Analysis of English general practice level data linking medication levels, service activity and demography to levels of glycaemic control being achieved in type 2 diabetes to improve clinical practice and patient outcomes.

OBJECTIVE: Evaluate relative clinical effectiveness of treatment options for type 2 diabetes mellitus (T2DM) using a statistical model of real-world evidence within UK general practitioner practices (GPP), to quantify the opportunities for diabetes care performance improvement. METHOD: From the National Diabetes Audit in 2015-2016 and 2016-2017, GPP target glycaemic control (TGC-%HbA1c ≤58 mmol/mol) and higher glycaemic risk (HGR -%HbA1c results >86 mmol/mol) outcomes were linked using multivariate linear regression to prescribing, demographics and practice service indicators. This was carried out both cross-sectionally (XS) (within year) and longitudinally (Lo) (across years) on 35 indicators. Standardised ß coefficients were used to show relative level of impact of each factor. Improvement opportunity was calculated as impact on TGC & HGR numbers. RESULTS: Values from 6525 GPP with 2.7 million T2DM individuals were included. The cross-sectional model accounted for up to 28% TGC variance and 35% HGR variance, and the longitudinal model accounted for up to 9% TGC and 17% HGR variance. Practice service indicators including % achieving routine checks/blood pressure/cholesterol control targets were positively correlated, while demographic indicators including % younger age/social deprivation/white ethnicity were negatively correlated. The ß values for selected molecules are shown as (increased TGC; decreased HGR), canagliflozin (XS 0.07;0.145/Lo 0.04;0.07), metformin (XS 0.12;0.04/Lo -;-), sitagliptin (XS 0.06;0.02/Lo 0.10;0.06), empagliflozin (XS-;0.07/Lo 0.09;0.07), dapagliflozin (XS -;0.04/Lo -;0.4), sulphonylurea (XS -0.18;-0.12/Lo-;-) and insulin (XS-0.14;0.02/ Lo-0.09;-). Moving all GPP prescribing and interventions to the equivalent of the top performing decile of GPP could result in total patients in TGC increasing from 1.90 million to 2.14 million, and total HGR falling from 191 000 to 123 000. CONCLUSIONS: GPP using more legacy therapies such as sulphonylurea/insulin demonstrate poorer outcomes, while those applying holistic patient management/use of newer molecules demonstrate improved glycaemic outcomes. If all GPP moved service levels/prescribing to those of the top decile, both TGC/HGR could be substantially improved.

Economic Impact of Diabetes in Japan.

PURPOSE OF REVIEW: The economic burden of diabetes in Japan is already serious and will become greater in the future. We review the economic impact of diabetes in Japan to examine viable options for mitigating its effects. RECENT FINDINGS: Medical costs for diabetes have been increasing by US $1 million annually, reaching US $11 million in 2009, of which US $7 million was accounted for by people aged 65 years or older. The quality of treatment of diabetes in Japan is higher than in other regions in the world. This can be more effective for achieving glycemic control, but is also more expensive compared with conventional treatment. Because of the high cost of diabetes in Japan, a coordinated response is needed. Intervention trials for people with prediabetes aimed at preventing the occurrence of diabetes seem to be the most cost-effective method for lowering the medical costs of diabetes, rather than the use of new, expensive antidiabetic drugs in patients with established diabetes.

Do cost containment policies save money and influence physicians' prescribing behavior? Lessons from South Korea's drug policy for diabetes medication.

