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Context 1
... complexity of the insulin supply chain is outlined schematically in Fig. 3. The insulin supply chain mirrors that of many other prescription drugs. As outlined,man- ufacturers set the list price for each insulin product. Manufacturers typically sell their medications to wholesalers, who handle distribution to individual pharmacies. But sometimes a pharmacy chain will deal directly with the manufacturer. Whole- salers typically purchase the medications for close to the list price, often receiving a handling fee from the manufacturer that is calculated as a fixed percentage of the list price. Wholesalers then sell the medications to pharmacies, with little to no markup. They may, however, charge the higher list price. Pharmacies dispense the medication to individual patients and col- lect cost-sharing required by the patient's health plan (if any). Pharmacies then submit a bill to the individual's health insurance plan (if any) to be reimbursed for the cost of the medication dispensed to the patient, less any cost-sharing collected, plus a dispens- ing fee. If a patient does not have or use health insurance for the medication, the pharmacy typically charges the patient a price relatively close to its purchase price, with a markup. Whilethemedicationitselftakesarather direct path from manufacturer to whole- saler to pharmacy to patient, the flow of money is far less direct and transparent. Furthermore, PBMs often manage the pharmacy benefit portion of a health plan on behalf of their clients. Their clients are the payersforhealthcare,suchaslargeemploy- ers, health insurers providing pharmacy benefits to Medicare enrollees, health in- surers covering state Medicaid program enrollees, or health insurance plans sold directly to individuals. It is important to note, therefore, that PBMs' primary cus- tomers are health plans and employers, not ...
Context 2
... holders in the insulin supply chain, the WorkingGroup remainsconcerned bythe complexity of the system. As outlined, there are numerous stakeholders in- volved in the delivery of insulin, with multiple opaque transactions between and among these stakeholders (Fig. 3). It was also the consensus of the Working Group that incentives throughout the insulin supply chain facilitate and may even promote high list prices. The follow- ing sections provide the conclusions and recommendations of the Working ...
Context 3
... of drugs in general, and for insulin specifically, is very complex. Numerous stakeholders (i.e., manufacturers, whole- salers, PBMs, pharmacies, health plans, and employers) are involved in the insulin supply chain, and the distribution and payment systems involve multiple trans- actionsamongthesestakeholders (Fig.3). With this system, there is no one agreed- upon price for any insulin formulation. The price ultimately paid by the person with diabetes at the point of sale results from the prices, rebates, and fees nego- tiated among the stakeholders. Stakehold- ers in the insulin supply chain have varying degrees of negotiating power, which adds to the complexity. The following narrative represents the Working Group's under- standing of the U.S. insulin delivery system as obtained by research and in specific interviews with the ...
Context 4
... complexity of the insulin supply chain is outlined schematically in Fig. 3. The insulin supply chain mirrors that of many other prescription drugs. As outlined,man- ufacturers set the list price for each insulin product. Manufacturers typically sell their medications to wholesalers, who handle distribution to individual pharmacies. But sometimes a pharmacy chain will deal directly with the manufacturer. Whole- salers typically purchase the medications for close to the list price, often receiving a handling fee from the manufacturer that is calculated as a fixed percentage of the list price. Wholesalers then sell the medications to pharmacies, with little to no markup. They may, however, charge the higher list price. Pharmacies dispense the medication to individual patients and col- lect cost-sharing required by the patient's health plan (if any). Pharmacies then submit a bill to the individual's health insurance plan (if any) to be reimbursed for the cost of the medication dispensed to the patient, less any cost-sharing collected, plus a dispens- ing fee. If a patient does not have or use health insurance for the medication, the pharmacy typically charges the patient a price relatively close to its purchase price, with a markup. Whilethemedicationitselftakesarather direct path from manufacturer to whole- saler to pharmacy to patient, the flow of money is far less direct and transparent. Furthermore, PBMs often manage the pharmacy benefit portion of a health plan on behalf of their clients. Their clients are the payersforhealthcare,suchaslargeemploy- ers, health insurers providing pharmacy benefits to Medicare enrollees, health in- surers covering state Medicaid program enrollees, or health insurance plans sold directly to individuals. It is important to note, therefore, that PBMs' primary cus- tomers are health plans and employers, not ...
