Recent national and regional drug reforms in Sweden: Implications for pharmaceutical companies in Europe

PharmacoEconomics

Volumn 26, Issue 7, 2008, Pages 537-550

  Wettermark, Björn ^a,b   Godman, Brian ^c   Andersson, Karolina ^d   Gustafsson, Lars L ^a,b   Haycox, Alan ^e   Bertelé, Vittorio ^c  

^a KAROLINSKA INSTITUTE   (Sweden)

^b STOCKHOLM COUNTY COUNCIL   (Sweden)

^c MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^d NORDIC SCHOOL OF PUBLIC HEALTH   (Sweden)

^e UNIVERSITY OF LIVERPOOL MANAGEMENT SCHOOL   (United Kingdom)

Author keywords

Cost effectiveness; Formularies; Guideline utilisation; Health policy; Pricing; Reimbursement

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ANTACID AGENT; CONSTA; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; EFALIZUMAB; GENERIC DRUG; HISTAMINE H2 RECEPTOR ANTAGONIST; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; NARATRIPTAN; OMEPRAZOLE; PANTOPRAZOLE; PARATHYROID HORMONE[1-34]; PROTON PUMP INHIBITOR; RISPERIDONE; ROSUVASTATIN; SUMATRIPTAN; TETRAHYDROLIPSTATIN; TRIPTAN DERIVATIVE;

CLINICAL DECISION MAKING; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG USE; ECONOMIC ASPECT; ELDERLY CARE; EUROPE; EVIDENCE BASED PRACTICE; GASTROESOPHAGEAL REFLUX; HEALTH CARE; HEALTH CARE POLICY; HEARTBURN; HUMAN; MIGRAINE; PHARMACY; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; QUALITY CONTROL; REIMBURSEMENT; REVIEW; STANDARD; SWEDEN;

DRUG COSTS; DRUG INDUSTRY; DRUG UTILIZATION; DRUGS, GENERIC; EUROPE; HEALTH CARE REFORM; INSURANCE, HEALTH, REIMBURSEMENT; SWEDEN;

EID: 45749157159     PISSN: 11707690     EISSN: None     Source Type: Journal    
DOI: 10.2165/00019053-200826070-00001     Document Type: Review

References (72)

