1. IMPACT OF INTRODUCTION OF STATINS TO THE PRIVATE AND STATE SECTORS IN SRI LANKA ON UTILISATION, COST AND PRESCRIPTION PATTERN Galappatthy P Cooray BPR Galappatthy GKS Fernandopulle BMR Department of Pharmacology Faculty of Medicine University of Colombo and Cardiology Unit National Hospital of Sri Lanka

2. Background  Ischaemic heart disease is the leading cause of death in Sri Lanka with 18 deaths per 100,000 population (Annual Health Bulletin, Ministry of Health -2002)  HMG CoA reductase inhibitors (Statins) improve survival in IHD  They were introduced only recently to SL  High cost of statins is a limiting factor for statin use even in developed countries  WHO recommends selection of statins at national level based on local availability and costs as all statins have comparable and efficacy and safety. (WHO Drug information: proposed INN list 2002;16:2)

3. Study aims  To find out the current utilisation of statins in Sri Lanka and sales pattern since their introduction  To find the costs per daily defined doses(DDD) of different brands of statins available in the market  To find the prescription pattern, indications for use, age and sex distribution and side effects of statins in patients attending a Cardiology clinic  To make recommendations on the choice of statins for Sri Lanka based on local data

4. Methods- 1  Utilisation was calculated in number of DDD per thousand inhabitants per day according to the Guidelines for ATC Classification and DDD assignment (World Health Organisation 2000)  Information on costs and supply of statins to state and private sector was obtained from State Pharmaceuticals Corporation (SPC) from 1996 -2003 and from private sector importers from 2000-2003

5. Methods- 2  Prescription pattern, indications for use, patient characteristics and side effects were obtained from 180 consecutive patients taking statins, attending the Cardiology clinic in National Hospital of Sri Lanka in 2002  Three investigators visited the Cardiology clinics on two days of the week to gather above data and all those who complained of any side effects were evaluated by a specialist for diagnosis and causality assessment

6. Results - 1  Only 3 statins were available in Sri Lanka StatinYear of introduction Number of brands in 2003 Lovastatin199610 Simvastatin20009 Atorvastatin20018 Table 1 – Available statins in Sri Lanka

7. Results -2 Table -3 Supply to government hospitals statinDDD (in mg) Total consumption Total DDD (millions) Lovastatin3090.8 Kg3.027 Simvastatin1581 KG5.40 atorvastatin1054kg5.40 Table 2- DDD and total consumption in 2003 Statin year amount Atorvastatin2002 2 kg lovastatin20030.8 kg

8. Results -3  Total consumption in DDD= 13.82million  Population in Sri Lanka=19.5 million  Utilisation=number of DDD per 1000 inhabitants per day =1.94 DDD per 1000 inhabitants per day  Utilisation in a developed country (Finland) = 54.6 DDD per 1000 inhabitants per day

9. Results - 4 Figure 1 - Sales in Kg of statins by SPC from 1996-2003 Sales in kg

10. Results -5 Figure 2 - Cost of DDD of several brands of different statins available in the market SLR = 0.01USD

11. Results - 6 Figure - 3 Cost of DDD in USD of innovator brand [IB], most sold generic [MSG] and lowest cost generic [LCG] USD

12. Results - 7 Figure 4- Cost of DDD in SLR of lowest cost generic products over the last 3 years SLR

13. Results -8 Figure 5 - Cost in SLR of DDD of innovator brands over last 3 years SLR

14. Results -9 Figure 6- Prescription pattern of statins Percentage

15. Results -10  Age range of patients - 38-79 years  males -64%females -36%  indication - secondary prevention in 90%  Side effects - muscle pain or cramps - 14.4% most resolved spontaneously, CPK normal gastro intestinal manifestations - abdominal pain(2.7%), flatulence (5.1%), nausea(1.67%) - short lasting and resolved no serious adverse reactions noted Side effects noted were similar for all 3 drugs

16. Conclusions -1  Utilisation of statins increased from 1996 but it still remains very low  Only a small fraction of total consumption is provided by the state  A wide gap exists in costs of innovator and generic brands  with introduction of different statins and brands costs of generics have come down but that of innovator has gone up

17. Conclusions -2  Atorvastatin has the lowest cost per DDD  Most commonly prescribed statin and the most commonly consumed statin is still lovastatin  Use of atorvastatin would be more cost effective than other 2 statins in view of its lower DDD and availability of low cost generic products

18. Recommendations  Statins should be made available in adequate quantities to government hospitals considering the high mortality due to IHD in Sri Lanka and availability of low cost generic products  National needs based on mortality and morbidity data, cost per DDD of drugs in same class, efficacy, safety and availability should be considered when procuring drugs  Based on our data, supply of atorvastatin can be recommended to government hospitals in Sri Lanka as it has the lowest cost per DDD with comparable safety and efficacy to other statins.