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