'Didn't See the Need': Misperceptions about glucagon from the perspectives of people with diabetes and their caregivers.

AIMS: Severe hypoglycaemia among people with diabetes who use insulin can be a life-threatening complication if left untreated. Although glucagon has been approved for treatment of hypoglycaemia since the 1960s, it has been underutilized. We aimed to understand the perceptions of people with diabetes and their caregivers about glucagon. METHODS: We conducted in-depth, one-on-one telephone interviews with people with diabetes and their caregivers in the United States. The interviews included questions around general awareness of glucagon, reasons for owning or not owning glucagon, and suggestions for improving understanding of glucagon as treatment for severe hypoglycaemia. Initial synopsis and inductive codebook schema were used to analyse the responses by two independent researchers. Themes were developed from the codes, and codes were re-mapped back to the themes. RESULTS: There were 60 dyads of people with diabetes and their caregivers (N = 120). Four themes developed from the interviews: (1) for most participants, the stated reasons for not owning or renewing a prescription for glucagon included unawareness of the medication, its advantages and its value; (2) misperceptions about glucagon occurred frequently; (3) caregivers often lacked confidence in administering reconstituted injectable glucagon; and (4) education and training from healthcare providers about glucagon would be welcomed. CONCLUSIONS: This study emphasizes the need for healthcare providers to discuss hypoglycaemia prevention and events at each clinical visit, including the use of glucagon in the case of severe hypoglycaemia. Healthcare providers are encouraged to assess the knowledge of people with diabetes and their caregivers regarding treatment and prevention of hypoglycaemia.

People With Diabetes and Caregivers Prefer Rescue Glucagon Treatment With a Wider Storage Temperature Range and a Nasal Administration, When Efficacy is Similar: A Discrete Choice Experiment in Spain.

BACKGROUND: Conventional injectable glucagon (IG) and nasal glucagon (NG), both having similar efficacy, are two options for the emergency treatment of severe hypoglycemia in Spain. This study elicited the effect of changes in key attributes on preferences for NG and IG medication profiles of people with diabetes and caregivers in Spain. METHODS: The relative attribute importance (RAI) that participants placed on glucagon preparation, preparation and administration time, delivery method, recovery time, device size, storage temperature, and headache risk was estimated from an online discrete choice experiment. In addition, patients and caregivers were presented with NG and IG profiles that included rates of successful administration; the proportion of participants choosing each profile was summarized. RESULTS: The analysis included 276 adults with diabetes (65% type 1) and 270 caregivers (49% type 1). Overall mean age was 40 years; 51% were female. The most important attributes were storage temperature (RAI [95% confidence interval] = 27.3% [22.9-32.2]) and delivery method (17.4% [13.1-21.9]). Headache risk (16.2% [11.8-20.7]), time to prepare and administer (14.5% [10.1-18.8]), glucagon preparation (11.4% [6.8-15.8]), recovery time (8.9% [4.3-13.3]), and device size (4.3% [0.3-8.8]) were also relevant. When comparing medication profiles, significantly more participants (78%) preferred NG over IG profiles (P < .001). CONCLUSION: Adults with diabetes and caregivers prefer a glucagon treatment with a higher rate of successful administration, wider storage temperature, and nasal delivery method, when efficacy is similar. Participants favored NG over conventional IG as a rescue medication for severe hypoglycemia. This information may help decision-making by payers and treatment discussions between health care professionals and patients.

Conversations and Reactions Around Severe Hypoglycemia (CRASH) Study: Results From People With Diabetes and Caregivers in the United States.

A survey was conducted in eight countries to examine conversations around, and experiences and treatments during, severe hypoglycemia among people with diabetes and caregivers of people with diabetes. This article reports a subgroup analysis from the United States involving 219 people with diabetes and 210 caregivers. Most respondents (79.7%) did not use professional health care services during their most recent severe hypoglycemic event, and 40.3% did not report the event to their health care providers at a subsequent follow-up visit. Hypoglycemic events left respondents feeling scared (70.9%), unprepared (42.7%), and helpless (46.9%). These clinically important psychosocial impacts on people with diabetes and caregivers underscore the need for conversations about hypoglycemia prevention and management.

Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia.