OBJECTIVE: We evaluate the effects of drug price reduction policy on pharmaceutical expenditure and prescription patterns in diabetes medication. DESIGN: An interrupted time series study design using generalized estimating equations. SETTING: This study used National Health Insurance claim data from 2010 to 2013. PARTICIPANTS: A total of 68 127 diabetes patients and 12 465 hospitals. INTERVENTION(S): The drug price reduction policy. MAIN OUTCOME MEASURES: The primary outcome is pharmaceutical expenditure and prescription rate. To evaluate changes in prescription rate, we measured prescription rates such a brand-name drug and drug price reduction rate. RESULTS: Although the drug price reduction policy associated with decreased pharmaceutical expenditure (-13.22%, P < 0.0001), the trend (-0.01%, P = 0.9201) did not change significantly compared with the pre-intervention period. In addition, the trends in the monthly prescription rate of brand-name drugs decreased (-0.14%, P = 0.0091), while the immediate change was an increase (5.72%, P < 0.0001). Regardless of the drug reduction rate, the prescription rate after the introduction of the drug price reduction policy decreased compared with the pre-intervention period, and this decline was significant for reduction rates of 0% (-2.74%, P < 0.0001) and 10% (-0.13%, P = 0.0018). CONCLUSIONS: Our results provide evidence of the effects of the drug price reduction policy on pharmaceutical expenditure and prescription patterns. This policy did not affect the prescribing behavior of healthcare providers and did not increase the use of drugs not subject to this policy. Although this study did not observe changes in the cost of pharmaceuticals after the introduction of the drug price reduction policy, further research is needed on the long-term changes in such costs.

Effects of a price cut reform on the cost and utilization of antidiabetic drugs in Korea: a national health insurance database study.

BACKGROUND: Despite the potential widespread application and a significant need, the policy effectiveness of prescribed medications price controls has not been studied extensively. We aimed to explore the effects of a price cut introduced in April 1st of 2012 on the cost and utilization of antidiabetics in South Korea. METHODS: We identified approximately four million outpatients who filed at least one diabetes-related claim during the index period (January 2010 to December 2012) using the National Health Insurance claims data. We performed interrupted time series analyses for cost and utilization of "overall," "reduced price," and "constant price" antidiabetics between January 2009 and June 2013, and measured the growth rate for incidents of medical and surgical procedures for diabetes-induced complications. RESULTS: The segmented regression suggests that spending on overall and reduced price antidiabetics would drop by 6 and 23%, respectively; spending on constant price antidiabetics would rise by 16% in a year after the new pricing compared to if the policy were not in existence. There were a few immediate changes in utilization, and its trend indicated a significant decrease in reduced price antidiabetics and an increase in constant price antidiabetics. Incidents of medical and surgical procedures relating to diabetic complications were unaffected. CONCLUSIONS: The Korean price cut program contained costs by immediately reducing the cost of pharmaceuticals without any major signals associated with compromised clinical conditions in diabetic patients.

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.

Broad bean (Vicia faba L.) pods: a rich source of bioactive ingredients with antimicrobial, antioxidant, enzyme inhibitory, anti-diabetic and health-promoting properties.

This study was aimed at investigating the chemical composition (proximate, minerals, fatty acids and phenolic compounds) and the in vitro (antimicrobial, radical scavenging, anti-acetylcholinesterase and protein denaturing activities) and in vivo (anti-diabetic and histo-protective effects in alloxan-induced diabetic mice) biological activities of broad bean pods (BBPs), a food waste by-product material. The results showed that BBPs have high dietary fiber (57.46%), carbohydrate (18.93%) and protein (13.81%) content versus low fat content (<1%) contributing to a low energy value of 139.24 kcal per 100 g. Profiling of fatty acids showed an abundance of the essential polyunsaturated α-linolenic and linoleic acids, exhibiting an excellent nutritional quality as revealed by their low atherogenic and thrombogenic indices and their hypocholesterolemic properties. The methanol extract which exhibited the highest total phenolic, flavonoid and tannin contents was found to be the most active extract in terms of antimicrobial and anti-radical activities. In alloxan-induced diabetic mice, the oral administration of a methanol extract (500 mg per kg bw) attenuated the elevated levels of serum alanine aminotransferase (ALA), aspartate aminotransferase (AST), and alkaline phosphatase activities, and urea, uric acid, and creatinine. It effectively normalized the status of lipid profiles, mitigated oxidative stress through the activation of antioxidant enzymes (CAT, GPx and SOD), and alleviated oxidative stress-mediated histopathological changes in the pancreas, liver, kidney and testis. Compositional analysis by HPLC-PDA-ESI-MS/MS revealed the presence of flavan-3-ols (catechin, epicatechin and their derivatives), flavones (apigenin derivatives) and flavonols (glycosides of quercetin and kaempferol), among others. These findings suggest that BBPs may be an effective functional food for the management of diabetes and its complications.

