IMS Health Research Articles

The extent and correlates of community‐based pharmaceutical opioid utilisation in Australia

There has been concern regarding the increasing use of opioids and related harm. We present data on opioid utilisation across Australia and consider sociodemographic factors that may affect utilisation rates. IMS Health national sales data for over-the-counter (codeine) and prescription opioids (buprenorphine, codeine, dextropropoxyphene, fentanyl, hydromorphone, methadone, morphine, oxycodone, tapentadol and tramadol) were used to estimate total utilisation rates in the community during 2013, mapped to Statistical Local Areas (SLAs) and Remoteness Areas. All opioid amounts were measured in pack sales and milligrammes then converted to oral morphine equivalent milligrammes (OME mg) for comparison across opioids. Data on the demographic characteristics of SLAs were obtained from the ABS (sex and age distribution, income and levels of physical labour) and other sources (number of pharmacies in SLAs) and were included in linear regression analyses. In 2013, an estimated 10 747 kg (OME) of opioids were sold across Australia, equating to 481 OME mg per person. There was considerable geographic variation in opioid utilisation, with higher rates of use in rural and regional areas. Geographic areas that were less populated, had more men and older people, proportionally more low-income earning households and greater proportions in jobs requiring physical labour had higher utilisation rates. Substantial geographic variation in opioid utilisation was identified, with areas outside of major cities having higher rates of utilisation of all types of opioids. Prescription monitoring and best practice interventions aimed at improving opioid use need to have a particular focus on areas outside of major cities. Copyright © 2016 John Wiley & Sons, Ltd.

Prevalence of Eosinophilic Gastritis, Gastroenteritis, and Colitis: Estimates From a National Administrative Database.

Eosinophilic esophagitis (EoE) is becoming increasingly more common, but the prevalence of other eosinophilic gastrointestinal disorders (EGIDs) is unknown. Our objective was to estimate the prevalence of eosinophilic gastritis, gastroenteritis, and colitis in the United States. We used the IMS Health LifeLink PharMetrics Plus Claims Database, data representative of a US national commercially insured population containing medical and pharmaceutical claims for > 75 million individuals. We restricted our sample to patients ages 0 to 64 with continuous enrollment between July 1, 2009, and June 30, 2011. We identified patients with eosinophilic gastritis, gastroenteritis, and colitis as defined by ≥ 1 instance of the International Classification of Diseases, Ninth Revision codes 535.70, 558.41, and 558.42, respectively. We calculated the prevalence of the codes in the database and then standardized the estimates to the US population by age and sex. The standardized estimated prevalences of eosinophilic gastritis, gastroenteritis, and colitis were 6.3/100,000, 8.4/100,000, and 3.3/100,000, respectively. The prevalence of eosinophilic gastroenteritis was the highest among children age < 5 years, whereas eosinophilic gastritis was more prevalent among older age groups. We observed no age differences for eosinophilic colitis. Among affected patients, there was a high proportion of coexisting allergic conditions, 38.5% for eosinophilic gastritis, 45.6% for gastroenteritis, and 41.8% for colitis. Concomitant allergic disease was most commonly identified in pediatric patients. The prevalence of non-EoE EGIDs remains rare in the United States, with < 50,000 total patients affected. There appears to be a female predominance and a high co-occurrence of atopic comorbidities.