Background: For individuals managing diabetes, the administration of glucagon for severe hypoglycemia can be lifesaving, yet, until recently, there were no easy-to-use devices for these stressful emergencies. New products have emerged to meet this need, including nasal glucagon (NG) and auto-injector glucagon (AI). This study evaluated the psychometric properties of a new measure, the Glucagon Device Attitudes Questionnaire (GDAQ), in assessing attitudes toward NG and AI from the perspectives of persons with diabetes on insulin (PWDs), caregivers, and acquaintances. Methods: Developed based on qualitative research, the GDAQ consists of 38 rating items for each device and 16 direct-elicitation of attitudes of device relative to each other. It was administered to participants via a cross-sectional online survey. Twenty-six rating items were included in principal component analysis and confirmatory factor analysis. Items comprising each factor were averaged to form scales. Additionally, 12 direct elicitation items were averaged to form an overall "Attitudes" scale. Reliability and validity analyses were conducted. Descriptive statistics were provided for the rating items not included in the factor analysis. Results: A total of 405 PWDs, 313 caregivers, and 305 acquaintances participated. Three factors were identified: "Prepared and Protected" (7 items), "Hesitation" (12 items), and "Device Perceptions by Others" (7 items); factor loadings ranged from 0.13 to 0.92, 0.50 to 0.89, and 0.16 to 0.92, respectively. Cronbach's alpha for the four scales ranged from 0.76 to 0.96. Correlations of the scales with their global item ranged from 0.30 to 0.90. The items outside of the factor analysis showed good distribution in responses and differentiation between the two devices. Discussion: This study supports the validity and reliability of the GDAQ, which successfully conceptualizes attitudes towards devices for administering glucagon among different respondent groups. Use of the GDAQ can help guide the development and testing of new glucagon drug/device combinations.

The multinational Conversations and Reactions Around Severe Hypoglycemia (CRASH) study: Impact of health care provider communications and recommendations on people with diabetes.

The multinational CRASH study found that substantive recommendations from health care providers were predictive of actions taken by people with diabetes during and after a severe hypoglycemic event, which highlights the importance of equipping people with actionable strategies to prevent and treat severe hypoglycemia should a severe hypoglycemic event arise.

Conversations and Reactions Around Severe Hypoglycemia (CRASH): Japan Results From a Global Survey of People with T1DM or Insulin-Treated T2DM and Caregivers.

AIMS: The CRASH study examined severe hypoglycemia (SH) experiences among people with diabetes (PWD) and caregivers across eight countries. Here we report findings from the Japan cohort, with references to data from the United Kingdom (UK) cohort. MATERIALS AND METHODS: Adults with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) and caregivers (not necessarily related) were recruited from online patient panels. Participants who had experienced at least one SH event in the past 3 years were eligible for study inclusion. Participants completed an online survey regarding their experience with SH, its treatment, and actions during and after an event. RESULTS: Of the 9367 PWD and caregivers from the online patient panels, 8475 participants were ineligible and a total of 53 Japanese participants (35 T1DM, 9 T2DM, 9 caregivers) completed the survey. Most SH incidents occurred at home and were unattended by a healthcare provider. For T1DM, 29% of Japan PWD and 13% of the UK PWD called an ambulance during an SH event; of these, 90% (Japan) and 50% (UK) were transported to hospital. Glucagon use was low (3% Japan and 10% UK for T1DM). Japanese respondents reported emotional impacts of SH, including feeling scared (86% T1DM, 56% T2DM), unprepared (63% T1DM, 78% T2DM), and helpless (60% T1DM, 33% T2DM). Despite the emotional burden, most PWD did not immediately discuss their SH event with a healthcare provider, with the majority (75% T1DM, 71% T2DM) waiting until their next doctor's appointment. CONCLUSION: Conversations around SH between healthcare providers and PWD appear to be insufficient in Japan. An emotional burden of SH was reported by PWD and caregivers. Education regarding the prevention of SH and available treatment options may reduce SH events and improve treatment preparation, while alleviating PWD concerns.

Evaluation of the cost and medical resource use outcomes associated with nasal glucagon versus injectable glucagon for treatment of severe hypoglycemia in people with diabetes in Canada: a modeling analysis.

