Access to Cancer Medications in Low and Middle Income CountriesGilberto de Lima Lopes, Jr., M.D., M.B.A, F.A.M.S.       Se...
Why It Matters...
The “Forgotten Disease” in the      Developing World  Cancer kills more patients yearly   than Malaria, AIDS and   Tubercu...
Cancer Act Increased NCI autonomy   and funding  The Cancer Act
Made partnerships between government funded agencies/ universities and private companies possible The Bay-Dhole Act - 1980
These and other actions…Increased funding for research that  has increased our understanding of  cancer cells…            ...
How Are We Doing   with Cancer Control?Childhood CancerAdult Cancers
Childhood Cancer    New cases increased   10y Survival is now    but Deaths are down     70-75%ASCO 2009
In Adults in the US   In Men cancer death              In Women cancer     rates have declined              death rates ha...
Causes of Improvement in Cancer          Death RatesPrevention  Vaccines: HCC, Cervical Cancer  Reduced Smoking: Lung Canc...
Targeted Therapy:“The Magic Bullet”
www.bayer.com
Genomic Sequencing
For those of us who treat patients in low and middle income countries, these improvements are but an aspiration and hope f...
...Moreover, with targeted  agents, personalized  medicine and genomic  profiling, the control and  outcomes gap between h...
Low and Middle Income Countries      Spend Less in Cancer Control                     Per Patient          As a percentage...
More than 60% of cancer cases and deaths occur in Low and Middle Income countries and these nations represent only 6.2% of...
Why are newer medications so expensive?
Treatment Costs Have EscalatedRegimen                                  US$/3 Week Cycle  DDP + Vinorelbine                ...
Birth of a Drug
The Cost of Developing     New Drugs    Has Escalated
Current Cost to Develop a Drug:             USD 1.778 Bn.Paul et al. Nature Reviews Drug Discovery 2010
In the US…Medicare and private insurers pay for bevacizumab and for cetuximab for instance…             .. But can the Ame...
Current Access to Innovative Cancer Drugs in SE AsiaSummary of the First South East Asia Cancer Care Access Network Meetin...
SEACCAN Survey: Clinical         ScenariosColon    Oxaliplatin in Stage III         Bevacizumab and Cetuximab         in S...
Access to Innovative CancerDrugs in SE Asia: Overall Index
Predictors of Access: GDP per capita                                Singapore                     Malaysia                ...
Predictors of Access:Cost-Effectiveness of Drug        Oxaliplatin  Trastuzumab         Gefitinib                       So...
SEACCAN Survey: ConclusionsCost-effectiveness of a drug correlated with access; while cost was a weak predictorConversely,...
How to Improve Cost Effectiveness? Decreasing Cost and Increasing Value  of Cancer Medications     Making Drug Development...
Biomarkers Decrease Clinical Trial Risk and Cost of Drug DevelopmentIn Breast Cancer, the use of Her2  increases the rate ...
In Asia:  Sorafenib in HCC (No biomarker)            1.6 LY at a Cost of US$ 80k/LY  Trastuzumab (Her2Neu)            1.44...
Policy Options to Increase AccessGovernment Intervention  • Price Control and Negotiation  • Patent withdrawal – Compulsor...
Policy Options to Increase AccessMost Important and Effective Options: Quality generics Price Discrimination, aka, Afforda...
Universal CoveragePools resources from a large base of  individualsFinancial Protection from the cost of illnessIn the 198...
Universal Coverage: ChallengesFunding – Average USD 13,000/capita at  implementationIncreased public expenditure – In Chin...
Suing the State for CoverageBrazil and Colombia constitutions enshrine the right to health care access240,000 lawsuits a y...
GenericsHatch-Waxman Act, 1984 The Drug Price Competition and Patient  Term Restoration Act
Generic PrescriptionsGeneric medicines account for 69% of all prescriptions dispensed in the United States, yet only 16% o...
Savings to U.S. Health Care System     1999-2008: US$734 Bn.$140.0                                                        ...
What is a Generic After All?A generic drug is a pharmaceutical product, usually intended to be interchangeable with an inn...
How Do We Measure  Bioequivalence?
Accepted Bioequivalence         ParametersUS, Europe, Australia Cmax and AUC have to fall between 80 and 120% of the origi...
Actual Results: US FDA12-year review of 2,070 studiesMean +/- SD              1.00 +/- 0.06 C(max)                        ...
Generics: Essentials Drug List A WHO initiative Includes several oncology drugs, such as   anthracyclines, 5FU, paclitaxel...
Generics and Biosimilars: Challenges Patient and Health Care Workers  Perception Quality Issues Except for growth factors ...
Negotiating Prices:Compulsory Licensing
Compulsory LicensingWTO – TRIPS Agreement went into effect in  January 1995Allows countries to produce/import generics whi...
Compulsory Licensing in OncologyThailand in 2008  Docetaxel, Letrozole, Erlotinib, [Imatinib]  Savings in excess of US$ 14...
Compulsory Licensing: ChallengesDecrease in investment In Egypt, Pfizer pulled out of a new planned factoryOffice of the U...