Variability in Potency Among Commercial Preparations of Berberine.

Berberine is an isoquinoline alkaloid plant extract that is widely available as a dietary supplement in the United States and has demonstrated efficacy in the treatment of type 2 diabetes mellitus and dyslipidemia. Because of its increased use and purported pharmacological properties, potential variations in product quality could pose a barrier to berberine's safety and effectiveness in clinical practice. Thus, this study evaluated the potency of dietary supplements containing berberine available in the U.S. commercial market. Fifteen unique dietary supplements containing berberine were purchased through U.S. dietary supplement vendors. For each product, berberine was extracted from 3 unique capsules and analyzed by ultra-high-performance liquid chromatography tandem mass spectrometry. Percentage content based on the product label claim was determined for each product. The average berberine content across the products was found to be 75% ± 25% of the product label claim, with product potency ranging from 33% to 100%. Nine of the 15 tested products (60%) failed to meet the potency standards of 90% to 110% of labeled content claim, as commonly required of pharmaceutical preparations by the U.S. Pharmacopeial Convention. Evaluation of the relationship between product cost and the measured potency failed to demonstrate an association between quality and cost. Variability in product quality may significantly contribute to inconsistencies in the safety and effectiveness of berberine. In addition, the quality of the berberine product cannot be inferred from its cost.

Use of Complementary Health Approaches Among Diverse Primary Care Patients with Type 2 Diabetes and Association with Cardiometabolic Outcomes: From the SF Bay Collaborative Research Network (SF Bay CRN).

PURPOSE: To describe use of complementary health approaches (CHAs) among patients with type 2 diabetes, and independent associations between CHA use and Hemoglobin A1c (A1C) and lower-density lipoprotein (LDL) cholesterol. METHODS: Participants were enrolled onto the SMARTSteps Program, a diabetes self-management support program conducted between 2009 and 2013 in San Francisco. At the 6-month interview, CHA use in the prior 30 days was estimated using a 12-item validated instrument. Demographic and diabetes-related measures A1C were assessed at baseline and 6-month followup. AIC and LDL values were ascertained from chart review over the study period. Medication adherence was measured using pharmacy claims data at 6 and 12 months. RESULTS: Patients (n = 278) completed 6-month interviews: 74% were women and 71.9% were non-English speaking. Any CHA use was reported by 51.4% overall. CHA modalities included vitamins/nutritional supplements (25.9%), spirituality/prayer (21.2%), natural remedies/herbs (24.5%), massage/acupressure (11.5%), and meditation/yoga/tai chi (10.4%). CHA costs per month were $43.86 (SD = 118.08). Nearly one third reported CHA (30.0%) specifically for their type 2 diabetes. In regression models, elevated A1C (>8.0%) was not significantly associated with overall CHA use (odds ratio [OR] = 1.78; 95% confidence interval [CI], 0.7 to 4.52) whereas elevated LDL was (OR = 3.93; 95% CI, 1.57 to 9.81). With medication adherence added in exploratory analysis, these findings were not significant. CONCLUSIONS: CHA use is common among patients with type 2 diabetes and may be associated with poor cardiometabolic control and medication adherence.

The changing cost to prevent diabetes: A retrospective analysis of the Diabetes Prevention Program.

