Analysis of pharmacoeconomic value of sitagliptin in the treatment of diabetes mellitus.

OBJECTIVE: Diabetes mellitus is a chronic metabolic disease which has an adverse impact on the quality of patient's life, so patients often need to receive treatment for a long time. Selection of medications with high therapeutics effects and low cost is very important for patients to take medicine for a longer period of time. Sitagliptin is a drug which is widely used in clinics and can effectively control blood glucose level. This article explores the pharmacoeconomic value of Sitagliptin in the treatment of diabetes mellitus. PATIENTS AND METHODS: A total of 100 patients with diabetes mellitus treated were recruited in this study. The patients were randomly divided into 4 groups with 25 cases in each group. Patients in group A were treated with pioglitazone, group B with Sitagliptin, group C with metformin and group D with glimepiride. The cost of the drugs, the treatment results and adverse effects were compared. RESULTS: Compared with group A, C and D, the cost-effectiveness ratio of group B was low (p<0.05), and the therapeutic effect was high (p<0.05). In addition, the incidence of adverse reactions in group B was lower than that in group A, C and D (p<0.05). There was no significant difference in the levels of FPG, 2hPG and HbAlc in patients among the four groups before treatment (p>0.05). After treatment, the levels of FPG, 2hPG and HbAlc in group B were significantly lower than those in groups A, C and D (p<0.05). Finally, there was no significant difference in waist circumference and BMI among the four groups before treatment (p>0.05). After treatment, the waist circumference and BMI in group B were lower than those in groups A, C and D (p<0.05). CONCLUSIONS: The application of Sitagliptin in the treatment of diabetic patients can effectively enhance the therapeutic effect. The cost effectiveness is satisfactory, and the blood glucose level can be maintained at a stable state.

Pharmacogenetic-guided glimepiride therapy in type-2 diabetes mellitus: a cost-effectiveness study.

The demonstration of the link between certain genetic variations and drug response has allowed the emergence of pharmacogenetics, which offers many opportunities to improve patient care. Type-2 diabetes mellitus is a disease for which several gene polymorphisms have been reported to be associated with drug response. Sulfonylureas are commonly used for the management of this disease. Genetic polymorphisms of CYP2C9, the main enzyme involved in the metabolism of sulfonylureas, have been associated with the risk of severe hypoglycaemia, particularly in poor metabolizers carrying CYP2C9 *3/*3 genotype, and especially in the case of patients treated with glimepiride. The objectives of the present study were to evaluate the potential clinical and economic outcomes of using CYP2C9 genotype data to guide the management of SU regimen in patients initiating glimepiride therapy, and to identify factors affecting the cost-effectiveness of this treatment scheme. The analysis was conducted using a decision tree, considering a 1-year time horizon, and taking as perspective that of the French national health insurance system. With pharmacogenetic-guided therapy, the cost to avoid an episode of severe hypoglycaemia event per 100 000 patients treated was €421 834. Genotyping cost was the most influential factor on the incremental cost-effectiveness ratio. In conclusion, the potential cost of CYP2C9 genotype-guided dosing for glimepiride therapy is relatively high, and associated with modest improvements with respect to the number of hypoglycaemia avoided, as compared with standard dosing. Additional economic studies are required to better specify the usefulness of CYP2C9 genotyping prior to glimepiride regimen initiation.

[Medical expenses for diabetes care in Japan: Analysis of inter-prefecture differences].