Price Discrimination     [including Access Programs]Important concept in Economics and BusinessCompanies charge different ...
Price DiscriminationIMS data: Little Variation in Average Unit Price (USD)  per Country for all drugs combined [Lopes, 2011]
Price Discrimination    [including Access Programs]Many pilot projects in the region have seen increase in access and, in ...
Price Discrimination: ChallengesParallel ImportsPolitical Backlash in higher income  countries, especially in times of eco...
Innovative Payment MethodsHealth Technology Assessment Increased use of HTA in LMICValue-Based insurance coverage Next step!
Participation in Clinical TrialsMeans of accessing new medicationsShare of patients enrolled to clinical trials  outside o...
Participation in Clinical Trials:              ChallengesEthical:  informed consent, conflicts of interestLack of access t...
Drug Development Geared Towards      Emerging Markets OnlyNew PhenomenonWorth WatchingExamples: Icotinib in China, Nanoxel...
Public Private Partnerships:The GAVI Alliance and The International   Finance Facility for ImmunizationThe global alliance...
GAVI and IFFIAdditional 325 million children immunized5.5 million premature deaths avertedIn cancer prevention, GAVI has c...
Brave New World!
What we saw todayCancer kills more people yearly worldwide than Malaria, AIDS and Tuberculosis together:              a tr...
What We Saw TodayChemotherapy and new rationally  designed targeted therapies have  helped improve outcomes in CancerA few...
What We Saw TodayCancer has a major economic impactGeneric medications have generated substantial savings in health care b...
Hope for the futurePatient selection will improve and enable  us to choose therapies with greater  efficacy and safetyBett...
Hope for the FutureUniversal Coverage with value-based pricing and wider use of pharmacoeconomics, generics, biosimilars a...
How to do it!It will take the whole world to control  cancer in low and middle income  countries
How to do it!We need the creation of a global fund to fight cancer, a cancer alliance and international finance facility b...
How to do it!Join the fight!
“Strive not to be a success, but rather to be of value”               Albert Einstein
Access to cancer medications in low and middle income countries 2013.03.27
Access to cancer medications in low and middle income countries 2013.03.27
Access to cancer medications in low and middle income countries 2013.03.27
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  • Cancer control and access to treatment is a personal issue. Most of us will be touched by the disease as a patient or family member, not just as healhtcare workers. This picture shows my grandfather, the gentleman wearing the blue shirt, and his younger brother, Fabio, both sporting the South American cowboy, Gaucho, garb. They represent the generation that had to leave the farms of their forebearers and headed to the cities, where they worked hard and made sure that their children and grandchildren studies so they could become lawyers, physicians, business people (and, as I am from Brazil after all, even a football player). Unfortunately my great-uncle was not able to attend his granddaughter’s graduation from law school a couple of years ago. He developed chronic myelogenous leukemia at a time in which the Brazilian health care system did not provide access to imatinib, the drug that has revolutionized the management of this disease and died about 15 years ago. My grandfather served in the army during world war II and because of that had adequate health care coverage. He had bladder cancer approximately 10 years ago, was treated and will celebrate his 90 th birthday this coming July. There could not be a better example than these two brothers on the different consequences of adequate coverage.
  • The process of developing a new drug is long and costly.
  • Very few patients in low and middle income countries have access to newer medications
  • It took 5 years from the discovery of EML4ALK fusion gene to the approval of Crizotinib in 2011
  • Access to cancer medications in low and middle income countries 2013.03.27

    1. 1. Access to Cancer Medications in Low and Middle Income CountriesGilberto 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 OncologyJohns 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 CancerAdult 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 agoAmerican Cancer Society 2009-2012
    10. 10. Causes of Improvement in Cancer Death RatesPrevention Vaccines: HCC, Cervical Cancer Reduced Smoking: Lung CancerEarly Detection Breast and Colorectal CancerBetter 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/CapitaSouth 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 gapLopes et al. Nature Reviews Clinical Oncology,2013 in press, based on data from LiveStrong andAmerican Cancer Society
    18. 18. Why are newer medications so expensive?
