ACCISS MULTI-STAKEHOLDER MEETING

TOOLS TO IMPROVE ACCESS TO INSULIN

This collection of papers aims to present a set of practical tools to understand the underlying parameters
that define universal access (and the lack thereof) to insulin for people living with type 1 and 2 diabetes in
low- and middle-income countries (LMICs). The documents describe the current evidence on choices and
questions related to access to insulin, and provide practical recommendations for national and
international health policy makers, health care funders, and other stakeholders interested in improving
access to insulin as part of universal access to diabetes care and treatment for those in need.

The documents here represent only some of the tools that will eventually be housed in the ACCISS online toolbox.
Many of these documents will be presented as posters during the ACCISS Multi-stakeholder Meeting, and are
indicated as such within this overview document. Others serve as background for the discussion during the
meeting.

GUIDELINES FOR INSULIN DONATIONS IN LOW- AND

MIDDLE-INCOME COUNTRIES
Hans V Hogerzeil, MD, PHD, FRCP Ed
Graningen University, The Netherlands

Short description of the tool

This document contains a short description of major insulin
donation programmes, with their impact on health and public health. It presents practical
recommendations, supported with summary text on justification and practical implications of each.
The document also presents a ten-step plan to phase out insulin donation programme in LMICs, working
towards a sustainable national programme of universal access to insulin.

Who is this tool for?

The document is directed towards agencies involved in insulin donations, national diabetes programmes,
and national health policy makers.

How is it used?
Some recommendations are for immediate application (e.g. those on the quality of insulin donations,
arguments for the continuation of donation programmes, and practical advice on improved reporting), and
are especially relevant for donors and national diabetes programmes. The recommendations on a gradual
transition to a sustainable national system are also directed to national health policy makers.

Main recommendations
1. Donor agencies should ensure that all donations of medicines, diagnostics and equipment follow the
WHO Guidelines for Medicine Donations
2. Donor agencies should report regularly on programme targets, the number of people living with
diabetes covered, health outcomes, key health system data, the role of partners, and project financing
3. National diabetes programmes and donor agencies should plan well in advance the transition of
recipients of donated insulin beyond their eligibility to programme support. This transition should be
supported with specific investments and programme activities; links with existing insulin discount
programmes should be strengthened
4. Donor-supported programmes such as LFAC and CDiC should be continued and expanded in
countries in need, as long as the diagnosis and treatment of type 1 diabetes and its complications are not
yet included in national health insurance schemes
5. Ten steps to phase out an insulin donation programme (see body of text)

REVIEW OF THE EVIDENCE ON INSULIN AND ITS USE

IN DIABETES
Sylvia Kohlonbrink, MD et al
Endocrinology Fellow Brigham and womwns hospital
Senior fellow Havard Humanitarian Initiative

Short description of the tool

This document reviews in detail all relevant evidence on four important clinical topics:
1. Clinical outcomes of human versus analogue insulin
2. Clinical outcomes of pen delivery versus syringe and vial
3. Use of insulin in type 2 diabetes
4. Interchangeability of common insulins and biosimilars

NB: See also tools on the comparative cost-effectiveness of insulin and insulin analogues and the
interchangeability of biosimilars

Who is this tool for?

The document is directed towards national and institutional formulary committees, committees preparing
national clinical guidelines on the use of insulin, and reimbursement authorities, with a focus on low-
resource settings.

How is it used?
This information can be used when formulating evidence-based recommendations on national clinical
guidelines and reimbursement decisions.

Key points from the tool

• For people living with diabetes requiring insulin in low resource settings, human insulin should remain
first line therapy. Analogue insulin, particularly basal insulin, should be available for a small subset of
people with severe insulin deficiency for whom all risk factors for hypoglycaemia have been addressed
but continue to exhibit recurrent severe hypoglycaemia.
• Although pen devices appear to be preferable in terms of treatment adherence and persistence, as well
as quality of life, the data to support improved clinical outcomes is lacking. Therefore, in settings where
resources are limited, the use of the more affordable vial and syringe is encouraged and justified.
• The decision to use insulin in type 2 diabetes depends on the degree of insulin deficiency of the
individual and the effectiveness (or lack thereof) of non-insulin agents. The decision to add insulin
depends on the individual glycaemic target, hypoglycaemia risk, and individual/system-level affordability.
A conceptual framework to guide the use of insulin in type 2 diabetes using medications included in the
2017 WHO Model List of Essential Medicines is presented.
• Current guidelines state that biosimilarity and interchangeability are not the same. Therefore, caution is
needed when switching from one insulin to another. Glucose monitoring, follow-up, and comprehensive
diabetes education for patients and clinicians remain needed.
INTERCHANGEABILITY OF BIOSIMILARS IN
THE EUROPEAN UNION
Dr. Thijs Gjezen
Foundation Pharmacy for Hospitals in Haarleem
Member of the medicines evaluation board, Netherlands