Context 5
... holders in the insulin supply chain, the WorkingGroup remainsconcerned bythe complexity of the system. As outlined, there are numerous stakeholders in- volved in the delivery of insulin, with multiple opaque transactions between and among these stakeholders (Fig. 3). It was also the consensus of the Working Group that incentives throughout the insulin supply chain facilitate and may even promote high list prices. The follow- ing sections provide the conclusions and recommendations of the Working ...
Context 6
... of drugs in general, and for insulin specifically, is very complex. Numerous stakeholders (i.e., manufacturers, whole- salers, PBMs, pharmacies, health plans, and employers) are involved in the insulin supply chain, and the distribution and payment systems involve multiple trans- actionsamongthesestakeholders (Fig.3). With this system, there is no one agreed- upon price for any insulin formulation. The price ultimately paid by the person with diabetes at the point of sale results from the prices, rebates, and fees nego- tiated among the stakeholders. Stakehold- ers in the insulin supply chain have varying degrees of negotiating power, which adds to the complexity. The following narrative represents the Working Group's under- standing of the U.S. insulin delivery system as obtained by research and in specific interviews with the ...
Context 7
... of drugs in general, and for insulin specifically, is very complex. Numerous stakeholders (i.e., manufacturers, whole- salers, PBMs, pharmacies, health plans, and employers) are involved in the insulin supply chain, and the distribution and payment systems involve multiple trans- actionsamongthesestakeholders (Fig.3). With this system, there is no one agreed- upon price for any insulin formulation. The price ultimately paid by the person with diabetes at the point of sale results from the prices, rebates, and fees nego- tiated among the stakeholders. Stakehold- ers in the insulin supply chain have varying degrees of negotiating power, which adds to the complexity. The following narrative represents the Working Group's under- standing of the U.S. insulin delivery system as obtained by research and in specific interviews with the ...
Context 8
... complexity of the insulin supply chain is outlined schematically in Fig. 3. The insulin supply chain mirrors that of many other prescription drugs. As outlined,man- ufacturers set the list price for each insulin product. Manufacturers typically sell their medications to wholesalers, who handle distribution to individual pharmacies. But sometimes a pharmacy chain will deal directly with the manufacturer. Whole- salers typically purchase the medications for close to the list price, often receiving a handling fee from the manufacturer that is calculated as a fixed percentage of the list price. Wholesalers then sell the medications to pharmacies, with little to no markup. They may, however, charge the higher list price. Pharmacies dispense the medication to individual patients and col- lect cost-sharing required by the patient's health plan (if any). Pharmacies then submit a bill to the individual's health insurance plan (if any) to be reimbursed for the cost of the medication dispensed to the patient, less any cost-sharing collected, plus a dispens- ing fee. If a patient does not have or use health insurance for the medication, the pharmacy typically charges the patient a price relatively close to its purchase price, with a markup. Whilethemedicationitselftakesarather direct path from manufacturer to whole- saler to pharmacy to patient, the flow of money is far less direct and transparent. Furthermore, PBMs often manage the pharmacy benefit portion of a health plan on behalf of their clients. Their clients are the payersforhealthcare,suchaslargeemploy- ers, health insurers providing pharmacy benefits to Medicare enrollees, health in- surers covering state Medicaid program enrollees, or health insurance plans sold directly to individuals. It is important to note, therefore, that PBMs' primary cus- tomers are health plans and employers, not ...
Context 9
... holders in the insulin supply chain, the WorkingGroup remainsconcerned bythe complexity of the system. As outlined, there are numerous stakeholders in- volved in the delivery of insulin, with multiple opaque transactions between and among these stakeholders (Fig. 3). It was also the consensus of the Working Group that incentives throughout the insulin supply chain facilitate and may even promote high list prices. The follow- ing sections provide the conclusions and recommendations of the Working ...
Citations
... While the market for insulin was expanding, production costs were declining and by 2018 ranged from $3.69 to $17.35 for a 10mL vial of analogue insulin and from $2.38 to $4.93 for human insulin [91]. The 7.4 million Americans who use insulin [92] pay the highest prices in the world, estimated at an average of $99 per vial [93]. Not surprisingly, the US is also the most lucrative and coveted market for the three big manufacturers. ...