OBJECTIVES: Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of rescue therapy, and choosing the most effective and cost-effective option will improve outcomes for patients and may reduce costs for healthcare payers. The present analysis aimed to compare costs and use of medical services with nasal glucagon and injectable glucagon in people with type 1 and 2 diabetes in Canada when used to treat severe hypoglycemic events when impaired consciousness precludes treatment with oral carbohydrates using an economic model, based on differences in the frequency of successful administration of the two interventions. METHODS: A decision tree model was prepared in Microsoft Excel to project outcomes with nasal glucagon and injectable glucagon. The model structure reflected real-world decision-making and treatment outcomes, based on Canada-specific sources. The model captured the use of glucagon, emergency medical services (EMS), emergency room, inpatient stay, and follow-up care. Costs were accounted for in 2019 Canadian dollars (CAD). RESULTS: Nasal glucagon was associated with reduced use of all medical services compared with injectable glucagon. EMS call outs were projected to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect, and combined costs of CAD 1,249, CAD 460, and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations. CONCLUSIONS: When a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services.

Conversations and Reactions Around Severe Hypoglycaemia (CRASH): Results from the German Cohort of a Global Survey of People with Type 1 Diabetes or Insulin-Treated Type 2 Diabetes and Caregivers.

BACKGROUND: A global cross-sectional survey (CRASH) was designed to provide information about the experiences of people with diabetes (PWD) and their caregivers in relation to severe hypoglycaemic events. METHODS: Adults with type 1 diabetes or insulin-treated type 2 diabetes who had experienced one or more severe hypoglycaemic events within the past 3 years, and adult caregivers for such people, were recruited from medical research panels using purposive sampling. We present here results from Germany. RESULTS: Approximately 100 individuals in each of the four participant groups completed a 30-minute online survey. Survey results indicated that the most recent severe hypoglycaemic event made many participants feel scared (80.4%), unprepared (70.4%), and/or helpless (66.5%). Severe hypoglycaemia was discussed by healthcare professionals at every visit with only 20.2% of participants who had ever had this conversation, and 53.5% of participants indicated that their insulin regimen had not changed following their most recent event. 37.1% of PWD/people with diabetes cared for by caregivers owned a glucagon kit at the time of survey completion. CONCLUSIONS: The survey identified areas for improvement in the prevention and management of severe hypoglycaemic events. For healthcare professionals, these include enquiring more frequently about severe hypoglycaemia and adjusting blood glucose-lowering medication after a severe hypoglycaemic event. For individuals with diabetes and their caregivers, potential improvements include ensuring availability of glucagon at all times. Changes in these areas could lead not only to improved patient wellbeing but also to reduced use of emergency services/hospitalisation and, consequently, lower healthcare costs.

Conversations and Reactions Around Severe Hypoglycemia Study: Results of Hypoglycemia Experiences in Canadian Adults With Insulin-Treated Diabetes and Their Caregivers.

OBJECTIVES: The Conversations and Reactions Around Severe Hypoglycemia cross-sectional study was conducted to better understand the severe hypoglycemia experiences in persons with diabetes (PWD) and their caregivers (CGs). METHODS: Adults with type 1 or type 2 diabetes and CGs were recruited in 8 countries; Canadian cohort data are reported in this study. Insulin-treated PWD who reported a severe hypoglycemic event within the past 3 years and CGs who care for PWD ≥4 years old and who met the criteria were eligible for the study. Participants completed an online survey about their experience with severe hypoglycemia, its treatment and actions during and after severe hypoglycemia. RESULTS: Of the 324 respondents, 139 (43%) reported discussions about severe hypoglycemia with a health-care provider (HCP) at every visit. During the most recent severe hypoglycemic event, the most common actions taken included ingestion of oral carbohydrates and calling emergency medical services; glucagon was rarely used. Despite many respondents (67%) feeling scared because of the most recent severe hypoglycemic event, only 55% (51% with type 1 and 61% with type 2) discussed this event with an HCP. The event affected the mood/emotional status, physical activities and sleep of PWD and CGs. CONCLUSIONS: Severe hypoglycemia impacts the emotional and physical status of PWD and CGs. Despite this, many respondents did not report discussions about the most recent severe hypoglycemic event with HCPs. Furthermore, <50% of the respondents reported discussions about severe hypoglycemia with HCPs at every visit. Purposeful communication about severe hypoglycemia can help fulfil Diabetes Canada guideline recommendations to review experiences with hypoglycemia among PWD at every visit.