THE COSTS OF REGIONAL ANESTHESIA WITH THE USE OF LEVOBUPIVACAINE, RACEMIC BUPIVACAINE AND ROPIVACAINE

Background and Objective . Currently in clinical practice are widely used local anesthetics, including racemic bupivacaine, levo isomer of its levobupivacaine and structurally similar to bupivacaine levo isomer ropivacaine. The aim of this work was to assess the cost of anesthesia levobupivacaine, bupivacaine and ropivacaine. Material and methods . In accordance with the results of comparative clinical trials and expert evaluation analysis was conducted in two ways: under the assumption of equal clinical effectiveness of levobupivacaine and bupivacaine and a higher efficiency of levobupivacaine compared with ropivacaine (assumed in various clinical situations with an equal volume of solution used ropivacaine in concentrations of 0.5% may be replaced without reducing clinical efficacy of levobupivacaine in a concentration of 0.5%, ropivacaine in a concentration of 0.75% – levobupivacaine in a concentration of 0.5 and 0.75% (in equal proportions); ropivacaine at a concentration of 1% – levobupivacaine at a concentration of 0.75%. The ropivacaine dose equivalent to 1 mg of levobupivacaine, made when calculating the average of 1.20 mg), and under the assumption of equal clinical effectiveness compare local anesthetics. The analysis was carried out for medicines containing 10 ml of solution per ampoule on the basis of registered prices of bupivacaine and ropivacaine. The cost of levobupivacaine was calculated based on expected rates of registration in the case of inclusion in the Essential Drugs List (0,5% R-R amp. 10 ml №10 – 947,74 RUB; 0.75% of p-p amp. 10 ml №10 – 1421,60 RUB). Results . Subject to the adopted scenario 1 assumptions levobupivacaine allows you to reduce costs 29.6-56.9 per cent compared with bupivacaine and ropivacaine. Taking into account the consumption of local anesthetics in 2016 (according to IMS Health), the replacement of bupivacaine and ropivacaine by levobupivacaine will allow you to reduce costs on average by 38.0%. Projected savings when replacing bupivacaine and ropivacaine in concentrations of 0.5-1.0% in ampoules of 10 ml will be 69,305 million RUB/year, taking into account the accepted assumptions. Under the assumption of equal effectiveness bupivacaine, ropivacaine and levobupivacaine (scenario 2), the replacement of bupivacaine and ropivacaine on levobupivacaine will reduce costs by an average of 29.6%. Given the amount of consumption savings will be 34,012 million RUB/year. Conclusion. Replacement of bupivacaine and ropivacaine in concentrations of 0.5-1.0% in vials of 10 ml levobupivacaine at a concentration of 0.5-0.75% will allow taking into account assumptions significantly reduce budget costs without reducing the effectiveness of treatment. Reducing the burden on the budget could be achieved under the assumption of equal efficacy of drugs and replacement of bupivacaine and ropivacaine by levobupivacaine in the same concentration.

Effect of a “pill mill” law on opioid prescribing and utilization: The case of Texas

BackgroundStates have attempted to reduce prescription opioid abuse through strengthening the regulation of pain management clinics; however, the effect of such measures remains unclear. We quantified the impact of Texas’s September 2010 “pill mill” law on opioid prescribing and utilization. MethodsWe used the IMS Health LRx LifeLink database to examine anonymized, patient-level pharmacy claims for a closed cohort of individuals filling prescription opioids in Texas between September 2009 and August 2011. Our primary outcomes were derived at a monthly level and included: (1) average morphine equivalent dose (MED) per transaction; (2) aggregate opioid volume; (3) number of opioid prescriptions; and (4) quantity of opioid pills dispensed. We compared observed values with the counterfactual, which we estimated from pre-intervention levels and trends. ResultsTexas’s pill mill law was associated with declines in average MED per transaction (−0.57mg/month, 95% confidence interval [CI] −1.09, −0.057), monthly opioid volume (−9.99kg/month, CI −12.86, −7.11), monthly number of opioid prescriptions (−12,200 prescriptions/month, CI −15,300, −9,150) and monthly quantity of opioid pills dispensed (−714,000 pills/month, CI −877,000, −550,000). These reductions reflected decreases of 8.1–24.3% across the outcomes at one year compared with the counterfactual, and they were concentrated among prescribers and patients with the highest opioid prescribing and utilization at baseline. ConclusionsFollowing the implementation of Texas’s 2010 pill mill law, there were clinically significant reductions in opioid dose, volume, prescriptions and pills dispensed within the state, which were limited to individuals with higher levels of baseline opioid prescribing and utilization.

An ecological study of the extent and factors associated with the use of prescription and over-the-counter codeine in Australia.

The extent and factors associated with codeine use in the community remain poorly understood despite the widespread global use of codeine. The aim of this study was to examine the use of prescription and over-the-counter (OTC) codeine in Australia and identify the geographic and socio-demographic characteristics associated with prescription and OTC codeine use. National sales data for prescription and OTC codeine (supplied by IMS Health) were used to estimate codeine utilisation (in pack sales and milligrammes) in Australia during 2013, mapped to Australian Bureau of Statistics (ABS) Statistical Local Areas (SLAs) and Remoteness Areas. Socio-demographic characteristics and total population estimates of SLAs were obtained from the ABS. SLA-level data on sex, age distribution, income, occupations involving physical labour and number of pharmacies were included in linear regression analyses to examine their association with total, prescription and OTC codeine use. In total, 27,780,234 packs of codeine were sold in Australia during 2013, equating to 12,376 kg. OTC codeine preparations accounted for 15,490,207 packs (55.8 %) or 4967.30 kg (40.1 %). Nationally, an estimated 1.24 packs (or 554.10 mg) of codeine were sold per person; utilisation was higher in more remote areas. SLAs with a higher percentage of low-income earning households had the highest rates of prescription codeine use (β 0.16, p < 0.001), whereas SLAs with a higher percentage of males had the highest rates of OTC codeine use (β 0.22, p < 0.001). Codeine use is common in Australia, with clear distinctions in the geographic and socio-demographic characteristics associated with prescription and OTC codeine use.

