USE OF HEALTH INFORMATION SYSTEM: COMPARATION OF TWO MODELS OF REFERENCE PRICE SYSTEM

Određivanje referentnih cijena lijekova je jedna od mjere snižavanja cijena lijekova i kontrole rasta zdravstvene potrošnje. Uporabom zdravstvenoinformacijskog sustava napravljena je usporedba modela određivanja referentnih cijena lijekova na ATK razini III-V i modela određivanja referentnih cijena lijekova na ATK razini V kako bi se prikazali mogući financijski učinci provedbe jednog ili drugog modela određivanja referentnih cijena lijekova. Prikazana je korisnost primjene zdravstveno informacijskog sustava u svakodnevnom radu u procesu donošenje odluka vezano uz odabir modela određivanja referentnih cijena lijekova. Primjenom modela određivanja referentnih cijena lijekova na ATK razini III-V moguće je postići veću uštedu u odnosu na model određivanja referentnih cijena lijekova na ATK razini V.A determination of referent prices of drugs is one of measures of the pharmaceutical costs reduction and control of total health costs. In order to present financial effects of the application of the model of reference price system at the Anatomical Therapeutic Chemical Classification System (ATC) III-V level and the model of reference price system at ATC V level, a comparative analysis of those two models has been performed using health information system. In Croatia, the model of reference price system at ATC III-V level has been applied. For the model of reference price system at ATC III-V level, applied in 2012, a comparative model of reference price system at ATC V level has been performed. Those two models have been compared based on the financial benefits projection related to their application. Financial benefits projection has been made based on the drug expenditure in the year that preceded a price referencing year. Financing benefits projection using the model of reference price system at ATC III -V level has been estimated on 318.398.149,58 kuna, whereas financing benefits projection using the model of reference price system at ATC V level has been estimated on 254.451.262,30 kuna. Benefits of the use of health information system in a reference price system, related to selection of the best price referencing model, have been presented. Financial benefits using the price referencing system model on the ATC III-V level seemed to be greater than using the price referencing system model on the ATC V level

Essential to increase the use of generics in Europe to maintain comprehensive health care?

INTRODUCTION: Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. OBJECTIVE: To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. METHODOLOGY: A narrative review of published papers combined with case histories. RESULTS: The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. CONCLUSIONS: Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other

Policies for biosimilar uptake in Europe : an overview

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

Generic pregabalin : current situation and implications for health authorities, generics and biosimilars manufacturers in the future

The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain: its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, generics could be legally prescribed for any approved indication once one indication loses its patent. We aim to establish the current situation with pregabalin among principally European countries. Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact and collated into five tables. The scenarios ranged from extending the patent life of Lyrica (e.g. France), endorsing the prescribing of Lyrica for neuropathic pain (e.g. Catalonia and South Korea), and current prescribing of pregabablin for all indications (e.g. Serbia and Germany). Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication

Introduction and utilization of high priced HCV medicines across Europe; implications for the future

Background: Infection with the Hepatitis C Virus (HCV) is a widespread transmittable disease with a diagnosed prevalence of 2.0%. Fortunately, it is now curable in most patients. Sales of medicines to treat HCV infection grew 2.7% per year between 2004 and 2011, enhanced by the launch of the protease inhibitors (PIs) boceprevir (BCV) and telaprevir (TVR) in addition to ribavirin and pegylated interferon (pegIFN). Costs will continue to rise with new treatments including sofosbuvir, which now include interferon free regimens. de Bruijn et al. HCV Medicines Objective: Assess the uptake of BCV and TVR across Europe from a health authority perspective to offer future guidance on dealing with new high cost medicines. Methods: Cross-sectional descriptive study of medicines to treat HCV (pegIFN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIQs) and expenditure in Euros/DDD. Health authority activities to influence treatments categorized using the 4E methodology (Education, Engineering, Economics and Enforcement). Results: Similar uptake of BCV and TVR among European countries and regions, ranging from 0.5 DIQ in Denmark, Netherlands and Slovenia to 1.5 DIQ in Tayside and Catalonia in 2013. However, different utilization of the new PIs vs. ribavirin indicates differences in dual vs. triple therapy, which is down to factors including physician preference and genotypes. Reimbursed prices for BCV and TVR were comparable across countries. Conclusion: There was reasonable consistency in the utilization of BCV and TVR among European countries in comparison with other high priced medicines. This may reflect the social demand to limit the transmission of HCV. However, the situation is changing with new curative medicines for HCV genotype 1 (GT1) with potentially an appreciable budget impact. These concerns have resulted in different prices across countries, with their impact on budgets and patient outcomes monitored in the future to provide additional guidance

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed

Use of health information system: a comparison of two models of reference price systema

