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Access to cancer medications in low and middle income countries 2013.03.27

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Access to cancer medications in low and middle income countries 2013.03.27

  1. 1. Access to Cancer Medications in Low and Middle Income Countries Gilberto de Lima Lopes, Jr., M.D., M.B.A, F.A.M.S. Senior Consultant in Medical Oncology Program Leader for Health Economics Assistant Director for Clinical Research Assistant Professor of Oncology Johns Hopkins Singapore International Medical Centre Johns Hopkins University School of Medicine
  2. 2. Why It Matters...
  3. 3. The “Forgotten Disease” in the Developing World Cancer kills more patients yearly than Malaria, AIDS and Tuberculosis
  4. 4. Cancer Act Increased NCI autonomy and funding The Cancer Act
  5. 5. Made partnerships between government funded agencies/ universities and private companies possible The Bay-Dhole Act - 1980
  6. 6. These and other actions… Increased funding for research that has increased our understanding of cancer cells… …Helping usher in an era in which diagnostic techniques and treatment advances improved the treatment of patients with cancer
  7. 7. How Are We Doing with Cancer Control? Childhood Cancer Adult Cancers
  8. 8. Childhood Cancer New cases increased 10y Survival is now but Deaths are down 70-75% ASCO 2009
  9. 9. In Adults in the US In Men cancer death In Women cancer rates have declined death rates have nearly 21% declined 12% Overall 2/3 of patients with cancer now live for 5 years or longer vs. 1/2 a couple of decades ago American Cancer Society 2009-2012
  10. 10. Causes of Improvement in Cancer Death Rates Prevention Vaccines: HCC, Cervical Cancer Reduced Smoking: Lung Cancer Early Detection Breast and Colorectal Cancer Better Treatment Breast, Ovarian, Lymphoma
  11. 11. Targeted Therapy: “The Magic Bullet”
  12. 12. www.bayer.com
  13. 13. Genomic Sequencing
  14. 14. For those of us who treat patients in low and middle income countries, these improvements are but an aspiration and hope for the future...
  15. 15. ...Moreover, with targeted agents, personalized medicine and genomic profiling, the control and outcomes gap between high and low income countries will widen
  16. 16. Low and Middle Income Countries Spend Less in Cancer Control Per Patient As a percentage of GNI/Capita South America US$ 7.92 0.12% China US$ 4.32 0.05% India US$ 0.54 0.11% United Kingdom US$ 183 0.51% Japan US$ 244 0.6% United States US$ 460 1.02% Lopes et al. Lancet Oncology, in press 2013
  17. 17. More than 60% of cancer cases and deaths occur in Low and Middle Income countries and these nations represent only 6.2% of global cancer costs and a whopping 89% of the cancer global expenditure gap Lopes et al. Nature Reviews Clinical Oncology, 2013 in press, based on data from LiveStrong and American Cancer Society
  18. 18. Why are newer medications so expensive?
  19. 19. Treatment Costs Have Escalated Regimen US$/3 Week Cycle DDP + Vinorelbine 600 Carboplatin + Paclitaxel 1,000 Gefitinib 1,500 Erlotinib 2,200 Cisplatin + Pemetrexed 2,800 CP + Bevacizumab 5,800 DDP + Vinorelbine + C225 5,550 Lopes 2009. Based on Singapore drug costs for class A patient at a government restructured hospital
  20. 20. Birth of a Drug
  21. 21. The Cost of Developing New Drugs Has Escalated
  22. 22. Current Cost to Develop a Drug: USD 1.778 Bn. Paul et al. Nature Reviews Drug Discovery 2010
  23. 23. In the US… Medicare and private insurers pay for bevacizumab and for cetuximab for instance… .. But can the American Society pay for ever increasing drug costs?
