1. LIST OF DRUGS COVERED BY HEALTH INSURANCE FUND OF THE REPUBLIC OF MACEDONIA Ms. Maja Parnardzieva – Zmejkova, MSc, CEO October 2011

2. Content 1. Positive list of drugs 2.Reference pricing of drugs 3.Some data about amounts for for drugs from the budget of the HIF 4.Generic drugs 5.Conclusion and next steps 2

3. Population: 2 040 000 citizens 1.8 million insurees Urban population: 66.9% Area: 25 713 km2 in 2010: $9.0 billion USD GDP in 2010: $9.0 billion USD Government healthcare insurance fund Mandatory health insurance system Insurance premium stipulated by law (7.3 % from the gross salary) Mean life expectancy at birth - Men 71.9 years - Women 76.1 years 3

4. Positive list of Drugs (PLD)  Health Insurance Fund (HIF) is a purchaser of health services (2007)  Since 2003 PLD is defined by generic name (INN)  Conflict about the mandate for creating PLD, (HIF vs. MH/ 2009-2011)  New regulation – clear mandate 2011  For the first time HIF is preparing a rulebook for PLD  PLD to be prepared by a Committee on Positive list, appointed by the Government (13 members)  HIF - secretariat for the Committee on Positive list 4

5. Reference pricing of drugs  HIF objective: Health care system to be supplied with high- quality drugs in sufficient quantity and at the best possible prices  HIF established a pricing system for PLD drugs in 2008 (amending the law)  New rulebook based on the comparative methodology for old and new prices for PHC drugs in 2009/2010  First year - implementation (2010)  Second year – revision (2011)  Pricing process evolves increasing the competition – (positive result for HIF and insurees)  Next step: Revising the Prices for Hospital Health Care drugs from PLD 5

6. Comparison of drugs with and without co-payment 2009/2010/2011 75% of all drugs with reference price on PHC, are with level of co-payment to 1.5 euro 6

7. Pharmaceuticals market in RM source: Bureau for Drugs 7 ~ 250 wholesalers ~ 250 wholesalers 210 manufacturers ( 3 domestic) 210 manufacturers ( 3 domestic) Ministry of Health Bureau for drugs 230 OTC drugs 230 OTC drugs 2700 Rp. /H drugs 2700 Rp. /H drugs Total no. of drugs ~ 3000 Total no. of drugs ~ 3000 Expansion at the local pharmaceuticals market

8. Drugs covered by HIF (2011) By brand name (with RP) – 1030 drugs (30% of total pharmaceuticals market in RM) By INN – ~430 medications Primary Health Care By brand name (with RP) – 1600 drugs (60% of total pharmaceuticals market in RM) By INN – ~900 medications (incl. PHC) Hospital Health Care 8

9. Primary Health Care: HIF contracted Pharmacies 2008 - 2011 Source: HIF Total No. of Pharmacies in RM in 2011 – 855 (Data Bureau for Drugs) HIF contracted Pharmacies = 750 ( ~90 % ) 9 Year2008200920102011 No. Pharmacies592651703750 Index11,11,21,3

10. PHC: Comparison of planned and spent amounts (Eur), 2008 - 2010 10 Realization 79 % 90 % 85 % Average 81 %

11. PHC: Effects from the new prices Number of prescriptions and amounts 2008-2010 year Rp. per yearIndex Total amount per year (MKD/EUR) Index 200810.288.509 1 1.319.484.643 (21,45 Mil EUR)1 200914.965.727 1,45 1.829.110.673 (29,74 Mil EUR)1,39 201015.277.792 1,48 1.778.028.785 ( 28.91 Mil EUR)1,35 11

12. PHC: Consumption by prescriptions / packages / 2008 - 2010 (ATC - third level) A - ALIMENTARY TRACT AND METABOLISMA - ALIMENTARY TRACT AND METABOLISM B - BLOOD AND BLOOD FORMING ORGANSB - BLOOD AND BLOOD FORMING ORGANS C - CARDIOVASCULAR SYSTEM D – DERMATOLOGICALS G - GENITO URINARY SYSTEM AND SEX HORMONESG - GENITO URINARY SYSTEM AND SEX HORMONES H - SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINSH - SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS J - ANTIINFECTIVES FOR SYSTEMIC USEJ - ANTIINFECTIVES FOR SYSTEMIC USE L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTSL - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS M - MUSCULO-SKELETAL SYSTEMM - MUSCULO-SKELETAL SYSTEM N - NERVOUS SYSTEM P - ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTSP - ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS R - RESPIRATORY SYSTEM S - SENSORY ORGANS 12

13. Importance of generic medicines Offering front-line treatment for key chronic diseases ; Extending access to affordable quality, safe and effective medicines to more citizens; Savings in the pharmaceuticals costs, thus enabling free funds to finance innovation; Incorporating generic medicines with newer formulations and methods of delivery, which in turn provide more available treatments for patients; Fostering competition in the pharmaceutical market 13

14. Conclusions Generic drugs are dominated on pharmaceuticals market in Macedonia Creating savings in the pharmaceutical costs, thus providing free sources to finance innovative medications Transparent procedure for creating Rulebook for PLD for the first time 14

15. Next Steps Close cooperation between the HIF and Ministry of Health Ministry of Health creates a new methodology for the national limit prices for drugs New Ministry’s methodology will directly affect the HIF prices and balance out the existing differences

16. THANK YOU FOR YOUR ATTENTION Ohrid – the city of UNESSCO www.fzo.org.mk majap@fzo.org.mk 16