Real-world mapping of allergy immunotherapy in the United States: The argument for improving adherence.

Background: There is a dearth of real-world evidence studies focused on allergy immunotherapy (AIT) use among patients with allergic rhinitis (AR). Objective: This study examined claims data of AR patients residing in the United States to assess patient characteristics and health outcomes. Methods: AR patients were identified in the IBM MarketScan database between January 1, 2014, and March 31, 2017. Patients receiving AIT were identified with relevant billing codes (earliest AIT claim for vaccine as the index date); patients without AIT were identified with claims that contained a diagnosis code for AR (earliest AR claim as the index date). All the patients were required to have continuous enrollment 12 months prior to and following their index date. AIT patients reaching 25+ injection claims were analyzed as a separate maintenance cohort. Patients were assessed for demographic characteristics, comorbid conditions, and health care utilization. Results: A total of 2,334,530 AR patients were included; 103,207 had at least one AIT claim, with 45,279 (43.9%) of these patients reaching maintenance. Patients who reached AIT maintenance presented higher rates of baseline comorbidities than both the full AIT cohort and the patients with no AIT claims, including asthma (34.6% versus 30.1% versus 7.5%) and upper respiratory tract infections (63.1% versus 60.3% versus 34.2%). From baseline to follow-up, maintenance AIT patients demonstrated reductions in all AR-related comorbidities assessed, along with reductions in all-cause and AR-related service utilization. Conclusion: Patients initiating AIT presented the greatest need for therapeutic intervention, as evidenced by higher allergy-related comorbidities; those who reached maintenance demonstrated improved outcomes following the initiation of therapy. Continued efforts to increase patient awareness and adherence to AIT are needed.

Administration burden associated with recombinant human growth hormone treatment: perspectives of patients and caregivers.

Patients treated with recombinant human growth hormone (rhGH) for growth hormone disorders follow a challenging treatment schedule. This study assessed patient and caregiver experiences with rhGH therapy treatment regimens. Patients 13 years or older with growth hormone deficiency and caregivers completed Web-based surveys. A total of 61 patients and 239 caregivers participated. Storage of rhGH was considered burdensome by more than a third. More than 51% considered storage "somewhat more" to "much more of a burden" relative to the burden while not traveling. "Away from home or traveling" was the most frequently endorsed reason for missing a dose. rhGH treatment while traveling is challenging because of rhGH storage burden.

Preference for sublingual immunotherapy with tablets in a Spanish population with allergic rhinitis.

BACKGROUND: This study investigated patients' preference for allergy immunotherapy (AIT) administered as either sublingual immunotherapy-tablets versus monthly or weekly subcutaneous immunotherapy (SCIT) from a Spanish patient perspective. METHODS: A discrete choice experiment (DCE) consisting of two blocks with eight choice sets in each was constructed to elicit the preferences for AIT. Three attributes were included in the DCE for the mode of administration, including the frequency of administration, the risk of systemic reactions and the co-payment. Adults and caregivers of children with moderate to severe allergic rhinitis (AR) were included if they were not currently receiving or had not previously received AIT. RESULTS: In total, 587 adults and 613 caregivers started the survey. Of those, 579 adults and 611 caregivers completed the survey and were included in the study. Both adults and caregivers had a significant preference for tablets compared with both monthly and weekly injections (p ≤ 0.0001). Furthermore, the respondents showed a significant preference for reducing the risk of systemic reactions. Subgroup analyses showed that caregivers of polyallergic children and female caregivers were significantly less price sensitive when choosing their preferred treatment. CONCLUSION: Our study demonstrated that both adults with AR and caregivers of children with AR prefer daily SLIT-tablets to SCIT with either a weekly or monthly dose schedule.

Evaluation of the long-term cost-effectiveness of insulin detemir compared with neutral protamine hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in Sweden.

