Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs

Frontiers in Pharmacology

Volumn 5 JUN, Issue , 2014, Pages

  Godman, Brian ^a,b   Malmström, Rickard E ^a   Diogene, Eduardo ^c   Jayathissa, Sisira ^d   McTaggart, Stuart ^e   Cars, Thomas ^f,g   Alvarez Madrazo, Samantha ^b   Baumgärtel, Christoph ^h   Brzezinska, Anna ⁱ   Bucsics, Anna ^j,k   Campbell, Stephen ^l   Eriksson, Irene ^f   Finlayson, Alexander ^m   Fürst, Jurij ⁿ   Garuoliene, Kristina ^o   Gutiérrez Ibarluzea, Iñaki ^p   Hviding, Krystyna ^q   Herholz, Harald ^r   Joppi, Roberta ^s   Kalaba, Marija ^t   Laius, Ott ^u   Malinowska, Kamila ^v,w   Pedersen, Hanne B ^x   Markovic Pekovic, Vanda ^y,z   Piessnegger, Jutta ^k   Selke, Gisbert ^aa   Sermet, Catherine ^d   Spillane, Susan ^ab   Tomek, Dominik ^ac   Vončina, Luka ^ad   Vlahović Palčevski, Vera ^ae   Wale, Janet ^af   Wladysiuk, Magdalena ^ag   van Woerkom, Menno ^ah   Zara, Corinne ^ai   Gustafsson, Lars L ^a   more..

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d Clinical Pharmacology Service Vall d'Hebron University Hospital Fundació Institut Català de Farmacologia Autonomous University of Barcelona ^*

^e INFORMATION SERVICES DIVISION   (United Kingdom)

^f STOCKHOLM COUNTY COUNCIL   (Sweden)

^g UPPSALA UNIVERSITY   (Sweden)

^h Austrian Medicines and Medical Devices Agency   (Austria)

ⁱ Agency for Health Technology Assessment in Poland   (Poland)

^j UNIVERSITY OF VIENNA   (Austria)

^k Hauptverband der Osterreichischen Sozialversicherungstrager   (Austria)

^l UNIVERSITY OF MANCHESTER   (United Kingdom)

^m UNIVERSITY OF OXFORD   (United Kingdom)

ⁿ Health Insurance Institute   (Slovenia)

^o National Health Insurance Fund   (Lithuania)

^p Basque Government   (Spain)

^q Norwegian Medicines Agency   (Norway)

^r Kassenärztliche Vereinigung in Hessen KVH   (Germany)

^s Pharmaceutical Drug Department   (Italy)

^t Republic Institute for Health Insurance   (Serbia)

^u State Agency of Medicines   (Estonia)

^v School of Public Health   (Poland)

^w National Health Fund   (Poland)

^x WHO REGIONAL OFFICE FOR EUROPE   (Denmark)

^y UNIVERSITY OF BANJA LUKA   (Bosnia and Herzegovina)

^z MINISTRY OF HEALTH AND SOCIAL WELFARE   (Bosnia and Herzegovina)

^aa Wissenschaftliches Institut der AOK WIdO   (Germany)

^ab TRINITY COLLEGE DUBLIN   (Ireland)

^ac Department of Pharmaceutical Analysis and Nuclear Pharmacy   (Slovakia)

^ad Ministry of Health   (Croatia)

^ae KBC RIJEKA   (Croatia)

^af Independent Consumer Advocate   (Australia)

^ag HTA CONSULTING   (Poland)

^ah Dutch Institute for Proper Use of Medicines   (Netherlands)

^ai C Agy Hlth Technol Assess Res   (Spain)

more..

Author keywords

Critical drug evaluation; Dabigatran; Demand side measures; Managed introduction new medicines; Registries

Indexed keywords

ANTITHROMBOCYTIC AGENT; DABIGATRAN; WARFARIN;

AGED; ANTICOAGULANT THERAPY; BLEEDING; CEREBROVASCULAR ACCIDENT; CLINICAL PRACTICE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DESCRIPTIVE RESEARCH; DRUG COST; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG UTILIZATION; EDUCATION; EUROPE; FEMALE; HEALTH INSURANCE; HEART ATRIUM FIBRILLATION; HUMAN; IRELAND; ITALY; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEW ZEALAND; PRESCRIPTION; PREVALENCE; PROCESS OPTIMIZATION; QUALITY ADJUSTED LIFE YEAR; REVIEW; RISK FACTOR; SLOVENIA; SPAIN; SWEDEN; UNITED KINGDOM;

EID: 84904859153     PISSN: None     EISSN: 16639812     Source Type: Journal    
DOI: 10.3389/fphar.2014.00109     Document Type: Review

References (36)

