ACTs in East Africa REALITY CHECK. Nathan Mulure MD Novartis Pharma

Transcription

1 ACTs in East Africa REALITY CHECK Nathan Mulure MD Novartis Pharma 1

2 Agenda Introduction and background Drug resistance to antimalarials Policy change Antimalarial market Challenges 2

3 Malaria Burden 34,000 deaths in Kenya every year. 20 million cases/annum 9.8million people infected in Uganda (2003 data) Tanzania: 18 million cases/year deaths in 2003 Zambia: 3.5 million cases/ annum (2003) 3

4 Malaria Main challenges Rapid development of resistance Inadequate resource allocation Poor quality drugs 4

5 Malaria drug resistance 5

6 Efficacy studies: CQ resistance in E.Africa 6

7 Clinical efficacy SP 7

8 Amodiaquine cure rates low in Kenya AQ+AS AQ 95%CI P Kenya 28 day cure rate PCR corrected 123/180(68%) 144/180 (80%) 41% 54% <0.001 Senegal 28 day cure rate PCR corrected Gabon 28 day cure rate PCR corrected 130/159(82%),, 80/94(85%) 85/94(90%) 123/156 (79),, 70/98(71%) 77/98(79%) Adjuick et al. AS+AQ vs AQ for uncomplicated P. falciparum Malaria in children. Lancet

9 Study Efficacy Studies 28 day Cure rates Mutabingwa et al 2005 AQ alone, AQ+SP, AQ+AS, and AL for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet 365: N=300 Makanga et al 2006 Efficacy and safety of the six-dose regimen of Artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual Patient data.n=554. Am J trop med Van Vugt et al 2005 A randomized trial of artemether-lumefantrine versus Mefloquine-artesunate for the treatment of uncomplicated multi-drug resistant Plasmodium falciparum on the western border of Thailand Published 2005 AQ =62% AQ+AS=88% AQ+SP =66.2% AL =97.3% AL =96% AL =98.8% AS+MQ=96.3% 9

10 Change and implementation of policy change takes time Country Old policy and Resistance Current Policy 1 st line Deployment Kenya Uganda Zambia CQ resistance in 1978, Policy change to SP in Resistance to 34%, to CQ resistance 1978, policy change to CQ+SP in 2000 CQ resistance widespread in Policy change to AL AL Recommended in 2004 AL Recommended in 2005 AL recommended in 2002 Mid 2006 Early Tanzania CQ resistance in 1978 In 1990s, 70% resistance Policy change to SP in 2000 AL 2005 Late early

11 Obstacles in implementation of policy change Slow process due to funds transfer issues Huge stock of monotherapies and other anti- malarials Poor import controls to sustained use of monotherapy Local manufacturers inelasticity to change Inadequate monitoring and inspection by health authorities 11

12 Gap exists despite implementation of policy supply chain needs to be properly managed to meet demand 62 million treatments delivered by Novartis in 2006 Total needs: Not covered -Stock outs -Inadequate distribution -Non premium private market unsupported 12

13 Proportion of Health facilities where Coartem was seen, Uganda Survey of Health Facilities Proportion of H.F with Coartem P roportion in % <15 kg 15-<25 kg 25-<35 kg >35 kg Category Ref: Rapid assessment of new treatment policy implementation, Uganda- August-Sept 2006 Dr Kato et al, NMCP meeting Kampala

14 Health Facilities with anti-malarials other than Coartem Uganda August-Sept 2006 Coartem % Series1 AC T Quinine inj CQ inj SP Quinine Tabs Drugs C Q tabs Homepack red Hgreen 14

15 Month-year April 2006 July 2006 August 2006 Sept 2006 Oct 2006 Nov 2006 Dec 2006 Jan 2007 Stock out reports in Kenya Source NMCP* Facilities reporting Facilities with stock outs On average only 16% of sites are reporting 0 0 Proportion % reporting no stock

16 Improving situation in Kenya A recent health facility survey showed that over 85% of dispensaries and health centers had AL available on the day of the survey. For hospitals (both Mission and GOK) it was 100% availability Need for continuous vigilance on stocks 16

17 Availability of AL packs and stock outs in Zambia preceding survey 2006 In stock on survey day HFs with stock out Mean No of stock out days % time out of stock AL 6 pack 18% 95% % AL 12 pack 31% 89% % AL 18 pack 27% 91% % AL 24 pack 39% 81% % Ref Dejan Zurovac,, Quality of care: AL case management in Zambia and Kenya 17

18 Non premium private market Consist of rural and urban poor Big proportion of population Most affected during stock outs Cannot afford prices in pharmacies 18

19 Private Market AN EXCESS! Of anti Malarials 19

20 Antimalarials in a pharmacy in Nairobi 20

21 Antimalarials in a Kampala Pharmacy 21

22 Antimalarials in Tanzania pharmacy 22

23 Anti-malarials in East Africa Retail price/treatment Product Mefloquine Amodiaquine Sulphamethoxazole -Pyrimethanine innovator Lariam-Roche Camoquine-Park Davis France Metakelfin Pharmacia Upjohn Price range USD No. of branded generics in Mkt Fansidar Roche

24 Artemisinin Monotherapies in East Africa Product Consunate Arinate/Artesian (suspension) Gsunate Arinate/Artesian (suspension) Gsunate Cotexin (DHA) Arsumax Paluther (Artemether) Retail price/treatment Company Cosmos Dafra GVS Labs Dafra GVS Labs Holley Sanofi-Aventis Sanofi-Aventis Price USD

25 ALs in East Africa Private Market Product Coartem 24 Tablets Coartesiane Powder, OD dose Lumartem 24-Tablets Artefan 16 Tabs Lonart 24-Tablets And dry Syrup* INN AL AL AL AL AL Manufacturer Novartis Dafra Belgium Cipla India Ajanta India GVS-labs India Price USD Average retail price per treatment

26 Product Other ACTs in E. AFRICA. Private Market Generic Retail price/treatment Manufacturer Price USD Arsucam AS+AQ Sanofi-Aventis Artequin AS +MQ Mepha 5-7 Artekin Fixed combination Larimal Loose blister pack Amqunate Loose blister pack Falcimon Loose blister pack DHT+PPQ AS+AQ AS+AQ AS+AQ Holley Cotec IPCA Cosmos Cosmos

27 OPTIONS How can we Increase Access in Premium Private market 1. General price controls on essential medicines? 2. ACT global subsidy for informal private sector (exclude regular pharmacy channel)? 3. Repackaging : Ensure local GMP facilities for repackaging? 4. High quality generics with WHO prequalification? 27

28 What drives the uptake and penetration of ACTs in private sector Biggest driver is Government policy. 1 st line treatment Efficacy * Price* Tolerability* National registration *AC. Nielsen 2006 Malaria market survey 28

29 Continued registration of antimalarials despite change in policy Amin,, Kokwaro, Bob Snow et al. Health policy and planning A commentary 29

30 Challenges facing policy implementation Lack of efficacy studies in the majority of generics Difficult to withdraw existing anti-malarials which are not conforming to policy changes Need to regulate quality of antimalarials to avoid development of resistance plausible with substandard molecules Need for comprehensive PHARMACOVIGILANCE 30

31 Acknowledgements MMV NMCP Kenya, Uganda, Tanzania, Zambia Manuscripts: Prof Bob Snow, Dorothy Memusi, Dejan Zurovac,, FK Kato, (for articles and presentations during NMCP meeting in Kampala) Novartis Pharma 31