AIMS: To evaluate the long-term clinical and economic outcomes associated with insulin detemir and neutral protamine hagedorn (NPH) insulin in combination with mealtime insulin aspart in patients with type 1 diabetes in Sweden, based on data from a two-year, multi-national, open-label, randomized, controlled trial. METHODS: Insulin detemir was associated with significant improvements in glycaemic control after 24 months (HbA1c 7.36% versus 7.58%, mean difference -0.22%, p = 0.022) and major hypoglycaemic events (69% risk reduction, p = 0.001) versus NPH. Patients treated with detemir gained less weight (1.7 versus 2.7 kg, P = 0.024). Based on these findings, a published and validated computer model (IMS CORE Diabetes Model) was used to estimate life-expectancy, quality-adjusted life expectancy and both direct medical costs and indirect costs. RESULTS: Basal-bolus therapy with insulin detemir was projected to improve life expectancy by 0.14 years (15.02 ± 0.19 versus 14.88 ± 0.18 years) and quality-adjusted life expectancy by 0.53 quality-adjusted life years (QALYs) versus NPH (8.35 ± 0.11 versus 7.82 ± 0.10 QALYs). Improvements in QALYs were driven by avoided or delayed diabetes-related complications and fewer hypoglycaemic events. Direct medical costs over patient lifetimes were SEK 26,144 higher in the insulin detemir arm (SEK 995,025 ± 19,580 versus 968,881 ± 19,769), leading to an incremental cost-effectiveness ratio of SEK 49,757 per QALY gained. Capturing indirect costs led to insulin detemir being cost saving over patient lifetimes, by SEK 80,113, compared to NPH (SEK 2,959,909 ± 64,727 versus 3,040,022 ± 62,317). CONCLUSIONS: Compared with NPH, insulin detemir is likely to be cost-effective from a healthcare payer perspective and dominant from a societal perspective in patients with type 1 diabetes in Sweden.

Economic benefits of improved insulin stability in insulin pumps.

PURPOSE: Insulin pump users discard unused medication and infusion sets according to labeling and manufacturer's instructions. The stability labeling for insulin aspart (rDNA origin] (Novolog) was increased from two days to six. The associated savings was modeled from the perspective of a hypothetical one-million member health plan and the total United States population. DESIGN: The discarded insulin volume and the number of infusion sets used under a two-day stability scenario versus six were modeled. METHODS: A mix of insulin pumps of various reservoir capacities with a range of daily insulin dosages was used. Average daily insulin dose was 65 units ranging from 10 to 150 units. Costs of discarded insulin aspart [rDNA origin] were calculated using WAC (Average Wholesale Price minus 16.67%). The cost of pump supplies was computed for the two-day scenario assuming a complete infusion set change, including reservoirs, every two days. Under the six-day scenario complete infusion sets were discarded every six days while cannulas at the insertion site were changed midway between complete changes. AWP of least expensive supplies was used to compute their costs. PRINCIPAL FINDINGS: For the hypothetical health plan (1,182 pump users) the annual reduction in discarded insulin volume between scenarios was 19.8 million units. The corresponding cost reduction for the plan due to drug and supply savings was $3.4 million. From the U.S. population perspective, savings of over $1 billion were estimated. CONCLUSIONS: Using insulin that is stable for six days in pump reservoirs can yield substantial savings to health plans and other payers, including patients.

Real-world evidence costs of allergic rhinitis and allergy immunotherapy in the commercially insured United States population.

OBJECTIVE: To assess total and allergic rhinitis (AR)-related healthcare costs among AR patients residing in the United States with a focus on patients persisting with AIT. METHODS: AR patients were identified in the IBM MarketScan database between 1 January 2014 to 31 March 2017. Patients receiving allergy immunotherapy (AIT) were identified with relevant billing codes (earliest AIT claim = index date); non-AIT patients were identified with claims containing a diagnosis code for AR (earliest AR claim = index date). AIT patients reaching 25+ injection claims were analyzed as a separate maintenance cohort. All patients were required to have continuous enrollment for 12 months preceding and following index. RESULTS: A total of 2,334,530 AR patients were included; 103,207 had at least 1 AIT claim, with 45,279 (43.9%) of these patients reaching maintenance, and 24,640 AIT patients (23.9%) never presenting a single injection claim. Compared to non-AIT patients, patients initiating AIT presented higher rates of baseline comorbidities, including asthma (30.1% vs. 7.5%) and conjunctivitis (21.7% vs. 4.4%). During the follow-up period, patients reaching the maintenance phase of AIT incurred lower total costs than the overall AIT cohort ($10,431±$16,606 vs. $11,612±$24,797), and also presented lower follow-up hospitalization costs ($698±$7,248 vs. $1,281±$12,991) and total medical costs ($7950±$13,844 vs. $8989±$22,019). CONCLUSIONS: Continued efforts are needed to increase patient awareness of available options and adherence to AIT, along with reducing wastage. Despite AIT patients presenting fairly progressed disease at the time of treatment initiation, this therapy remains an economical treatment option, as it was not accompanied by substantial increases in overall healthcare expenditure, and may promote positive societal impacts beyond the direct medical costs.What is known on this topicThe prevalence of allergic diseases has increased over the past 50 years and affects between 10-30% of the world population.Allergic rhinitis (AR) poses a significant economic burden in the form of both direct and indirect costsAllergy immunotherapy (AIT) is the only treatment option able to modify the underlying course of the disease.What this study addsSpecific all-cause and AR-related healthcare costs decreased following the initiation of AIT among patients diagnosed with AR, with the largest decreases observed among AIT patients reaching the maintenance phase of treatment, while non-AIT patients showed increases in all categories assessed over a similar follow-up period.Cost decreases among AIT patients were observed despite increased levels of comorbidities compared to non-AIT patients, as the AIT cohort presented elevated rates of atopic dermatitis (7.1% vs. 2.7%), conjunctivitis (21.7% vs. 4.4%), asthma (30.1% vs. 7.5%), and chronic sinusitis (22.6% vs. 4.9%).An analysis of patients' index subcutaneous AIT consultation revealed substantial variability in the initial treatment costs, with nearly 20% of paid amounts exceeding $1,000; given nearly 1 in 4 AIT patients who get AIT mixed never came back for their first injection, this highlights an opportunity to target frontloaded billing practices and the timing of mixing/injection as an area to minimize healthcare waste.