Patient perspectives on the use of half-unit insulin pens by people with type 1 diabetes: a cross-sectional observational study.

BACKGROUND: Half-unit pens offer the ability to dose insulin more precisely. Information about half-unit pen use and evidence of their benefits and drawbacks is limited. This study aims to characterize people with type 1 diabetes (T1D) who have used (current/former = EVER) vs. those who have never used half-unit pens (NEVER users) and to understand their perspective. METHODS: An observational cross-sectional online survey was administered through T1D Exchange's online patient community, myGlu.org, to understand the use of half-unit insulin pens. RESULTS: The 278 adult participants (156 EVER, 122 NEVER) had a mean age of 41.8 ± 12.7 years, body mass index of 26.0 ± 3.8 kg/m2, glycated hemoglobin of 6.3% ± 1.0%, and 55% were male. EVER users had T1D for a shorter duration than NEVER users (p < .001). EVER users were less likely to use continuous subcutaneous insulin infusion (p < .001) and more likely to start correcting high blood glucose at a lower level (p < .001) and low blood glucose at a higher level (p < .001). The highest ranked benefits of half-unit pen reported by its current users (N = 131) included prevention of hyperglycemia (40.5%), less anxiety or worry (23.7%), and prevention of hypoglycemia (16.8%). CONCLUSIONS: Half-unit insulin pen is perceived as an insulin device that may help people with T1D to avoid hypo- and hyperglycemic events and decrease their level of disease worry and anxiety. This study highlights the need for patients and health care providers to understand the benefits of half-unit pens while considering options for individualized diabetes management.

Treatment and prevention of severe hypoglycaemia in people with diabetes: Current and new formulations of glucagon.

Some therapies for diabetes increase the risk of hypoglycaemia, in particular all insulins and insulin secretagogues, including the glinides and sulfonylureas. Hypoglycaemia remains a major limiting factor to successful glycaemic management, despite the availability of prevention options such as insulin analogues, continuous glucose monitoring, insulin pumps, and dogs that have been trained to detect hypoglycaemia. Non-severe (self-treated) and severe (requiring assistance for recovery) hypoglycaemia rates are higher in people with type 1 diabetes, but those with insulin-treated type 2 diabetes are also at risk. Education and regular review are essential between people with diabetes and their caregivers and healthcare professionals about symptoms, prevention and treatment. Awareness of the potential dangers of hypoglycaemia is fundamental to the optimal management of diabetes. When therapy is intensified to achieve glycaemic targets, it is important that people at risk of severe hypoglycaemia, and particularly their caregivers, have ready access to effective treatment for hypoglycaemia emergencies. The current and potential formulations of glucagon available for treatment of severe hypoglycaemia are reviewed.

Perceptions About Glucagon Delivery Devices for Severe Hypoglycemia: Qualitative Research With Patients, Caregivers, and Acquaintances.

