A ccess to insulin: current challenges and constraints - PowerPoint Presentation

1. Access to insulin: current challenges and constraintsDavid BeranDivision of Tropical and Humanitarian MedicineGeneva University Hospitals and University of GenevaAdvisor to the Board International Insulin Foundation1

2. The Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020Aims to serve as a guide for Member States by providing them with a variety of policy options to help achieve progress on nine global NCD targets25% relative reduction in premature mortality from NCDs by 2025An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilitiesWHO 20132

3. Challenges of access to essential medicines for NCDs Fall into four distinct categories: Generic oral medicines available cheaply on the international market but intermittently available in countries and of uneven quality (e.g. oral anti diabetic medicines, anti hypertensives, etc.)Asthma inhalers and insulin available at high cost, and quality assessment is highly challengingNCD medicines still under patent and accessible only through expanded access programmes (e.g. certain cancer medicines)Opioid analgesics for palliative care often limited by excessive regulationBeran et al. Lancet Glob Health 20143

4. Procurement prices of common NCD medicines (excl. duties, taxes and mark-ups)NCD Alliance 20124

5. 1921: The Discovery of Insulin5

6. 1922: Insulin changes the life of Leonard Thompson“A new race of diabetics has come upon the scene” – E. Joslin (1922)“Now modern discoveries, particularly insulin, have completely changed the outlook. There is no reason why a diabetic should not if he can be taught to do so, lead a long normal life.” – R.D. Lawrence (1925) 6

7. Impact of the miracle of insulinGale Lancet 2003; USA Today 2011At age 10Pre-insulin eraInsulin eraLife expectancy (years)Overall7

8. Global dominance of 3 multi-nationals8

9. Yudkin Lancet 20009

10. Creation in 2002 of the International Insulin FoundationUK Registered CharityGlobal leading academics and clinicians in diabetes10

11. Ideally what is needed to manage insulin-requiring diabetes in resource poor settings? Barriers to care existHow can these be clearly identified?Development of the Rapid Assessment Protocol for Insulin Access (RAPIA)Understanding the barriers to access11

12. Tanzania 200312

13. CountryPerson with diabetesCareMinistry of HealthInsulin and medicines for diabetesOther ProblemsUnderstanding the barriers to accessBeran et al. BMC Health Serv Res 200613

14. Multi-level assessment of Health systemMacroMinistry of Health Ministry of TradeMinistry of FinanceCentral Medical StoreNational Diabetes AssociationPrivate/Public drug importerEducatorsMesoRegional Health OrganisationHospitals, Health Centres, etc.Pharmacies, Drug DispensariesMicroHealthcare WorkersTraditional DoctorsPeople with diabetesPerspectives on the problem of access to insulin and diabetes care Rapid Assessment Protocol for Insulin Access – multi-level assessment of health systemBeran et al. BMC Health Serv Res 200614

15. Zambia (2003)Mozambique (2003) Reassessment (2009)Nicaragua (2007)Philippines (2008)*Mali (2004)Vietnam (2008)* - carried out by WHOKyrgyzstan (2009)Countries assessed15

16. Prices of insulin per 10ml 100 IU vial16

17. Affordability and availability in the public sector to the individualHI = Health Insurance 40% of interviewees had health insuranceIfL = Insulin for Life – supplies two of the three main paediatric hospitals in VietnamBeran and Yudkin DRCP 2010 17

18. ChallengesMozambique and Zambia access to differential pricingDifferent prices between government tender price and price to the facilityInsulin purchased locally more expensive (Mozambique 25-125%; Zambia 85–125%)Maputo Province equals 11.3% of the total population, receives 77.3% of total amount of insulin in Mozambique A snapshot survey carried out by Health Action International Significant differences in average prices in Europe and South East AsiaAcross the WHO regions the average price of insulin from one company doubled from US$ 15 per vial in South East Asia to US$ 32 in EuropeBeran et al. Diab Care 2006; HAI 201018

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20. OutpatientFinal price: 118%-124%PatientFinal price: 130%-149%Private Pharmacies+5% VAT100%+5% import dutyMedicineCIFVietnamDistributorWholesalerPublic HospitalPatients without Health InsurancePatients with Health InsuranceOutpatientFinal price: 124%-136%InpatientFinal price: 118%-124%InpatientFinal price: 118%-124%10-20%+7% distribution and other costs+7% distribution and other costs+5%+7% distribution and other costs+5%0%0%0%5-10%Mark-ups, example of VietnamBeran et al. 200820