Preference for Immunotherapy with Tablets by People with Allergic Rhinitis.

BACKGROUND: People with allergic rhinitis (AR) who are not controlled on conventional therapy can be treated using allergy immunotherapy (AIT) administered as tablets, injections or drops. In the US, the use of sublingual immunotherapy as tablets (SLIT-tablets) is limited in comparison to subcutaneous immunotherapy (SCIT). OBJECTIVE: This study investigated patients' preference for SLIT-tablets vs monthly or weekly SCIT from a US patient perspective. METHODS: We carried out a discrete choice experiment (DCE) consisting of two blocks with eight choice sets. Adults and caregivers of children with moderate-to-severe AR were included if they had not previously or were not currently receiving AIT. Three attributes were included in the design: the mode and frequency of administration, the risk of systemic reactions and the co-payment. RESULTS: A total of 724 adults with AR and 665 caregivers of children with AR were included in the study. Both adults and caregivers had a significant preference for SLIT-tablets compared with both weekly and monthly injections and for less risk of anaphylactic shock. Caregivers were more risk-averse than adults when choosing their treatment, and the younger the child, the more risk-averse the caregiver. The preference for SLIT-tablets was found for both monoallergic and polyallergic adults and caregivers of monoallergic and polyallergic children. Respondents not wanting AIT for free were more risk-averse than those indicating that they wanted AIT for free. CONCLUSION: Our findings suggest that SLIT-tablets is the preferred route of administration for AIT among adults and caregivers of children with AR.

Subcutaneous immunotherapy takes more than the time in the clinic.

OBJECTIVE: The aim of this study was to investigate the time use and both direct and indirect costs associated with subcutaneous immunotherapy (SCIT) for adults with allergic rhinitis (AR) and caregivers of children with AR in the US. METHODS: We conducted a survey to assess the retrospective time use and direct costs of SCIT. The populations surveyed included adults and caregivers of children (aged 5-17) with symptomatic AR of moderate or higher severity who are currently receiving or have previously started allergy immunotherapy (AIT). The retrospectively collected, self-reported time consumption and direct costs per clinic visit when receiving SCIT were assessed as well as the productivity loss associated with SCIT. Data were analyzed using univariate descriptive statistics. RESULTS: The study included 106 adults with AR and 191 caregivers of children with AR. We found that the median time spent per visit to the clinic was 50 min for both groups, including travel time and time at the clinic. The direct costs related to each visit included parking fees, road tolls and other costs. Adults spent $10 on parking, $9 on tolls and $10 on other costs. Finally, a median of 4 h of work was missed for both the adult patients and the adults accompanying a child. CONCLUSIONS: We found that SCIT is associated with substantial direct patient costs and productivity loss for both adults with AR and caregivers of children with AR.

A comparison of insulin use, glycemic control, and health care costs with insulin detemir and insulin glargine in insulin-naive patients with type 2 diabetes.