  24. 24. Current Access to Innovative Cancer Drugs in SE Asia Summary of the First South East Asia Cancer Care Access Network Meeting and Survey Lopes et al. 2011. Available at http://www.ispor.org/regional_chapters/Singapore/documents/presenta tion%20of-the-SE-Asia-Cancer-Care-Access-Network.pdf
  25. 25. SEACCAN Survey: Clinical Scenarios Colon Oxaliplatin in Stage III Bevacizumab and Cetuximab in Stage IV Breast Trastuzumab in early HER2 + Liver Sorafenib in Stage IV Lung Erlotinib and/or Gefitinib in advanced EGFR +
  26. 26. Access to Innovative Cancer Drugs in SE Asia: Overall Index
  27. 27. Predictors of Access: GDP per capita Singapore Malaysia Thailand Indonesia Philippines Vietnam
  28. 28. Predictors of Access: Cost-Effectiveness of Drug Oxaliplatin Trastuzumab Gefitinib Sorafenib Cetuximab Bevacizumab
  29. 29. SEACCAN Survey: Conclusions Cost-effectiveness of a drug correlated with access; while cost was a weak predictor Conversely, cost of treatment with a drug was predictive of overall sales, while Cost- Effectiveness was not
  30. 30. How to Improve Cost Effectiveness? Decreasing Cost and Increasing Value of Cancer Medications Making Drug Development Cheaper and More Effective Using Biomarkers Using generics, biosimilars, price discrimination and access programs
  31. 31. Biomarkers Decrease Clinical Trial Risk and Cost of Drug Development In Breast Cancer, the use of Her2 increases the rate of success by 50% and decreases cost by 30% In Lung Cancer, the use of biomarkers increases trial success rates from 11 to 50% and development cost by 27% Lopes et al, Breast Cancer Res Treat 2012 Lopes et al, submitted ASCO 2013
  32. 32. In Asia: Sorafenib in HCC (No biomarker) 1.6 LY at a Cost of US$ 80k/LY Trastuzumab (Her2Neu) 1.44 QALY at US$ 19 k/QALY Oncotype Dx in Adjuvant Breast Generates Cost Savings EGFR Mutation Testing and Gefitinib Generates Cost Savings Lopes, ASCO GI 2009, BMC Cancer 2010, ASCO and WCLC 2011, Cancer 2012
  33. 33. Policy Options to Increase Access Government Intervention • Price Control and Negotiation • Patent withdrawal – Compulsory Licensing • Social Insurance, Subsidies, Medication Assistance Funds Market Based Alternatives: • Better Private Insurance Coverage • Greater use of Generics • Price discrimination and Market Access Programs • Award for Innovation • Innovative Financing, Philanthropy • Risk Sharing Schemes
  34. 34. Policy Options to Increase Access Most Important and Effective Options: Quality generics Price Discrimination, aka, Affordable Pricing including access programs Adequate Insurance Coverage: Universal Coverage and Value-Based Design
  35. 35. Universal Coverage Pools resources from a large base of individuals Financial Protection from the cost of illness In the 1980s and 1990s many countries in Latin America and SE Asia implemented schemes In 2010s China and Indonesia
  36. 36. Universal Coverage: Challenges Funding – Average USD 13,000/capita at implementation Increased public expenditure – In China, for instance public share of health care expenses increased from 35% to 60% in the last decade Weak institutions, favouritism, corruption Lopes et al. Nature Reviews Clinical Oncology, 2013 in press
  37. 37. Suing the State for Coverage Brazil and Colombia constitutions enshrine the right to health care access 240,000 lawsuits a year in Brazil [2011] at a cost of US$72 Million [2010] 60% of claims come from 2 richest states Lopes et al. Nature Reviews Clinical Oncology, 2013 in press
  38. 38. Generics Hatch-Waxman Act, 1984 The Drug Price Competition and Patient Term Restoration Act
  39. 39. Generic Prescriptions Generic medicines account for 69% of all prescriptions dispensed in the United States, yet only 16% of all dollars spent on prescriptions. (source: IMS Health) Cost of Medication my drop by 80% after introduction of a generic
  40. 40. Savings to U.S. Health Care System 1999-2008: US$734 Bn. $140.0 $121 $120.0 $101 $100.0 $86 $78 $80.0 $65 $69 $60 $60.0 $51 $55 $49 $40.0 $20.0 $0.0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
  41. 41. What is a Generic After All? A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. WHO Definition
  42. 42. How Do We Measure Bioequivalence?
  43. 43. Accepted Bioequivalence Parameters US, Europe, Australia Cmax and AUC have to fall between 80 and 120% of the originator with a 90% Confidence Interval
  44. 44. Actual Results: US FDA 12-year review of 2,070 studies Mean +/- SD 1.00 +/- 0.06 C(max) 1.00 +/- 0.04 for AUC Average difference in C(max) and AUC was 4.35% and 3.56% Ann Pharmacother. 2009 Oct;43(10):1583-97.
