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Access to insulin: current challenges and constraints David Beran Division of Tropical and Humanitarian Medicine Geneva University Hospitals and University.

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Presentation on theme: "Access to insulin: current challenges and constraints David Beran Division of Tropical and Humanitarian Medicine Geneva University Hospitals and University."— Presentation transcript:

1 Access to insulin: current challenges and constraints David Beran Division of Tropical and Humanitarian Medicine Geneva University Hospitals and University of Geneva Advisor to the Board International Insulin Foundation 1

2 The Global Action Plan for the Prevention and Control of Noncommunicable Diseases Aims 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 targets 25% relative reduction in premature mortality from NCDs by 2025 – An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilities WHO

3 Challenges of access to essential medicines for NCDs Fall into four distinct categories: 1.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.) 2.Asthma inhalers and insulin available at high cost, and quality assessment is highly challenging 3.NCD medicines still under patent and accessible only through expanded access programmes (e.g. certain cancer medicines) 4.Opioid analgesics for palliative care often limited by excessive regulation Beran et al. Lancet Glob Health

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

5 1921: The Discovery of Insulin 5

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 insulin Gale Lancet 2003; USA Today 2011 At age 10 Pre-insulin era Insulin era Life expectancy (years) Overall 7

8 Global dominance of 3 multi-nationals 8

9 Yudkin Lancet

10 Creation in 2002 of the International Insulin Foundation UK Registered Charity Global leading academics and clinicians in diabetes 10

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

12 Tanzania

13 Understanding the barriers to access Beran et al. BMC Health Serv Res

14 Multi-level assessment of Health system Macro Ministry of Health Ministry of Trade Ministry of Finance Central Medical Store National Diabetes Association Private/Public drug importer Educators Meso Regional Health Organisation Hospitals, Health Centres, etc. Pharmacies, Drug Dispensaries Micro Healthcare Workers Traditional Doctors People with diabetes Perspectives on the problem of access to insulin and diabetes care Rapid Assessment Protocol for Insulin Access – multi-level assessment of health system Beran et al. BMC Health Serv Res

15 Zambia (2003) Mozambique (2003) Reassessment (2009) Nicaragua (2007) Philippines (2008)* Mali (2004)Vietnam (2008) * - carried out by WHO Kyrgyzstan (2009) Countries assessed 15

16 Prices of insulin per 10ml 100 IU vial 16

17 Affordability and availability in the public sector to the individual HI = Health Insurance 40% of interviewees had health insurance IfL = Insulin for Life – supplies two of the three main paediatric hospitals in Vietnam Beran and Yudkin DRCP

18 Challenges Mozambique and Zambia access to differential pricing Different prices between government tender price and price to the facility Insulin purchased locally more expensive (Mozambique %; 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 Asia – Across 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 Europe Beran et al. Diab Care 2006; HAI

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20 Outpatient Final price: 118%-124% Patient Final price: 130%-149% Private Pharmacies +5% VAT 100% +5% import duty Medicine CIF Vietnam Distributor WholesalerPublic Hospital Patients without Health Insurance Patients with Health Insurance Outpatient Final price: 124%-136% Inpatient Final price: 118%-124% Inpatient Final price: 118%-124% 10-20%  +7% distribution and other costs  +5%  +7% distribution and other costs  +5% 0% 5-10% Mark-ups, example of Vietnam Beran et al

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

22 WHO Essential Medicines List

23 Transition from human to analogue insulin (red: human; blue: analogue; green: animal) High Income Upper Middle Income Lower Middle IncomeLow Income 23

24 Insulin Total units (10ml 100IU vial equivalent) Percentage of total volume Cost per 10ml 100IU vial equivalent (US$) Cost (US$) Percentage of total cost Meeting WHO criteria 160,00071% ,400 43% Not meeting WHO criteria* 64,15029%16.651,068,18457% Total224,150 1,886,584 All insulin purchased using WHO criteria 224,150100%5.121,147,648 Potential saving 738,936 Financial implications at a country-level * - Analogue insulin or insulin in penfill US$ 738,936 = healthcare expenditure for ≈ 11,000 people Beran et al. Int J Health Plann Mngt

25 Human versus Analogue the financial implications High overall cost due to choice of penfill versus vial and analog versus human – Comparison of different treatment options Assumptions: – 15 units long acting per day – 20 units short acting per day – 5 injections with one syringe or needle for pen – Pen amortised over 12 months Monthly total cost (US$)Ratio Vial (Protophane and Actrapid) Penfill (Protophane and Actrapid) Analog (Lantus and NovoRapid)

26 Delivery devices and impact on overall cost 26

27 Barriers identified – costs of care to the individual Beran and Yudkin DRCP

28 The example of Vietnam: Average monthly costs of care for Type 1 diabetes Beran et al

29 Diabetes Type 1Type 2 MINSA30222,296 CIPS71414,283 RAPIA63138,501 Diabetes Type 1Type 2 IDF1,300224,074 CAMDI186,708 5% of total cost x 5-10 ? Diabetes expenditure in Nicaragua: the tip of the iceberg Beran et al