OBJECTIVES: The goal of this study was to compare daily insulin use, glycemic control, and health care costs in insulin-naive patients with type 2 diabetes who initiated treatment with either insulin detemir or insulin glargine. METHODS: This was a retrospective cohort analysis of health care claims data and laboratory results for adult, insulin-naive patients with type 2 diabetes who were enrolled in a large US managed care organization and initiated basal therapy with insulin detemir or insulin glargine between May 1, 2006, and December 31, 2006. The daily average consumption (DACON) of insulin was calculated as the total number of units dispensed (excluding the last fill) divided by the number of days between the index date and the date of the last fill of the index insulin. Glycemic control was evaluated by comparing mean glycosylated hemoglobin (HbA(1c)) values in the preindex period (the 180 days before the index date) and the follow-up period (the 180 days after the index date). Mean all-cause and diabetes-related health care costs in the preindex and follow-up periods were calculated and compared. RESULTS: The analysis included 48 patients initiating therapy with insulin detemir and 258 initiating therapy with insulin glargine. The mean age of the 2 cohorts was approximately 54 years, and most patients in each cohort were male (52.1% and 59.7%, respectively). Few patients in either cohort had a baseline HbA(1c) value <7% (13% and 10%), suggesting poor glycemic control at the time of insulin initiation. After adjustment for confounders (eg, preindex diabetes medication), the DACON of insulin was comparable between cohorts (29.3 and 29.6 U/d; P = NS), as were follow-up HbA(1c) values (8.2% and 7.9%). Insulin detemir and insulin glargine also were associated with comparable mean adjusted all-cause pharmacy costs ($3074 and $2899), medical costs ($2319 and $3704), and total health care costs ($6014 and $7023). However, insulin glargine was associated with significantly higher mean adjusted diabetes-related medical costs compared with insulin detemir ($1510 vs $707, respectively; P = 0.03), as well as significantly higher mean adjusted total diabetes-related health care costs ($3408 vs $2261; P = 0.03). CONCLUSIONS: In this managed care population of insulin-naive patients who initiated therapy with insulin detemir or insulin glargine, the daily insulin dose and glycemic control did not differ significantly between the 2 insulins. However, patients receiving insulin detemir incurred lower diabetes-related medical and total health care costs.

Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries.

OBJECTIVES: The aim of this analysis was to evaluate the long-term clinical and economic outcomes associated with insulin detemir and neutral protamine Hagedorn (NPH) insulin in combination with mealtime insulin aspart in patients with type 1 diabetes in Belgian, French, German, Italian and Spanish settings. METHODS: The published and validated IMS CORE Diabetes Model was used to make long-term projections of life expectancy, quality-adjusted life expectancy and direct medical costs. The analysis was based on patient characteristics and treatment effects from a 2-year randomised controlled trial. Events were projected for a time horizon of 50 years. Potential uncertainty using a modelling approach was addressed. RESULTS: Basal-bolus therapy with insulin detemir was projected to improve quality-adjusted life expectancy by 0.45 years versus NPH in the German setting, with similar improvements in the other countries. Insulin detemir was associated with cost savings in Belgium, Germany and Spain. In France and Italy, lifetime costs were slightly higher in the detemir arm, leading to incremental cost-effectiveness ratios of 519 euro per QALY gained and 3,256 euro per QALY gained, respectively. CONCLUSIONS: Compared to NPH, insulin detemir is likely to be a dominant treatment strategy in Belgium, Germany and Spain and highly cost-effective in France and Italy in patients with type 1 diabetes.

Indirect comparison of once daily insulin detemir and glargine in reducing weight gain and hypoglycaemic episodes when administered in addition to conventional oral anti-diabetic therapy in patients with type-2 diabetes.