21. A new challenge? Or a repeat of the past?21

22. WHO Essential Medicines List 2011http://www.who.int/selection_medicines/Complete_UNEDITED_TRS_18th.pdf 22

23. Transition from human to analogue insulin (red: human; blue: analogue; green: animal)High IncomeUpper Middle IncomeLower Middle IncomeLow Income23

24. InsulinTotal units (10ml 100IU vial equivalent)Percentage of total volumeCost per 10ml 100IU vial equivalent (US$) Cost (US$)Percentage of total costMeeting WHO criteria160,00071%5.12 818,400  43%Not meeting WHO criteria*64,15029%16.651,068,18457%Total224,150  1,886,584 All insulin purchased using WHO criteria224,150100%5.121,147,648 Potential saving738,936Financial implications at a country-level* - Analogue insulin or insulin in penfillUS$ 738,936 = healthcare expenditure for ≈ 11,000 peopleBeran et al. Int J Health Plann Mngt 201324

25. Human versus Analogue the financial implicationsHigh overall cost due to choice of penfill versus vial and analog versus humanComparison of different treatment optionsAssumptions:15 units long acting per day20 units short acting per day5 injections with one syringe or needle for penPen amortised over 12 monthsMonthly total cost (US$)RatioVial (Protophane and Actrapid)5.841.0Penfill (Protophane and Actrapid)14.512.5Analog (Lantus and NovoRapid) 49.458.525

26. Delivery devices and impact on overall cost26

27. Barriers identified – costs of care to the individualBeran and Yudkin DRCP 201027

28. The example of Vietnam: Average monthly costs of care for Type 1 diabetesBeran et al. 200828

29. Diabetes Type 1 Type 2 MINSA 302 22,296CIPS 714 14,283RAPIA 631 38,501Diabetes Type 1 Type 2IDF 1,300 224,074CAMDI 186,708 5% of total costx 5-10 ?Diabetes expenditure in Nicaragua: the tip of the icebergBeran et al. 200729

30. Lancet November 2006What is the commonest cause of death in a child with diabetes? The answer from a global perspective is lack of access to insulinInsulin still fails to reach all those who need it 30

31. Accessibility and affordability of MedicinesHealthcare workersOrganised centres for careData collectionPrevention measuresDiagnostic tools and infrastructureDrug procurement and supplyAdherence issuesPatient education and empowermentCommunity involvement/diabetes associationPositive policy environmentA positive diabetes environmentBeran and Yudkin Lancet 200631

32. Insulin for Type 1 diabetes = survivalBeran Diab Med 201432

33. Human cost – decreased life expectancyCalculated life expectancies for people with Type 1 diabetes in Mali, Mozambique, Zambia, Nicaragua and Vietnam33

34. A comparison of life expectancies between Boston (1897-1945), Mozambique (2003) and Nicaragua (2007)At age 100-14Pre-insulin eraInsulin eraLife expectancy (years)34

35. Improvements can be made: Diabetes UK-Mozambique Twinning ProjectTraining of trainers programme initiated by the Ministry of HealthSpecialised trainingPatient education materialsOrganisation of World Diabetes Day eventsAdvocacy and policy support to Ministry of HealthDevelop core group of people involved in diabetesDevelopment of diabetes associationLong term research programmes in Mozambique in Health Services and Basic ScienceREPÚBLICA DE MOÇAMBIQUE_____________MINISTÉRIO DA SAÚDE35

36. RAPIA reassessment resultsResults of targeted action in MozambiqueIndicator20032009InsulinProportion of total amount of insulin in Maputo 77%46%Time for tender (maximum)12 months9 monthsAverage tender price per vial of insulin (18 months)$6.86$4.50Insulin always present at %age of hospitals20%100%Affordability (%age of GDP per capita PPP)4%1%Presence of diagnostic toolsBlood glucose machine 21%87%Are consumables available for the Blood glucose machine6%27%Urine testing strips18%73%Presence ketone strips8%73%Healthcare workersNumber of healthcare workers who have received training in diabetes (2003 basic, 2009 specialised)52%65%Beran et al. Diab Med 2010Increase in estimated life expectancy36

