Addressing Insulin Access and Affordability: An Endocrine Society Position Statement.

Rising costs have made access to affordable insulin far more difficult for people with diabetes, especially low-income individuals, those on high deductible health plans, beneficiaries using Medicare Part B to cover insulin delivered via pump, Medicare beneficiaries in the Part D donut hole, and those who turn 26 and must transition from their parents' insurance, to manage their diabetes and avoid unnecessary complications and hospitalizations. For many patients with diabetes, insulin is a life-saving medication. Policymakers should immediately address drivers of rising insulin prices and implement solutions that would reduce high out-of-pocket expenditures for patients. The Endocrine Society recommends policy options to expand access to lower cost insulin in this paper.

A global perspective on the issue of access to insulin.

The discovery of insulin in 1921 changed the prognosis for people with type 1 diabetes. A century later, availability and affordability of insulin remain a challenge in many parts of the globe. Using the WHO's framework on understanding the life cycle of medicines, this review details the global and national challenges that affect patients' abilities to access and afford insulin. Current research and development in diabetes has seen some innovations, but none of these have truly been game-changing. Currently, three multinational companies control over 95% of global insulin supply. The inclusion of insulin on the WHO's Prequalification Programme is an opportunity to facilitate entry of new companies into the market. Many governments lack policies on the selection, procurement, supply, pricing and reimbursement of insulin. Moreover, mark-ups in the supply chain also affect the final price to the consumer. Whilst expenses related to diabetes are mostly covered by insurance in high-income countries, many patients from low- and middle-income countries have to pay out of their own pockets. The organisation of diabetes management within the healthcare system also affects patient access to insulin. The challenges affecting access to insulin are complex and require a wide range of solutions. Given that 2021 marks the centenary of the discovery of insulin, there is need for global advocacy to ensure that the benefits of insulin and innovations in diabetes care reach all individuals living with diabetes.

Nearly a Century of Insulin at Sanofi: Looking Back Over the Decades of Production and Development.

Almost a century ago, the first insulin was produced by Banting, Best, MacLeod and Collip in Toronto, thereby enabling life-saving treatment for people with diabetes. Since then, there have been many advancements in insulin production and development of new insulin analogues. In this article, we reflect on the rich heritage of Sanofi and its predecessor, Hoechst, in insulin production and development, from being one of the first companies to produce insulin in Europe in 1923, to modern-day insulin analogues and integrated care solutions at present-day Sanofi.

Access to insulin: applying the concept of security of supply to medicines.

Security of supply of medicines is fundamental to ensure health for all. Furthermore, improving access to medicines is included in sustainable development goal 3. However, the concept of security of supply has mostly been applied to food, water and energy. Diversity of supply, vulnerability to disruption, expenditure, infrastructure, stability of exporting countries, ownership of production, price stability, access and equity, affordability, intellectual property, safety and reliability of supply, and countries' capacity to adapt to market changes are all elements of security of supply. Based on these elements, we assessed security of supply for insulin, since access to insulin is a global problem. We found that three multinational companies, in Denmark, France and Germany, control 99% of the value of the global insulin market. Prices and affordability of insulin and access to it vary considerably between countries. Some countries are vulnerable to insulin shortage because they import insulin from only one source. Many countries spend large amounts of money on insulin and costs are increasing. Some countries lack an adequate infrastructure for procurement, supply chain management and distribution of insulin. Applying the security of supply concept to insulin showed that diversification of suppliers needs to be fostered. Global health actors should adopt a security of supply approach to identify medicines that are susceptible to supply issues and address this concern by strategic promotion of local production, strengthening regulatory harmonization, and adding local products to the World Health Organization's programme on prequalification of medicines.

La sécurité de l'approvisionnement en médicaments est fondamentale pour garantir une bonne santé pour tous. De plus, l'amélioration de l'accès aux médicaments figure dans l'Objectif de développement durable n°3. Or, le concept de sécurité d'approvisionnement a jusqu'à présent été principalement appliqué aux aliments, aux boissons et à l'énergie. La diversité d'approvisionnement, la vulnérabilité face aux perturbations de la chaîne d'approvisionnement, les infrastructures, la stabilité des pays exportateurs, la propriété des moyens de production, la stabilité des prix, l'accès et l'équité, l'accessibilité des prix, la propriété intellectuelle, la sûreté et la fiabilité de l'approvisionnement ainsi que la capacité des pays à s'adapter aux évolutions du marché sont autant de notions inhérentes à la sécurité d'approvisionnement. À partir de ces éléments, nous avons évalué la sécurité d'approvisionnement pour l'insuline, étant donné que l'accès à l'insuline constitue un enjeu mondial. Nous avons constaté que trois multinationales (au Danemark, en France et en Allemagne) contrôlent 99% de la valeur du marché mondial de l'insuline. Les prix, leur accessibilité ainsi que l'accès à l'insuline varient considérablement d'un pays à un autre. Certains pays sont vulnérables face aux pénuries d'insuline, car ils n'importent l'insuline qu'auprès d'une seule source. De nombreux pays dépensent énormément d'argent pour l'insuline, et les coûts sont en augmentation. Certains pays n'ont pas d'infrastructures appropriées pour les achats, la gestion de la chaîne d'approvisionnement et la distribution de l'insuline. L'application du concept de sécurité d'approvisionnement à l'insuline nous a montré que la diversification des fournisseurs doit être encouragée. Les acteurs mondiaux de la santé devraient adopter une approche de sécurité d'approvisionnement pour identifier les médicaments susceptibles de connaître des problèmes d'approvisionnement et répondre à cet enjeu par la promotion stratégique d'une production locale, le renforcement de l'harmonisation réglementaire et l'ajout de produits locaux dans le programme de l'Organisation mondiale de la Santé sur la préqualification des médicaments.