The impact of treatment compliance on fracture risk in women with breast cancer treated with aromatase inhibitors in the United Kingdom.

No study has yet analyzed the impact of compliance with aromatase inhibitor(AI) treatments on fracture risk in a real-world setting in women with breast cancer. In this study, 8732 women with BC treated with AI, 8732 treated with tamoxifen (TAM), and 8732 age-matched women without BC selected from the Disease Analyzer database (IMS Health) were included. The main outcome measure was the impact of compliance with AI treatment on fracture risk. Demographic data included age, body mass index (BMI), and smoking status. Alcohol dependency, dementia, bone density, visual disturbances, diabetes, and use of corticosteroids were also assessed. Kaplan-Meier curves were used to analyze the proportion of patients with fracture over time, and multivariate Cox regression models were performed to assess the adjusted fracture risk. Mean age was 67.3years. 17.6, 8.7, and 8.8% of AI, TAM, and non-cancer patients, respectively, were diagnosed with fracture within 5years after the index date (p<0.001). The proportion of women receiving AI with fracture increased with treatment compliance, rising from 8.6% when treatment persisted for less than a year to 18.0% when it persisted for between 4 and 5years (p<0.001). By contrast, the proportion of fractures in women with BC receiving TAM for the same time periods decreased from 13.0 to 7.9% (p<0.001). The risk of fracture was higher in women with BC using AI than in the non-cancer group (HR=3.00; p<0.0001). Finally, current smoking status, BMI, dementia, and prescription of corticosteroids had significant impacts on fracture risk. Compliance with AI treatment in women with BC is associated with a clear increase in the risk of fracture, which is much higher than previously reported.

Few Surprises In 2015

Major drug companies came into 2015 with the wind at their backs thanks to a surge in new drugs with blockbuster potential. But price pressure and competition against products that lost patent protection whittled away at revenue growth. On balance, according to IMS Health, worldwide pharmaceutical sales grew about 5% to $958 billion from June 2014 to June 2015, the most recent period for which the firm offers data. The lineup of the world’s top pharmaceutical firms saw little change. Gilead Sciences rose one position to eighth place on the strength of sales of its hepatitis C drugs Sovaldi and Harvoni. Abbvie just edged out Amgen for tenth place, also rising one spot. Six of the top companies will experience slight drops in revenue this year. GlaxoSmithKline is typical, posting a modest slide in sales from $35.7 billion in 2014 to an expected $35.4 billion in 2015. Nearly holding steady ...

Healthcare Utilization and Costs Among Patients with Hairy Cell Leukemia: Analysis of a Large US Administrative Claims Database

Background and Objective: Hairy cell leukemia (HCL) is an uncommon condition with an estimated 900 incident cases annually and accounts for approximately 2% of all leukemia cases in the United States. Purine analogs including cladribine and pentostatin are the two agents of choice in managing patients with HCL. Limited information exists with regard to costs associated with the management of patients with HCL. Thus, this study evaluated real-world all-cause and HCL-related healthcare utilization and costs among patients with HCL.Methods: A retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database for the period 2006-2014. The database includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Database includes medical and outpatient pharmacy claims for individuals enrolled in managed care health plans. Information on charged and paid amounts along with co-pay information is included in claim records. Additionally, claim records include details on, but not limited to, diagnoses, procedures, date of service, and discharge date (inpatient visit). Adult (≥18 years of age) patients with at least two claims with a diagnosis of HCL (ICD-9-CM code: 202.4x) were selected and the first observed claim defined the "index date." Patients with evidence of other malignancies (identified using relevant ICD-9-CM codes) during the 6-month prior (pre-index period) to the index date were excluded. Patients were required to have at least 90 days of continuous enrollment (the variable "follow-up" period) in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition) or until the end of database. Study measures including baseline costs (pre-index period) and follow-up period all-cause and HCL-related (assessed based on presence of HCL diagnosis code and/or HCL-associated therapies) utilization and costs were evaluated on a per-patient basis. Annualized healthcare utilization and costs were also estimated [(annualized rate of use/costs = (units used or costs post-index)/(days follow-up post-index/365)]. All analyses were descriptive in nature with continuous measures (e.g., HCL-related inpatient costs) measures presented using mean, median, standard deviation (SD) and categorical measures (e.g., patient with a HCL-related inpatient admission) using frequency and percentages. Cost analyses were conducted from a payer perspective (i.e., paid amounts [not charged amounts] were used in cost estimation).Results: The study cohort included 749 patients with mean (SD) post-diagnosis follow-up of 32 (22) months. Over 3/4th of patients were males (77%) and the mean age (SD) at diagnosis was 56 (10) years. The mean pre-index per patient costs for the study cohort was $5,858 ($13,836). Slightly more than a third (38%) of patients initiated first-line chemotherapy over the available follow-up, and pre-index costs were higher among patients initiating chemotherapy compared with to those who did not initiate chemotherapy ($6,635 [$7,246] vs. $5,389 [$16,584]). 36% of patients had at least 1 HCL-related inpatient admission and over 95% had at least 1 HCL-related physician office visit during the follow-up period. The average follow-up period all-cause costs were $55,904 of which 50% were related to outpatient care, 40% related to inpatient care and 9% related to outpatient pharmacy costs. The mean annualized all-cause costs were $50,585 of which over 65% (mean: $33,111) attributed to inpatient costs. The follow-up period HCL-related total costs were $31,234 of which HCL-related inpatient costs accounted for 55% and 44% were attributed to HCL-related outpatient care. The mean annualized HCL-related costs were $38,588 with the vast majority (81%) attributed to inpatient costs.Conclusion: The current study provides real-world all-cause and HCL costs estimates from a payer perspective among patients with HCL. With newer therapies being developed for HCL, findings from this study can serve as inputs in the development of cost-effectiveness models comparing new and existing treatments. DisclosuresDivino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Karve:AstraZeneca: Employment. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Background and Objective: Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database.Methods: This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature.Results: The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy.Conclusion: The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. DisclosuresKarve:AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

