European drug statistics What is the reason for the differences between the various EU countries Ulrich Schwabe

1. European drug statistics What is the reason for the differences betweenthe various EU countries Ulrich Schwabe Pharmakologisches Institutder Ruprecht-Karls-Universität Heidelberg Perspectives and Achievements with Rational Pharmacotherapy6. November 2002, Copenhagen

2. Drug expenditures in 15 EU countries in 1999 EU average 252 € Sales per inhabitants per year in € Rosian I. et al.: Drug expenditures, strategies for cost containement in the European Union. Austrian Federal Institute of Health Service (ÖBIG), Vienna 2001.

3. Drug markets in 15 EU countries in 1999 Rosian I. et al.: Drug expenditures, strategies for cost containement in the European Union. Austrian Federal Institute of Health Service (ÖBIG), Vienna 2001.

4. Drug utilization as defined daily doses (DDD) Sales in 1999 € DDD in 1999 Sales (€) or DDD per inhabitant per year Denmark Germany Norway Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Prescription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

6. The ATC/DDD System Anatomical therapeutic chemical (ATC)classification system Classification by 14 main groups at 5 different levels 1. Level: A Alimentary tract and metabolism Anatomical main group 2. Level: A10 Drugs used in diabetes Therapeutic main group 3. Level: A10B Oral blood glucose lowering drugs Therapeutic subgroup 4. Level: A10B A Biguanides Pharmacological subgroup 5. Level: A10B A02 Metformin (INN) Chemical substance subgroup Definition of the defined daily dose (DDD) The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. DDD of metformin: 2000 mg Presentation of data: DDDs per 1000 inhabitants per day

7. Drug utilization data in EU countries

8. Prescription of statins 1993–2001 Norway Germany DDD per 1000 inhabitants per day Denmark Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Prescription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

9. Prescription of statins in 2000 Simvastatin Lovastatin Pravastatin Fluvatatin Atorvastatin Cerivastatin 59.6 DDD per 1000 inhabitants per day 26.5 23.9 15.4 Denmark England Germany Norway

10. 35 Simvastatin Atorvastatin 29.8 30 25 21.0 20 DDD per 1000 inhabitants per day 15 11.5 9.7 9.4 7.5 10 5.5 4.6 5 0 Germany Norway Denmark England Prescription of the two leading statins 2000

11. Evidence for statines from clinical trials

12. DDD costs of statins in several European countries 2 Simvastatin Atorvastatin 1.47 1.5 1.28 1.25 1.16 1.07 1.05 Treatment costs (€ per DDD) 0.93 0.92 1 0.5 0 Germany Norway Denmark England

13. Prescriptions of therapeutically disputed drugsin Germany Sales Prescriptions in millions Sales in billion € Prescriptions Schwabe U., Paffrath D. (eds.): Arzneiverordnungs-Report 2002. Springer-Verlag, Berlin Heidelberg (2002), p. 816.

14. Sales of therapeutically disputed drugsin Germany 2000 2001 –7.6% –3.4% Sales (million €) –3.6% –7.8% +4.4% –6.3% Expecto-rants Topical antirheu-matic drugs Antivaricose therapy Antidementiadrugs Antineuro-pathicdrugs Vaso-dilators

15. Prescription of peripheral vasodilators 2001in Germany Sales in million € Pentoxifylline Naftidrofuryl Buflomedil Ginkgo biloba Moxaverine

16. 3.0 2.58 2.5 2.0 DDD per 1000 inhabitants per day 1.5 1.0 0.53 0.5 0.1 0 Germany Denmark Norway Prescription of peripheral vasodilators 2001in 3 European countries

17. Pentoxifylline trials in patients with intermittent claudication

18. Exercise training in claudicatio intermittens

19. Comparison of treatment in claudicatio intermittens Walking distance 400 m 318 m 300 m 200 m 82 m 100 m 68 m 64 m 16 Studies 10 Studies 9 Studies 10 Studies 0 m Ginkgo biloba Pentoxifylline Naftidrofuryl Exercise

20. E. Housley Clinic for Peripheral Vascular Diseases Royal Infirmary of EdinburghBrit. Med. J. 296: 1483–1484 (1988)

21. Prescription of pentoxifylline Germany DDD per 1000 inhabitants per day Norway Denmark Denmark: The Danish Medicines Agency: Medicinal product statistics Denmark 1995–1999 and 1997–2001 Germany: Schwabe U., Paffrath D. (eds.): Drug Presription Report 2002. Springer-Verlag, Berlin Heidelberg New York Norway: Norwegian Institute of Public Health: Drug consumption in Norway 1993–1997 and 1997–2001

22. Drug utilization studiesas health care indicator

23. 100% before after 80% 60% Patients 40% 20% 0% Diabetes Obesity BMI >30 kg/m2 Smoking Hypertension >140/90 mm Hg Hyperchol-esterolemia>212 mg/dl Secondary prevention of coronary heart disease in 1996 Retrospective survey of 3569 patients with CHD in 9 European countries 6–48 month after hospital discharge EUROASPIRE Study Group: Eur. Heart J. 18: 1569-1582 (1997)

24. Prescription of lipid lowering agents in Germany Treatment for 2.4 mio. patients 32.8 Statins DDD per 1000 inhabitants per day Fibrates Schwabe U., Paffrath D. (eds.): Arzneiverordnungs-Report 2002. Springer-Verlag, Berlin Heidelberg (2002), p. 521

25. Prevalence of coronary heart diseasein Germany

26. Number of statin-treated patients in Germany Total number ofcoronary patients 2,84 83% 66% Treated patients according to DDD utilization (mio.) 22% treated patients

27. Objectives of drug utilization studies • Report on the volume and structure of drug prescriptions by physisians • Annual information on drug utilization for –physicians –sick funds –pharmacists • Transparency of the drug market – market share of generic drugs –role of "me-too" drugs –drugs of disputed therapeutic efficacy • Evaluation of market changes –introduction of new drugs –withdrawal of drugs to due adverse effects