1. Adamski, J., Godman, B., Ofierska-Sujkowska, G., Osinska, B., Herholz, H., Wendykowska, M., et al. (2010). Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv. Res. 10:153. doi: 10.1186/1472-6963-10-153
2. Arznei. V (2014). Antikoagulantien und Plättchen - funktionshemmer. Available online at: http://www.arzneiundvernunft.at/uploads/20140225_Leitlinie_Antikoagulantien_211_DE.pdf
3. Barry, M. (2013). New oral anticoagulants for non-valvular atrial fibrillation - safety issues. Ir. Med. J. 106, 69.
4. Carley, B., Griesbach, S., Larson, T., and Krueger, K. (2014). Assessment of Dabigatran utilization and prescribing patterns for atrial fibrillation in a physician group practice. Am. J. Cardiol. 113, 650-664. doi: 10.1016/j.amjcard.2013.11.008
5. Civaner, M. (2012). Sale strategies of pharmaceutical companies in a 'pharmerging' country: the problems will not improve if the gaps remain. Health Policy 106, 25-32. doi: 10.1016/j.healthpol.2012.05.006
6. Davidson, T., Husberg, M., Janzon, M., Oldgren, J., and Levin, L. Å. (2013). Cost-effectiveness of dabigatran compared with warfarin for patients with atrial fibrillation in Sweden. Eur. Heart J. 34, 177-183. doi: 10.1093/eurheartj/ehs157
7. European Medicines Agency (EMA). (2011). Update on Safety of Pradaxa. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001390.jsp&mid=WC0b01ac058004d5c1
8. Evaluate Pharma. (2012). Surveying Tomorrow's BioPharma Landscape - The NASDAQ Biotech Index Up Close. 2012. Available online at: http://info.evaluatepharma.com/rs/evaluatepharmaltd/images/EvaluatePharma_NBI_Up_Close_2012.pdf
9. Ferrario, A., and Kanavos, P. (2013). Managed Entry Agreements for Pharmaceuticals: The European Experience. Available online at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf
10. Forslund, T., Wettermark, B., Wändell, P., von Euler, M., Hasselström, J., and Hjemdahl, P. (2013). Risk scoring and thromboprophylactic treatment of patients with atrial fibrillation with and without access to primary healthcare data: experience from the Stockholm health care system. Int. J. Cardiol. 170, 208-214. doi: 10.1016/j.ijcard.2013.10.063
11. Fritz, J., and Cleland, J. (2003). Effectiveness versus efficacy: more than a debate over language. J. Orthop. Sports Phys. Ther. 33, 163-165. doi: 10.2519/jospt.2003.33.4.163
12. Garattini, S., Bertele, V., Godman, B., Haycox, A., Wettermark, B., Gustafsson, L. L., et al. (2008). Enhancing the rational use of new medicines across European healthcare systems - a position paper. Eur. J. Clin. Pharmacol. 64, 1137-1138. doi: 10.1007/s00228-008-0537-z
13. Godman, B., Campbell, S., Suh, H. S., Finlayson, A. E., Bennie, M., and Gustafsson, L. L. (2013). Ongoing measures to enhance prescribing efficiency across Europe: implications for other countries. J. Health Technol. Assess. 1, 27-42.
14. Godman, B., Paterson, K., Malmstrom, R., Selke, G., Fagot, J., and P, Mrak, J. (2012). Improving the managed entry of new medicines: sharing experiences across Europe. Exp. Rev. Pharmacoecon. Outcomes Res. 12, 439-441. doi: 10.1586/erp.12.44
15. Harper, P., Young, L., and Merriman, E. (2012). Bleeding risk with dabigatran in the frail elderly. N. Engl. J. Med. 366, 864-866. doi: 10.1056/NEJMc1112874
16. Irish Medicines Board. (2013). Irish Medicines Board Drug safety Newsletter - October 2013. Novel Oral Anticoagulants (NOACs) and Risk of Bleeding - Reinforcement of Risk Minimisation Advice for Dabigatran (Pradaxa®), Rivaroxaban (Xarelto®) and Apixaban (Eliquis®). Available online at: http://www.imb.ie/images/uploaded/documents/Drug%20Safety%20Newsletter%2056-Web%20version%20hyperlinked.pdf
17. Joppi, R., Cinconze, E., Mezzalira, L., Pase, D., Poggiani, C., Rossi, E., et al. (2013). Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: a population-based study. Eur. J. Intern. Med. 24, 318-323. doi: 10.1016/j.ejim.2013.02.018
18. Kaiser, J. (2012). New cystic fibrosis drug offers hope, at a price. Science 335:645. doi: 10.1126/science.335.6069.645
19. Legrand, M., Mateo, J., Aibaud, A., Ginisty, S., Eftekhari, P., Huy, P. T., et al. (2011). The use of dabigatran in elderly patients. Arch. Intern. Med. 8, 432-439.