1. Anell A, Persson U. Reimbursement and clinical guidelines for pharmaceuticals in Sweden: do health-economic evaluations support decision making? Eur J Health Econ 2005; 50: 274-9
2. Glenngård AH, Hjalte F, Svensson M, et al. Health systems in transition. Copenhagen: WHO Regional Office for Europe, on behalf of the European Observatory on Health Systems and Policies, 2005
3. Anell A. Swedish healthcare under pressure. Health Econ 2005; 14: S237-S54
4. Granlund D, Rudholm N, Wikström M. Fixed budgets as a cost containment measure for pharmaceuticals. Eur J Health Econ 2006; 7: 37-45
5. Lundkvist J. Pricing and reimbursement of drugs in Sweden. Eur J Health Econ 2002; 3: 66-70
6. Bergström G, Karlberg I. Decentralized responsibility for costs of outpatient prescription pharmaceuticals in Sweden: assessment of models for decentralized financing of subsidies from a management perspective. Health Policy 2007; 81: 358-67
7. Moïse P, Docteur E. Pharmaceutical pricing and reimbursement in Sweden. 2007 Sep 13 (OECD health working papers no.: 28) [online]. Available from URL: http://www.olis.oecd.org/olis/2007doc.nsf/FREDATCORPLOOK/NT00002E52/ $FILE/JT03231887.pdf [Accessed 2008 Feb 2]
8. Gerdtham UG, Lundin D. Why did drug spending increase during the 1990s? A decomposition based on Swedish data. Pharmacoeconomics 2004; 22: 29-42
9. Andersson K, Petzold MG, Sonesson C, et al. Do policy changes in the pharmaceutical reimbursement schedule affect drug expenditures? Interrupted time series analysis of cost, volume and cost per volume trends in Sweden 1986-2002. Health Policy 2006; 79: 231-43
10. The National Corporation of Swedish Pharmacies, Apoteket AB, Statistikenheten, Stockholm FDB. Sales data; supplied 2007 Jun 11. (Data on file)
11. Aaserud M, Dahlgren AT, Kösters JP, et al. Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies. Cochrane Database Syst Rev 2006; (2): CD005979
12. Andersson K, Sonesson C, Petzold M, et al. What are the obstacles to generic substitution? An assessment of the behaviour of prescribes, patients and pharmacies during the first year of generic substitution in Sweden. Pharmacoepidemiol Drug Saf 2005; 14: 341-8
13. Act (2002:160) on pharmaceutical benefits, etc. Solna: Pharmaceuticals Benefits Board, 2002 [online]. Available from URL: http://www.lfn.se/upload/ English/ENG_Act_2002-160.pdf [Accessed 2007 Jan 19]
14. The Swedish pharmaceutical reimbursement system. Solna: Pharmaceuticals Benefits Board, 2007 Jan [online]. Available from URL: http://www.lfn.se/upload/ Bakgrundsmaterial/swedish_pharmaceutical_reimbursement_system_070122.pdf [Accessed 2007 Mar 5]
15. Engström A, Jacob J, Lundin D. Sharp drop in prices after the introduction of generic substitution. Solna: Pharmaceuticals Benefits Board, 2006 [online]. Available from URL: http://www.lfn.se/upload/Pressmeddelanden/ generiskt_utbyte_engelsk_061010.pdf [Accessed 2007 Mar 5]
16. The National Corporation of Swedish Pharmacies - Apoteket AB, Statistikenheten, Stockholm, Sweden. Data on prices; data supplied 2007 Dec 17. (Data on file)
17. Working guidelines for the pharmaceutical reimbursement review. Solna: Pharmaceuticals Benefits Board, 2006. Reference: 1023/2003 [online]. Available from URL: http://www.lfn.se/upload/Genomgangen/GLS_060815_guidelines_english.pdf [Accessed 2007 Mar 12]
18. Cohen J, Stolk E, Niezen M. The increasingly complex fourth hurdle for pharmaceuticals. Pharmacoeconomics 2007; 25 (9): 727-34
19. Schreyögg J, Henke K-D, Busse R. Managing pharmaceutical regulation in Germany [discussion paper 2004/6]. Berlin: Technische Universität Berlin, Fakultät Wirtschaft und Management, 2004
20. Rocchi F, Addis A, Martini N, et al. Current national initiatives about drug policies and cost control in Europe: the Italy example. J Ambulatory Care Manage 2004; 27: 127-31
21. Hedberg N, Ramsberg J. The review of medicines used for treating migraine: a summary. Solna: Pharmaceuticals Benefits Board, 2006 [online]. Available from URL: http://www.lfn.se/upload/Bakgrundsmaterial/ migraine_review_summary.pdf [Accessed 2007 Mar 5]
22. Wessling A, Lundin D. The review of drugs against disease caused by acid stomach: a summary. Solna: Pharmaceuticals Benefits Board, 2006 [online]. Available from URL: http://www.lfn.se/upload/genomgangen/ engelsk_sammanfattning_magsyra_slutgiltig.pdf [Accessed 2007 Mar 5]
