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
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
2
WHO 2013
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 2014
3
Procurement prices of common NCD
medicines
(excl. duties, taxes and mark-ups)
NCD Alliance42012
1921: The Discovery of Insulin
5
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,
6
lead a long normal life.” – R.D. Lawrence (1925)
Impact of the miracle of insulin
Insulin era
80
74.49
70
Life expectancy (years)
60
50
40
30
45
39.8
20
10
31.7
Pre-insulin era
14.3
1.3
2.6
1897-1913
1914-1922
0
1922-1925
1926-1928
At age 10
1929-1938
1939-1945
2011
Overall
7
Gale Lancet 2003; USA Today 2011
Global dominance of 3 multi-nationals
8
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)
11
Rapid Assessment Protocol for Insulin
Access – multi-level assessment of health
Multi-level assessment of Health system
system
Macro
Meso
Micro
•Ministry of Health
•Ministry of Trade
•Ministry of Finance
•Central Medical Store
•National Diabetes Association
•Private/Public drug importer
•Educators
•Regional Health Organisation
•Hospitals, Health Centres, etc.
•Pharmacies, Drug Dispensaries
•Healthcare Workers
•Traditional Doctors
•People with diabetes
Perspectives on the problem of access to insulin and diabetes care
Beran et al. BMC Health Serv Res142006
Countries assessed
Kyrgyzstan (2009)
Nicaragua (2007)
Mali (2004)
Zambia (2003)
Vietnam (2008)
Philippines
(2008)*
Mozambique (2003)
Reassessment (2009)
* - carried out by WHO
15
Prices of insulin per 10ml 100 IU vial
16
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
17
Vietnam
Beran and Yudkin DRCP 2010
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 25125%; 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
18
Beran et al. Diab Care 2006; HAI 2010
19
Mark-ups,
example of
Vietnam
Medicine
100%
CIF
+5% import
duty
Vietnam
+5% VAT
Distributor
+7% distribution and
other costs
+5%
Public Hospital
Patients with
Health Insurance
0%
+7% distribution and
other costs
Wholesaler
Patients without
Health Insurance
0%
0%
+7% distribution and
other costs
+5%
Private Pharmacies
10-20%
5-10%
Patient
Inpatient
Outpatient
Inpatient
Outpatient
Final price:
118%-124%
Final price:
118%-124%
Final price:
118%-124%
Final price:
124%-136%
Final price:
130%-149%
20
Beran et al. 2008
A new challenge? Or a repeat of the
past?
21
WHO Essential Medicines List 2011
http://www.who.int/selection_medicines/Complete_UNEDITED_TRS_18th.pdf
22
Transition from human to analogue insulin
(red: human; blue: analogue; green: animal)
Upper Middle Income
High Income
100%
100%
90%
90%
80%
80%
70%
70%
60%
60%
50%
50%
40%
40%
30%
30%
20%
20%
10%
10%
0%
0%
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Lower Middle Income
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2002
2003
2004
2005
2006
2007
2008
Low Income
100%
100%
90%
90%
80%
80%
70%
70%
60%
60%
50%
50%
40%
40%
30%
30%
20%
20%
10%
10%
0%
23
0%
1999
2000
2001
2002
2003
2004
2005
2009
2006
2007
2008
2009
1999
2000
2001
2009
Human versus Analogue the financial
implications
• High overall cost due to choice of penfill versus vial and
analog versus human
Monthly total cost (US$)
Vial (Protophane and Actrapid)
Ratio
5.84
1.0
Penfill (Protophane and Actrapid)
14.51
2.5
Analog (Lantus and NovoRapid)
49.45
8.5
– 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
25
Barriers identified – costs of care to the
individual
Beran and Yudkin DRCP272010
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
30
A positive diabetes environment
Accessibility and
affordability of
Medicines
Data collection
Positive policy
environment
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
31
Insulin for Type 1 diabetes = survival
32
Beran Diab Med 2014
Human cost – decreased life expectancy
Calculated life expectancies for people with Type 1 diabetes in Mali, Mozambique, Zambia,
Nicaragua and Vietnam
Life expectancy (years)
25
22
20
15
11.2
10
7.2
3.5
5
1
0
Mali
Mozambique
Vietnam
Zambia
Nicaragua
33
Improvements can be made: Diabetes
UK-Mozambique Twinning Project
1.
2.
3.
4.
5.
6.
7.
8.
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
35
Results of targeted action in Mozambique
Indicator
• RAPIA reassessment
results
2003
2009
Insulin
Proportion of total amount of insulin in Maputo
Time for tender (maximum)
Average tender price per vial of insulin (18 months)
Insulin always present at %age of hospitals
Affordability (%age of GDP per capita PPP)
Presence of diagnostic tools
Blood glucose machine
Are consumables available for the Blood glucose machine
Urine testing strips
Presence ketone strips
Healthcare workers
77%
12 months
$6.86
20%
4%
46%
9 months
$4.50
100%
1%
21%
6%
18%
8%
87%
27%
73%
73%
52%
65%
Number of healthcare workers who have received training in diabetes
(2003 basic, 2009 specialised)
Increase in estimated life expectancy
Beran et al. Diab Med362010
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. Lancet372013
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
On the road to the insulin centenary –
need to map the global insulin market
40
Need to understand…
• The 4%
– Who, how, where…
•
•
•
•
•
IP issues
Pricing
Distribution
Biosimilar regulatory issues
Existing initiatives
41
Addressing the Challenges and
Constraints of Insulin Sources and
Supply (ACCISS) Study
Margaret Ewen,
Coordinator, Global Projects (Pricing)
Health Action International
42
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
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
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
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
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
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
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
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