PURPOSE: People with diabetes taking insulin are at risk of severe hypoglycemia, an unpredictable, life-threatening event that requires assistance from others. Outside the clinical setting, glucagon is indicated for the treatment of hypoglycemia. However, there is significant unmet medical need to improve successful administration of glucagon by caregivers and acquaintances. This study assesses perceptions about glucagon delivery and potential effects of 2 glucagon delivery devices for severe hypoglycemia. METHODS: Qualitative interviews were conducted with people with diabetes (patients), caregivers, and acquaintances from a general population panel composed of individuals across the United States who have agreed to be recruited for research studies. Participants were recruited via email with a link to an online screener to determine eligibility. Experienced qualitative researchers conducted telephone interviews after a semistructured discussion guide, developed by the authors, that focused on aspirational device features and perceptions about the 2 devices: nasal glucagon and autoinjector glucagon; visuals of the instructions for use were displayed. Verbatim transcripts were developed, and a qualitative analysis software program, MaxQDA, was used to code responses and themes that emerged from the data. FINDINGS: A total of 45 (15 patients, 15 caregivers, and 15 acquaintances) interviews were conducted (mean ages, 55, 40, and 51, respectively). The most frequently spontaneously identified aspirational features for a new glucagon device were ease of use (29 [64%]), including being uncomplicated, premixed/ready to use, and ability to use quickly; small/easy to carry (9 [20%]); needle-free/no long needles (8 [18%]); and easy instructions (4 [9%]). In general, participants indicated that having a glucagon delivery device on hand would make them feel prepared, protected, and confident that others could assist in the event of severe hypoglycemia. More participants across all subgroups preferred nasal glucagon versus autoinjector glucagon (33 [73%] vs 12 [27%]). Favorable comments about nasal glucagon included that it appeared to be easy to carry, easy to use, and lacked a needle, that one does not need to remove clothing to use it, and that others likely would be more comfortable using it. Favorable comments about autoinjector glucagon included that it was familiar as a rescue device and that patients felt confident that the full dose would be delivered with it. There may be more hesitation using autoinjector glucagon versus nasal glucagon because of anxiety about needles and locating an injection site. Participants indicated that they would feel more comfortable socially using nasal glucagon because it was viewed as more discreet and less embarrassing than using autoinjector glucagon; it was also considered less traumatic for use in children. IMPLICATIONS: This research suggests that patients with diabetes, caregivers, and acquaintances prefer a device that is simple, compact, and ready to use. Nasal glucagon was generally preferred over autoinjector glucagon primarily because it lacks a needle and it appears to be less complicated.

Nasal Glucagon Versus Injectable Glucagon for Severe Hypoglycemia: A Cost-Offset and Budget Impact Analysis.

BACKGROUND: Severe hypoglycemic events (SHEs) in patients with diabetes are associated with substantial health care costs in the United States (US). Injectable glucagon (IG) is currently available for treatment of severe hypoglycemia but is associated with frequent handling errors. Nasal glucagon (NG) is a novel, easier-to-use treatment that is more often administered successfully. The economic impact of this usability advantage was explored in cost-offset and budget impact analyses for the US setting. METHODS: A health economic model was developed to estimate mean costs per SHE for which treatment was attempted using NG or IG, which differed only in the probability of treatment success, based on a published usability study. The budget impact of NG was projected over 2 years for patients with type 1 diabetes (T1D) and type 2 diabetes treated with basal-bolus insulin (T2D-BB). Epidemiologic and cost data were sourced from the literature and/or fee schedules. RESULTS: Mean costs were $992 lower if NG was used compared with IG per SHE for which a user attempted treatment. NG was estimated to reduce SHE-related spending by $1.1 million and $230 000 over 2 years in 10 000 patients each with T1D and T2D-BB, respectively. Reduced spending resulted from reduced professional emergency services utilization as successful treatment was more likely with NG. CONCLUSIONS: The usability advantage of NG over IG was projected to reduce SHE-related treatment costs in the US setting. NG has the potential to improve hypoglycemia emergency care and reduce SHE-related treatment costs.

GLUCAGON PRESCRIPTIONS FOR DIABETES PATIENTS AFTER EMERGENCY DEPARTMENT VISITS FOR HYPOGLYCEMIA.

OBJECTIVE: To determine the proportion of prescription fills for glucagon within 90 days of an emergency department (ED) visit for hypoglycemia. METHODS: This was a retrospective research study of glucagon prescriptions filled after an ED visit for hypoglycemia (from January 2011 to June 2014) by people with type 1 diabetes (T1D) or type 2 diabetes (T2D) taking insulin who did not already have an unexpired glucagon prescription within the Truven Health MarketScan® Research Database. RESULTS: Less than 10% (T1D: 10.9%; T2D: 3.5%) filled a glucagon prescription after the ED visit. CONCLUSION: A substantial opportunity exists to improve care for at-risk patients with diabetes through a more consistent provision of glucagon, perhaps through the implementation of a quality metric. ABBREVIATIONS: DM = diabetes mellitus; ED = emergency department; IQR = interquartile range; T1D = type 1 diabetes; T2D = type 2 diabetes.

