2006 to 2013. Medicine purchases were aggregated by volume and expenditure for each year. Data on expenditure were adjusted for inflation using the Extended National Consumer Price Index (IPCA) for December 31, 2013. Lorenz distribution curves were used to study the cumulative proportion of purchased therapeutic classes. Expenditure variance analysis was performed to determine the impact of each factor, price and/or volume, on total expenditure variation. Annual expenditure on medicines increased 2.72 times, while the purchased volume of drugs increased 1.99 times. A limited number of therapeutic classes dominated expenditure each year. Drugs for infectious diseases drove the increase in expenditures from 2006 to 2009 but were replaced by antineoplastic and immunomodulating agents beginning in 2010. Immunosuppressants (L04), accounted for one third of purchases since 2010, showing the most substantial growth in expenditures during the period (250-fold increase). The overwhelming price-related increase in expenditures caused by these medicines is bound to have a relevant impact on the sustainability of the pharmaceutical supply system. We observed increasing trends in expenditures, especially in specific therapeutic classes. We propose the development and implementation of better medicine procurement systems, and strategies to allow for monitoring of product price, effectiveness, and safety. This must be done with ongoing assessment of pharmaceutical innovations, therapeutic value and budget impact.

Why do generic drugs fail to achieve an adequate market share in Greece? Empirical findings and policy suggestions

ObjectivesSince 2010, the memoranda of understanding were implemented in Greece as a measure of fiscal adjustment. Public pharmaceutical expenditure was one of the main focuses of this implementation. Numerous policies, targeted on pharma spending, reduced the pharmaceutical budget by 60.5%. Yet, generics’ penetration in Greece remained among the lowest among OECD countries. This study aims to highlight the factors that affect the perceptions of the population on generic drugs and to suggest effective policy measures. MethodologyThe empirical analysis is based on a national cross-sectional survey that was conducted through a sample of 2003 individuals, representative of the general population. Two ordinal logistic regression models were constructed in order to identify the determinants that affect the respondents’ beliefs on the safety and the effectiveness of generic drugs. FindingsThe empirical findings presented a positive and statistically significant correlation with income, bill payment difficulties, safety and effectiveness of drugs, prescription and dispensing preferences and the views toward pharmaceutical companies. Also, age and trust toward medical community have a positive and statistically significant correlation with the perception on the safety of generic drugs. Policy interventions are suggested on the bases of the empirical results on 3 major categories; (a) information campaigns, (b) incentives to doctors and pharmacists and (c) to strengthen the bioequivalence control framework and the dissemination of results.

Supply-side and demand-side policies for biosimilars: an overview in 10 European member states

ABSTRACTObjective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs.Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries.Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician’s responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs.Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake.

Initiatives to increase the prescribing of low cost generics; the case of Scotland in the international context

Getting the most out of the pharmaceutical budget is critical across all countries as the financial pressures on healthcare systems intensify. In this paper, we review global practice on encouraging the use of low costs generics versus branded pharmaceuticals, including patented products in the same class where care is not compromised. Our review ranges widely among European countries as well as other high income countries, including Abu Dhabi, Japan and the USA, and other low and middle income Countries. There is a particular focus on Scotland, building on previous publications. We conclude based on multiple publications, including several case studies, that achieving efficiency in pharmaceutical spending is possible in virtually all environments, although there are examples of technologies where generic or therapeutic substitution should not be encouraged. However, there is no magic bullet to achieving full and appropriate use of generics. Countries have to be prepared to use a number of different education, economic, engineering and enforcement methods to achieve success. Similarly, different approaches to achieve low prices for good quality generics. The combination of low prices and increased use of generics will help achieve or attain universal healthcare, benefiting all key stakeholder groups. We conclude with a call for greater cross-country learning in pursuit of what should be a common goal for all health systems.

Italian monitoring registries: a tool for a safer use of innovative drugs? Data from the national pharmacovigilance system

ABSTRACTObjectives: Our aim was to investigate the ADR reports of drugs with a monitoring registry (MR drugs), in particular those related to abuse/misuse, medication error, overdose, which might indicate an unsafe use. We compared these reports with those of similar drugs without a registry (non-MR drugs), thus verifying whether the registries could be useful tools for a safer use of innovative drugs.Methods: All ADR reports included in the Italian Pharmacovigilance Network database from January 1st 2013 to December 31st 2015 (vaccines and literature cases excluded) were analysed. We compared the ADR reports of MR and non-MR drugs with the same ATC class at III level.Results: The percentage of ADR reports with a completed ‘Section 7’ was significantly lower for MR compared to non-MR drugs (2.0 versus 6.2, p < 0.001). The difference concerned in particular the ADR reports related to abuse/misuse, medication errors and overdose. These reports, more strictly related to inappropriate use, were less frequent for MR drugs in all the considered ATC classes.Conclusions: Our study suggests that monitoring registries could be a useful tool for the reduction of frequency of ADRs related to inappropriate use, besides the control of pharmaceutical budget.