23. Office of Fair Trading (UK). The pharmaceutical price regulation system: an OFT study. Annexe K: international survey of pharmaceutical pricing and reimbursement schemes. London: The Office of Fair Trading, 2007 [online]. Available from URL: http://www.oft.gov.uk/shared_oft/reports/comp_policy/ oft885k.pdf [Accessed 2007 Mar 6]
24. Hugosson K, Engström A. Review of medicines against asthma, COPD, and coughs: a summary. Solna: Pharmaceuticals Benefits Board, 2007 [online]. Available from URL: http://www.lfn.se/upload/Genomgangen/ GLS_asthma_summary_070829.pdf [Accessed 2007 Nov 12]
25. Hedberg N, Jacob J. A review of medicines for lowering blood pressure: a summary. Solna: Pharmaceuticals Benefits Board, 2008 [online]. Available from URL: http://www.lfn.se/upload/Genomgangen/Summary%20Hypertension_080221.pdf [Acessed 2008 17 Mar]
26. Gustafsson LL. Drug and Therapeutic Committees: concept, experience and capacity to improve use of drugs. Stockholm: 2005 Jan [online]. Available from URL: http://www.janusinfo.se/imcms/servlet/GetDoc?.meta_id=7148 [Accessed 2007 Mar 5]
27. Sjöqvist F, Bergman U, Dahl ML, et al. Drug and therapeutics committees: a Swedish experience. WHO Drug Information 2002; 16: 207-13
28. Stålsby Lundborg C, Hensjö LO, Gustafsson LL. "Academic drug detailing": from project to practice in a Swedish urban area. Eur J Clin Pharmacol 1997; 52: 167-72
29. Mason A, Towse A, Drummond M, et al. Influencing prescribing in a primary care led NHS. London: OHE Publications, 2002
30. O'Brien MA, Oxman AD, Davis DA, et al. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 1997; (4): CD000409
31. Beishon J, McBride T, Scharaschkin S, et al. Prescribing costs in primary care. London: National Audit Office, 2007 May 18 [online]. Available from URL: http://www.nao.org.uk/publications/nao_reports/06-07/0607454.pdf [Accessed 2007 May 21]
32. Sturm H, Austvoll-Dahlgren A, Aaserud M, et al. Pharmaceutical policies: effects of financial incentives for prescribers. Cochrane Database Syst Rev 2007; (3): CD006731
33. Kloka Listen: physician version [in Swedish]. Stockholm County Council, Regional Drug & Therapeutics Committee, 2007 [online]. Available from URL: http://www.janusinfo.se/klokalistan/external/baselist.asp [Accessed 2007 Nov 13]
34. Wettermark B, Nyman K, Bergman U. Five years' experience of quality assurance and feedback with individual prescribing profiles at a primary healthcare centre in Stockholm, Sweden. Qual Prim Care 2004; 12: 225-34
35. Larsson DG, de Petro C, Paxeus N. Effluent from drug manufactures contains extremely high levels of pharmaceuticals. J Hazard Mater 2007; 148 (3): 751-5
36. Kloka Listen: patient version [in Swedish]. Stockholm County Council, Regional Drug & Therapeutics Committee, 2007 [online]. Available from URL: http://www.janusinfo.se/imcms/servlet/GetDoc?meta_id=8943 [Accessed 2007 Nov 13]
37. Eliasson M, Bastholm P, Forsberg P, et al. Janus computerised prescribing system provides pharmacological knowledge at point of care: design, development and proof of concept. Eur J Clin Pharmacol 2006; 62: 251-8
38. Wettermark B, Pehrsson A, Jinnerot D, et al. Drug utilisation 90% profiles: a useful tool for quality assessment of prescribing in primary health care in Stockholm. Pharmacoepidemiol Drug Saf 2003; 12: 499-510
39. Almkvist H, Bergman U, Edlert M, et al. Quality report - Stockholm County Council's incentive schemes for drug prescribing in primary healthcare [in Swedish]. Läkartidningen. In Press
40. Wettermark B. Drug utilization 90%: using aggregate drug statistics for the quality assessment of prescribing. Stockholm: Repro Print, AB, 2004
41. Wettermark B, Haglund K, Gustafsson LL, et al. A study of adherence to drug recommendations by providing feedback of outpatient prescribing patters to hospital specialists. Pharmacoepidemiol Drug Saf 2005; 14: 579-88
42. Wettermark B. Internal report produced for Stockholm County Council on outcomes following adherence to county guidelines [internal report]. Stockholm: Stockholm County Council, 2007 Mar
43. Jansson S, Anell A. The impact of decentralised drug-budgets in Sweden: a survey of physicians' attitudes towards costs and cost-effectiveness. Health Policy 2006 May; 76: 299-311
44. Ohlsson H, Merlo J. Understanding the effects of a decentralised budget on physicians' compliance with guidelines for statin prescription: a multilevel methodological approach. BMC Health Serv Res 2007; 7: 68
