| 1. |
- de Bruijn, Winnie, et al.
(författare)
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Introduction and Utilization of High Priced HCV Medicines across Europe : Implications for the Future
- 2016
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Ingår i: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- 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 (Hs) 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 (pegIEN, ribavirin, BCV and TVR) among European countries from 2008 to 2013. Utilization measured in defined daily doses (DDDs)/1000 patients/quarter (DIOs) 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 Pls 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.
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| 2. |
- Eriksson, Irene, et al.
(författare)
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Did we see it Coming? : An Evaluation of the Swedish Early Awareness and Alert System
- 2019
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Ingår i: Applied Health Economics and Health Policy. - : Springer. - 1175-5652 .- 1179-1896. ; 17:1, s. 93-101
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Early awareness and alert systems have been established in many countries but evidence on their ability to accurately prioritize new medicines (for early assessment) is limited.OBJECTIVE: The purpose of this study was to assess whether the Swedish Early Awareness and Alert System identified and prioritized (i.e., produced early assessment reports for) new medicines that would go on to have substantial economic impact.METHODS: We adapted a study design commonly used in the assessment of diagnostic test accuracy. The prioritization made by the Swedish Early Awareness and Alert System prior to marketing authorization comprised the index test and the national drug sales data in the second year post-authorization served as the reference standard. All initial marketing authorization applications for medicinal products processed by the European Medicines Agency between 2010 and 2015 (study population) were classified using the index test and the reference standard.RESULTS: Two hundred and fifty-three new medicinal products processed by the European Medicines Agency comprised the study population. Of these, 71 were prioritized by the Swedish Early Awareness and Alert System and 21 were classified as having substantial economic impact. The sensitivity and positive predictive value were 76.2% and 22.5%, respectively. Subgroup analyses showed that the accuracy of prioritization, in terms of sensitivity, was 100% for antineoplastic/immunomodulating agents.CONCLUSIONS: The Swedish Early Awareness and Alert System identified all new medicines that would go on to have substantial economic impact and prioritized most of these medicines. Our findings provide reassurance to decision makers who rely on the outputs of the Swedish Early Awareness and Alert System to keep informed about new medicines. Moreover, this study also provides valuable insights to stakeholders willing to establish or evaluate their own early awareness and alert activities and systems.
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| 3. |
- Eriksson, Irene, et al.
(författare)
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The Early Awareness and Alert System in Sweden : History and Current Status
- 2017
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Ingår i: Frontiers in Pharmacology. - : Frontiers Media S.A.. - 1663-9812. ; 8
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Forskningsöversikt (refereegranskat)abstract
- The Swedish EAA System started as a regional initiative and rapidly grew to become a national level activity. An important feature of the system today is its complete integration into the national process for managed introduction and follow-up of new medicines. The system will continue to evolve as a response both to the changing landscape of health innovations and to new policy initiatives at the regional, national and international level.
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| 4. |
- Wilking, Nils, et al.
(författare)
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Drug utilization research in the area of cancer drugs
- 2016
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Ingår i: Drug Utilization Research: Methods and Applications. - 9781118949788 ; , s. 315-327
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Bokkapitel (refereegranskat)abstract
- Increased biological understanding of cancer diseases has resulted in a paradigm shift in the medical treatment of cancer. Despite encouraging advances, most cancer types are still incurable and cancer is the second most common cause of death in developed countries.The high price of cancer drugs is a major challenge to equal access and puts heavy strains on public health care payers. After sharp increases in the 2000s, total expenditures on cancer drugs have levelled off due to patent expiration of many expensive and widely used drugs.Cancer drug utilization studies cover a great variety of topics. Four main research areas are patient adherence, physician adherence to guidelines, effectiveness and safety (outcomes research) and access (market uptake).Most cancer drugs are classified under Anatomical Therapeutic Chemical (ATC) group L. The use of defined daily dose (DDD) as a measurement unit is feasible for oral cancer drugs. As most cancer drugs are administered as infusions or injections at hospitals, usage is commonly measured in milligrams.Drug utilization research in the area of cancer is faced with a lack of data. Comparisons are challenging, as prices and population bases vary across regions. The linkage of registries and health care databases that include cancer drug usage will create improved opportunities in the future.
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