Objectives　Medical expenses for diabetes differ between Japan's 47 prefectures. The medical care expenditure regulation plan aims to reduce regional differences in outpatient medical costs through prevention of severe diabetes, promotion of specific health checkups and specific health guidance, promotion of generic drugs, and proper use of medicines. To achieve this goal, we need to conduct an in-depth analysis of inter-prefecture differences in diabetes care expenses. This study analyzed regional differences in prescription fees for dipeptidyl peptidase-4 (DPP-4) inhibitors and the use of generic sulfonylureas (SUs), glinides, biguanides, α-glucosidase inhibitors (α-GIs), and thiazoline derivatives, using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). Furthermore, we analyzed regional differences in consultancy fees for dialysis prevention.Methods　We analyzed the 2nd NDB Open Data Japan website of the Ministry of Health, Labor, and Welfare. Pearson's correlation coefficient (r) was used to evaluate the relationship between the medical costs of diabetes and each factor. The correlation coefficient was analyzed with Student's t-test, and a P-value<0.05 was considered statistically significant.Results　Regarding oral hypoglycemic drugs, prefectures with a large number of DPP-4 inhibitors tended to have higher medical costs of diabetes (r=0.40, P=0.0048). Furthermore, such expenses tended to be low in prefectures where the use of generic SU drugs was high (r=-0.43, P=0.0023).Conclusions　In conclusion, the results revealed regional differences in the use of DPP-4 inhibitors and generic SU drugs, which may contribute to the regional differences in medical expenses for diabetes. This study suggests that NDB open data are useful for policy making to reduce regional differences in outpatient medical costs of diabetes.

Decreased Antihyperglycemic Drug Use Driven by High Out-of-Pocket Costs Despite Medicare Coverage Gap Closure.

OBJECTIVE: Using the 2016 Medicare Part D coverage gap as an example, we explored effects of increased out-of-pocket costs on adherence to branded dipeptidyl peptidase 4 inhibitors (DPP-4i) in patients without financial subsidies relative to subsidized patients who do not experience increased spending during the gap. We also explored seasonality of reinitiation, because discontinuers may be more likely to reinitiate in January when benefits reset. RESEARCH DESIGN AND METHODS: We identified DPP-4i or sulfonylurea initiators, aged ≥66 years, from a 20% sample of 2015-2016 Medicare claims. Difference-in-differences Poisson regression was used to compare adherence before and after entering the coverage gap between nonsubsidized and subsidized patients. Among discontinuers, monthly hazard ratios (HRs) for reinitiation relative to January 2016 were derived with Cox models. As a second control, we repeated analyses using sulfonylureas, generic low-cost alternatives. RESULTS: In 2016, 8,096 subsidized and 6,173 nonsubsidized DPP-4i initiators entered the coverage gap. For nonsubsidized patients, copayment in the coverage gap was 45% ($227 per DPP-4i prescription), and adherence decreased from 68.4% to 49.0% after gap entry. Accounting for adherence differences in subsidized patients, nonsubsidized patients demonstrated reduced adherence to DPP-4i (difference-in-difference: -16.9%; 95% CI -18.7%, -15.1%) but not sulfonylureas (-1.6%; 95% CI -3.4%, 0.2%). Reinitiation was lowest in the months before January (HR 0.4-0.5) among nonsubsidized DPP-4i patients, demonstrating a strong seasonal pattern. CONCLUSIONS: Increased out-of-pocket costs negatively affect adherence and reinitiation of branded antihyperglycemic drugs among patients without financial subsidies. Despite closure of the coverage gap, affordability remains a concern given increasing list prices for many drugs on Medicare and the growing use of deductibles and coinsurance by commercial health plans.

Budget impact analysis for dapagliflozin in type 2 diabetes in Egypt.

Introduction: Type 2 diabetes mellitus (T2DM) is a major health problem in Egypt with a high impact on morbidity, mortality, and healthcare resources. This study evaluated the budget impact and the long-term consequences of dapagliflozin versus other conventional medications, as monotherapy, from both the societal and health insurance perspectives in Egypt.Methods: A static budget impact model was developed to estimate the financial consequences of adopting dapagliflozin on the healthcare payer budget. We measured the direct medical costs of dapagliflozin (new scenario) as monotherapy, compared to metformin, insulin, sulphonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinedione, and repaglinide (old scenarios) over a time horizon of 3 years. Myocardial infarction (MI), ischemic stroke, hospitalization for heart failure (HHF), and initiation of renal replacement therapy (RRT) rates were captured from DECLARE TIMI 58 trial. One-way sensitivity analyses were conducted.Results: The budget impact model estimated 2,053,908 patients eligible for treatment with dapagliflozin from a societal perspective and 1,207,698 patients from the health insurance (HI) perspective. The new scenario allows for an initial savings of EGP121 million in the first year, which increased to EGP243 and EGP365 million in the second and third years, respectively. The total cumulative savings from a societal perspective were estimated at EGP731 million. Dapagliflozin allows for savings of EGP71, EGP143, and EGP215 million in the first, second and third years respectively, from the HI perspective, with total cumulative savings of EGP430 million over the 3 years.Conclusion: Treating T2DM patients using dapagliflozin instead of conventional medications, maximizes patients' benefits and decreases total costs due to drug cost offsets from fewer cardiovascular and renal events. The adoption of dapagliflozin is a budget-saving treatment option, resulting in substantial population-level health gains due to reduced event rate and cost savings from the perspective of the national healthcare system.