La seguridad en el suministro de medicamentos es fundamental para garantizar la salud de todos. Además, la mejora del acceso a los medicamentos está incluida en el objetivo de desarrollo sostenible 3. Sin embargo, el concepto de seguridad en el suministro se ha aplicado principalmente a los alimentos, el agua y la energía. La diversidad del suministro, la vulnerabilidad a las perturbaciones, el gasto, la infraestructura, la estabilidad de los países exportadores, la propiedad de la producción, la estabilidad de los precios, el acceso y la equidad, la asequibilidad, la propiedad intelectual, la seguridad y la fiabilidad del suministro y la capacidad de los países para adaptarse a los cambios del mercado son todos elementos que se incluyen en la seguridad en el suministro. Con base en estos elementos, se ha evaluado la seguridad del suministro de insulina, ya que el acceso a esta es un problema mundial. Se ha descubierto que tres empresas multinacionales, en Dinamarca, Francia y Alemania, controlan el 99 % del valor de mercado mundial de insulina. Los precios y la asequibilidad de la insulina y el acceso a ella varían considerablemente de un país a otro. Algunos países son vulnerables a la escasez de insulina porque la importan de una sola fuente. Muchos países gastan grandes cantidades de dinero en insulina y los costes aumentan. Algunos países carecen de una infraestructura adecuada para la adquisición, la gestión de la cadena de suministro y la distribución de insulina. La aplicación del concepto de seguridad en el suministro a la insulina demostró que es necesario fomentar la diversificación de los proveedores. Los agentes de la salud mundial deberían adoptar un enfoque de seguridad en el suministro para identificar los medicamentos que son susceptibles de problemas de suministro y abordar esta preocupación mediante la promoción estratégica de la producción local, el fortalecimiento de la armonización de los reglamentos y la incorporación de los productos locales al programa de la Organización Mundial de la Salud sobre la precalificación de los medicamentos.

The importance of insulin donations for children in 43 low- and middle-income countries.

Diabetes mellitus is rapidly becoming one of the major diseases affecting people's health globally. Over half of 100 million diabetes patients who need insulin to survive, especially in low- and middle-income countries (LMIC), are not able to get this medicine and die prematurely. Since 2000, insulin-producing companies have started support programmes with a component of insulin donations to children and youth with type 1 diabetes in 43 LMIC. Based on their experiences we conclude, contrary to common belief, that the diagnosis, treatment, and prevention of fatal complications in children with type 1 diabetes in LMIC are very possible in practice, with large improvements in survival, mean body weight, mean glucose levels, and frequency of complications. Medicine donations can never offer a sustainable solution and we now propose a ten-step transition process towards a fully sustainable national diabetes care and prevention programme for children and youth with diabetes type 1.

Estimation of global insulin use for type 2 diabetes, 2018-30: a microsimulation analysis.

BACKGROUND: The amount of insulin needed to effectively treat type 2 diabetes worldwide is unknown. It also remains unclear how alternative treatment algorithms would affect insulin use and disability-adjusted life-years (DALYs) averted by insulin use, given that current access to insulin (availability and affordability) in many areas is low. The aim of this study was to compare alternative projections for and consequences of insulin use worldwide under varying treatment algorithms and degrees of insulin access. METHODS: We developed a microsimulation of type 2 diabetes burden from 2018 to 2030 across 221 countries using data from the International Diabetes Federation for prevalence projections and from 14 cohort studies representing more than 60% of the global type 2 diabetes population for HbA1c, treatment, and bodyweight data. We estimated the number of people with type 2 diabetes expected to use insulin, international units (IU) required, and DALYs averted per year under alternative treatment algorithms targeting HbA1c from 6·5% to 8%, lower microvascular risk, or higher HbA1c for those aged 75 years and older. FINDINGS: The number of people with type 2 diabetes worldwide was estimated to increase from 405·6 million (95% CI 315·3 million-533·7 million) in 2018 to 510·8 million (395·9 million-674·3 million) in 2030. On this basis, insulin use is estimated to increase from 516·1 million 1000 IU vials (95% CI 409·0 million-658·6 million) per year in 2018 to 633·7 million (500·5 million-806·7 million) per year in 2030. Without improved insulin access, 7·4% (95% CI 5·8-9·4) of people with type 2 diabetes in 2030 would use insulin, increasing to 15·5% (12·0-20·3) if insulin were widely accessible and prescribed to achieve an HbA1c of 7% (53 mmol/mol) or lower. If HbA1c of 7% or lower was universally achieved, insulin would avert 331 101 DALYs per year by 2030 (95% CI 256 601-437 053). DALYs averted would increase by 14·9% with access to newer oral antihyperglycaemic drugs. DALYs averted would increase by 44·2% if an HbA1c of 8% (64 mmol/mol) were used as a target among people aged 75 years and older because of reduced hypoglycaemia. INTERPRETATION: The insulin required to treat type 2 diabetes is expected to increase by more than 20% from 2018 to 2030. More DALYs might be averted if HbA1c targets are higher for older adults. FUNDING: The Leona M and Harry B Helmsley Charitable Trust.