Biotechnology has had a dramatic impact on how insulin is manufactured, and how much it costs to produce it. This paper examines the political, economic and social impact of biotechnology on the global insulin market. It provides an assessment of claims made by manufacturers since the early 1980s that insulin produced using recombinant DNA technology would enhance affordability, safety, effectiveness, and access to this vital medicine. This study utilises primary and secondary sources, historical and current, over the period 1921 to 2024 including academic and medical journals, archival databases, legal opinions, government reports, newspaper and magazine articles and books, and personal files. The study finds that biotechnology has failed on each of the counts claimed by the manufacturers, ie, affordability, safety, effectiveness, and access. Instead, it has transformed the global insulin market, leading to a collapse of domestic manufacturing in many countries and the emergence of a powerful oligopoly composed of three corporations: Novo Nordisk, Eli Lilly, and Sanofi. This has jeopardised the welfare of those who need secure access to safe and affordable insulin, particularly — but not only — those in low- and middle-income countries. A growing movement of diabetes activists around the globe is demanding changes to the global insulin market and to government policies.
... On top of the cost, PWD often act as as a intermediaries between various healthcare entities, including health insurance companies, DME suppliers, pharmacies, and clinics (23). Our findings indicate that PWD experience frustration with the significant time commitment needed to communicate with these organizations, with many participants specifically citing prior authorizations as a major cause of delays in obtaining their DMS. ...
Objectives
People with diabetes (PWD) face significant barriers to accessing insulin and diabetes supplies, including high prices, leading some to turn to social media for material support. This study explores emotions among PWD who have relied on assistance from social media networks when navigating access to diabetes medications and supplies (DMS).
Methods
We conducted a mixed methods study of individuals with type 1 diabetes (T1D) and their caregivers who have used social media to obtain DMS. Participants were recruited through social media based on self-reported use of social media to obtain diabetes support. Transcripts of semi-structured, telephone interviews were analyzed and categorized, and consensus discussions resolved discrepancies and refined definitions of themes.
Results
Thirty individuals (mean age 31+/- 8 years, 29 female, 5 caregivers) were interviewed. The analysis revealed four categories of emotions: anxiety and stress, fear of health problems and financial consequences, frustration with the healthcare system, and feelings of powerlessness and vulnerability. Nearly all interviewees reported anxiety or stress due to the financial burden of managing diabetes and fear for their or their child’s health and safety. Diabetic ketoacidosis, unnecessary bodily harm or sickness, or fear of dying due to running out of insulin worried participants. Most participants described the process of obtaining DMS to be more stressful than their daily diabetes management.
Conclusions
PWD described strong negative emotions related to navigating the healthcare system and acquiring DMS. Policy changes are urgently needed to support to individuals with type 1 diabetes in order to enhance their quality of life, guarantee equitable access to care, and cultivate a more compassionate and inclusive healthcare system. The reported magnitude of stress is notable, especially given the attention typically focused on the stress of diabetes management.
... No hay evidencias de diferente eficacia entre la insulina NPH y los análogos lentos. Los estudios realizados con el objetivo de registrar la equivalencia o ensayos de no inferioridad demostraron una eficacia similar; con la ventaja de los análogos de primera y segunda generación se observó menor frecuencia de hipoglucemias nivel 2 194 (glucemias ≤55 mg/dl) y nocturnas 195 . Por otro lado, evidencias relacionadas con el costo-efectividad de los análogos no son concluyentes, por lo que se estima conveniente precisar las situaciones individuales en las que se los utilice 196 . ...