37. National level barriers and solutionsKnown and documented barriersPossible solutions and initiatives being implementedBUT…What about global level?Lessons from HIV/AIDS to improve access to insulinHogerzeil et al. Lancet 201337

38. Challenges with insulinHigh costLimited producersHeat stability and cold chainData from study carried out by UNIGE and MSFTransition to analoguesBiological versus chemical entityRegulatory issues for biosimilars versus genericsNot only an issue in poor resource settingsIn the US insulin discontinuation was the leading precipitating cause of DKA in 68% of people in a US inner city setting 27% reported lack of money to buy insulin Greece during the financial crisisIncreasing burden on health budgets e.g. UK38

39. www.100campaign.org39

40. On the road to the insulin centenary – need to map the global insulin market40

41. Need to understand…The 4% Who, how, where…IP issuesPricingDistributionBiosimilar regulatory issuesExisting initiatives41

42. Addressing the Challenges and Constraints of Insulin Sources and Supply (ACCISS) StudyMargaret Ewen, Coordinator, Global Projects (Pricing)Health Action International42

43. ACCISS StudySupported by The Leona M. And Harry B. Helmsley Charitable Trust Goal:To improve the life-expectancy and quality of life for people with diabetes requiring insulin by addressing inequities and inefficiencies in the global insulin market 43

44. ACCISS StudyObjectives are to develop:Comprehensive, first-of-its-kind evidence base on the global insulin market, including the type, extent and impact of barriers to global insulin access.Innovative models of supply, policies and interventions to overcome the barriers to global insulin access learning from other pioneering access programmes.Toolbox in collaboration with multiple stakeholders, to influence policy change and reduce, or eliminate, the barriers to global insulin access. 44

45. Mapping the insulin market from different angles The first phase will be to gain an overall understanding of the insulin market in terms of volumes, prices and any intellectual property issues. Analysis of:PatentsPrices and Price componentsInsulin market (volume, value, types)TradeRegulatory status (Biosimilars)Distribution channelsExisting initiatives45

46. Understanding who produces insulin and challenges in the distribution channel Interviews and site visits to the identified manufacturers in Phase 1 will be the main component of the second phase. In addition, the distribution chain in the countries visited will be assessed to measure the ‘add-on’ costs in the supply chain.Assess factors around manufacturers’Market reach, types of insulin produced, and quality assurance standards Study the distribution chain looking at the different price components46

47. Developing interventions to re-shape the insulin market The results of the mapping exercise will be presented at a multi-stakeholder meeting in order to brainstorm the best way forward to address the issue of access to insulin Present results from Phase 1 and 2 of this studyIn working groups discuss different options, such as WHO prequalification, group or bulk tendering and differential pricingInitiate the development of guidelines for countries and procurement agencies Develop a proposal for piloting the models etc. and other next steps of this project47

48. Advocacy and CommunicationMapping individuals, organisations, networks, initiatives, media outlets and events that may serve as allies and channels for the materials of the ACCISS StudyIssue paper will be prepared As Phase 1 and 2 are completed preparation of fact sheets and journal articles48

49. Expected resultsClear understanding of the global insulin marketAssessment of insulin manufacturers Development of interventions for improving insulin availability and affordabilityDevelopment of a virtual advocacy campaign around the issue of access to insulinProposal developed on implementation of the toolkit and its evaluationPeer reviewed publications and other research outputs (Reports, factsheets)49

50. ACCISS Study TeamManagement and Research TeamDavid Beran, Geneva University Hospitals and University of GenevaMarg Ewen, Health Action InternationalRichard Laing, Boston UniversityAdvisory GroupMark Atkinson, University of FloridaJennifer Cohn, MSF Access CampaignEdwin Gale, IIF, Lancet Diabetes CommissionJenny Hirst, Insulin Dependent Diabetes TrustHans Hogerzeil, University of GroningenCécile Macé, WHOCarla Silva-Matos, Ministry of Health Republic of MozambiqueZafar Mirza, WHOJohn S. Yudkin, IIF2 spokespersons from the global south representing people living with Type 1 diabetes (TBD)Technical GroupMerith Basey, UAEMJaime Espin, Andalusian School of Public HealthEllen ‘t Hoen, IndependentWarren Kaplan, Boston UniversityMolly Lepeska, AYUDAChristophe Perrin, MSF Access CampaignJoan Rovira, Andalusian School of Public HealthVeronika Wirtz, Boston University50