1 / 16

Coartem – the story so far

Coartem – the story so far. Lee Wells, Head of Global Access to Medicines Policy Novartis International AG APPG on Malaria – 11 th June 2008. Novartis Commitment - Coartem is company’s largest product by volume. In May 2001, Novartis committed to a unique public-private agreement with WHO

teresawbaker
Download Presentation

Coartem – the story so far

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Coartem – the story so far Lee Wells, Head of Global Access to Medicines Policy Novartis International AG APPG on Malaria – 11th June 2008

  2. Novartis Commitment - Coartem is company’s largest product by volume In May 2001, Novartis committed to a unique public-private agreement with WHO To make Coartem available without profit for distribution to public sector agencies in malaria-endemic developing countries To supply Coartem, procured through WHO with funds from donors; grants are provided by the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to public sector agencies To establish sustainable supply chains for distribution In September 2006, Novartis reduced the average price of Coartem from USD 1.57 to USD 1.00 to help expand access to medicine In April 2008, Novartis reduced the average price to USD 0.80

  3. The Issue of Resistance… 60-70% Treatment Failures! • Drug resistance hasincreased rapidly: • Suboptimal dosing • Misuse and poor prescribing habits • Lack of compliance to the proper dosing regimen by patients • Serious drug resistance to established therapies e.g. chloroquine and SP exists in much of Africa and South-East Asia (60-70% treatment failure rates); resistance already seen with amodiaquine, especially in East Africa • World Health Organization (WHO) called for use of artemisinin correctly in combination therapies; in January 2006, WHO called for terminating the distribution and sale of artemisinin monotherapies mefloquine quinine sulphadoxine- pyrimethamine (SP) chloroquine

  4. A Three-Day Cure to Fight Malaria Artemisinin-based Combination Therapy (ACT) is the best available treatment ACTs are the only effective treatment in drug resistant areas and are recommended by WHO as first line therapy Novartis’ ACT, Coartem, is the first fixed-dose artemisinin combination prequalified by WHO Coartem provides: • Prompt control of fever in as little as 24 to 36 hours • Rapid parasite clearance stopping disease propagation • Cure rates >96% after three days of therapy • Good tolerance throughout treatment

  5. Coartem’s Contribution to Patient OutcomesKwaZulu Natal Successful deployment of ACT/Coartem in combination with indoor residual spraying Cases reduced by 78% in 2001 and 86% in 2002 Hospital admissions for malaria reduced by 82% Insecticide Spraying Coartem 1999 2000 2001 2002 2003 2004 2005 2006

  6. ACT Production: More Complex than Most Drugs Jan Apr Aug Nov Feb Raw Materials/Drug Substances Drug Product Production Lumefantrine Up to 7 months Seeds secured from prior Autumn DS shipment 1 month Tabletting 1 month Packaging 1 month Shipping to country 1 month Planting of seeds in nursery, plantation in fields, growing, harvest Artemisinin - 7 months Extraction Artemisinin 1 month Production Artemether 2 months Minimum total of 14 months lead time, if capacities are established Deliveryof finished product ContractsArtemisinin ContractsLumefantrine Content ofleaves known

  7. In 2005, Novartis Took Unprecedented Steps to Ensure Delivery of Millions of Coartem Treatments Expanded artemisinin production in China and Africa Transferred chemical production from Switzerland to China Dedicated pharmaceuticals production/packaging in Suffern, NY

  8. The Frame in Which We OperateThe challenge of unprecedented scale-up 580% 7% 125% In millions of treatments Production meets demand – but still frequent stock outs at health facility levels Deliveries Excess production capacity Produced, but not picked up in 2005 100 100 66 62 ErraticOrders 33* Global Policy Uncertain Funding Uncertain Supply Challenges 4 9 1.3 0.1 0.2 *14 mio Tx were ordered for delivery in 2005, but only 9 mio were picked up

  9. Speed and Timeliness of OrdersMore donor funding and treatments available than ever to meet medical needs but erratic orders brings great financial risk Drug Supply:  Medical Need: Lack of orders creates stock-outs in countries   Funds:

  10. Putting 66 Million Treatments into Perspective 15 jumbo cargo planes full

  11. ACT Adoption in Africa

  12. Trouble ahead? The importance of the three pronged approach……… Malaria can be prevented and controlled by three main strategies: Insecticide Spraying • Control of the mosquitoes by spraying and drainage of areas where they live • Indoor residual insecticide spraying (IRS) Insecticide-treatedBed Nets (ITN) DrugTreatment • ACT (artemisinin-combination therapies) • Coartem (artemether – lumefantrine) is the first WHO pre-qualified fixed-dose ACT to be included on the WHO’s Model List of Essential Medicines

  13. Trouble ahead? ‘Not all drugs are created equal’…

  14. Trouble ahead? • Using all the tools at our disposal • Quality of medicine is crucial • Bruntland – “The age of poor medicines for poor patients is over” • Global Fund uses UK/US funds used to buy drugs that could not be given to US/UK patients • Challenges of pharmaco-vigilance in Africa makes quality more important not less • Local production – industrial policy dictating health policy • What is the evidence and the quality • AMFm • Right idea – wrong model? • Billions of dollars won’t secure Artemisia annua supply

  15. Saving Precious Lives An Achievable Goal in Malaria

  16. Training of Healthcare Professionals Coartem/WHO Field training Materials consisting of: Training manual Detailed cards Surgery posters Produced in 5 official languages and many local languages. All distributed for free in conjunction with WHO

More Related