AIMS: Basal insulin administered to type-2 diabetic patients with poor glycaemic control when managed with oral anti-diabetics (OADs) alone can lead to an increased risk of weight gain and hypoglycaemia. In the absence of head-to-head trials, an indirect comparison of the once-daily insulin detemir with insulin glargine was conducted on the following outcomes: weight gain, hypoglycaemic episodes, and HbA(1c). METHODS: Parallel-group randomised controlled trials of at least 20 weeks duration that compared once-daily evening glargine or detemir with a common comparator, neutral protamine Hagedorn insulin (evening), were selected. Trials focused on insulin-naïve, type-2 diabetic patients poorly controlled with OAD. Five open-label trials were identified (n = 2,092 patients; n = 1 detemir and n = 4 glargine trials), with an indirect comparison of glargine (n = 869 patients) and detemir trials (n = 169 patients) carried out using meta-regression to control for covariates. Weight gain was analysed as weighted mean differences (WMD), hypoglycaemic episodes as odds ratios (OR), and HbA(1c) at the end of study as standardised mean differences (SMD). RESULTS: Patients receiving evening detemir gained significantly less weight (unadjusted WMD -1.22 kg, 95% CI -2.15, -0.29 kg; p = 0.010) and significantly fewer of them experienced hypoglycaemic episodes versus evening glargine (unadjusted OR 0.52, 95% CI 0.28, 0.98; p = 0.044). There was no significant difference between treatments for the mean HbA(1c) level at study endpoint (unadjusted SMD 0.09, 95% CI -0.16, 0.33; p = 0.480). CONCLUSIONS: Once-daily use of insulin detemir resulted in significantly less weight gain and fewer hypoglycaemic episodes than glargine, while maintaining clinically appropriate HbA(1c) levels in type-2 diabetic patients currently receiving OAD.

Evaluating the cost-effectiveness of therapy conversion to insulin detemir in patients with type 2 diabetes in Germany: a modelling study of long-term clinical and cost outcomes.

OBJECTIVES: To evaluate the long-term cost-effectiveness of transferring type 2 diabetes patients to an insulin detemir regimen after failure to achieve adequate control with oral antidiabetic agents (OADs) alone, or in combination with neutral protamine hagedorn (NPH) insulin, or with insulin glargine in Germany. METHODS: A computer simulation model of diabetes was used to make long-term projections of future clinical outcomes and direct medical costs based on findings from a German subanalysis of the PREDICTIVE trial. The study analysed the impact of converting patients failing their current treatments to an insulin detemir regimen. Therapy conversion to insulin detemir +/- OADs was associated with a significant reduction in glycosylated haemoglobin (HbA(1)c) compared with OADs alone, NPH insulin +/- OADs, and insulin glargine +/- OADs. Across all three groups, hypoglycaemia rates decreased by 80% and patients lost an average of 0.9 kg of body weight during treatment with insulin detemir +/- OADs. RESULTS: Therapy conversion to insulin detemir +/- OADs was projected to improve life expectancy by 0.28 years compared with OADs alone, and by 0.13 years compared with the NPH and glargine regimens. Transfer to insulin detemir was associated with improvements in quality-adjusted life expectancy of 0.21 quality-adjusted life years (QALYs) over OADs alone, 0.28 QALYs over NPH +/- OADs, and 0.29 QALYs over glargine +/- OADs. Insulin detemir was associated with savings over patient lifetimes due to reduced diabetes-related complications in all three comparisons. CONCLUSIONS: Therapy conversion to insulin detemir +/- OADs in type 2 diabetes patients failing OADs alone, NPH or insulin glargine regimens was associated with improvements in life expectancy, quality-adjusted life expectancy and cost savings in all three scenarios evaluated.

The cost-effectiveness of bimatoprost, latanoprost and timolol in treatment of primary open angle glaucoma in five European countries.

OBJECTIVE: The objective of this cost-effectiveness analysis is to evaluate cost-effectiveness ratios of the intraocular pressure (IOP)-lowering agents bimatoprost, latanoprost and timolol in five major European countries: France, Germany, Italy, Spain and the UK. METHODS: The cost-effectiveness analysis is based on achievement of IOP targets between 13 and 18 mm Hg. Thus, the cost-effectiveness ratios express the costs of having one patient successfully achieving IOP target. The perspective of the analysis is that of the health care sector payer, including costs of medicine and costs of ophthalmologist visits. The time frame is first year of glaucoma treatment. Four treatment strategies are analysed: Timolol as first line with add-on latanoprost or bimatoprost if IOP targets are not met, and latanoprost and bimatoprost as first line with add-on timolol. RESULTS: In the UK, Spain, Italy and Germany the timolol first with add-on of bimatoprost is the least expensive treatment. This strategy dominates both strategies involving latanoprost (as add-on to timolol or as first line) in these four countries. The incremental cost-effectiveness ratio of bimatoprost first-line therapy versus timolol with add-on bimatoprost varies from each country and target (from 305 pounds sterlings to 43,720 euros per patient). In France the timolol first line and latanoprost add-on is not dominated and is the cheapest alternative. The incremental cost-effectiveness ratio of timolol with add-on bimatoprost versus add-on latanoprost lies between 71 euros and 355 euros per patient depending on target (18 and 13 mm Hg, respectively). CONCLUSION: First-line treatment of latanoprost is dominated in all countries. In four out of five countries the timolol first-line therapy with add-on latanoprost is also dominated. Based on this pharmacoeconomic analysis, the most cost-effective strategy seems to be timolol first line with add-on bimatoprost if target is not met after 3 months.