45. Janus [online]. Available from URL: http://www.janusinfo.se/imcms/ servlet/GetDoc?meta_id=10148e [Accessed 2007 Mar 5]
46. Wettermark B, Tomson G, Bergman U. Quality indicators for drug prescribing: the situation in Sweden [in Swedish]. Lakartidningen 2006; 103: 3607-11
47. Smith PC, York N. Quality incentives: the case of UK general practitioners. Health Affairs 2004; 23 (1): 112-8
48. McGuire A, Drummond M, Rutten F. Reimbursement of pharmaceuticals in the European Union in 'Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality'. Maidenhead, Berkshire: McGraw-Hill Education, 2004
49. General guidelines for economic evaluations from the Pharmaceutical Benefits Board (LFNAR 2003:2). Solna: Pharmaceuticals Benefits Board, 2003 [online]. Available from URL: http://www.lfn.se/upload/English/ENG_lfnar2003- eng.pdf [Accessed 2007 Mar 5]
50. Hoey R. Experts disagree over NICE's approach for assessing drugs. Lancet 2007; 370: 643-4
51. Rawlins M, Culyer A. National Institute for Clinical Excellence and its value judgements. BMJ 2004; 329: 224-7
52. Wells J, Cheong-Leen C. NICE appraisals should be everyone's business. BMJ 2007; 334: 936-8
53. Office of Fair Trading (UK). The pharmaceutical price regulation system: an OFT study. London: OFT 2007 Feb [online]. Available from URL: http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885.pdf [Accessed 2007 Mar 6]
54. Barrett A, Roques T, Small M, et al. How much will herceptin really cost? BMJ 2006, 20
55. The Swedish Pharmaceutical Benefits Board (LFN) 2006 annual report [in Swedish; online]. Available from URL: http://www.lfn.se/upload/Om_oss/ arsredovisning_2006.pdf [Accessed 2006 Jun 25]
56. The Swedish Pharmaceutical Benefits Board (LFN) 2007 annual report [in Swedish; online]. Available from URL: http://www.lfn.se/upload/Om_oss/ Arsredovisning%20layoutad%20080328.pdf [Accessed 2008 Feb 27]
57. Sweden approves Acomplia reimbursement. Scrip 2006 Nov 13: S00940206
58. IRIS: introduction of Rimonabant in Stockholm [project plan: 2007-04-03]. Stockholm: Stockholm County Council, 2007
59. Wettermark B, Raaschou P, Forslund T, et al. Fortsatta frågetecken kring bantningsmedlet rimonabant. Lakartidningen 2007; 51: 3879-81
60. Godman B, Haycox A, Schwabe U, et al. Having your cake and eating it: Office of Fair Trading proposal for funding new drugs to benefit patients and innovative companies. Pharmacoeconomics 2008; 26 (2): 91-8
61. Rabbata S. The legislation on saving of drug costs is effective [in German]. Dtsch Arzteblatt 2007; 104: A308
62. Office of Fair Trading (UK). The pharmaceutical price regulation system: an OFT study. Annexe A: market for prescription pharmaceuticals in the NHS. London: The Office of Fair Trading, 2007 [online]. Available from URL: http://www.oft.gov.uk/shared_oft/reports/comp_policy/oft885a.pdf [Accessed 2007 Mar 6]
63. UK NHS Business Services Authority electronic drug tariff 2007 [online]. Available from URL: http://www.ppa.org.uk/edt/March_2008/mindex.htm [Accessed 2008 24 Mar]
64. Simoens S, De Coster S. Sustaining generic markets in Europe. Leuven: Katholieke Universiteit Leuven, Research Centre for Pharmaceutical Care and Pharmacoeconomics, 2006 [online]. Available from URL: http://www.egagenerics. com/doc/simoens-report_2006-04.pdf [Accessed 2006 Oct 16]
65. Atella V, Schafheutle E, Noyce P, et al. Affordability of medicines and patients' cost-reducing behaviour: empirical evidence based on SUR estimates from Italy and UK. Appl Health Econ Health Policy 2005; 4: 23-35
66. Le Pen C. The drug budget silo mentality: the French case. Value Health 2003; 6 Suppl. 1: S10-9
67. WHO medicines strategy 2004-2007 [online]. Available from URL: http://www.who.int/publications [Accessed 2007 Oct 10]
68. Garattini S, Bertele V. How can we regulate medicines better. BMJ 2007; 335: 803-5
69. Garattini S, Bertele V. Non-inferiority trials are unethical because they disregard patients' interests. Lancet 2007; 370: 1875-7
70. Lapostolle F, Catineau J, Lapandry C, et al. Endpoints in studies on myocardial infarction. Lancet 2007; 369: 1430
71. Apolone G, Joppi R, Bertele V, et al. Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures. Br J Cancer 2005; 93: 504-9
72. Lundkvist J, Jonsson B, Rehnberg C. The costs and benefits of regulations for reimbursement of new drugs. Health Policy 2006; 79: 337-4