GLUCAGON PRESCRIPTION PATTERNS IN PATIENTS WITH EITHER TYPE 1 OR 2 DIABETES WITH NEWLY PRESCRIBED INSULIN.

OBJECTIVE: To describe glucagon prescription patterns in patients with type 1 (T1DM) or type 2 diabetes (T2DM) who received an initial insulin prescription. METHODS: Retrospective analyses were conducted with data from Truven Health MarketScan databases to assess time to glucagon prescriptions: filled within 1.5 months after index date (early) or after 1.5 months postindex (nonearly). The index date was the date of first insulin prescription between January 1, 2009 and December 31, 2011; for T2DM, without an insulin prescription in the previous 6 months; for T1DM, diabetes diagnosis preindex or within 3 months postindex. RESULTS: Analysis included 8,814 patients with T1DM and 47,051 with T2DM (49.3% and 2.4%, respectively) who had glucagon prescriptions filled. The median times to first glucagon prescription were 196 days (T1DM) and 288 days (T2DM). The rates of filling glucagon were highest in the first 1.5 months. The times to first hypoglycemia-related emergency room (ER) visit for T1DM and T2DM cohorts were initially similar for those with early glucagon versus nonearly glucagon prescriptions. After 10.8 and 2.5 months postindex, respectively, the percentage of hypoglycemia-related ER visits was lower for those with early glucagon prescriptions. CONCLUSION: Glucagon prescriptions filled for patients with diabetes who are initiating insulin are low. Patients with T1DM who were younger and healthier filled glucagon prescriptions more often; patients with T2DM who were younger and sicker and had a higher percentage of hypoglycemia-related ER visit history filled glucagon prescriptions more often. Glucagon filled early was associated with a lower incidence of hypoglycemia-related ER visits.

Antihyperglycaemic treatment patterns, observed glycaemic control and determinants of treatment change among patients with type 2 diabetes in the United Kingdom primary care: a retrospective cohort study.

BACKGROUND: The initial treatment strategy for patients with type 2 diabetes includes lifestyle change recommendations. When patients are not successful in controlling their blood glucose levels through healthier lifestyle pharmaceutical agents are recommended. The objective of this study is to identify determinants of initial treatment change following initiation of non-insulin antihyperglycaemic treatment (OAD) for UK patients with type 2 diabetes. METHODS: A retrospective cohort study using primary care data from the Clinical Practice Research Datalink between January 2006 and February 2011. Each patient had an OAD prescription. The main treatment pattern outcomes were discontinuation, switching, augmentation and initiation of insulin. Glycaemic control was assessed using HbA1c. RESULTS: 63,060 patients initiated OAD therapy 2006-2010 and 3.4% were prescribed insulin during follow-up. 26% with at least four years of follow-up remained on the initial treatment. Metformin dominated (90%) in UK primary care. Around 75% had a record of HbA1c testing prior to initiating therapy. On initiating OAD, half the patients had HbA1c values >65 mmol/mol and one quarter >80 mmol/mol. The initial values of HbA1c were reduced after 12 months and remained stable. There were 15%-18% of patients whose values increased since initiating OAD. Increased baseline HbA1c is associated with increased chance of augmentation and decreased chance of discontinuation. HbA1c values at 1 year were associated with a three-fold increase in the chance of augmentation, 130% increase in the chance of switching and 14% increase in the chance of discontinuation with each 10 mmol/mol increase. Following initiation of OAD, HbA1c was reduced by an average of 16 mmol/mol during the first year. CONCLUSION: There are patients for whom glycaemic control worsens and a majority remained above the recommended level, suggesting an unmet need despite the availability of many OAD.

The Health Technology Assessment Environment in Mainland China, Japan, South Korea, and Taiwan-Implications for the Evaluation of Diabetes Mellitus Therapies.