Analytic review of bimatoprost, latanoprost and travoprost in primary open angle glaucoma.

OBJECTIVE: The objective of this review was to evaluate different measures of efficacy of the intraocular pressure (IOP) lowering lipid class agents bimatoprost, latanoprost and travoprost in the treatment of primary open angle glaucoma. Study arms of timolol in trials including the above mentioned lipid class drugs were also included. METHODS: MEDLINE and EMBASE were searched for randomized clinical trials including one or more of the lipid class drugs bimatoprost, latanoprost and travoprost. The study results were pooled, and the simple, weighted IOP-lowering efficacy was compared among the lipid class drugs and timolol, where data were available. Efficacy parameters were reviewed, including mean reduction of IOP and percentage of patients achieving different levels of IOP. RESULTS: 161 articles were identified of which 42 were included in the analysis. A total of 9295 patients participated in the included trials. Based on all studies, timolol on average had a weighted mean IOP reduction of 22.2%, while latanoprost, travoprost and bimatoprost had a weighted mean IOP reduction of 26.7%, 28.7% and 30.3%, respectively. Analysis of target achievement to various IOP levels shows that bimatoprost seems more efficacious than latanoprost. The direct comparisons (head-to-head studies) also show that bimatoprost is the most efficacious treatment, however it is not conclusive whether latanoprost or travoprost is better in reducing IOP. CONCLUSIONS: This review shows that bimatoprost seems to be the most efficacious treatment in lowering IOP. Head-to-head studies confirm this.

Differences in rates of hypoglycemia and health care costs in patients treated with insulin aspart in pens versus vials.

OBJECTIVES: To study whether initiation of insulin aspart therapy with a pen vs. a vial/syringe has an impact on the risk of subsequent hypoglycemic episodes and health care costs. METHODS: This was a longitudinal, retrospective analysis of the MarketScan and IMS LifeLink health plan claims databases for patients with type 1 or type 2 diabetes who initiated insulin aspart with a pen or a vial/syringe. Included were adults (≥18 years) who had received no short-acting insulin for the 6 months prior to their index date (date of first claim for either treatment) and who initiated treatment with insulin aspart with a pen or with a conventional vial/syringe during the period from January 1, 2004, through December 31, 2007, based on outpatient pharmacy claims data. Patients were excluded if they did not have at least two claims for the index treatment during the 12 month post-index period. Hypoglycemic episodes were identified by any claim containing a diagnosis code for hypoglycemia. RESULTS: Analyses include 6065 patients in the pen group and 5523 patients in the vial/syringe group in the MarketScan database and 4512 patients in the pen group and 3782 patients in the vial/syringe group in the LifeLink database. Vial/syringe use was associated with 35% greater odds of at least one hypoglycemic episode than pen use in the MarketScan database (P < 0.001) and 44% greater odds in the LifeLink database (P < 0.001). Use of vials/syringes was associated with 89% and 62.7% greater health care costs for hypoglycemic events than use of pens, respectively (P < 0.001 for both databases). Patient groups were subject to selection bias as they did not have random assignment to treatment groups. CONCLUSIONS: In two independent claims databases, initiation of insulin aspart treatment with pen was associated with fewer hypoglycemic events and lower diabetes-related health care costs than initiation with vial/syringe.

Evidence supporting an association between hypoglycemic events and depression.

