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.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.

Parkinson's disease (PD) is the second most common neurological disease affecting older adults. Consequently, this disease should be a focus among payers, with increasing utilization of newer premium-priced patent-protected add-on therapies to stabilize or even improve motor function over time. However, expenditure can be moderated by reforms. Consequently, there is a need to assess the influence of these reforms on the prescribing efficiency for drugs to treat PD in Croatia before proposing additional measures. Prescribing efficiency is defined as increasing the use of add-on therapies for similar expenditure. An observational retrospective study of the Croatian Institute for Health Insurance database of drugs to treat patients with PD in Croatia from 2000 to 2010 was carried out, with utilization measured in defined daily doses (defined as the average maintenance dose of a drug when used in its major indication in adults). The study years were chosen to reflect recent reforms. Only reimbursed expenditure is measured from a health insurance perspective. Utilization of drugs to treat PD increased by 218% between 2000 and 2010. Reimbursed expenditure increased by 360%, principally driven by increasing utilization of premium-priced patent-protected add-on therapies, including ropinirole and pramipexole. However, following recent reforms, reducing expenditure/defined daily dose for the different drugs, as well as overall expenditure, stabilized reimbursed expenditure between 2005 and 2010. Treatment of PD is complex, and add-on therapies are needed to improve care. Reimbursed expenditure should now fall following stabilization, despite increasing volumes, as successive add-on therapies lose their patents, further increasing prescribing efficiency.

Introduction: 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. Aims: 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. Results: 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. Conclusion: 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.

A445shortages. Methods: The survey was distributed among national health authority and health insurance company experts knowledgeable of the European pharmaceutical markets. It included questions pertaining to: 1) general characteristics of drug shortages; 2) alertness on drug shortages and description of information systems; 3) public service obligations; 4) regulations associated with the problem of drug shortages. Results: The findings are based on feedback from 16 European countries. In the majority of countries formal definitions of drug shortages currently don't exist. Shortages have occurred in all countries throughout the last decade and have typically been increasing. The types of medicines experiencing shortages are generally well recognized, however the frequency and duration of shortages are varied and unpredictable. The notification-related obligations of Marketing Authorization Holders in cases which could lead to drug shortages exist in almost all countries. At least one institution per country is involved in national reporting system but access to information is often limited to the public. In the majority of countries, there exist formal obligations associated with supplying medicines to cover patients' needs so as not to compromise patient care. A few countries have attempted to limit parallel exports to cope with drug shortages. ConClusions: Drug shortages have become an increasingly important public health problem. Its characteristics varies across the European countries. Several lessons can be drawn based on a collective international experience.