Analyses of Real World Data on Overall Survival in Multiple Myeloma Patients with at Least 3 Prior Lines of Therapy Including a PI and an IMiD, or Double Refractory to a PI and an IMiD

Background: To fully evaluate the potential benefit of novel agents for the treatment of patients with multiple myeloma (MM) who are heavily pretreated and refractory, it is important to understand the outcomes of this patient population based on current real-world experience. An International Myeloma Working Group study determined that the median overall survival (OS) of patients refractory to bortezomib (proteasome inhibitor, PI) and at least 1 immunomodulatory drug (IMiD) was 9 months (Kumar S et al. Leukemia 2012; 26: 149). Since then, other therapies have been approved for relapsed and refractory MM in the United States (US), including pomalidomide (IMiD) and carfilzomib (PI). In this analysis, real-world data were used to define the treatment landscape and outcomes of patients with MM refractory to PIs and IMiDs or who had received ³3 prior lines of therapy (LOT; including a PI and an IMiD) and provide context to results from the single-agent daratumumab phase 2 study MMY2002 (Sirius) recently presented at ASCO 2015 (Lonial S. J Clin Oncol 33, 2015 suppl; abstr LBA8512).Methods: Two independent databases were analyzed.TheIMS LifeLink: IMS Oncology Electronic Medical Records (EMR) Database (IMS Health Incorporated, Danbury, CT) and the OPTUM Database (OPTUM, Inc., Eden Prairie, MN) both comprised US patients only. For the IMS LifeLink database, patient records from the index period of 2000-2011 were screened. For the OPTUM database, the indexing period was 2007-2014. Median OS was assessed for cohorts that met the criteria of disease that was double refractory to a PI and IMiD (Criteria 1) or had been treated with ³3 LOT including a PI and IMiD and showed disease progression within 60 days on completion of last regimen (Criteria 2). Patients who met Criteria 1 could have received ³3 prior LOT, however those who met Criteria 2 only did not meet the double refractory criteria. Subgroup analyses of the eligible population were conducted on those who were only double refractory and triple/quadruple refractory.Results: For the IMS LifeLink database, 4,030 patients with MM were screened, approximately 90% of patients were diagnosed with MM in 2006 or later, and 500 met the criteria for the target population. Of the 500 patients, 323 patients met Criteria 1 and 177 patients only met Criteria 2. For the OPTUM database, 3,837 patients with MM were screened, approximately 90% of patients were diagnosed after 2009, and 162 met the criteria for the target population, 120 of whom met Criteria 1 and 42 of whom only met Criteria 2. In the total eligible populations, median OS was 239 days in the IMS LifeLink dataset compared with 240 days in the OPTUM dataset (P = 0.5358). Among patients that were only double refractory (triple/quadruple refractory patients excluded), median OS was 228 days (n = 253) in the IMS LifeLink dataset compared with 259 days (n = 97) in the OPTUM dataset (P = 0.8052). In triple/quadruple refractory patients, median OS was 154 days (n = 70) in the IMS LifeLink dataset and 95 days (n = 23) in the OPTUM dataset (P = 0.6675). The results from both databases were consistent, hence the data were pooled for further analyses; the pooled analyses indicated that the median OS was 240 days for the eligible population (n = 662), 237 days for patients who were only double refractory (n = 350), and 154 days for patients who were triple/quadruple refractory (n = 93). A naïve comparison of the OS curves from the MMY2002 study and the pooled analysis suggests a survival benefit with daratumumab versus the real-world historical control (Figure).Conclusions: Analyses of real-world data from two independent US patient databases indicated that outcomes remain poor among patients with MM who are heavily pretreated and/or highly refractory despite the availability and use of newer PIs and IMiDs, such as carfilzomib and pomalidomide. Median OS of approximately 8 months was observed in patients with ≥3 LOT (including a PI and IMiD) or refractory to a PI and IMiD. These data not only highlight the critical need for new MM treatments for patients with advanced MM, but also provide a point of reference against which novel agents such as daratumumab could be evaluated. [Display omitted] DisclosuresUsmani:Onyx: Consultancy, Honoraria, Research Funding; Janssen: Research Funding; Celgene Corporation: Consultancy, Honoraria. Ahmadi:Janssen: Employment. Ng:Janssen: Employment. Lam:Janssen: Employment. Potluri:Smart Analyst: Employment. Mehra:Janssen: Employment.