OBJECTIVES: Diabetes prevention interventions are poorly implemented. While health care costs generally increase, 2 factors affect the relative cost of diabetes prevention interventions: the declining cost of metformin (even without insurance) and the new recommendation for vitamin B12 monitoring during metformin treatment. The study's objective was to update the relative health system cost estimate of metformin for diabetes prevention by incorporating the current health system cost of metformin and the cost of addressing potential metformin-associated vitamin B12 deficiency. The study was designed to assess whether metformin with vitamin B12 supplementation is a cost-saving measure for diabetes prevention and for the updated cost estimate to be useful in assessing future implementation studies. METHODS: In 2012, the Diabetes Prevention Program Research Group published detailed per capita total direct health system costs for the Diabetes Prevention Program (DPP) and the Diabetes Prevention Program Outcomes Study (DPPOS). The present analysis incorporated the declining cost of metformin and the increasing cost of metformin monitoring into the detailed per capita health system costs found in the DPP and DPPOS. The updated costs were used to assess the total cost of metformin use for diabetes prevention relative to placebo and lifestyle intervention. RESULTS: The current health system cost to acquire metformin ranges from $0 to $72 per year. The estimated health system cost to address potential metformin-associated vitamin B12 deficiency is $28 per metformin-treated patient per year. The 10-year total health system cost for metformin in diabetes prevention can decrease by $329 or increase by $21 depending on the cost to acquire metformin. Compared with placebo, the unadjusted cost savings of metformin is generally maintained, although it may double or quadruple depending on how metformin is acquired by patients. Metformin with vitamin B12 supplementation remained less costly and less effective than lifestyle intervention. CONCLUSION: Metformin is generally more cost-saving for diabetes prevention than previously reported because of decreasing costs for patients to acquire metformin. The cost savings was increased despite increased management cost associated with addressing metformin-associated vitamin B12 deficiency.

Long-term cost reduction of routine medications following a residential programme combining physical activity and nutrition in the treatment of type 2 diabetes: a prospective cohort study.

OBJECTIVES: To demonstrate that lifestyle modifications will reduce the cost of routine medications in individuals with type 2 diabetes (T2D), through a mechanism involving glycaemic control. DESIGN: A within-trial cost-medication analysis with a 1-year time horizon. SETTING: Controlled environment within the spa resort of Chatel-Guyon, France. PARTICIPANTS: Twenty-nine participants (aged 50-70 years) with T2D. INTERVENTIONS: A 1-year follow-up intervention, beginning with a 3-week residential programme combining high exercise volume (15-20 hours/week), restrictive diet (-500 kcal/day) and education. Participants continued their routine medication, independently managed by their general practitioner. MAIN OUTCOME MEASURES: Number of medications, number of pills, cost of medications and health-related outcomes. RESULTS: Twenty-six participants completed the 1-year intervention. At 1 year, 14 patients out of 26 (54%) stopped/decreased their medications whereas only 5 (19%) increased or introduced new drugs (χ2=6.3, p=0.02). The number of pills per day decreased by 1.3±0.3 at 12 months (p<0.001). The annual cost of medications for T2D were lower at 1 year (€135.1±43.9) versus baseline (€212.6±35.8) (p=0.03). The regression coefficients on costs of routine medication were 0.507 (95% CI 0.056 to 0.959, p=0.027) for HbA1c and 0.156 (95% CI -0.010 to 0.322, p=0.06) for blood glucose levels. Diabetics patients with HbA1c >6.5% in the highest (last) quartile doubled their routine medication costs (66% vs 33%, p=0.037). CONCLUSIONS: Individuals with T2D reduced routine medication costs following a long-term lifestyle intervention that started with a 3-week residential programme. Combining high exercise volume, restrictive diet and education effectively supported the health of T2D. The main factor explaining reduced medication costs was better glycaemic control, independent of weight changes. Despite limitations precluding generalisability, cost-effective results of reduced medication should contribute to the evidence base required to promote lifestyle interventions for individuals with T2D. TRIAL REGISTRATION NUMBER: NCT00917917; Post-results.

Cost-Effectiveness of Dapagliflozin versus Acarbose as a Monotherapy in Type 2 Diabetes in China.