PHP321 - Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

The European Union Member States (EU MS) are seeking for effective cost-containment measures to ensure sustainability of health care systems. With growing budget impact of costly biologic medicines, biosimilar promises for health care cost-savings are thoroughly scrutinised by payers. This study aimed to provide an overview of biosimilar policies implemented in selected EU MS. Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden and UK) were selected. A comprehensive review of the literature was performed to identify publications describing 1) supply-side policies and 2) demand-side policies in place in the selected countries through Medline, Embase, Cochrane library databases, GaBi, ISPOR and HTAi websites, National Health Authorities websites and grey literature. 1) Supply-side policies for biosimilars: price linkage and tendering were common practices in almost all countries, while pricing through internal or external reference pricing was more scattered between countries; health technology assessment was reported to be conducted in six countries. 2) Demand-side policies for biosimilars: six countries reported different approaches to control biosimilar prescription through pharmaceutical prescription budgets and/or prescription quotas, sometimes applying financial incentives or penalties measures. Except for Poland, switching and automatic substitution are generally not recommended, and decisions lie with physician’s responsibility; despite not being enforced, France was the first EU MS which legislated biosimilar substitution for naïve patients. Patient co-payment system is in place in all countries; specific co-payment systems to favor use of the cheaper treatment are reported in some countries. Education and information tools retrieved for biosimilars did not generally target a specific audience. Important heterogeneity was seen between (even within) selected countries in policies towards biosimilars; information was generally scarce on educative measures implemented to enhance biosimilar adoption by different stakeholders. This heterogeneity might contribute to explain differences in biosimilar uptakes reported across EU MS.

PND31 - Analysis Of Expenditure In Multiple Sclerosis Disease Modifying Therapies Evolution Between 2004-2015 In Spain

To analyze factors of recent evolution of Multiple Sclerosis (MS) Disease Modifying Therapies (DMT) budgets in Spain between 2004 and 2015. 2004-2015 single DMT monthly expenditure was provided by IMS Health. For each DMT line: (First line: subcutaneous and intramuscular interferon (IFN) β-1a, subcutaneous IFN β-1b glatiramer acetate injection dimethyl fumarate and teriflunomide. Second line: natalizumab, alemtuzumab and fingolimod) were calculated monthly and annually evolution of number of patients, billing, drug cost per patient and cost per year of treatment. Two periods: 2004-2015 and 2007 (start marketing second lines DMT)-2015 period were analyzed for each DMT line. During 2004-2015 DMT expenditure increased from 115.5M€ to 397.3M€ due to: A greater number of patients 192% (10.28% annual growth per year) and a further growth of annual cost per patient: 17.79% (1.50 % annual growth per year). In December 2015 second lines correspond to a 38.39% of DMT expenditure. Annual cost per patient in second line represents 56% over cost per treated patient and 90% greater than first line DMT cost per year. If year 2007 is omitted from analysis (Only 68 second-line treatments and 1.44M€ of associated expense) and is analyzed 2008-2015 period, second-line DMT represent 47% of new treatments causing a 65% increase in DMT expenditure. In 2015 second line DMT participation reaches 38% of new regimens causing the 60.88% of increase DMT expenditure. The growing incorporation of new therapies and the appreciable rise in the number of treated patients (10.28 % annual growth per year) are components to consider in the pharmaceutical budget management.

Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study.

IntroductionThe implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients’ associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value.Design and ObjectivesCross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested.SettingLatin America.MeasuresTo assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries’ minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs.ResultsWe found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries’ income per capita or minimum wage.ConclusionThe implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety profiles and limited therapeutic value, putting patients at risk and causing budgetary strains in pharmaceutical budgets.