    19. 19. Treatment Costs Have EscalatedRegimen 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 AsiaSummary of the First South East Asia Cancer Care Access Network Meeting and SurveyLopes et al. 2011. Available athttp://www.ispor.org/regional_chapters/Singapore/documents/presenta tion%20of-the-SE-Asia-Cancer-Care-Access-Network.pdf
    25. 25. SEACCAN Survey: Clinical ScenariosColon Oxaliplatin in Stage III Bevacizumab and Cetuximab in Stage IVBreast Trastuzumab in early HER2 +Liver Sorafenib in Stage IVLung Erlotinib and/or Gefitinib in advanced EGFR +
    26. 26. Access to Innovative CancerDrugs 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: ConclusionsCost-effectiveness of a drug correlated with access; while cost was a weak predictorConversely, 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 DevelopmentIn 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 2012Lopes 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 SavingsLopes, ASCO GI 2009, BMC Cancer 2010,ASCO and WCLC 2011, Cancer 2012
    33. 33. Policy Options to Increase AccessGovernment Intervention • Price Control and Negotiation • Patent withdrawal – Compulsory Licensing • Social Insurance, Subsidies, Medication Assistance FundsMarket 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 AccessMost 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 CoveragePools resources from a large base of individualsFinancial Protection from the cost of illnessIn the 1980s and 1990s many countries in Latin America and SE Asia implemented schemesIn 2010s China and Indonesia
    36. 36. Universal Coverage: ChallengesFunding – Average USD 13,000/capita at implementationIncreased public expenditure – In China, for instance public share of health care expenses increased from 35% to 60% in the last decadeWeak institutions, favouritism, corruptionLopes et al. Nature Reviews Clinical Oncology,2013 in press
    37. 37. Suing the State for CoverageBrazil and Colombia constitutions enshrine the right to health care access240,000 lawsuits a year in Brazil [2011] at a cost of US$72 Million [2010]60% of claims come from 2 richest statesLopes et al. Nature Reviews Clinical Oncology,2013 in press
    38. 38. GenericsHatch-Waxman Act, 1984 The Drug Price Competition and Patient Term Restoration Act
    39. 39. Generic PrescriptionsGeneric 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 $0.0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
    41. 41. What is a Generic After All?A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights.WHO Definition
    42. 42. How Do We Measure Bioequivalence?
    43. 43. Accepted Bioequivalence ParametersUS, Europe, Australia Cmax and AUC have to fall between 80 and 120% of the originator with a 90% Confidence Interval
    44. 44. Actual Results: US FDA12-year review of 2,070 studiesMean +/- SD 1.00 +/- 0.06 C(max) 1.00 +/- 0.04 for AUCAverage difference in C(max) and AUC was 4.35% and 3.56%Ann Pharmacother. 2009 Oct;43(10):1583-97.
    45. 45. Generics: Essentials Drug List A WHO initiative Includes several oncology drugs, such as anthracyclines, 5FU, paclitaxel, docetaxel, etoposide and othersLopes et al. Nature Reviews Clinical Oncology,2013 in press
    46. 46. Generics and Biosimilars: Challenges Patient and Health Care Workers Perception Quality Issues Except for growth factors such as G-CSF and EPO only India has had significant experience with Biosimilars in OncologyLopes et al. Nature Reviews Clinical Oncology,2013 in press
    47. 47. Negotiating Prices:Compulsory Licensing
    48. 48. Compulsory LicensingWTO – TRIPS Agreement went into effect in January 1995Allows countries to produce/import generics while medications are still protected by patent in cases on grounds of public interestWidely used for AIDS medicationsOccasionally used for cancer medicationsThe US threatened its use to create stockpiles of ciprofloxacin during Anthrax scare
    49. 49. Compulsory Licensing in OncologyThailand in 2008 Docetaxel, Letrozole, Erlotinib, [Imatinib] Savings in excess of US$ 140 millionIndia in 2012 Sorafenic
    50. 50. Compulsory Licensing: ChallengesDecrease in investment In Egypt, Pfizer pulled out of a new planned factoryOffice 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 BusinessCompanies charge different prices in different markets or segments, increasing number of consumers able to afford a product or serviceWidely used outside of health care [Think of discounts and rebates in electronics, for instance]
    52. 52. Price DiscriminationIMS 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, revenueSome 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: ChallengesParallel ImportsPolitical Backlash in higher income countries, especially in times of economic difficultiesLower prices might still not be low enough in the absence of Universal Coverage and Economic Development
    55. 55. Innovative Payment MethodsHealth Technology Assessment Increased use of HTA in LMICValue-Based insurance coverage Next step!
    56. 56. Participation in Clinical TrialsMeans of accessing new medicationsShare of patients enrolled to clinical trials outside of US and Europe increased from less than 5% to approximately 30% in the last decadeLower cost of running trials might eventually translate into lower drug development costs
    57. 57. Participation in Clinical Trials: ChallengesEthical: informed consent, conflicts of interestLack of access to new medications after trial ends
    58. 58. Drug Development Geared Towards Emerging Markets OnlyNew PhenomenonWorth WatchingExamples: 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 ImmunizationThe 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 IFFIAdditional 325 million children immunized5.5 million premature deaths avertedIn 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 todayCancer kills more people yearly worldwide than Malaria, AIDS and Tuberculosis together: a true “Hidden Disease” in the Developing WorldMajor Progress has been made in the treatment of patients with cancerAccess is a major issue in ALL countries
    63. 63. What We Saw TodayChemotherapy and new rationally designed targeted therapies have helped improve outcomes in CancerA few positive and negative predictive factors already exist and are used in practiceResearch is ongoing on better selection of drugs for both efficacy and toxicity
    64. 64. What We Saw TodayCancer has a major economic impactGeneric 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 cancerUnsafe medicines are a potential serious problem
    65. 65. Hope for the futurePatient selection will improve and enable us to choose therapies with greater efficacy and safetyBetter selection and fewer adverse events will make cancer care more cost-efficientThis will be achieved with an increase in funding for translational and clinical research
    66. 66. Hope for the FutureUniversal 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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