OBJECTIVES: This retrospective study investigated the association between hypoglycemic events (HEs) and depression events (DEs) in patients with diabetes mellitus (type 1 and type 2). METHODS: Analyzed data were from health care claims for individuals with employer-sponsored primary or Medicare supplemental insurance from the Thomson Reuters Market Scan database during the years 2008 and 2009. A baseline period (January 2008 to December 2008) was used to identify eligible patients and collect baseline clinical and demographic characteristics. Eligible patients were aged ≥18 years with diabetes (ICD-9-CM codes: 250.00, 250.01, 250.02, 250.03) who had not experienced any HEs or DEs and were not on antidepressant therapy during the baseline period. We studied the relationships between the DEs and HEs before and after adjusting for the covariates. RESULTS: Of the 923,024 patients meeting the inclusion criteria, 22,735 (2.46%) patients had HEs (ICD-9-CM coded: 251.0, 251.1, 251.2, 250.8) and 6164 (0.67%) patients had DEs (ICD-9-CM: 311) during the evaluation period. Patients reporting HEs had 78% higher odds of experiencing depression than patients without HEs before adjusting for the covariates. Similarly, after adjusting for the covariates, data indicated that patients with HEs had higher odds of experiencing depression (OR = 1.726; 95% CI = 1.52-1.96). Similar analyses in different age categories showed that the OR monotonically increases with age regardless of whether the other covariates are included in the model. CONCLUSIONS: ICD-9-CM-coded HEs were independently associated with an increased risk of DEs in patients with diabetes, and this incidence increased with the patients' age. KEY LIMITATIONS: A key limitation to this study is that only those HEs that resulted in health care provider contact and subsequent claims coding indicative of hypoglycemia were included. It is likely that many cases of mild hypoglycemia, particularly those not severe enough to warrant medical attention, were not captured in this study.

Cost of self-monitoring of blood glucose in the United States among patients on an insulin regimen for diabetes.

BACKGROUND: People with diabetes are at an increased risk of developing numerous complications, resulting in increased health care expenditures, economic burden, and higher mortality. For patients using an insulin pump or multiple insulin injections, self-monitoring of blood glucose (SMBG) is recognized as a core component of effective diabetes self-management. However, little is known about the real-world frequency and true costs associated with SMBG as a percentage of an insulin regimen in the United States. OBJECTIVE: To evaluate SMBG frequency, SMBG-related costs (including blood glucose test strips and testing supplies), and insulin therapy costs among insulin-dependent patients with diabetes and at least 1 pharmacy claim for blood glucose testing strips during a 12-month follow-up period. METHODS: A retrospective database analysis was conducted using the IMS LifeLink Health Plan Claims database to capture the frequency and costs associated with SMBG in relation to a specific insulin regimen, and SMBG expenditure compared with other treatment costs. The study employed a retrospective cohort analysis of patients with 2 or more claims for insulin between January 1, 2007, and June 30, 2009, with the first such claim representing the index date. All patients were required to have 6 months of pre-index continuous enrollment (pre-index period) and 12 months of post-index continuous enrollment (follow-up period). Patients were also required to have a diagnosis of diabetes in the pre-index period and to have no gaps of more than 90 days between consecutive insulin claims during the 360-day follow-up period. Patients without at least 1 pharmacy claim for blood glucose testing strips during the 12-month follow-up period and patients with pharmacy claims with extreme values (greater than 1,500 strips) were excluded. Depending on the insulin types used within the 30 days immediately following their index date, patients were subcategorized into 1 of 4 insulin regimen groups (basal, bolus, premixed, or basal-bolus). Patients' frequency of blood glucose testing was measured throughout their 12-month post-index follow-up period through analysis of clinical codes found on pharmacy claims. Quantity supplied fields on pharmacy claims were used to calculate total tests utilized over the follow-up period (e.g., 50 test strips dispensed=50 tests assumed). Insulin-related costs were also evaluated for the 12-month follow-up period. RESULTS: Among an initial sample of 373,946 patients with at least 2 claims for insulin between January 1, 2007, and June 30, 2009, 45,555 patients (12.2%) formed the final overall cohort who met the inclusion and exclusion criteria. SMBG-related pharmacy costs accounted for 27% of the insulin-and SMBG-related treatment costs for insulin users with an average $772 per patient in prescription testing strips and supplies versus $2,078 for insulin prescriptions and supplies. With an overall mean utilization for pharmacy-based SMBG testing of 764.3 strips per year, the average cost per testing strip was $0.98. Annual SMBG costs were 24.5% of total insulin and SMBG-related pharmacy costs for the basal insulin group compared with 35.8% for bolus, 21.0% for premixed, and 26.4% for basal-bolus. CONCLUSION: For insulin users with at least 1 pharmacy claim for glucose test strips, SMBG-related costs accounted for about one-fourth of total insulin and SMBG-related pharmacy costs.

Assessing achievement and maintenance of glycemic control by patients initiating basal insulin.