FINANCING OF MEDICINES FOR TREATMENT OF RARE DISEASES OF THE NERVOUS SYSTEM. ORPHAN DRUGS IN RARE NEUROLOGICAL DISEASES

Nervous system involvement is expected up to 60-70% in case of rare diseases. This article aims to present the financial methods and expenditures of rare neurological diseases' orphan medicinal products being financed in the frame of Hungarian social insurance system in 2012. The subsidized orphan medicines were selected on the Orphanet portal 2012 while orphans financed by compessionate use were provided by the Hungarian National Insurance Fund Administration (OEP) database. Three products exist without orphan designation, however those are intended for the treatment of rare neurological ailments. The medicines were categorized by financial methods and determined by costs. Numerically, out of 36 pieces of subsidized orphan or orphan criteria fulfilled medicines 17 were authorized for the treatments of rare neurological diseases in the year of 2012. Most of the drugs (14 pieces) were to be financed in the frame of compassionate use by the reimbursement system. The cost amount of social insurance for 387 rare neurological disease patients reached more than 4.5 billion HUF (1.4% of the total pharmaceutical budget in outpatient care). In Hungary half of the subsidized orphans are intended for the treatments of rare neurological ailments. 30% of the total amount of social insurance for rare diseases' medicinal treatments were used to subsidizing rare neurological disease patients in 2012. Most of the orphan medicines were to be financed in the frame of compassionate use by the reimbursement system for outpatient care. Consequently, a great deal of crucial problems occurred in relation with the unconventional subsidizing method. At the end of 2012 new financial methods have been elaborated and introduced in a pilot phase from 1 January 2013. In spite of the high cost commitment, nearly the entire diagnosed rare disease subpopulation has been provided with subsidized treatments in Hungary. In order to facilitate the access to orphan drugs, collaboration is needed between the financing agencies and the professional representatives for identifying the optimal form of financial subsidy.

Biosimilar medicines: creating sustainable competition in an era of a new patent cliff in biological medicines

For many years European governments have sought to ensure a high degree of competition in off-patent pharmaceutical markets in order to generate price competition - and consequently benefits such as improved patient access or savings for payers after patent expiry. The pharmaceutical industry believes that access to valuable new treatments and post-exclusivity competition are essential for the sustainability of healthcare systems. Biological medicines have become increasingly important over the last years. Twenty-seven per cent of pharmaceutical sales in Europe come from biological medicines. This market grew by 5.5% vs. a total market growth of 1.9% in value sales between 2012 and 2013. Many of Europe's top selling biologic molecules are facing patent expiry by 2020[1]. Most biological medicines come at a high cost and governments have difficulty in coping with these costs in their constrained pharmaceutical budgets, especially in current times of austerity. To date, biosimilars account for less than 0.5% of the $221 billion market of biological medicines worldwide. Biosimilars can bring huge savings for payers, and will increase the access to medicines for patients who could not otherwise afford treatment[2]. Figure 1 The biologics Market - IMS Health Thought Leadership, September 2013 Governments must realize that biosimilar medicines are different to generic medicines and as such a unique approach is needed. By applying the generic pricing model to biosimilar medicines, governments risk marking the biosimilar market unsustainable and patients and payers will no longer benefit.

New Zealand patients' understanding of brand substitution and opinions on copayment options for choice of medicine brand.

Objective The aim of the present study was to better understand the views and experiences of New Zealand patients on switching between brands of prescription medicines and on alternative funding options for the provision of medicines, including an increase in copayments. Methods A self-administered questionnaire was offered to selected patients through participating community pharmacies. Pharmacies were stratified according to level of deprivation of the community served before random selection and invitation for involvement in the study. Patient understanding of and rationale for brand substitution was assessed. Preference for different copayment options was elicited, together with demographic and other explanatory information. Results In all, 194 patient-completed questionnaires were returned. Some gaps in patient knowledge and understanding of brand changes were evident. Most respondents indicated a preference for the existing subsidy arrangements with little desire expressed for alternatives. Around half were willing to contribute towards paying for a choice of brand other than the subsidised brand; however, the maximum contribution nominated was disproportionately lower than real cost differences between originator brand and generics. Conclusion The findings of the present study suggest that although most patients have experienced brand changes without any problems occurring, a lack of knowledge about substitution does persist. There may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing to reinforce the benefits of the Pharmaceutical Management Agency (PHARMAC) purchasing model. What is known about the topic? Generic reference pricing is used as a mechanism to make savings to pharmaceutical budgets; however, reticence to the use of generic medicines persists. What does this paper add? Most New Zealand patients experience brand changes without any problems occurring; however, a lack of knowledge about substitution does persist. The dollar value patients indicate they would contribute for brand choice is lower than the true cost difference between brands. What are the implications for practitioners? Opportunities exist for healthcare professionals to reinforce generic policies and there may be some additional gain in ensuring New Zealanders are aware of the full cost of their medicines at the point of dispensing.