  45. 45. Generics: Essentials Drug List A WHO initiative Includes several oncology drugs, such as anthracyclines, 5FU, paclitaxel, docetaxel, etoposide and others Lopes et al. Nature Reviews Clinical Oncology, 2013 in press
  46. 46. Generics and Biosimilars: Challenges Patient and Health Care Workers Perception Quality Issues Except for growth factors such as G-CSF and EPO only India has had significant experience with Biosimilars in Oncology Lopes et al. Nature Reviews Clinical Oncology, 2013 in press
  47. 47. Negotiating Prices: Compulsory Licensing
  48. 48. Compulsory Licensing WTO – TRIPS Agreement went into effect in January 1995 Allows countries to produce/import generics while medications are still protected by patent in cases on grounds of public interest Widely used for AIDS medications Occasionally used for cancer medications The US threatened its use to create stockpiles of ciprofloxacin during Anthrax scare
  49. 49. Compulsory Licensing in Oncology Thailand in 2008 Docetaxel, Letrozole, Erlotinib, [Imatinib] Savings in excess of US$ 140 million India in 2012 Sorafenic
  50. 50. Compulsory Licensing: Challenges Decrease in investment In Egypt, Pfizer pulled out of a new planned factory Office of the US Trade Representative withdrew duty-free status of three Thai products
  51. 51. Price Discrimination [including Access Programs] Important concept in Economics and Business Companies charge different prices in different markets or segments, increasing number of consumers able to afford a product or service Widely used outside of health care [Think of discounts and rebates in electronics, for instance]
  52. 52. Price Discrimination IMS data: Little Variation in Average Unit Price (USD) per Country for all drugs combined [Lopes, 2011]
  53. 53. Price Discrimination [including Access Programs] Many pilot projects in the region have seen increase in access and, in some, revenue Some companies now have specific policies to provide medications at a different cost in low and middle income countries [GSK in all emerging markets, ROCHE in India]
  54. 54. Price Discrimination: Challenges Parallel Imports Political Backlash in higher income countries, especially in times of economic difficulties Lower prices might still not be low enough in the absence of Universal Coverage and Economic Development
  55. 55. Innovative Payment Methods Health Technology Assessment Increased use of HTA in LMIC Value-Based insurance coverage Next step!
  56. 56. Participation in Clinical Trials Means of accessing new medications Share of patients enrolled to clinical trials outside of US and Europe increased from less than 5% to approximately 30% in the last decade Lower cost of running trials might eventually translate into lower drug development costs
  57. 57. Participation in Clinical Trials: Challenges Ethical: informed consent, conflicts of interest Lack of access to new medications after trial ends
  58. 58. Drug Development Geared Towards Emerging Markets Only New Phenomenon Worth Watching Examples: Icotinib in China, Nanoxel in India, Nimotuzumab in several countries in Asia and Latin America
  59. 59. Public Private Partnerships: The GAVI Alliance and The International Finance Facility for Immunization The global alliance for vaccines and immunization receives funding from donors such as the Bill and Melinda Gates foundation and the World Bank combined with technical assistance from the WHO and UNICEF
  60. 60. GAVI and IFFI Additional 325 million children immunized 5.5 million premature deaths averted In cancer prevention, GAVI has created a market for low cost interventions and has helped decrease the cost of each dose of hepatitis B vaccine to US$0.50 and of HPV vaccine to US$5
  61. 61. Brave New World!
  62. 62. What we saw today Cancer kills more people yearly worldwide than Malaria, AIDS and Tuberculosis together: a true “Hidden Disease” in the Developing World Major Progress has been made in the treatment of patients with cancer Access is a major issue in ALL countries
  63. 63. What We Saw Today Chemotherapy and new rationally designed targeted therapies have helped improve outcomes in Cancer A few positive and negative predictive factors already exist and are used in practice Research is ongoing on better selection of drugs for both efficacy and toxicity
  64. 64. What We Saw Today Cancer has a major economic impact Generic medications have generated substantial savings in health care budgets and helped expand access to care in several diseases and have a great potential role in the treatment of cancer Unsafe medicines are a potential serious problem
  65. 65. Hope for the future Patient selection will improve and enable us to choose therapies with greater efficacy and safety Better selection and fewer adverse events will make cancer care more cost-efficient This will be achieved with an increase in funding for translational and clinical research
  66. 66. Hope for the Future Universal Coverage with value-based pricing and wider use of pharmacoeconomics, generics, biosimilars and price discrimination will increase access to cancer care for millions of patients worldwide
  67. 67. How to do it! It will take the whole world to control cancer in low and middle income countries
  68. 68. How to do it! We need the creation of a global fund to fight cancer, a cancer alliance and international finance facility bringing together donors, the world bank, WHO, IAEA, UICC, NGOs and other stakeholders to effectively tackle cancer control
  69. 69. How to do it! Join the fight!
  70. 70. “Strive not to be a success, but rather to be of value” Albert Einstein

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