Twenty-year trends in the prescription costs of Type 2 diabetes: Real world data and empirical analysis in Greece.

AIMS: To estimate and compare the prescription costs for the management of patients with diabetes over a period of 20 years in Greece, based on real world data. METHODS: The records of outpatients with T2D, monitored at three diabetes centres, were examined in four cross-sections (1998, 2006, 2012, 2018). Prescribed medicines per patient, along with a set of clinical indicators were recorded. Annual costs of pharmaceutical treatment per patient were calculated by using each year's nominal retail prices, as well as by adjusting for 2018 price levels, in order to account for price differences over time. RESULTS: 4066 patients were included in the analysis. Prescription patterns indicate a quick uptake of the new classes of glucose-lowering drugs and a reduction in the proportional use of sulfonylurea and glitazone. Adjusting for 2018 prices, the average total annual prescription cost per patient was 381.54 Euros (s.d. 297.44) in 1998 and 1147.21 Euros (s.d. 814.39) in 2018. Glucose-lowering drug costs per patient increase from 1998 onwards, whereas the costs of antihypertensive, antiplatelet and lipid-lowering treatment declined gradually, especially after 2006. CONCLUSIONS: Per patient prescription costs for glucose-lowering drugs present a steep increase, in Greece over the last 20 years. Real-world evidence studies that compare this increase with the changes in patient outcomes are essential in order to examine whether a costs-vs-outcomes balance is optimal.

Reducing the Burden of Diabetes Treatment: A Review of Low-cost Oral Hypoglycemic Medications.

BACKGROUND: The vast majority of individuals diagnosed with diabetes are low/middle income and may have access to only three of the 11 oral hypoglycemic medications (OHMs) due to cost: metformin intermediate release (IR) or extended release (ER), sulfonylureas (glimepiride, glipizide, glyburide), and pioglitazone. Sulfonylureas and pioglitazone have had significant controversy related to potential adverse events, but it remains unclear whether these negative outcomes are class, drug, or dose-related. OBJECTIVE: We conducted a narrative review of low-cost OHMs. METHODS: We evaluated the maximum recommended (MAX) compared to the most effective (EFF) daily dose, time-to-peak change in HbA1c levels, and adverse events of low-cost oral hypoglycemic medications. RESULTS: We found that the MAX was often greater than the EFF: metformin IR/ER (MAX: 2,550/2,000 mg, EFF: 1,500-2,000/1,500-2,000 mg), glipizide IR/ER (MAX: 40/20 mg, EFF: 20/5 mg), glyburide (MAX: 20 mg, EFF: 2.5-5.0 mg), pioglitazone (MAX: 45 mg, EFF: 45 mg). Time-to-peak change in HbA1c levels occurred at weeks 12-20 (sulfonylureas), 25-39 (metformin), and 25 (pioglitazone). Glimepiride was not associated with weight gain, hypoglycemia, or negative cardiovascular events relative to other sulfonylureas. Cardiovascular event rates did not increase with lower glyburide doses (p<0.05). Glimepiride and pioglitazone have been successfully used in renal impairment. CONCLUSION: Metformin, glimepiride, and pioglitazone are safe and efficacious OHMs. Prescribing at the EFF rather than the MAX may avoid negative dose-related outcomes. OHMs should be evaluated as individual drugs, not generalized as a class, due to different dosing and adverse-event profiles; Glimepiride is the preferred sulfonylurea since it is not associated with the adverse events as others in its class.