20. Malmström, R. E., Godman, B., Diogene, E., Baumgärtel, C., Bennie, M., Bishop, I., et al. (2013). Dabigatran - a case history demonstrating the need for comprehensive approaches to optimise the use of new drugs. Front. Pharmacol. 4:39. doi: 10.3389/fphar.2013.00039
21. Mannuci, M., Nobil, A., and Garattini, S. (2012). New drugs for thromboprophylaxis in atrial fibrillation. Eur. J. Intern. Med. 23, 1-5. doi: 10.1016/j.ejim.2011.11.007
22. Marshall, S., Fearon, P., Dawson, J., and Quinn, T. (2013). Stop the clots, but at what cost? Pharmacoeconomics of dabigatran etexilate for the prevention of stroke in subjects with atrial fibrillation: a systematic literature review. Exp. Rev. Pharmacoecon. Outcomes Res. 13, 29-42. doi: 10.1586/erp.12.79
23. National Medicines Information Centre. (2012). National Medicines Information Centre: Update on Oral Anticoagulation Therapy 8. Available online at: http://www.imb.ie/images/uploaded/documents/Drug%20Safety%20Newsletter%2056-Web%20version%20hyperlinked.pdf
24. NICE. (2012). "Dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation," in NICE Technology Appraisal Guidance 249 March 2012. Available online at: http://www.nice.org.uk/nicemedia/live/13677/58470/58470.pdf
25. Pink, J., Lane, S., Pirmohamed, M., and Hughes, D. (2011). Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses. BMJ 343:d6333. doi: 10.1136/bmj.d6333
26. Reilly, P. A., Lehr, T., Haertter, S., Connolly, S. J., Yusuf, S., Eikelboom, J. W., et al. (2014). The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J. Am. Coll. Cardiol. 63, 321-328. doi: 10.1016/j.jacc.2013.07.104
27. Scott, C. L., and McTaggart, S. A. (2013) "Uptake and patterns of use of dabigatran and rivaroxaban in primary care in Scotland," in American Society of Health System Pharmacists Midyear Meeting 2013 (Orlando) [Poster 1-256].
28. Scottish Medicines Consortium. (2008). "SMC Advice No. 466/08 dabigatran etexilate, 75mg and 110mg hard capsules (Pradaxa®)," in Scottish Medicines Consortium. 09 June 2008. Available online at: http://www.scottishmedicines.org/files/dabigatran_etexilate_Pradaxa_FINAL_May_2008_for_website.pdf
29. Scottish Medicines Consortium. (2011). "SMC Advice No. 672/11 dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa®)," in Glasgow: Scottish Medicines Consortium. Available online at: http://www.scottishmedicines.org/files/advice/dabigatran_Pradaxa_FINAL_August_2011_Amended_05.09.11_for_website.pdf
30. Spatz, I., and McGee, N. (2013). Speciality Pharmaceuticals. Complex New Drugs Hold Great Promise for People with Chronic and Life-Threatening Conditions. The Drugs are Also a Driver of Spending Growth. Health Affairs Policy Brief. Available at online at: http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_103.pdf
31. Thomas, K. (2014). Study of Drug for Blood Clots Caused a Stir, Records Show. New York Times. Available online at: http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html [Accessed March 2014]
32. Thorne, K., Jayathissa, S., Dee, S., Briggs, N., Taylor, J., Reid, S., et al. (2014). Adherence and outcomes of patients prescribed dabigatran (Pradaxa) in routine clinical practice. Intern. Med. J. 44, 261-265. doi: 10.1111/imj.12370
33. Troncoso, A., and Diogène, E. (2014). Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia, Spain: the need to manage the introduction of new drugs. Eur. J. Clin. Pharmacol. 70, 249-250. doi: 10.1007/s00228-013-1593-6
34. Wells, K. B. (1999). Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. Am. J. Psychiatry 156, 5-10.
35. Wettermark, B., Godman, B., Jacobsson, B., and Haaijer-Ruskamp, F. (2009). Soft regulations in pharmaceutical policymaking - an overview of current approaches and their consequences. Appl. Health Econ. Health Policy 7, 137-147. doi: 10.1007/BF03256147
36. Xu, Y., Holbrook, A., Simpson, C., Dowlatshahi, D., and Johnson, A. (2013). Prescribing patters of novel oral anticoagulants following regulatory approval for atrial fibrillation in Ontario, Canada: a population-based descriptive analysis. CMAJ Open 1, E115-E119. doi: 10.9778/cmajo.20130032