Risks of thromboembolism associated with hormonal contraceptives related to body mass index and aging in Japanese women

ObjectiveThe aim of this study is to estimate the risk of thromboembolism related to body mass index (BMI) and aging among users of hormonal contraceptives in Japan. MethodsA case–control study of the risk of obesity and a descriptive study of the risk of age were conducted. We used the Pharmaceuticals and Medical Devices Agency database, and extracted thromboembolic events of combined oral contraceptive (COC) products. Control data were from the National Health and Nutrition Survey in Japan. Denominator of descriptive study was from IMS Health, JPM. ResultsA total of 306 thromboembolic events and 6423 controls were analyzed. The odds ratios (95% confidence interval) of the obesity groups (BMI≥25) were 2.32 (1.71–3.15) for venous thromboembolism (VTE), 1.16 (0.62–2.18) for arterial embolism and thrombosis (ATE), and 1.83 (1.38–2.43) for overall thromboembolic events compared with the standard group (BMI of 18.5–24.9) as a reference. The estimated incidence rates of VTE, ATE and overall thromboembolic events per 10,000person-years in users of therapeutic remedies for dysmenorrhea (35μg ethinylestradiol combined with norethisterone, 20μg ethinylestradiol combined with drospirenone and dienogest) among women aged 10–59years from 2009 to 2013 were 2.38 (2.08–2.74), 0.63 (0.48–0.82), and 3.17 (2.81–3.57), respectively. This tendency was not seen for dienogest. ConclusionsThe risk of VTE in the obesity group among COC users was more than 2 times higher than in the standard group. The incidence rates of VTE in Japanese users of all remedies for dysmenorrhea except dienogest were as high as in people in Western countries.

Risk of stillbirth in pregnant women with obesity in the United Kingdom

The stillbirth rate in the United Kingdom (UK) is approximately 3.5-4 per 1000 births. The country has one of the highest stillbirth rates in Europe, constituting a substantial portion of the UK perinatal death rate, which was estimated in 2013 at 6.7 deaths per 1000 births. To analyse the risk of stillbirth in pregnant women with and without increased BMI in the United Kingdom (UK). Retrospective study based on Disease Analyzer database (IMS Health). A total of 44,060 pregnant women with or without an increased BMI who gave birth to a single child were examined using a Disease Analyzer database that included 102 general practices. Selected patients were observed for a period of at least 10 months between January 1994 and December 2013. Standard BMI ranges were considered: 18.5-24.9 (normal weight), 25-29.9 (overweight), 30-39.9 (class I and class II obese), 40-49.9 (class III) and over 50 (class IV). Multivariate logistic models were used to estimate the relationship between increasing BMI and the rate of stillbirth adjusted for demographic data and co-morbidities. BMI increase was associated with an increase in stillbirth OR, from 1.37 (95% CI: 1.02-1.85) in the overweight group to 5.04 (95% CI: 1.79-14.07) in the group of pregnant women with a BMI higher than or equal to 50. Pregnant women with obesity and even moderate overweight exhibit an increased risk of stillbirth in UK primary care practices over 20 years.