Cost Utility of Sodium-Glucose Cotransporter 2 Inhibitors in the Treatment of Metformin Monotherapy Failed Type 2 Diabetes Patients: A Systematic Review and Meta-Analysis.

OBJECTIVES: Type 2 diabetes mellitus (T2DM) and associated ailments are leading economic burdens to society. Sodium glucose cotransporter-2 (SGLT2) inhibitors are recent antidiabetic medications with beneficial clinical efficacy. This meta-analysis was conducted to quantitatively pool the incremental net benefit of SGLT2 inhibitors in T2DM patients who failed metformin monotherapy. METHODS: Relevant economic evaluation studies of T2DM patients were identified from PubMed, Scopus, ProQuest, the Cochrane Library, and the Tufts Cost-Effective Analysis Registry until June 2018. Studies were eligible if they studied T2DM patients who failed metformin monotherapy and assessed the cost-effectiveness/utility between SGLT2 inhibitors and other treatments. Details of the study characteristics, economic model inputs, costs, and outcomes were extracted. Risk of bias was assessed using the biases in economic studies (ECOBIAS) checklist. The incremental net benefit was calculated with monetary units adjusting for purchasing power parity for 2017 US dollars. This was then pooled across studies stratified by the country's level of income using a random-effect model if heterogeneity was present and with a fixed-effect model otherwise. Heterogeneity was assessed using the Q test and I2 statistic. RESULTS: A total of 13 studies with 22 comparisons, mainly from high-income countries, were eligible. Six and 4 studies compared SGLT2 with dipeptidyl peptidase-4 inhibitors (DPP4i) and sulfonylureas, respectively. The pooled incremental net benefits (95% confidence interval) for these corresponding comparisons were $164.95 (-$534.71 to $864.61; I2 = 0%) and $3675.09 ($1656.46-$5693.71; I2 = 85.4%), respectively. These results indicate that SGLT2s were cost-effective in comparison with sulfonylureas but not DPP4i. CONCLUSION: SGLT2s were cost-effective as compared with sulfonylureas but not DPP4i. Most of the evidence was from high-income countries with few comparative drug groups, and the results might not be representative of the actual global scenario. Further studies from middle and lower economies and other comparators are still required.

Drug price, dosage and safety: Real-world evidence of oral hypoglycemic agents.

OBJECTIVES: Drug price reduction is one of the major policies to restrain pharmaceutical expenses worldwide. This study explores whether there is a relationship between drug price and clinical quality using real-world data. METHODS: Patients with newly-diagnosed type 2 diabetes receiving metformin or sulfonylureas during 2001 and 2010 were identified using the claim database of the Taiwan universal health insurance system. Propensity score matching was performed to obtain comparable subjects for analysis. Pharmaceutical products were categorized as brand-name agents (BD), highpriced generics (HP) or low-priced generics (LP). Indicators of clinical quality were defined as the dosage of cumulative oral hypoglycemic agents (OHA), exposure to other pharmacological classes of OHA, hospitalization or urgent visit for hypoglycemia or hyperglycemia, insulin utilization and diagnosis of diabetic complications within 1 year after diagnosis. RESULTS: A total of 40,152 study subjects were identified. A generalized linear mix model showed that HP and BD users received similar OHA dosages with comparable clinical outcomes. By contrast, LP users had similar outcomes to BD users but received a 39% greater OHA dosage. A marginally higher risk of poor glycemic control in LP users was also observed. CONCLUSIONS: Drug price is related to indicators of clinical quality. Clinicians and health authorities should monitor the utilization, effectiveness and clinical safety indicators of generic drugs, especially those with remarkably low prices.

Pharmaceutical quality evaluation of different glimepiride brands marketed in Karachi (Pakistan): In pursuance to global issue of availability and affordability of quality medicines.