OBJECTIVE: To estimate the long-term cost-effectiveness of dapagliflozin versus acarbose as monotherapy in treatment-naïve patients with type 2 diabetes mellitus (T2DM) in China. METHODS: The Cardiff Diabetes Model, an economic model designed to evaluate the cost-effectiveness of comparator therapies in diabetes was used to simulate disease progression and estimate the long-term effect of treatments on patients. Systematic literature reviews, hospital surveys, meta-analysis and indirect treatment comparison were conducted to obtain model-required patient profiles, clinical data and costs. Health insurance costs (2015¥) were estimated over 40 years from a healthcare payer perspective. Univariate and probabilistic sensitivity analyses were performed. RESULTS: The model predicted that dapagliflozin had lower incidences of cardiovascular events, hypoglycemia and mortality events, was associated with a mean incremental benefit of 0.25 quality-adjusted life-years (QALYs) and with a lower cost of ¥8,439 compared with acarbose. This resulted in a cost saving of ¥33,786 per QALY gained with dapagliflozin. Sensitivity analyses determined that the results are robust. CONCLUSION: Dapagliflozin is dominant compared with acarbose as monotherapy for Chinese T2DM patients, with a little QALY gain and lower costs. Dapagliflozin offers a well-tolerated and cost-effective alternative medication for treatment-naive patients in China, and may have a direct impact in reducing the disease burden of T2DM.

Incidence, prevalence, costs and quality of care of type 1 diabetes in Italy, age 0-29 years: The population-based CINECA-SID ARNO Observatory, 2002-2012.

BACKGROUND AND AIMS: To assess temporal trend in incidence (2003-12) and prevalence (2002-12) of type 1 diabetes in children and young adults, direct costs and selected indicators of quality of care under the coverage of the universalistic Italian National Health System (NHS). METHODS AND RESULTS: The ARNO Observatory, a healthcare monitoring system based on administrative data, identified a population-based multiregional cohort of subjects aged 0-29 years. Type 1 diabetes was defined by at least two prescriptions of insulin over 12 months and continuous insulin-treatment in the following year. Indicators of quality of care and directs costs were assessed in persons with diabetes and in people without diabetes, individually matched for age, gender and health unit (1:4 ratio). We identified 2357 incident cases of type 1 diabetes aged 0-29 years (completeness of ascertainment, 99%). Incidence rates were similar in ages 0-14 (15.8, 95% CI 14.9-16.8) and 15-29 years (16.3, 15.4-17.2), with no significant trend. Prevalence increased from 137 to 166.9/100,000, particularly in the age 15-29 years. Direct costs accounted for € 2117 in persons with diabetes and € 292 in control individuals. A statistically significant decreasing trend in hospitalization for acute complications was evident (p < 0.001), which was almost completely due to ketoacidosis. People with at least one HbA1c measurement over the year were 48.5%. CONCLUSION: We showed high incidence and increasing prevalence of type 1 diabetes in young adults in Italy, which impact on direct costs under the universalistic coverage of the NHS.

Impact of a Combined Value-Based Insurance Design and Medication Therapy Management Program on Diabetes Medication Adherence.