Introducción: la diabetes mellitus (DM) es una de las condiciones crónicas más prevalentes en el mundo que afecta a 537 millones de personas; el 90% de los casos corresponde a diabetes mellitus tipo 2 (DM2), lo que representa un significativo desafío para los sistemas de salud. Objetivos: a) actualizar la Guía de Tratamiento de la Diabetes Mellitus tipo 2 de la Sociedad Argentina de Diabetes (SAD) publicada en 2016; 2) proporcionar al equipo de salud una herramienta actualizada para optimizar el manejo terapéutico de las personas que viven con esta enfermedad, basada en la evidencia más reciente. Materiales y métodos: se convocó a un grupo de expertos, miembros titulares de la SAD, para revisar la evidencia disponible y realizar una actualización de las recomendaciones para el tratamiento de la DM2. Se designó un responsable de redacción para la compilación final del documento. Resultados: el manejo integral de la DM2 debe abordar no solo la alimentación y la actividad física, sino también aspectos claves del estilo de vida saludable como la cesación tabáquica, la abstención del consumo de alcohol, la higiene del sueño y la atención de la salud mental. Estos componentes constituyen la base de la terapéutica y deben considerarse en todas las etapas del tratamiento. La metformina sigue siendo un fármaco de primera línea, siempre que no existan contraindicaciones o intolerancia. En la selección del tratamiento farmacológico, es fundamental considerar la presencia de comorbilidades, especialmente la enfermedad cardiovascular. La presencia de enfermedad cardiovascular ateroesclerótica o de factores de alto riesgo cardiovascular debe orientar a la priorización temprana de agentes como los agonistas del receptor de GLP-1, los cuales demostraron reducir los eventos cardiovasculares. En personas con insuficiencia cardíaca o enfermedad renal crónica, los inhibidores de SGLT-2 se recomiendan porque su eficacia y seguridad en estos contextos están ampliamente respaldadas por la evidencia. Por otro lado, la presencia de obesidad debe orientar la elección de fármacos que no solo controlen la glucosa, sino que también favorezcan la pérdida de peso. Los agonistas del receptor de GLP-1 y los inhibidores de SGLT-2 tienen efectos beneficiosos en este aspecto. Es importante destacar que todas las clases de fármacos antidiabéticos, incluidos la insulina y sus análogos, pueden usarse como monoterapia o en combinación, respetando las contraindicaciones específicas y evitando el uso concomitante de fármacos con mecanismos de acción redundantes. El tratamiento debe ser reevaluado periódicamente cada 3-6 meses para evitar la inercia terapéutica y asegurar la optimización del control. Conclusiones: los algoritmos propuestos sintetizan las recomendaciones actualizadas, y reflejan el avance en la evidencia científica, incorporando nuevas terapias y estrategias, orientando la toma de decisiones sobre el tratamiento de la DM2 con un enfoque integral.
... The lack of evidence may have prevented some payers, such as Medicare, from covering CGMs for patients with type 2 diabetes who are not yet on insulin therapy 17 . Considering that approximately 80% of patients with type 2 diabetes in the US do not use insulin 1,18 , many patients who could potentially benefit from a CGM may have difficulty accessing or affording one. ...
Rates of type 2 diabetes (T2D) continue to rise in the United States, with many patients failing to achieve glycemic targets. Primary care providers often serve as the sole clinician managing diabetes. Continuous glucose monitors (CGMs) have shown promise in diabetes management, yet their adoption in primary care settings, especially among patients with T2D not using intensive insulin therapy, remains limited. We sought to evaluate the impact of CGM use on glycemic control in patients with T2D not using insulin and those using basal but not bolus insulin in a primary care setting. CGM use was associated with a significantly greater reduction in HbA1c (-0.62%, p < 0.01) compared with matched controls at 3 months (n = 182). Patients showed improvements in time in range (39.7–61.9%, p < 0.0001), time > 180 mg/dL (60.1–37.9%, p < 0.001), time > 250 mg/dL (27.6–8.5%, p < 0.001), mean estimated glucose value (212 mg/dL to 173 mg/dL, p < 0.001) and glucose management indicator (8.39–7.46%, p < 0.001). CGM use in a primary care setting compared to usual care significantly improved glycemic control in T2D patients not on bolus insulin, irrespective of treatment with non-insulin or basal insulin. This suggests potential for broader CGM integration in primary care.
... This study aimed to determine the most cost-effective price range for insulin icodec in the Chinese market, using insulin degludec as a reference, and to provide economic evidence for decision-makers and the government. 16 2 | METHODS ...