Availability of economical quality medicines is always required for chronic disease management. Price differences among multiple brands of a product do not essentially displays low quality for the more affordable brand, however in a few occurrences it appears. Glimepiride, an oral anti-diabetic drug, is produced by several national and multinational industries in Pakistan with considerable cost variation. The study aimed to evaluate the quality and economy of various Glimepiride brands available in Karachi, specifically of public sector hospitals. For this, eight glimepiride brands were collected and analyzed for the pharmaceutical quality using physical parameters, disintegration test, dissolution profile, spectrophotometric assay and content uniformity. Pharmacoeconomic assessment was also carried out such as availability, affordability and price variation. A profound discrepancy was observed among the prices of selected brands. All of the products found to be equivalent to the reference product except G5, the most inexpensive and highest consumed product of a public sector hospital. Study concludes that products with higher quality and lesser price can be used as a substitute to the costly brands while availability of a substandard product looks for consideration of pertinent authorities to assure the distribution of quality medicines.

Availability and affordability of essential medicines for diabetes across high-income, middle-income, and low-income countries: a prospective epidemiological study.

BACKGROUND: Data are scarce on the availability and affordability of essential medicines for diabetes. Our aim was to examine the availability and affordability of metformin, sulfonylureas, and insulin across multiple regions of the world and explore the effect of these on medicine use. METHODS: In the Prospective Urban Rural Epidemiology (PURE) study, participants aged 35-70 years (n=156 625) were recruited from 110 803 households, in 604 communities and 22 countries; availability (presence of any dose of medication in the pharmacy on the day of audit) and medicine cost data were collected from pharmacies with the Environmental Profile of a Community's Health audit tool. Our primary analysis was to describe the availability and affordability of metformin and insulin and also commonly used and prescribed combinations of two medicines for diabetes management (two oral drugs, metformin plus a sulphonylurea [either glibenclamide (also known as glyburide) or gliclazide] and one oral drug plus insulin [metformin plus insulin]). Medicines were defined as affordable if the cost of medicines was less than 20% of capacity-to-pay (the household income minus food expenditure). Our analyses included data collected in pharmacies and data from representative samples of households. Data on availability were ascertained during the pharmacy audit, as were data on cost of medications. These cost data were used to estimate the cost of a month's supply of essential medicines for diabetes. We estimated affordability of medicines using income data from household surveys. FINDINGS: Metformin was available in 113 (100%) of 113 pharmacies from high-income countries, 112 (88·2%) of 127 pharmacies in upper-middle-income countries, 179 (86·1%) of 208 pharmacies in lower-middle-income countries, 44 (64·7%) of 68 pharmacies in low-income countries (excluding India), and 88 (100%) of 88 pharmacies in India. Insulin was available in 106 (93·8%) pharmacies in high-income countries, 51 (40·2%) pharmacies in upper-middle-income countries, 61 (29·3%) pharmacies in lower-middle-income countries, seven (10·3%) pharmacies in lower-income countries, and 67 (76·1%) of 88 pharmacies in India. We estimated 0·7% of households in high-income countries and 26·9% of households in low-income countries could not afford metformin and 2·8% of households in high-income countries and 63·0% of households in low-income countries could not afford insulin. Among the 13 569 (8·6% of PURE participants) that reported a diagnosis of diabetes, 1222 (74·0%) participants reported diabetes medicine use in high-income countries compared with 143 (29·6%) participants in low-income countries. In multilevel models, availability and affordability were significantly associated with use of diabetes medicines. INTERPRETATION: Availability and affordability of essential diabetes medicines are poor in low-income and middle-income countries. Awareness of these global differences might importantly drive change in access for patients with diabetes. FUNDING: Full funding sources listed at the end of the paper (see Acknowledgments).

Sex and BMI Alter the Benefits and Risks of Sulfonylureas and Thiazolidinediones in Type 2 Diabetes: A Framework for Evaluating Stratification Using Routine Clinical and Individual Trial Data.