BACKGROUND: Value-based insurance design (VBID) waives or reduces prescription copayments in order to decrease member cost barriers to refilling medications. Medication therapy management (MTM) is a member clinical intervention designed to reinforce members' knowledge of their medications, which addresses barriers to medication adherence. Both methods have been shown to increase adherence in members, particularly when used in combination. To date, studies of such combined programs have often been completed within integrated health systems but have rarely included control populations. OBJECTIVE: To determine the effect of a combined VBID and MTM program on key medication adherence metrics among diabetic members of a large employer group in the Midwest. METHODS: A retrospective pre/post longitudinal analysis of pharmacy claims data was performed for 77 participants in a combined VBID/MTM program and 77 eligible nonparticipants, matched by the baseline adherence metrics of proportion of days covered (PDC) and number of days without therapy, also known as gaps in therapy (GIT). Oral antidiabetic medication adherence and cost-related outcomes for all pharmacy claims were evaluated within and between groups over a 6-month period. Post hoc analyses were performed to investigate the effect of the intervention by gender and among a less adherent subpopulation of participants with a PDC of < 100% at baseline. RESULTS: Introduction of the intervention resulted in a nonsignificant increase in PDC from 92.9% to 95.4%, in contrast to a nonsignificant decrease from 92.8% to 91.7% in the comparison group. GIT underwent a nonsignificant decrease of 2.83 days during intervention, while nonsignificantly increasing 2.82 days in the comparators. Pharmacy claims costs paid by the plan per member per 6-month period significantly increased in the intervention group from $1,991.23 to $3,092.74, compared with a nonsignificant increase from $1,402.21 to $1,645.68 in the comparison group. Among the less-adherent subpopulation, PDC increased significantly after intervention from 84.7% to 93.1% compared with a nonsignificant increase from 84.6% to 89.0% among nonparticipants. A significant 10.69-day decrease in GIT was also observed among nonadherent participants compared with a nonsignificant 3.59-day decrease among nonparticipants. Female participants experienced a significant PDC increase from 91.5% to 96.8% and a GIT decrease of 7.32 days, while male participants did not change significantly. CONCLUSIONS: While statistically significant improvements to adherence were not observed among this population of members who were highly adherent at baseline, improvement trends and subgroup analyses demonstrated that the combined VBD/MTM program may have the potential to influence member behavior in employer groups. Larger, longer-term studies are needed to confirm this potential. Additional benefit may be realized by targeting members with lower adherence metrics at baseline and examining potential cost savings associated with medical outcomes. DISCLOSURES: Funding for this project was provided by Navitus Health Solutions. Peaslee, Wickizer, and Olson are employed by Navitus Health Solutions. Peaslee is a clinical staff pharmacist working in Formulary Services and a former PGY-1 Managed Care Clinical Pharmacy Resident at this location. Wickizer is the Associate Manager of Clinical Programs and Residency Programs. Olson is the Director of Clinical Programs and Product Development. Topp is the Patricia A. Chin Nursing Research Endowed Professor at the Hahn School of Nursing and Health Science at the University of San Diego specializing in statistics. Topp received consulting fees from Navitus Health Solutions for work on this project. Study concept and design were contributed by Peaslee, Wickizer, and Olson, with assistance from Topp. Peaslee took the lead in data collection, with assistance from Wickizer, and data interpretation was performed by Peaslee, Topp, Wickizer, and Olson. The manuscript was written primarily by Peaslee, with assistance from the other authors, and revised by Topp, Wickizer, and Olson, assisted by Peaslee.

Dietary fish protein hydrolysates containing bioactive motifs affect serum and adipose tissue fatty acid compositions, serum lipids, postprandial glucose regulation and growth in obese Zucker fa/fa rats.

The world's fisheries and aquaculture industries produce vast amounts of protein-containing by-products that can be enzymatically hydrolysed to smaller peptides and possibly be used as additives to functional foods and nutraceuticals targeted for patients with obesity-related metabolic disorders. To investigate the effects of fish protein hydrolysates on markers of metabolic disorders, obese Zucker fa/fa rats consumed diets with 75 % of protein from casein/whey (CAS) and 25 % from herring (HER) or salmon (SAL) protein hydrolysate from rest raw material, or 100 % protein from CAS for 4 weeks. The fatty acid compositions were similar in the experimental diets, and none of them contained any long-chain n-3 PUFA. Ratios of lysine:arginine and methionine:glycine were lower in HER and SAL diets when compared with CAS, and taurine was detected only in fish protein hydrolysate diets. Motifs with reported hypocholesterolemic or antidiabetic activities were identified in both fish protein hydrolysates. Rats fed HER diet had lower serum HDL-cholesterol and LDL-cholesterol, and higher serum TAG, MUFA and n-3:n-6 PUFA ratio compared with CAS-fed rats. SAL rats gained more weight and had better postprandial glucose regulation compared with CAS rats. Serum lipids and fatty acids were only marginally affected by SAL, but adipose tissue contained less total SFA and more total n-3 PUFA when compared with CAS. To conclude, diets containing hydrolysed rest raw material from herring or salmon proteins may affect growth, lipid metabolism, postprandial glucose regulation and fatty acid composition in serum and adipose tissue in obese Zucker rats.