Aim
Insulin icodec is a first once‐weekly administration basal insulin analogue for type 2 diabetes. This study aimed to investigate the price range of icodec for type 2 diabetes in the Chinese market, taking insulin degludec as reference.
Materials and Methods
Long‐term health outcomes and costs for icodec and degludec were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model (version 2.1) over 40 years from the Chinese healthcare provider's perspective. The efficacy and safety data were obtained from the ONWARDS 2 trial (Switching to once‐weekly insulin icodec versus once‐daily insulin degludec in individuals with basal insulin‐treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat‐to‐target trial). Cost–utility analysis and a binary search were used to investigate the price range of icodec. Sensitivity analyses were performed to verify the robustness of the base‐case analysis results.
Results
After a 40‐year simulation, the quality‐adjusted life years (QALY) of icodec and degludec were 10.32 and 10.28 years, respectively. At the initial assumption of the same annual costs of icodec and degludec of 625.17–597.66–506.70–597.66 to $736.34 for patients with type 2 diabetes in China.
... 94 Despite these noble beginnings, an insulin affordability crisis has occurred in the United States, with prices of most insulin products tripling within the last 20 years due to price fixing by drug companies, lack of competitors, and strong barriers to entry into the insulin market. 95 Insulin is unique in the drug market in that it has been insulated from price competition. The insulin market is dominated by the "big 3" manufacturers Eli Lilly, Novo Nordisk, and Sanofi, who control up to 99% of the market share in the United States and internationally. ...
... The insulin market is dominated by the "big 3" manufacturers Eli Lilly, Novo Nordisk, and Sanofi, who control up to 99% of the market share in the United States and internationally. [95][96][97] Although complex reimbursement systems and higher rebates to pharmacy benefit managers also contributed to high prices, market dominance by the big 3 and a lack of viable competition have been cited as a major reason for these price increases. 96,98 An additional complicating factor is that insulin is classified as a biologic because it is synthesized from living systems, rather than chemicals. ...
The clinical use of insulin to treat diabetes started just over 100 years ago. The past century has witnessed remarkable innovations in insulin therapy, evolving from animal organ extracts to bioengineered human insulins with ultra-rapid onset or prolonged action. Insulin delivery systems have also progressed to current automated insulin delivery systems. In this review, we discuss the history of insulin and the pharmacology and therapeutic indications for a variety of available insulins, especially newer analog insulins. We highlight recent advances in insulin pump therapy and review evidence on the therapeutic benefits of automated insulin delivery. As with any form of progress, there have been setbacks, and insulin has recently faced an affordability crisis. We address the challenges of insulin accessibility, along with recent progress to improve insulin affordability. Finally, we mention research on glucose-responsive insulins and hepato-preferential insulins that are likely to shape the future of insulin therapy.
... In type 1 diabetes (T1D), due to the failure of insulin production by the pancreas [20], glucose uptake in adipose tissue is completely blunted, which contributes to hyperglycemia. There is an urgent need for affordable alternatives to insulin for the treatment of both T1D and T2D, since the cost of insulin is becoming unaffordable, even in developed countries [21][22][23], and the number of diabetic patients requiring insulin is rapidly increasing [24]. Therefore, finding an orally effective small molecule, which can activate INSR in white adipose tissue (WAT) in an insulin-independent manner, may represent an important advancement in the treatment of hyperglycemia in both T1D and T2D. ...
Finding an affordable and orally effective small compound, which can replace insulin to activate insulin receptor (INSR) in insulin-sensitive organs such as white adipose tissue (WAT), represents an important advancement in the management of hyperglycemia in diabetes. Adenosine, 5'-Se-methyl-5'-seleno-, 2',3'-diacetate (NPC43) is a recently identified non-peptidyl, small compound that can target liver and skeletal muscle to activate Insr in type 1 diabetic (T1D) and type 2 diabetic (T2D) mice (Lan et al, Cell Mol Life Sci, 2020 and BMJ Open Diabetes Res Care, 2020). However, whether NPC43 can target WAT to activate adipose Insr signaling for glucose uptake to mitigate hyperglycemia in diabetes remains unclear. In this study, we found that intraperitoneal administration of NPC43 into T2D Lepr db/db mice caused a significant decrease in blood glucose levels and a marked increase in Insr and AS160 phosphorylation in WAT. A significant increase in Insr and AS160 phosphorylation were also observed in WAT of Lepr db/db and streptozotocin-induced T1D mice following oral NPC43 treatment. In addition, NPC43 treatment was able to directly activate Insr/AS160 signaling and promote glucose uptake in differentiated NIH3T3L1-MBX adipocytes. Furthermore, a cooperative action between NPC43 and insulin in stimulating glucose uptake was observed in differentiated NIH3T3L1-MBX adipocytes. Together, these results indicate that NPC43 can target WAT to activate adipose Insr/AS160 signaling for glucose uptake to mitigate hyperglycemia in T1D and T2D. This, coupled with our earlier findings that NPC43 is effective when administered orally, underscores the potential of this compound as an effective, affordable, non-injectable alternative to insulin.