OBJECTIVE: The choice of therapy for type 2 diabetes after metformin is guided by overall estimates of glycemic response and side effects seen in large cohorts. A stratified approach to therapy would aim to improve on this by identifying subgroups of patients whose glycemic response or risk of side effects differs markedly. We assessed whether simple clinical characteristics could identify patients with differing glycemic response and side effects with sulfonylureas and thiazolidinediones. RESEARCH DESIGN AND METHODS: We studied 22,379 patients starting sulfonylurea or thiazolidinedione therapy in the U.K. Clinical Practice Research Datalink (CPRD) to identify features associated with increased 1-year HbA1c fall with one therapy class and reduced fall with the second. We then assessed whether prespecified patient subgroups defined by the differential clinical factors showed differing 5-year glycemic response and side effects with sulfonylureas and thiazolidinediones using individual randomized trial data from ADOPT (A Diabetes Outcome Progression Trial) (first-line therapy, n = 2,725) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) (second-line therapy, n = 2,222). Further replication was conducted using routine clinical data from GoDARTS (Genetics of Diabetes Audit and Research in Tayside Scotland) (n = 1,977). RESULTS: In CPRD, male sex and lower BMI were associated with greater glycemic response with sulfonylureas and a lesser response with thiazolidinediones (both P < 0.001). In ADOPT and RECORD, nonobese males had a greater overall HbA1c reduction with sulfonylureas than with thiazolidinediones (P < 0.001); in contrast, obese females had a greater HbA1c reduction with thiazolidinediones than with sulfonylureas (P < 0.001). Weight gain and edema risk with thiazolidinediones were greatest in obese females; however, hypoglycemia risk with sulfonylureas was similar across all subgroups. CONCLUSIONS: Patient subgroups defined by sex and BMI have different patterns of benefits and risks on thiazolidinedione and sulfonylurea therapy. Subgroup-specific estimates can inform discussion about the choice of therapy after metformin for an individual patient. Our approach using routine and shared trial data provides a framework for future stratification research in type 2 diabetes.

Pharmacoeconomic evaluation of glimepiride combined with other drugs in the treatment of diabetes.

The goal of diabetic drug treatment is to stabilize the blood sugar for a long time to close to the normal level, to correct the metabolic disorder and eliminate the symptoms. At present, glimepiride has become commonly used drugs for the treatment of diabetes with obesity. Compared with metformin, acarbose and rosiglitazone, glimepiride has different mechanisms of drug action, clinical combination showed synergistic hypoglycemic effect, good clinical curative effect. So, we use three treatments to study as group A (glimepiride and metformin); group B (glimepiride and acarbose); Group C (glimepiride and rosiglitazone). From the analysis of drug economics, glimepiride and metformin scheme is better, has the lowest cost per unit cost effect. From the comparison of scheme is efficient, the best curative effect is rosiglitazone plus glimepiride, effective rate as 96.7%. At the same time, the drug can be rationally used to reduce the occurrence of some drug-induced diseases and adverse drug reactions.

The pattern of prescribing of glucose modulating agents for type 2 diabetes in general practices in England 2016/17.

BACKGROUND: In the financial year 2016/17 there were 52.0 million items prescribed for diabetes at a total net ingredient cost of £983.7 million - up from 28.9 million prescription items and £572.4 million in 2006/07. Anti-diabetes drugs (British National Formulary section 6.1.2) make up 45.1 per cent of the total £983.7 million net ingredient cost of drugs used in diabetes and account for 72.0 per cent of prescription items for all diabetes prescribing. METHODS: We examined the way that agents licensed to treat type 2 diabetes were used across GP practices in England in the year 2016/2017. Analysis was at a GP practice level not at the level of patient data. RESULTS: Annual prescribing costs / patient / medication type for monotherapy varied considerable from £11/year for gliclazide and glimepiride to £885/year for Liraglutide. The use of SGLT-2i agents grew strongly at 70% per annum to around 100,000 DDD with prescriptions seen in 95% of GP practices. Liraglutide expenditure (11% of total) was high for a relatively small number of patients (1.3% of Defined Daily Doses), with still significant spend on exenatide. Liraglutide use significantly exceeded that of other glucagon-like peptide-1 (GLP-1) agonists. CONCLUSIONS: Our work demonstrates the significant cost of medication to modulate tissue glucose levels in type 2 diabetes and the dominance of some non-generic preparations in terms of number of prescriptions and overall spend. There are some older sulphonylureas in use, which should not generally be prescribed. Regular audit of patient treatment at a general practice level will ensure appropriate targeted use of licensed medications and of their cost effectiveness.

Cost-effectiveness analysis of metformin+dipeptidyl peptidase-4 inhibitors compared to metformin+sulfonylureas for treatment of type 2 diabetes.