Short description of the tool

This document contains information on the different regulatory approaches of the FDA and the EMA
towards the interchangeability of biosimilars, and presents updated information on studies in which
patients switched from an insulin reference product to a biosimilar, and advice on the use of biosimilars in
clinical practice.

Who is this tool for?

This document is directed towards national regulators, national and institutional formulary committees,
committees preparing national clinical guidelines on the use of insulin and biosimilars, and reimbursement
authorities.

How is it used?
The information from this document may promote understanding of the different regulatory pathways
between the FDA and the EMA, and in reaching clinical and reimbursement decisions on the use of
biosimilar insulins in the national situation.

Key points from the tool

• The FDA and the EMA have different regulatory approaches towards biosimilars
• The EMA has a rigorous approval process for biosimilars showing convincing data on similar quality,
safety and efficacy; regulatory approval basically implies interchangeability, and that switching can safely
be done.
• The FDA considers insulin biosimilars as small molecules. Market approval does not automatically imply
interchangeability in clinical practice, for which separate switching studies are needed.
• Switching studies are rare. Up till mid-2017, two biosmilars to insulin glargine have been approved by
the EMA, and one (by Biocon) by the Japanese authorities. The FDA has issued one provisional approval
(see also ‘Guidelines on the Selection of Insulin’).
• Based on the rigorous regulatory pathway, ten years of clinical practice in the EU and emerging clinical
evidence, there is increased confidence that switching is safe.

ALTERNATIVE FUNDING SOURCES TO

IMPROVE INSULIN ACCESS

Jing Luo, MD
Instructo r in Medicine, Program on Regulation,
Therapeutics, and Law (PORTAL)
Harvard Medical School, Brigham and
womens Hospital
Short description of the tool
This document presents a literature review of four alternative
financing strategies to increase funding universal health care
coverage and insulin in LMICs, with a discussion on the pros and cons of each method. The four possible
strategies discussed are:
1) A tax on sugar-sweetened beverages earmarked for insulin
2) An international transaction tax to support insulin procurement
3) A Trademark based revenue generation approaches
4) Social impact bonds
Who is this tool for?
The target audience of this report are national and international policymakers, health or finance officials,
and advocates who are interested in improving access to insulin and diabetes-related care in LMICs.
Strategies 1 and 4 are national strategies; strategies 2 and 4 require international collaboration.
How is it used?
This document can be used as background information when considering alternative funding
mechanisms, with several references to practical examples and more detailed information.
Key points from the tool
• These four approaches have varying degrees of empirical success. An excise tax on soft drinks
currently has the best potential for national replication.
• An excise tax on soft drinks can reduce consumption of taxed beverages and increase revenues at the
same time (e.g. in Mexico). The effect is more marked with low-income households; this effect can be
compensated by earmarking the earnings for programmes for the poor, e.g. child obesity or diabetes type
1 in children.
• International transaction taxes on commercial flights (e.g. UNITAID) have generated large amounts of
new revenue for lower-cost antiretrovirals, anti-malarials and anti-TB treatments. However, the
programmes have not been expanded to non-communicable diseases such as diabetes.
• Trademark-based revenue generation, e.g. (Red), has raised hundreds of millions of dollars for the
Global Fund, but similarly does not address diabetes related care.
• An early model for a social impact bond (i.e. financial contract between government an intermediary
organization and private investors) to improve insulin access is theoretically presented but not yet ready
for large-scale implementation.

POSITIVE CASE STUDIEs

Multiple authors
Short description of the tool
These case studies contain information on the national health system, diabetes epidemiology, and the
provision of free insulin to people living with diabetes. Challenges and lessons learnt are identified,
leading to some practical recommendations.
Who is this tool for?
These documents are directed towards national diabetes programme managers and senior health
policymakers, including national organisations dealing with financing health care and medical supplies.
How is it used?
The document can be used to learn about successful approaches in other LMICs in the supply of insulin
as part of universal health care coverage, with emphasis on lessons learnt. Some ideas and experiences
from this document may be used when designing or improving national diabetes programmes.