Pharmaceutical policies: effects of financial incentives for prescribers.

The proportion of total healthcare expenditures spent on drugs has continued to grow in countries of all income categories. Policy-makers are under pressure to control pharmaceutical expenditures without adversely affecting quality of care. Financial incentives seeking to influence prescribers' behaviour include budgetary arrangements at primary care and hospital settings (pharmaceutical budget caps or targets), financial rewards for target behaviours or outcomes (pay for performance interventions) and reduced benefit margin for prescribers based on medicine sales and prescriptions (pharmaceutical reimbursement rate reduction policies). This is the first update of the original version of this review. To determine the effects of pharmaceutical policies using financial incentives to influence prescribers' practices on drug use, healthcare utilisation, health outcomes and costs (expenditures). We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (searched 29/01/2015); MEDLINE, Ovid SP (searched 29/01/2015); EMBASE, Ovid SP (searched 29/01/2015); International Network for Rational Use of Drugs (INRUD) Bibliography (searched 29/01/2015); National Health Service (NHS) Economic Evaluation Database (searched 29/01/2015); EconLit - ProQuest (searched 02/02/2015); and Science Citation Index and Social Sciences Citation Index, Institute for Scientific Information (ISI) Web of Knowledge (citation search for included studies searched 10/02/2015). We screened the reference lists of relevant reports and contacted study authors and organisations to identify additional studies. We included policies that intend to affect prescribing by means of financial incentives for prescribers. Included in this category are pharmaceutical budget caps or targets, pay for performance and drug reimbursement rate reductions and other financial policies, if they were specifically targeted at prescribing or drug utilisation. Policies in this review were defined as laws, rules, regulations and financial and administrative orders made or implemented by payers such as national or local governments, non-government organisations, private or social insurers and insurance-like organisations. One of the following outcomes had to be reported: drug use, healthcare utilisation, health outcomes or costs. The study had to be a randomised or non-randomised trial, an interrupted time series (ITS) analysis, a repeated measures study or a controlled before-after (CBA) study. At least two review authors independently assessed eligibility for inclusion of studies and risks of bias using Cochrane Effective Practice and Organisation of Care (EPOC) criteria and extracted data from the included studies. For CBA studies, we reported relative effects (e.g. adjusted relative change). The review team re-analysed all ITS results. When possible, the review team also re-analysed CBA data as ITS data. Eighteen evaluations (six new studies) of pharmaceutical policies from six high-income countries met our inclusion criteria. Fourteen studies evaluated pharmaceutical budget policies in the UK (nine studies), two in Germany and Ireland and one each in Sweden and Taiwan. Three studies assessed pay for performance policies in the UK (two) and the Netherlands (one). One study from Taiwan assessed a reimbursement rate reduction policy. ITS analyses had some limitations. All CBA studies had serious limitations. No study from low-income or middle-income countries met the inclusion criteria.Pharmaceutical budgets may lead to a modest reduction in drug use (median relative change -2.8%; low-certainty evidence). We are uncertain of the effects of the policy on drug costs or healthcare utilisation, as the certainty of such evidence has been assessed as very low. Effects of this policy on health outcomes were not reported. Effects of pay for performance policies on drug use and health outcomes are uncertain, as the certainty of such evidence has been assessed as very low. Effects of this policy on drug costs and healthcare utilisation have not been measured. Effects of the reimbursement rate reduction policy on drug use and drug costs are uncertain, as the certainty of such evidence has been assessed as very low. No included study assessed the effects of this policy on healthcare utilisation or health outcomes. Administration costs of the policies were not reported in any of the included studies. Although financial incentives are considered an important element in strategies to change prescribing patterns, limited evidence of their effects can be found. Effects of policies, including pay for performance policies, in improving quality of care and health outcomes remain uncertain. Because pharmaceutical policies have uncertain effects, and because they might cause harm as well as benefit, proper evaluation of these policies is needed. Future studies should consider the impact of these policies on health outcomes, drug use and overall healthcare expenditures, as well as on drug expenditures.

PHP21 - Changes of the Hungarian Health Insurance Pharmaceutical Budget between 2007-2013

PHP21 - Changes of the Hungarian Health Insurance Pharmaceutical Budget between 2007-2013