[Changes in features of diabetes care in Hungary in the period of years 2001-2014. Aims and methods of the database analysis of the National Health Insurance Fund]. / A cukorbeteg-ellátás mutatóinak alakulása Magyarországon 2001-2014 között. Az Országos Egészségbiztosítási Pénztár adatbázis-elemzésének célja és módszertana.

In the last couple of years, database analyses have become increasingly popular among clinical-epidemiological investigations. In Hungary, the National Health Insurance Fund serves as central database of all medical attendances in state departments and purchases of drug prescriptions in pharmacies. Data from in- and outpatient departments as well as those from pharmacies are regularly collected in this database which is public and accessible on request. The aim of this retrospective study was to investigate the database of the National Health Insurance Fund in order to analyze the diabetes-associated morbidity and mortality in the period of years 2001-2014. Moreover, data of therapeutic costs, features of hospitalizations and practice of antidiabetic treatment were examined. The authors report now on the method of the database analysis. It is to be hoped that the upcoming results of this investigation will add some new data to recent knowledge about diabetes care in Hungary. Orv. Hetil., 2016, 157(32), 1259-1265.

Assessment of the Price-Volume Agreement Program in South Korea.

The Price-Volume Agreement Program (PVAP) was promulgated in 2007 in South Korea as the first attempt to adjust drug pricing according to total consumption in order to contain drug expenditure. This study was designed to assess the impact of the PVAP on diabetes drug expenditure for a period of a 10-year period (2003-2012) using claims data from the National Health Insurance Service. We estimated a multilevel mixed-effects linear regression model by comparing the level of total monthly diabetes drug expenditure for drugs subject to PVAP and existing drugs after adjusting the average differences in drug expenditure before and after the PVAP. The monthly total expenditure for drugs that were newly listed through the PVAP (negotiation drugs) was 7.03% higher on average compared to that for existing drugs, controlling for the baseline differences in expenditure before and after the PVAP. This increase was observed in all four subgroups of diabetes drugs, including sitagliptin, vildagliptin, exenatide, and others. The growth rate of total diabetes drug expenditure was reduced after the PVAP despite the sustained escalation of expenditure levels, which may imply that the PVAP has the potential to be an effective tool for drug expenditure control in the long term.

Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus.

ETHNOPHARMACOLOGICAL RELEVANCE: Life-long insulin is the standard treatment for type 1 diabetes mellitus (T1DM). The role of traditional Chinese medicine (TCM) in T1DM is still not clear. The aim of this study is to explore the prescription pattern of TCM and its impact on the risk of diabetic ketoacidosis (DKA) in patients with T1DM. MATERIALS AND METHODS: We retrieved samples from the registry for catastrophic illness patients from the National Health Insurance Research Database (NHIRD). Based on a frequency (1:4) matched case-control design, patients with T1DM in 2000-2011 were designated as cases (TCM users) and controls (non-TCM users). TCM treatment for patients with T1DM was analyzed. The incidence of DKA and the annual costs of emergency visits and hospitalizations were evaluated for all causes. RESULTS: Overall, 416 subjects were TCM users, whereas a total of 1608 matched subjects were classified as non-TCM users. The most common Chinese herbal formula and single herb is Liu-wei-di-huang-wan (Six-ingredient pill of Rehmannia) and Huang-qi (Radix Astragali; Astragalus membranaceus (Fisch.) Bunge, Astragalus membranaceus var. mongholicus (Bunge) P.K.Hsiao), respectively. Compared with non-TCM users, we found a 33% reduction in DKA incidence for all TCM users (aHR 0.67, 95% CI 0.56-0.81, p <0.000) and a 40% reduction for users receiving TCM treatment for more than 180 days (aHR 0.58, 95% CI 0.41-0.82, p <0.01). There were no significant differences between TCM users and non-users in the frequency and medical costs of emergency visits and hospitalizations. CONCLUSIONS: Integrative TCM use may reduce the risk of DKA in patients with T1DM. Our results suggest that TCM may have a substantial positive impact on the management of TIDM.