Codeine consumption from over-the-counter anti-cough syrup in Taiwan: A useful indicator for opioid abuse

ObjectiveOver-the-counter (OTC) anti-cough preparations, many of which contain codeine (an opioid) or dextromethorphan (an opioid-like), are widely available in Taiwan and thus susceptible to overuse or abuse. We aimed to investigate whether opioids in the form of OTC antitussives play a significant role in medication abuse in Taiwan. MethodsData on the consumption of codeine and dextromethorphan in antitussives and expectorants from 2011 through 2014 in Taiwan were provided by IMS Health (Intercontinental Marketing Services). These data were then analyzed for trends and variance according to availability, as prescription or OTC, and according to drug type, as codeine or dextromethorphan, in order to form four primary sectors under opioid-containing anti-cough syrup consumption. ResultsFrom 2011 to 2014, use of opioid-containing cough syrup fluctuated between 6% and 9% from year to year for all cough syrup consumption, with an overall declining trend (11.3% per year relative to 2011). Within the underlying sectors, mean consumption for prescription dextromethorphan (61.4%) outstripped the other three sectors, followed in decreasing order by OTC codeine (20.2%), OTC dextromethorphan (10.5%), and prescription codeine (8.0%). However, movement in consumption corresponded mainly with OTC codeine, whose variance greatly exceeded that of the other sectors, which follow in order of decreasing variance as OTC dextromethorphan, prescription dextromethorphan, and prescription codeine. ConclusionThe fairly low and stable consumption of prescription codeine suggested that physicians in Taiwan were careful in prescribing codeine, and that the medical demand for codeine was stable. The large variance in OTC codeine consumption suggested that a minority of consumers purchased significant quantities of codeine for non-medical purposes. Although opioids in cough syrup were not a large part of overall consumption and thus not widely abused, the data revealed that OTC codeine-containing cough syrup may serve as an indicator of potential drug abuse in the population as compared to prescription codeine.

Validating hospital antibiotic purchasing data as a metric of inpatient antibiotic use.

Antibiotic purchasing data are a widely used, but unsubstantiated, measure of antibiotic consumption. To validate this source, we compared purchasing data from hospitals and external medical databases with patient-level dispensing data. Antibiotic purchasing and dispensing data from internal hospital records and purchasing data from IMS Health were obtained for two hospitals between May 2013 and April 2015. Internal purchasing data were validated against dispensing data, and IMS data were compared with both internal metrics. Scatterplots of individual antimicrobial data points were generated; Pearson's correlation and linear regression coefficients were computed. A secondary analysis re-examined these correlations over shorter calendar periods. Internal purchasing data were strongly correlated with dispensing data, with correlation coefficients of 0.90 (95% CI = 0.83-0.95) and 0.98 (95% CI = 0.95-0.99) at hospitals A and B, respectively. Although dispensing data were consistently lower than purchasing data, this was attributed to a single antibiotic at both hospitals. IMS data were favourably correlated with, but underestimated, internal purchasing and dispensing data. This difference was accounted for by eight antibiotics for which direct sales from some manufacturers were not included in the IMS database. The correlation between purchasing and dispensing data was consistent across periods as short as 3 months, but not at monthly intervals. Both internal and external antibiotic purchasing data are strongly correlated with dispensing data. If outliers are accounted for appropriately, internal purchasing data could be used for cost-effective evaluation of antimicrobial stewardship programmes, and external data sets could be used for surveillance and research across geographical regions.

Adherence to a Novel Oral Anticoagulant Among Patients with Atrial Fibrillation.

Dabigatran is a direct thrombin inhibitor approved by the FDA in October 2010 for the treatment of nonvalvular atrial fibrillation. Little is known regarding patient adherence to this therapy. To examine adherence and persistence to dabigatran among adults with atrial fibrillation. We used IMS Health's LifeLink Health Plan Claims Database from 2010 to 2012 to identify patients with atrial fibrillation who were new users of dabigatran. We derived adherence and persistence for continuously enrolled patients at 6 months, 9 months, and 12 months of follow-up. We measured adherence using the medication possession ratio (MPR), defined as individuals with MPRs of 0.80 or greater as adherent, and examined persistence by identifying individuals with gaps in drug possession of 60 days or greater. Of 5,951 adults with atrial fibrillation who were new users of dabigatran, 49% had prevalent atrial fibrillation and at least 6 months of continuous follow-up. Of these, 89% used dabigatran as the only oral anticoagulant, whereas the remainder filled prescriptions for at least 1 other oral anticoagulant during the follow-up period. Among those using dabigatran alone (n = 2,713), the mean MPR was 0.73 (standard error = 0.30), 41% were nonadherent with therapy, and 32% had gaps of 60 days or greater. Among those observed for 9 (or 12) months who used dabigatran alone, rates of nonadherence were 47% (49%), whereas 48% (49%) discontinued therapy during follow-up. Rates of adherence and persistence were similar for patients with incident atrial fibrillation. Nonadherence to dabigatran was common among patients with atrial fibrillation. Future studies are needed to understand the reasons for nonadherence.

Early View of the Effectiveness of New Direct-Acting Antiviral (DAA) Regimens in Patients with Hepatitis C Virus (HCV).