Određivanje referentnih cijena lijekova jedna je od mjere snižavanja cijena lijekova i kontrole rasta zdravstvene potrošnje. Uporabom zdravstvenoinformacijskog sustava napravljena je usporedba modela određivanja referentnih cijena lijekova na ATK razini III-V i ATK razini V kako bi se prikazali mogući financijski učinci provedbe jednog ili drugog modela. Određivanje referentnih cijena lijekova u Hrvatskoj se provodi na ATK razini III-V. Na modelu određivanja referentnih cijena lijekova provedenom 2012. godine na ATK razini III-V napravljen je usporedni model određivanja referentnih cijena lijekova na ATK razini V. Navedena dva modela su uspoređena na osnovi projekcije moguće uštede vezano uz provedbu jednog ili drugog modela. Projekcija moguće uštede napravljena je na osnovi potrošnje lijekova u godini koja je prethodila postupku određivanja referentnih cijena. Primjenom modela određivanja referentnih cijena lijekova na ATK razini III-V procijenjena ušteda bi iznosila 318.398.149,58 kn dok bi primjenom modela određivanja referentnih cijena lijekova na ATK razini V procijenjena uštede bi iznosila 254.451.262,30 kn. Prikazana je korisnost primjene zdravstvenoinformacijskog sustava u svakodnevnom radu u procesu donošenje odluka vezano uz odabir modela određivanja referentnih cijena lijekova. Primjenom modela određivanja referentnih cijena lijekova na ATK razini III-V moguće je postići veću uštedu u odnosu na model koji se provodi ATK razini V.A determination of referent prices of drugs is one of measures of the pharmaceutical costs reduction and control of total health costs. In order to present financial effects of the application of the model of reference price system at the Anatomical Therapeutic Chemical Classification System (ATC) III-V level and the model of reference price system at ATC V level, a comparative analysis of those two models has been performed using health information system. In Croatia, the model of reference price system at ATC III-V level has been applied. For the model of reference price system at ATC III-V level, applied in 2012, a comparative model of reference price system at ATC V level has been performed. Those two models have been compared based on the financial benefits projection related to their application. Financial benefits projection has been made based on the drug expenditure in the year that preceded a price referencing year. Financing benefits projection using the model of reference price system at ATC III-V level has been estimated on 318.398.149,58 HRK, whereas financing benefits projection using the model of reference price system at ATC V level has been estimated on 254.451.262,30 HRK. Benefits of the use of health information system in a reference price system, related to selection of the best price referencing model, have been presented. Financial benefits using the price referencing system model on the ATC III-V level seemed to be greater than using the price referencing system model on the ATC V level

Pharmaceutical pricing in Croatia : a comparison of ordinances in 2013 versus 2009 and their potential savings to provide future guidance

Croatia has introduced a number of reforms to contain pharmaceutical expenditure whilst increasing access to new medicines. These include new regulations and new ordinances in 2013 including the pricing of new medicines and lowering the price of generics. Describe changes in the 2013 ordinance for new and established medicines in Croatia and the potential savings to provide future guidance. Methods: Descriptive review of the new ordinances for pricing and reimbursement of pharmaceuticals and calculations of potential savings from the various initiatives. There were changes in the ordinance for the pricing of new medicines in Croatia including the order of reference priced countries. There were also changes in the pricing of biosimilars as well as comparator levels with other countries. Projections show that with the new ordinance, ambulatory care expenditure for the 54 product groups (internal reference price system) will be reduced by 9.64% (318.4 million kunas) and prices of new medicines lowered by 8 to 10% following changes in the order of referenced price countries. This paper demonstrates that changes in the reference pricing system can lead to considerable differences in overall reimbursed expenditure. In addition, European countries with smaller populations can be active with introducing a variety of measures to keep pharmaceutical expenditure under control whilst increasing access to new medicines. Further reforms will be needed to improve the quality of prescribing. It is also likely further ordinances will be needed to keep pharmaceutical expenditure under control

Essential to increase the use of generics in Europe to maintain comprehensive health care?

Reforms have been introduced across Europe to increase prescribing efficiency with existing drugs. These include measures to lower prices of generics as well as increase their prescribing versus originators and patented products in a class or related class. This is essential to maintain comprehensive health care in Europe given continued pressures. The alternative is insufficient funds for new innovative drugs and increasing drug volumes with ageing populations. To review the influence of measures and initiatives to increase the prescribing and dispensing of generics at low prices on ambulatory care prescribing efficiency. In view of this, provide guidance as authorities strive to introduce further reforms to meet their goals. A narrative review of published papers combined with case histories. The different supply- and demand-side measures have reduced generic prices to as low as 2% to 3% of pre-patent loss prices in some cases as well as appreciably enhanced their utilisation. As a result, prescribing efficiency has increased without compromising care. In some cases, the reforms have led to expenditure actually falling despite appreciably increased volumes. Increasing use of generics at low prices will help maintain the European ideals of comprehensive and equitable health care. However, countries will continually need to learn from each other