BACKGROUND: Patients with type 2 diabetes (T2D) typically use several drug treatments during their lifetime. There is a debate about the best second-line therapy after metformin monotherapy failure due to the increasing number of available antidiabetic drugs and the lack of comparative clinical trials of secondary treatment regimens. While prior research compared the cost-effectiveness of two alternative drugs, the literature assessing T2D treatment pathways is scarce. The purpose of this study was to evaluate the long-term cost-effectiveness of dipeptidyl peptidase-4 inhibitors (DPP-4i) compared to sulfonylureas (SU) as second-line therapy in combination with metformin in patients with T2D. METHODS: A Markov model was developed with four health states, 1 year cycle, and a 25-year time horizon. Clinical and cost data were collected from previous studies and other readily available secondary data sources. The incremental cost-effectiveness ratio (ICER) was estimated from the US third party payer perspective. Both, costs and outcomes, were discounted at a 3% annual discount rate. One way and probabilistic sensitivity analyses were performed to evaluate the impact of uncertainty on the base-case results. RESULTS: The discounted incremental cost of metformin+DPP-4i compared to metformin+SU was $11,849 and the incremental life-years gained were 0.61, resulting in an ICER of $19,420 per life-year gained for patients in the metformin+DPP-4i treatment pathway. The ICER estimated in the probabilistic sensitivity analysis was $19,980 per life-year gained. Sensitivity analyses showed that the results of the study were not sensitive to changes in the parameters used in base-case. CONCLUSIONS: The metformin+DPP-4i treatment pathway was cost-effective compared to metformin+SU as a long-term second-line therapy in the treatment of T2D from the US health care payer perspective. Study findings have the potential to provide clinicians and third party payers valuable evidence for the prescription and utilization of cost-effective second-line therapy after metformin monotherapy failure in the treatment of T2D.

Trends in Diabetes Treatment and Monitoring among Medicare Beneficiaries.

BACKGROUND: Diabetes is a costly and common condition, but little is known about recent trends in diabetes management among Medicare beneficiaries. OBJECTIVE: To evaluate the use of diabetes medications and testing supplies among Medicare beneficiaries. DESIGN/SETTING: Retrospective cohort analysis of Medicare claims from 2007 to 2014. PARTICIPANTS: Traditional Medicare beneficiaries with a diagnosis of diabetes in the current or any prior year. MAIN MEASURES: We analyzed choices of first diabetes medication for those new to medication and patterns of adding medications. We also examined the use of testing supplies, use of statins and ACE inhibitors/angiotensin receptor blockers, and spending. KEY RESULTS: Diagnosed diabetes increased from 28.7% to 30.2% of beneficiaries from 2007 to 2014. The use of metformin as the most commonly prescribed first medication increased from 50.2% in 2007 to 70.2% in 2014, whereas long-acting sulfonylureas decreased from 16.6% to 8.2%. The use of thiazolidinediones fell considerably, while the use of new diabetes medication classes increased. Among patients prescribed insulin, long-acting insulin as the first choice increased substantially, from 38.9% to 56.8%, but short-acting or combination regimens remained common, particularly among older or sicker beneficiaries. Prescriptions of testing supplies for more than once-daily testing were also common. The mean total cost of diabetes medications per patient increased over the period due to the increasing use of high-cost drugs, particularly by those patients with costs above the 90th percentile of spending, although the median costs decreased for both medications and testing supplies. CONCLUSIONS: The use of metformin and long-acting insulin have increased substantially among elderly Medicare patients with diabetes, but a substantial subgroup continues to receive costly and complex treatment regimens.

Healthcare resource use and associated costs of hypoglycemia in patients with type 2 diabetes prescribed sulfonylureas.