IntroductionClinical trials have demonstrated the efficacy of all-oral direct-acting antiviral (DAA) regimens in the treatment of patients infected with hepatitis C virus (HCV). This study assessed real-world effectiveness of two recently approved regimens; paritaprevir/ritonavir/ombitasvir; dasabuvir (3D), and sofosbuvir/ledipasvir (SOF/LDV) in patients with HCV genotype 1.MethodsA retrospective analysis of administrative claims data (IMS Health Patient-Centric Data Warehouse/Medivo database) from October 1, 2013 to August 14, 2015 was conducted. Patients ≥19 years of age with a HCV genotype 1 infection, a prescription fill for 3D or SOF/LDV, and ≥1 HCV viral load (VL) assessment from weeks 4–30 post-treatment were selected for analysis. Percentages of patients achieving sustained virologic response (SVR; defined as HCV RNA ≤43 IU/mL) were determined. Unadjusted SVR rates were compared between treatment groups using Fisher’s exact tests. SVR rates were also assessed using multivariate regression with adjustment for age group, sex, and treatment history. Analyses were repeated for a subset of patients with VL assessment from 12 to 30 weeks post-treatment.ResultsA total of 1707 (44 3D and 1663 SOF/LDV) patients were included. The majority (60%) were male, 49% were aged 55–64 years, and 97% were treatment-naïve 1 year prior to index. The unadjusted relative risk (RR) for achieving SVR in patients treated with SOF/LDV compared with 3D was 0.98%, 95% confidence interval (CI): 0.93–1.02. After adjusting for the baseline covariates, the RR was 0.98%, 95% CI: 0.94–1.03.ConclusionsIn this early view of real-world data, effectiveness of all-oral DAA regimens in HCV genotype 1 patients was concordant with results from registration trials. SVR rates were similar for the two regimens. Further studies are needed to confirm these results.FundingAbbVie, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0258-5) contains supplementary material, which is available to authorized users.

Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs.

BackgroundAgency is a pervasive feature of the health care market, with doctors acting as agents for both patients and the health care system. In a context of scarce resources, doctors are required to take opportunity cost into account when prescribing treatments, while cost containment policies cannot overlook their active role in determining health care resource allocation. This paper addresses this issue, investigating the effects of cost containment measures in the market of biosimilar drugs that represent a viable and cost-saving strategy for the reduction of health care expenditure. The analysis focuses on a particular region in Italy, where several timely policies to incentivize biosimilar prescribing were launched.MethodsDrugs were identified by the anatomical therapeutic chemical classification system. Information about biosimilar drugs and their originator biological products was extracted from the IMS Health regional database. Drug consumption was expressed in terms of counting units, while expenditure was evaluated in Euro (€). The market penetration of biosimilars was analyzed by year and quarterly.ResultsIn the Campania region of Italy, the effects of cost containment policies, launched between 2009 and 2013, showed the prescription of biosimilars strongly increasing in 2010 until prescribing levels reached and exceeded the market share of the reference biological products in 2012. After a slight reduction, a plateau was observed at the beginning of 2013. At the same time, the use of the originator products had been decreasing until the first quarter of 2011. However, after a 1-year plateau, this trend was reversed, with a new increase in the consumption of the originators observed.ConclusionResults show that the cost containment policies, applied to cut health expenditure “to cure and not to care”, did not produce the cultural change necessary to make these policies effective in the long run. Therefore, top-down policies for cost containment are not successful; rather, a bottom-up approach based on consensus among professionals should become the preferred option.

HCP-06PATTERNS OF PHARMACOTHERAPY CHANGES AND SWITCHES SUGGEST UNMET NEED IN US PATIENTS WITH ACROMEGALY

BACKGROUND: Acromegaly, a slowly progressive disorder due to growth hormone excess, is managed with multiple treatment modalities in clinical practice. About 50% of acromegaly patients require adjuvant therapy after surgery, which may include multiple medications. Guidelines suggest a sequence of medical therapy, but treatment choices are usually individualized and actual treatment practices are unknown. METHODS: This retrospective cohort study used 2 databases (Truven Health Analytics MarketScan; IMS Health PharMetrics) of patients with ≥2 medical claims with acromegaly (ICD-9-CM code 253.0) and ≥1 pharmacotherapy claim during 1/1/2002-12/31/2013. We conducted descriptive analyses for varying patient cohorts to report on pharmacologic switch rates and stops, and subsequent pharmacotherapy among initial switchers who switched after 2007. A switch was an addition or change in pharmacotherapy. RESULTS: Depending on the year, 7.4-10.6% of all pharmacologically treated patients switched to a new treatment and 4.1-9.3% stopped treatment. For all patients who either stopped or switched therapy, 63.6% changed to a different treatment and 36.4% stopped pharmacologic treatment completely. Among patients who switched pharmacotherapy, 23.2% switched to a combination pharmacotherapy, followed by octreotide-LAR (19.1%), lanreotide (17%), cabergoline (16.3%), pegvisomant (14.2%), octreotide-SA (6.7%) and bromocriptine (3.4%). Combination treatments were least likely to end in cessation (10.0%) and treatment with bromocriptine and cabergoline were most likely to end with cessation of all pharmacotherapy (50.6% and 47.4%, respectively). CONCLUSIONS: From 2002-2013, 12.9-17.8% of patients annually either switched pharmacotherapy once or multiple times or stopped treatment altogether, with a greater proportion of these patients switching to a new treatment regimen. This suggests an unmet need for adequate treatment of acromegaly. Many patients who changed initial pharmacotherapy to combination therapy may have switched due to inadequate disease control. Dopamine agonists, generally less efficacious, were more commonly stopped than other pharmacotherapies. The role of radiotherapy and recently approved pasireotide were not examined in these treatment patterns.

