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Access to insulin: current challenges and constraints

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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

2 The Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020
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 2013

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 challenging NCD 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 regulation Beran et al. Lancet Glob Health 2014

4 Procurement prices of common NCD medicines (excl
Procurement prices of common NCD medicines (excl. duties, taxes and mark-ups) NCD Alliance 2012

5 1921: The Discovery of Insulin

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)

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

8 Global dominance of 3 multi-nationals

9 Yudkin Lancet 2000

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

11 Understanding the barriers to access
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)

12 Tanzania 2003

13 Understanding the barriers to access
Insulin and medicines for diabetes Care Other Problems Ministry of Health Country Person with diabetes Beran et al. BMC Health Serv Res 2006

14 Rapid Assessment Protocol for Insulin Access – 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 Beran et al. BMC Health Serv Res 2006

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

16 Prices of insulin per 10ml 100 IU vial

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 2010

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 2010


20 Mark-ups, example of Vietnam
Medicine 100% Mark-ups, example of Vietnam +5% import duty CIF +5% VAT Vietnam Distributor +7% distribution and other costs +7% distribution and other costs +7% distribution and other costs +5% +5% Public Hospital Wholesaler Private Pharmacies Patients with Health Insurance Patients without Health Insurance 10-20% 0% 0% 0% 5-10% Patient Final price: 130%-149% Inpatient Final price: 118%-124% Outpatient Final price: 118%-124% Inpatient Final price: 118%-124% Outpatient Final price: 124%-136% Beran et al. 2008

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

22 WHO Essential Medicines List 2011

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

24 Financial implications at a country-level
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 160,000 71% 5.12 818,400 43% Not meeting WHO criteria* 64,150 29% 16.65 1,068,184 57% Total 224,150 1,886,584 All insulin purchased using WHO criteria 100% 1,147,648 Potential saving 738,936 US$ 738,936 = healthcare expenditure for ≈ 11,000 people * - Analogue insulin or insulin in penfill Beran et al. Int J Health Plann Mngt 2013

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) 5.84 1.0 Penfill (Protophane and Actrapid) 14.51 2.5 Analog (Lantus and NovoRapid) 49.45 8.5

26 Delivery devices and impact on overall cost

27 Barriers identified – costs of care to the individual
Beran and Yudkin DRCP 2010

28 The example of Vietnam:
Average monthly costs of care for Type 1 diabetes Beran et al. 2008

29 Diabetes expenditure in Nicaragua: the tip of the iceberg
Type 1 Type 2 MINSA ,296 CIPS ,283 RAPIA ,501 Diabetes Type 1 Type 2 IDF 1, ,074 CAMDI 186,708 x 5-10 ? 5% of total cost Beran et al. 2007

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

31 A positive diabetes environment
Accessibility and affordability of Medicines Positive policy environment Data collection Community involvement/ diabetes association Prevention measures Patient education and empowerment Diagnostic tools and infrastructure Healthcare workers Adherence issues Organised centres for care Drug procurement and supply Beran and Yudkin Lancet 2006

32 Insulin for Type 1 diabetes = survival
Beran Diab Med 2014

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

34 A comparison of life expectancies between Boston (1897-1945), Mozambique (2003) and Nicaragua (2007)
Insulin era Life expectancy (years) Pre-insulin era At age 10 0-14

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

36 Presence of diagnostic tools
Results of targeted action in Mozambique RAPIA reassessment results Indicator 2003 2009 Insulin Proportion of total amount of insulin in Maputo 77% 46% Time for tender (maximum) 12 months 9 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 machine 21% 87% Are consumables available for the Blood glucose machine 6% 27% Urine testing strips 18% 73% Presence ketone strips 8% Healthcare workers Number of healthcare workers who have received training in diabetes (2003 basic, 2009 specialised) 52% 65% Increase in estimated life expectancy Beran et al. Diab Med 2010

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 2013

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


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

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

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

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

44 ACCISS Study Objectives 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.

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

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

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

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

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)

50 ACCISS Study Team Management and Research Team Technical Group
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

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