BACKGROUND: Diabetes mellitus (DM) is associated with a significant global economic and humanistic burden. The condition presents a real challenge in Asia, which accounts for more than 60% of individuals with DM globally. Health technology assessment (HTA) is a field of scientific research used to inform policy and clinical decision making relating to the introduction and diffusion of health technologies. OBJECTIVES: This article, examines the present use and predicted evolution of HTA with respect to pricing and reimbursement of drugs in mainland China, Japan, South Korea, and Taiwan. It makes specific reference to important assessment considerations for DM therapies, which should assist key stakeholders in choosing which data to capture, and what approaches to use, to help quantify the value of treatment. METHODS: The findings are informed by two Advisory Board discussions, a literature review, and the authors' personal experience. RESULTS: HTA already has a key role in South Korea and Taiwan, with current systems undergoing important changes. In contrast, in mainland China and Japan, HTA is not yet formally utilized, although this appears likely to change. Several elements are important for HTA to be meaningful and impactful for DM therapies, including a clear, transparent analytical framework for HTA that includes all relevant costs and outcomes; availability of local DM epidemiologic, economic, and quality-of-life data; acceptance of modeling as a core methodology; availability of real-life patient data; and recognition of specific evidence requirements associated with biosimilars. HTA has the potential to assist payors in making informed decisions about the coverage of DM medications.

Hypoglycaemic events in patients with type 2 diabetes in the United Kingdom: associations with patient-reported outcomes and self-reported HbA1c.

BACKGROUND: One possible barrier to effective diabetes self-management is hypoglycaemia associated with diabetes medication. The current study was conducted to characterize hypoglycaemic events among UK patients with type 2 diabetes (T2D) treated with antihyperglycaemic medications, and assess the relationship between experience of hypoglycaemic events and health outcomes, including glycaemic control, health-related quality of life, impairment to work and non-work activities, treatment satisfaction, adherence to treatment, fear of hypoglycaemia, and healthcare resource use. METHODS: An online survey of 1,329 T2D patients in UK drawn from an opt-in survey panel was conducted in February of 2012 with monthly follow-up questionnaires for five months. Measures included self-reported HbA1c, EQ-5D, Work Productivity and Activity Impairment questionnaire, Diabetes Medication Satisfaction Tool, Morisky medication adherence scale, the Hypoglycaemia Fear Survey (revised), and self-reported healthcare resource use. Comparisons were conducted using t-tests and chi-square tests for continuous and categorical variables, respectively. RESULTS: Baseline comparisons showed that worse HbA1c, greater diabetes-related healthcare resource use, greater fear of hypoglycaemia, and impaired health outcomes were associated with experience of hypoglycaemia in the four weeks prior to baseline. Longitudinal results were similar in direction but differences on few measures were significant. CONCLUSIONS: In real-world UK T2D patients, hypoglycaemia is associated with worse self-reported glycaemic control, behaviours that contribute to worse glycaemic control, and impairment in patient-reported outcomes.

Glycemic control and the first use of oral antidiabetic agents among patients with type 2 diabetes mellitus.

OBJECTIVE: Examine how patients diagnosed with type 2 diabetes mellitus (T2DM) are treated with oral antidiabetic (OAD) agents and the relationship between treatment patterns and glycemic control. RESEARCH DESIGN AND METHODS: Data were obtained from the i3 Invision Data Mart database (OptumInsight, Eden Prairie, MN, USA). The analyses examined 4627 individuals who received a first prescription for an OAD (with first date identified as index date) and received at least one HbA1c test in both the 1 year prior and 2 years post index date. Patients were categorized based upon their level of glycemic control pre index date and logistic multivariate analyses were used to examine the probability of a patient's first treatment pattern change being a switch, augmentation, or discontinuation compared to continuation on the intent-to-treat (ITT) OAD. RESULTS: Men tended to have worse glycemic control at OAD initiation. During the post-period, younger patients were more likely to switch, augment or discontinue therapy, while patients initially treated with metformin were more likely to switch or augment therapy. Results indicated that patients with moderate or poor glycemic control, compared to those with good glycemic control, were significantly more likely to switch or augment therapy. Practice patterns revealed minimal use of insulin although, on average, many patients were above target HbA1c levels at initiation. Interpretation of results are limited by the fact that only a small subset of patients had valid HbA1c data and that the analyses was not able to account for other factors, such as race and weight, that may also impact the analyses. CONCLUSIONS: Patient initial level of glycemic control was associated with changes in treatment patterns in the 2 years post initiation on an OAD, with patients with moderate or poor control more likely to switch or augment their ITT therapy, compared to individuals with good control.