Our experience on other diseases

Transcription

1 Global supply chain for MDR TB drugs Our experience on other diseases Dr Robert Sebbag 31 st July 2012 ACCESS TO MEDICINES 1

2 Second-line drugs for MDR TB Definition: resistance to (at least) R and H, the most potent drugs Develops if these drugs are misused or mismanaged Takes longer to treat and treatment is more expensive and with more sideeffects Very specific drugs: Small volumes Difficult management Expensive Difficult compliance Reliable diagnosis is mandatory: To strictly keep 2 nd line drugs for MDR TB To protect 2 nd line drugs from mis-usage, ACCESS TO MEDICINES 2

3 MDR-TB: 5.3% of all TB cases 490,000 cases & 110,000 deaths per year > 10% MDR Estonie (17%) Georgie (16%) Azerbaïdjan (15%) Moldavie (15%) Kazakhstan (14%) Ouzbekistan (13%) China + India + Russia = 62% of all MDR cases ACCESS TO MEDICINES 3 Source: Zignol, Bull WHO 2012

4 TB treatments guideline Active TB: 2 months RHZE (FDC) + 4 months RH (FDC) Multidrug-resistant TB: four 2 nd line drugs incl. one injectable (aminoside) 8 months for intensive phase, 20 months in total Correct active TB treatment prevents from MDR development High quality activetb treatment available Patient observance over the 6 months is key ( DOTS strategy) ACCESS TO MEDICINES 4

5 WHO guidelines for DR-TB Alternative groups of treatment Use at least 4 agents certain or highly likely to be effective Grouping Group 1: First-line oral drugs Group 2: Injectable drugs Group 3: Fluoroquinolones Drugs H, R, E, Z Streptomycin, Kanamycin, Amikacin, Capreomycin, Viomycin Cipro, Oflo, Levo, Moxi, Gatifloxacin Group 4: Oral bacteriostatic Ethionamide, protionamide, cycloserine, terizidone, P- aminosalicylic acid, thioacetazone Group 5: Unclear efficacy, not WHO approved for routine use Clofazimine, amoxicilline/clavulanate, clarithromycin, linezolid ACCESS TO MEDICINES 5 Guidelines for the programmatic management of drug-resistant tuberculosis, Geneva World Health Organization, 2006, WHO/HTM/TB/

6 Sanofi DOTS initiative in South Africa Training of trainers in the 9 Provinces of the country ACCESS TO MEDICINES 6

7 1st line drugs optimization Improve observance: Ease of use: malaria example Treatment time reduction: TB example ACCESS TO MEDICINES 7

8 Artemisinin-based combinations since 2007 Infant (<8 kg) ASAQ Artesunate-Amodiaquine Co-blister Arthemeter Lumefantrine AM PM Toddler (8-17 kg) 5-15 kg Child (17-35 kg) kg kg Adult (>35 kg) >35 kg ACCESS TO MEDICINES 8

9 Capitalizing on Rifapentine properties long term treatment medium term treatment short term treatment Rifapentine properties : Favorable PK profile Potent anti- mycobacterium activity Well-tolerated On-going rifapentine studies towards: Shorter and simpler drug susceptible regimen for active TB Shorter and intermittent treatment regimen for LTBI Improving adherence and facilitating supervision (DOTs) Reduce transmission of TB Prevent emergence of drug resistant TB mass latent therapy medium term treatment + mass latent therapy Epidemiological benefits of more-effective tuberculosis vaccines, drugs, and diagnostics Abu-Raddada et al. ACCESS TO MEDICINES 9

10 System strengthening: malaria example IEC / BCC program Because drug only is not enough Work with supply chain local actors Supply chain training (training of trainers concept) Central medical store support IEC: Information Education Communication BCC: Behavior Change Communication ACCESS TO MEDICINES 10

11 Tools for comprehensive management of malaria > National hospitals > Regional hospitals Physicians-GPs Nurses > District hospitals > Dispensaries Primary care centers Healthcare technicians > Health posts Communities and families ACCESS TO MEDICINES 11

12 A multipolaire world Fund Providers Global Fund World Bank President s Malaria Initiative UN entities Unicef UNDP Manufacturers WHO/PAHO Global Malaria Program TDR Prequalification Procurement UNITAID National Institutions Endemic countries Foundations B&M Gates Slim/Clinton Bi-lateral Cooperation OECD countries NGOs National International CSR GBC RBM /STOP TB Partnerships Development Foundations MMV DNDi FIND ACCESS TO MEDICINES 12

13 Partner with Central medical store CAPACITY BUILDING Technical partnership with ACAME since 2001: Dakar 2001 : Quality and accessibility of medicines Lomé 2007 : conterfeit drugs Madagascar 2008 : ACTs Supply chain challenges Avril 2009 : Visite of Sanofi anti-conterfeit control lab in France Abidjan 2009 : participation, sponsoring et intervention sur la Plutte contre la contrefaçon Ouagadougou 2009 : Training of CMS supply team on ACT supply chain Kinshasa 2010 : Training of CMS supply team on ACT supply chain Madagascar 2010 : Training of CMS supply team on ACT supply chain Yaounde 2011 : Quality : constraint or opportunity? Ouagadougou 2011 : Technical partnership in new Inter-University Training course on supply management for HIV, TB and Malaria drugs (Sanofi: technical expert on conterfeit) Nouakchott 2012 : Ensure access to quality medicines in integrated programs: example of Mental Health in Mauritania ACAME: Association des Centrales d Achat de Médicaments Essentiels African Central Medical Store Association ACCESS TO MEDICINES 13

14 Partner with Central medical store CAPACITY BUILDING Supply chain training (training of trainers concept) (in progress) Global supply chain for essential drugs Supply Chain Management training 9 modules Cascading process ACCESS TO MEDICINES 1 ACCESS TO MEDICINES 14

15 Conclusion Protect efficient 1st line drug Quality Availability Diagnosis Observance Develop future 1st line drugs Ease of use Treatment term reduction Latent TB Strenghten countries capacities for best practices At all supply chain and case management levels Strictly manage 2 nd line therapies To avoid XDR apparition and to keep treatment cost efficiency Partner with all actors for quick and large success against TB ACCESS TO MEDICINES 15

16 Thank you ACCESS TO MEDICINES 16