Influenza Antiviral Expenditures and Outpatient Prescriptions in the United States, 2003-2012.

The clinical efficacy and cost-effectiveness of influenza antiviral use are controversial, with recent analyses suggesting potentially limited value. Thus, the objectives of this study were to describe influenza antiviral expenditures overall and by health care setting over a 10-year period (2003-2012) and to assess the correlation between outpatient influenza antiviral prescription use and influenza-like illness (ILI) outpatient visits. Retrospective, cross-sectional study. IMS Health National Sales Perspectives and Xponent databases and Centers for Disease Control and Prevention ILINet national influenza surveillance system database. All prescriptions for oseltamivir, rimantadine, or zanamivir from community pharmacies, mail order pharmacies, clinics, nonfederal hospitals, and other health care settings (federal hospitals, military facilities, jails and prisons, universities, staff-model health maintenance organizations, veterinary hospitals and clinics, and long-term care facilities) between January 1, 2003, and December 31, 2012. Prescribing rates were calculated (prescriptions/1000persons) for each year from 2003 to 2012 by using U.S. Census Bureau data. Influenza season was defined as July 1-June 30 of each calendar year. Linear regression assessed the correlation between influenza antiviral expenditures, prescription use, and ILI diagnoses. From 2003 to 2012, influenza antiviral drug expenditures accounted for $3.74 billion, with the majority from community pharmacies. After adjusting for inflation, no growth was observed for expenditures. A total of 32.8 million influenza antiviral prescriptions were dispensed from community pharmacies during the study period, and these prescriptions experienced 133.2% growth from 2003 to 2012. One third of expenditures and one quarter of dispensed prescriptions were in 2009. Influenza seasons were correlated with ILI and antiviral prescriptions. Annual community pharmacy expenditures were also associated with influenza antiviral prescriptions dispensed over the 10-year period. Influenza antivirals totaled $3.74 billion in the United States from 2003 to 2012, with the majority in 2009 and from community pharmacies. Influenza antivirals constituted a small proportion of total medication expenditures, but unforeseen pandemics resulted in unusually high use and expenditures. Influenza antiviral prescriptions dispensed from community pharmacies were associated with ILI and drug expenditures.

PMH49 - The Economic Consequences of the use of Antidepressants in Belgium

Antidepressants use is increasing worldwide but is particularly high in Belgium compared to other EU countries whereas suicide-rates in Belgium are among the highest. This could reflect misuse of antidepressants resulting in an important economic burden. The former is part of a separate abstract. The aim here was to evaluate potential savings that could be realized in case prescriptions behavior in Belgium would be similar to neighbor countries. Current spending levels for antidepressants and mood stabilizer prescriptions were determined in Belgium, France and the Netherlands. Volume and value sales were determined per country (average number of pills sold/capita) based on IMS Health Belgian National Retail Database available to IMS Health in both countries via the IMS MIDAS platform (2013 data). The potential country-level prescription cost in Belgium was estimated by multiplying average number of pills/person in France and the Netherlands, with the cost/pill in Belgium and extrapolating the result to the total population in Belgium, assuming that prescribing levels in Belgium were equal to those in France and the Netherlands and using Belgian prices. In Belgium the number of pills per capita is respectively 45% and 48% higher compared to France and the Netherlands (34.17 vs. 23.62 vs. 23.15 pills/person). With a 30% smaller population than the Netherlands, spending in Belgium is 4 times higher. In France, having a 6 times larger population compared to Belgium, spending is only 3 times higher. The estimated savings for the Belgian payer applying the usage (pill/person) of respectively France and the Netherlands and current cost/pill in Belgium were €67 and €70 Mn, meaning around 30% of current spending in Belgium. By comparing Belgium’s prescription patterns to France and the Netherlands, we estimated important potential savings due to antidepressant mis-use/over-use that could be re-invested in for example mental health prevention.