OBJECTIVE: Describe characteristics of diabetic patients who initiated basal insulin and assess their glycemic control. RESEARCH DESIGN AND METHODS: Physician encounters in the General Electric EMR Database (2005-2010) were assessed for patients with type II diabetes (T2DM) who initiated basal insulin between February 2006 and August 2009, with initiation defined as no prescription record of insulin in prior 15 months. Patients were followed for an average 2.5 years after insulin initiation. The proportion and time to achieving HbA1c ≤ 7% ('goal') were assessed. Among patients who reached goal, the proportion and time to HbA1c increasing above 7% were analyzed. Cox proportional hazard models were estimated to identify predictors of HbA1c goal achievement and goal sustainability. RESULTS: Basal insulin initiators with T2DM (n = 13,373) were on average 60 years old, 50.5% were females, and 59.5% had HbA1c > 8%; 5840 (44%) patients reached goal within one year and 7699 (58%) reached goal during the ∼2.5-year follow-up. Being older, white or male, lower baseline HbA1c values, and no OAD use before insulin initiation were associated with significantly higher rates of reaching goal. Among patients who reached goal, 57.6% could not sustain the goal. Being Hispanic, higher baseline HbA1c values, and baseline OAD use were associated with significantly lower rates of goal sustainment. CONCLUSION: A high proportion of T2DM patients did not have adequate glycemic control after initiating basal insulin. Various factors existing prior to insulin initiation were related to successful treatment of T2DM. Further research on how to improve glycemic control is encouraged.

Cost-effectiveness of insulin detemir: a systematic review.

The prevalence of diabetes and cost of associated treatment are steadily increasing, as is the resulting burden on healthcare systems worldwide. Current treatment recommendations for Type 1 and Type 2 diabetes advise a prominent role for basal insulin. We examined the published health-economic literature pertaining to the basal insulin analog insulin detemir (IDet) to determine whether IDet is a cost-saving and/or cost-effective treatment for suboptimally controlled Type 1 or Type 2 diabetes. A total of 15 modeling studies were assessed, most of which found IDet to be cost effective compared with neutral protamine Hagedorn and as cost effective as insulin glargine. Those that did not find IDet to be cost effective set the disutility of hypoglycemic events to almost zero or assumed a higher dose of IDet with no difference in treatment effect, ignoring the clinical benefits and cost savings associated with IDet in studies demonstrating comparable or superior glycemic control with less hypoglycemia versus other basal insulins. The evidence suggests that IDet is cost effective versus neutral protamine Hagedorn and at least as cost effective as insulin glargine in the treatment of patients with suboptimally controlled Type 1 and Type 2 diabetes.

Coverage of insulin delivery devices and basal insulin analogs by US managed care organizations.

OBJECTIVE: The perception in the US is that insulin formulations prescribed for type 1 and type 2 diabetes and delivered via insulin pens are more costly to patients than the same or similar products provided in vials, and that basal insulin analogs offered either in pens or vials are likewise more costly to patients than human insulin formulations. This study compares levels of coverage and copays by private and Medicare Part D plans for insulin pens and vials containing basal insulin analogs and for NPH formulations in vials. METHODS: A commercially available formulary database (Access Point, Pinsonault Associates; updated quarterly) was analyzed as of January 2010 for private insurance plans and as of March 2010 for Medicare Part D plans. Analyses were performed for Tier-level coverage and copays per prescription for basal insulin analogs in pens and vials, and NPH in vials. RESULTS: Basal insulin analogs in pens were covered by >91% of private and Part D plans. NPH coverage was reported by >92% of private plans and 69-95% of Part D plans, depending on brand. Irrespective of delivery mode, copays in the majority of private plans for basal insulin analogs and NPH were in the >$10-35 range. Copays were higher in Part D plans, with the majority of plans and subscribers in a >$35-50 range. Prior authorization was required by <10% of insurance plans for insulin analog pen prescriptions, and <3% of plans for insulin analog or NPH prescriptions in vials. LIMITATIONS: This analysis was descriptive, copay stratification was not based on a statistical model but on copay ranges typically used by the plans, and there were no direct correlations performed on the numbers of subscribers per plan vs copay or Tier level. CONCLUSION: These results counter the widely held perception that insurance coverage is less extensive for insulin pens vs vials. Medicare Part D plans often had higher copay requirements than private plans for the same product at the same copay Tier.