AIMS: The objective of this study was to evaluate diabetes-related healthcare resource use and associated costs in patients with type 2 diabetes (T2DM) treated with a sulfonylurea (SU), with and without hypoglycemia. METHODS: In this retrospective cohort study, patients 18years or older receiving SU monotherapy or as add-on to metformin were identified from a US healthcare claims database (MarketScan®). Of 113,743 patients (56.8% male, average age 62.6years), 61.6% were on SU/metformin dual therapy and 38.4% were on SU monotherapy, and 5% had one or more episodes of hypoglycemia during the 12-month follow-up period. RESULTS: Adjusted for baseline characteristics, patients with hypoglycemia were three times more likely than those without to use emergency room services (OR 3.04, 95% CI: 2.82, 3.25), almost four times more likely to have inpatient admissions (OR 3.84, 95% CI: 3.58, 4.12), and had more frequent physician office visits (4.3 vs 3.0 visits, p<0.01) in the 12-month follow-up period. The adjusted annual diabetes-related medical expenditure was three times higher in patients with hypoglycemia compared with those without ($6884 vs $2392, p<0.001). CONCLUSIONS: This study demonstrated the higher healthcare utilization and costs associated with hypoglycemia in patients with T2DM treated with an SU.

Direct medical costs of severe hypoglycaemic events in patients with type 2 diabetes in England: A retrospective database study.

AIMS: Hypoglycaemia in patients with diabetes can be induced by insulins and sulfonylureas. We assessed the real-world impact of specific monotherapy and combination regimens on hypoglycaemic events requiring hospitalisation and related secondary costs to the English healthcare system. METHODS: This retrospective observational study used the Clinical Practice Research Datalink with linked hospital admission data during 2008-2012. Patients with type 2 diabetes mellitus (T2DM) using antihyperglycaemic agents (AHAs) were assigned to mutually exclusive subgroups (insulin- and non-insulin-containing regimens; treatment groups of interest; age group) based on treatment at index date (date of first AHA prescription). Outcomes were number and cost of hospital admissions with hypoglycaemic event-related diagnosis codes. RESULTS: We identified 110 206 patients with T2DM (mean age 64.9 years, time since diagnosis 5.4 years, HbA1c at index 7.4%), with 439 hypoglycaemic events requiring inpatient hospitalisation (mean length of stay 6.3 days, mean cost/stay £1351). Event rates and cost of stay were highest in patients treated with sulfonylurea- or insulin-based regimens. Event rates, duration and cost of stay were higher in older patients. CONCLUSION: Rates of severe hypoglycaemic events varied substantially between T2DM regimens. In this study of patients treated in clinical practice in England, sulfonylurea- and insulin-based regimens were associated with the highest event rates and costs associated with hospitalisation for severe hypoglycaemic events; hospitalisation for severe hypoglycaemic events was not observed with dipeptidyl peptidase-4 inhibitor monotherapy or with metformin.

The Influence of Varying Cost Formats on Preferences.

BACKGROUND: Numerous studies have found that cost strongly influences patients' decision making. The objective of this study was to explore the impact of varying cost formats on patients' preferences. METHODS: Mechanical Turk workers completed a choice-based conjoint (CBC) survey. The CBC survey was designed to examine stated preferences for the use of second-line agents to treat diabetes across 5 attributes: route of administration, efficacy, risk of low blood sugar, frequency of checking blood sugar levels, and cost. We developed 7 versions of the CBC survey that were identical except for the cost attribute. We described cost in terms of: Affordability, Monthly Co-pay, Dollar Sign Rating, How Expensive, or How Cheap compared with other medications, Working Hours Equivalent (per mo) and Percent of Monthly Income. The resulting part-worth utilities were used to calculate the relative importance of cost and to estimate treatment preferences for exenatide, a sulfonylurea, and insulin. RESULTS: The relative impact of cost varied significantly across the 7 formats. Cost had the greatest influence on participants' decisions when framed in terms of Affordability [mean (SD) relative importance, 37.3 (0.9)] and the lowest influence when framed in terms of How Cheap (compared with other drugs) [12.1 (0.9)]. A sulfonylurea was strongly preferred across 4 of the 7 formats. Preference for insulin, the most effective, albeit riskiest, option was low across all cost formats. CONCLUSIONS: The format used to describe cost affects how the attribute impacts patients' preferences. Individuals are most cost-sensitive when cost is framed in terms of affordability and least cost-sensitive when cost is described in terms of how cheap the medication is compared with others.