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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 Slide 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 2 Slide 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 2014 3 Slide 4 Procurement prices of common NCD medicines (excl. duties, taxes and mark-ups) NCD Alliance 2012 4 Slide 5 1921: The Discovery of Insulin 5 Slide 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 Slide 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 Slide 8 Global dominance of 3 multi-nationals 8 Slide 9 Yudkin Lancet 2000 9 Slide 10 Creation in 2002 of the International Insulin Foundation UK Registered Charity Global leading academics and clinicians in diabetes 10 Slide 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 Slide 12 Tanzania 2003 12 Slide 13 Understanding the barriers to access Beran et al. BMC Health Serv Res 2006 13 Slide 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 2006 14 Slide 15 Zambia (2003) Mozambique (2003) Reassessment (2009) Nicaragua (2007) Philippines (2008)* Mali (2004)Vietnam (2008) * - carried out by WHO Kyrgyzstan (2009) Countries assessed 15 Slide 16 Prices of insulin per 10ml 100 IU vial 16 Slide 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 17 Slide 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 25- 125%; Zambia 85125%) 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 18 Slide 19 19 Slide 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. 2008 20 Slide 21 A new challenge? Or a repeat of the past? 21 Slide 22 WHO Essential Medicines List 2011 http://www.who.int/selection_medicines/Complete_UNEDITED_TRS_18th.pdf 22 Slide 23 Transition from human to analogue insulin (red: human; blue: analogue; green: animal) High Income Upper Middle Income Lower Middle IncomeLow Income 23 Slide 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%5.12 818,400 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 2013 24 Slide 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) 5.841.0 Penfill (Protophane and Actrapid) 14.512.5 Analog (Lantus and NovoRapid) 49.458.5 25 Slide 26 Delivery devices and impact on overall cost 26 Slide 27 Barriers identified costs of care to the individual Beran and Yudkin DRCP 2010 27 Slide 28 The example of Vietnam: Average monthly costs of care for Type 1 diabetes Beran et al. 2008 28 Slide 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. 2007 29 Slide 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 Slide 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 2006 31 Slide 32 Insulin for Type 1 diabetes = survival Beran Diab Med 2014 32 Slide 33 Human cost decreased life expectancy Calculated life expectancies for people with Type 1 diabetes in Mali, Mozambique, Zambia, Nicaragua and Vietnam 33 Slide 34 A comparison of life expectancies between Boston (1897-1945), Mozambique (2003) and Nicaragua (2007) At age 100-14 Pre-insulin era Insulin era Life expectancy (years) 34 Slide 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 REPBLICA DE MOAMBIQUE _____________ MINISTRIO DA SADE 35 Slide 36 RAPIA reassessment results Results of targeted action in Mozambique Indicator20032009 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 Slide 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 37 Slide 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 Slide 39 www.100campaign.org 39 Slide 40 On the road to the insulin centenary need to map the global insulin market 40 Slide 41 Need to understand The 4% Who, how, where IP issues Pricing Distribution Biosimilar regulatory issues Existing initiatives 41 Slide 42 Addressing the Challenges and Constraints of Insulin Sources and Supply (ACCISS) Study Margaret Ewen, Coordinator, Global Projects (Pricing) Health Action International 42 Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Slide 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 Ccile Mac, 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