... Разработка в Канаде в 1936 г. протамин-цинкового инсулина положила начало эре базальной инсулинотерапии [5]. Хагедорну и Дженсену удалось скомбинировать инсулин с протамином рыб, который, кристаллизуясь с гексамерами инсулина, задерживает высвобождение его активных мономеров в кровоток. ...
... Существенными проблемами, которые невозможно игнорировать, являются цена инновационных инсулинов и доступ к этой жизненно важной терапии в целом. Инсулин часто находится в крайне ограниченном количестве и стоит непомерно дорого в развивающихся странах, но даже в странах с сильной экономикой доступ к инсулину остается проблематичным [5]. ...
2021 marks the 100th anniversary of the discovery of insulin, an event that forever changed the lives of people with diabetes mellitus. At present patients around the world experience the miracle of insulin therapy every day. A disease that used to kill children and teenagers in 2 years in 1920 has become a disease that can be controlled with a possibility to lead a long productive life. Over the past century, the great discovery of Banting, Best and Collip has forever changed the world and saved millions of lives. This review is devoted to the history of the development of insulin and its further improvement: from the moment of discovery to the present days. Various generations of insulin are considered: from animals to modern ultrashort and basal analogues. The article ends with a brief review of current trends in the development of new delivery methods and the development of new insulin molecules. Over the past century, insulin therapy has come a long way, which has significantly improved the quality of life of our patients. But research is actively continuing, including in the field of alternative methods of insulin delivery, which are more convenient for the patient, as well as in the development of «smart» molecules that will have a glucose-dependent effect.
... An estimated 100 million patients with diabetes require some form of insulin. 3 Hence, it is vital that patients with diabetes can obtain and afford the life-saving insulin needed for their well-being. Universal access to insulin is one of the critical elements of the WHO's Global Action Plan for controlling non-communicable diseases. ...
Universal access to insulin remains a global public health challenge mainly due to its high price. After unsuccessful healthcare reforms attempting to lower insulin prices over the past several decades, the novel pooled procurement—also known as the national volume-based procurement (NVBP)was initiated exclusively for insulin in China. The NVBP exclusively for insulin represents a unique approach to conquering the challenges in the pooled procurement many low-income and middle-income countries face. In this paper, we described how the pooled procurement mechanism was implemented for insulin in China. Forty-two insulin products from 11 companies were procured, with a median price reduction of 42.08%. The procurement price ranged from US1.63 (¥2.35–¥10.97) per defined daily dose (DDD). The median procurement price per DDD was US0.54 (¥3.63) for human insulins and US2.85 billion (¥19 billion) for the first year of the procurement agreement. Insulin affordability and accessibility improved substantially. This study reveals that the NVBP exclusively for insulin could effectively reduce insulin prices and improve access to this essential medicine. Even though the pooled procurement option looks efficient, its long-term impacts on the healthcare system should be closely monitored.
... The ADA's Insulin Access and Affordability Working Group compiled public information and convened a series of meetings with stakeholders throughout the insulin supply chain to learn how each entity affects the cost of insulin for the consumer. Their conclusions and recommendations are published in an ADA statement (2). ...
The American Diabetes Association (ADA) “Standards of Care in Diabetes” includes the ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, an interprofessional expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations and a full list of Professional Practice Committee members, please refer to Introduction and Methodology. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