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

31 Accessibility and affordability of Medicines Healthcare workers Organised centres for care Data collection Prevention measures Diagnostic tools and infrastructure Drug procurement and supply Adherence issues Patient education and empowerment Community involvement/ diabetes association Positive policy environment A positive diabetes environment Beran and Yudkin Lancet

32 Insulin for Type 1 diabetes = survival Beran Diab Med

33 Human cost – decreased life expectancy Calculated life expectancies for people with Type 1 diabetes in Mali, Mozambique, Zambia, Nicaragua and Vietnam 33

34 A comparison of life expectancies between Boston ( ), Mozambique (2003) and Nicaragua (2007) At age Pre-insulin era Insulin era Life expectancy (years) 34

35 Improvements can be made: Diabetes UK-Mozambique Twinning Project 1.Training of trainers programme initiated by the Ministry of Health 2.Specialised training 3.Patient education materials 4.Organisation of World Diabetes Day events 5.Advocacy and policy support to Ministry of Health 6.Develop core group of people involved in diabetes 7.Development of diabetes association 8.Long term research programmes in Mozambique in Health Services and Basic Science REPÚBLICA DE MOÇAMBIQUE _____________ MINISTÉRIO DA SAÚDE 35

36 RAPIA reassessment results Results of targeted action in Mozambique Indicator Insulin Proportion of total amount of insulin in Maputo 77%46% Time for tender (maximum) 12 months9 months Average tender price per vial of insulin (18 months) $6.86$4.50 Insulin always present at %age of hospitals 20%100% Affordability (%age of GDP per capita PPP)4%1% Presence of diagnostic tools Blood glucose machine21%87% Are consumables available for the Blood glucose machine6%27% Urine testing strips18%73% Presence ketone strips8%73% Healthcare workers Number of healthcare workers who have received training in diabetes (2003 basic, 2009 specialised) 52%65% Beran et al. Diab Med 2010 Increase in estimated life expectancy 36

37 National level barriers and solutions Known and documented barriers Possible solutions and initiatives being implemented BUT… What about global level? – Lessons from HIV/AIDS to improve access to insulin Hogerzeil et al. Lancet

38 Challenges with insulin High cost Limited producers Heat stability and cold chain – Data from study carried out by UNIGE and MSF Transition to analogues Biological versus chemical entity – Regulatory issues for biosimilars versus generics Not only an issue in poor resource settings – In 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 crisis – Increasing burden on health budgets e.g. UK 38

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40 On the road to the insulin centenary – need to map the global insulin market 40

41 Need to understand… The 4% – Who, how, where… IP issues Pricing Distribution Biosimilar regulatory issues Existing initiatives 41

42 Addressing the Challenges and Constraints of Insulin Sources and Supply (ACCISS) Study Margaret Ewen, Coordinator, Global Projects (Pricing) Health Action International 42

43 ACCISS Study Supported 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 Study Objectives are to develop: 1.Comprehensive, first-of-its-kind evidence base on the global insulin market, including the type, extent and impact of barriers to global insulin access. 2.Innovative models of supply, policies and interventions to overcome the barriers to global insulin access learning from other pioneering access programmes. 3.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: Patents Prices and Price components Insulin market (volume, value, types) Trade Regulatory status (Biosimilars) Distribution channels Existing initiatives 45

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 components 46

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 study – In working groups discuss different options, such as WHO prequalification, group or bulk tendering and differential pricing – Initiate the development of guidelines for countries and procurement agencies – Develop a proposal for piloting the models etc. and other next steps of this project 47

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

49 Expected results Clear understanding of the global insulin market Assessment of insulin manufacturers Development of interventions for improving insulin availability and affordability Development of a virtual advocacy campaign around the issue of access to insulin Proposal developed on implementation of the toolkit and its evaluation Peer reviewed publications and other research outputs (Reports, factsheets) 49

50 ACCISS Study Team Management and Research Team – David Beran, Geneva University Hospitals and University of Geneva – Marg Ewen, Health Action International – Richard Laing, Boston University Advisory Group – Mark Atkinson, University of Florida – Jennifer Cohn, MSF Access Campaign – Edwin Gale, IIF, Lancet Diabetes Commission – Jenny Hirst, Insulin Dependent Diabetes Trust – Hans Hogerzeil, University of Groningen – Cécile Macé, WHO – Carla Silva-Matos, Ministry of Health Republic of Mozambique – Zafar Mirza, WHO – John S. Yudkin, IIF – 2 spokespersons from the global south representing people living with Type 1 diabetes (TBD) Technical Group – Merith Basey, UAEM – Jaime Espin, Andalusian School of Public Health – Ellen ‘t Hoen, Independent – Warren Kaplan, Boston University – Molly Lepeska, AYUDA – Christophe Perrin, MSF Access Campaign – Joan Rovira, Andalusian School of Public Health – Veronika Wirtz, Boston University 50

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