Comparative cost-effectiveness of metformin-based dual therapies associated with risk of cardiovascular diseases among Chinese patients with type 2 diabetes: Evidence from a population-based national cohort in Taiwan.

OBJECTIVE: To assess the cost-effectiveness of metformin-based dual therapies associated with cardiovascular disease (CVD) risk in a Chinese population with type 2 diabetes. METHODS: We utilized Taiwan's National Health Insurance Research Database (NHIRD) 1997-2011, which is derived from the claims of National Health Insurance, a mandatory-enrollment single-payer system that covers over 99% of Taiwan's population. Four metformin-based dual therapy cohorts were used, namely a reference group of metformin plus sulfonylureas (Metformin-SU) and metformin plus acarbose, metformin plus thiazolidinediones (Metformin-TZD), and metformin plus glinides (Metformin-glinides). Using propensity scores, each subject in a comparison cohort was 1:1 matched to a referent. The effectiveness outcome was CVD risk. Only direct medical costs were included. The Markov chain model was applied to project lifetime outcomes, discounted at 3% per annum. The bootstrapping technique was performed to assess uncertainty in analysis. RESULTS: Metformin-glinides was most cost-effective in the base-case analysis; Metformin-glinides saved $194 USD for one percentage point of reduction in CVD risk, as compared to Metformin-SU. However, for the elderly or those with severe diabetic complications, Metformin-TZD, especially pioglitazone, was more suitable; as compared to Metformin-SU, Metformin-TZD saved $840.1 USD per percentage point of reduction in CVD risk. Among TZDs, Metformin-pioglitazone saved $1831.5 USD per percentage point of associated CVD risk reduction, as compared to Metformin-rosiglitazone. CONCLUSIONS: When CVD is considered an important clinical outcome, Metformin-pioglitazone is cost-effective, in particular for the elderly and those with severe diabetic complications.

Cost-Effectiveness of Dapagliflozin as Add-On to Metformin for the Treatment of Type 2 Diabetes Mellitus in Greece.

BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that has been spread worldwide over the past three decades and associated with increased morbidity and mortality resulting in considerable socioeconomic implications for national healthcare systems. Effective management of disease is highly needed ensuring patients receive the best possible care within the available budget. The objective of this study was to evaluate the long-term cost-effectiveness of dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, compared with a sulfonylurea (SU) or a dipeptidyl-peptidase-4 inhibitor (DPP-4i), when added to metformin, in T2DM patients inadequately controlled on metformin alone in Greece. METHODS: The published and validated Cardiff diabetes model, a lifetime micro-simulation model, was adapted to a Greek healthcare setting to determine the incidence of micro- and macro-vascular complications and diabetes-specific and all-cause mortality. Clinical, cost, and utility data were retrieved from literature and assigned to model parameters to calculate total quality-adjusted life-years (QALYs) and total costs as well as incremental cost-effectiveness ratios (ICERs). The analysis was conducted from the perspective of a third-party payer in Greece. Uncertainty surrounding important model parameters was explored with univariate and probabilistic sensitivity analyses (PSA). RESULTS: Over a patient's lifetime, dapagliflozin was associated with 0.48 and 0.04 incremental QALYs compared with SU and DPP-4i, respectively, at additional costs of €5142 and €756, respectively. The corresponding ICERs were €10,623 and €17,695 per QALY gained versus the treatment with SU and DPP-4i, respectively. Results were robust across various univariate and scenario analyses. At the defined willingness-to-pay threshold of €34,000 per QALY gained, PSA estimated that treatment with dapagliflozin had a 100 % and 79.7 % probability of being cost-effective relative to the SU and DPP-4i treatments. CONCLUSIONS: Dapagliflozin in combination with metformin was shown to be a cost-effective treatment alternative for patients with T2DM whose metformin regimen does not provide sufficient glycemic control in a Greek healthcare setting.