The cost-effectiveness of stepped care for the treatment of anxiety disorders in adults: A model-based economic analysis for the Australian setting.

OBJECTIVE: To evaluate the cost-effectiveness of stepped care compared to care as usual (CAU) for the treatment of adults with mild-to-moderate anxiety disorders from a health sector perspective in the Australian setting. METHOD: A decision tree model was constructed to estimate the cost per disability adjusted life year (DALY) averted over a 12-month time horizon. The model compared a three-step stepped care intervention to CAU. Stepped care included an initial phase of guided self-help, followed by face-to-face cognitive behavioural therapy, and pharmacotherapy as the final step. The model adopted a health sector perspective, used epidemiological parameters and disability weights obtained from the Global Burden of Disease Study 2013. Effect sizes were derived from a randomized trial of stepped care and a longitudinal cohort study. Costs were expressed in 2013 Australian dollars (A$). Multivariate probabilistic and univariate sensitivity analyses were performed. RESULTS: Stepped care was found to be cost-effective compared to CAU with an incremental cost-effective ratio of A$3093 per DALY averted. One-hundred percent of the uncertainty iterations fell below the A$50,000 per DALY averted willingness-to-pay threshold commonly used in Australia. The evaluation was most sensitive to changes in diagnosis rates and effect sizes. CONCLUSION: A three-step model of stepped care appears to be cost-effective for the treatment of adults with mild to moderate anxiety disorders from the Australian health sector perspective. These results can provide some assurance to decision-makers that stepped care represents an efficient use of health care resources.

Prevalence and economic burden of comorbid anxiety and depression among patients with moderate-to-severe psoriasis.

Objective: To describe the prevalence and costs of anxiety and depression among moderate-to-severe psoriasis (PsO) patients in a commercially-insured US population.Methods: The IBM MarketScan Commercial database was used to select adults with moderate-to-severe PsO (≥1 PsO diagnosis and ≥1 systemic or biologic medication) within each calendar year from 2014 to 2016. Adults with no diagnosis of PsO or similar disorders were randomly selected (2014-2016) and matched 1:1 to PsO patients to compare the prevalence of anxiety and depression each year. Moderate-to-severe PsO patients identified in 2014 with continuous enrollment through 2015 were stratified into those with treated anxiety and/or depression (≥1 anxiety or depression diagnosis plus any anxiolytics, antidepressants, or antipsychotics within 30 days) vs those without anxiety/depression, and then matched 1:1 to determine the incremental burden of treated anxiety/depression among PsO patients. All-cause and PsO-related healthcare costs were compared between the matched cohorts using generalized linear models.Results: In total, 69,644 matched PsO and non-PsO patients were identified in 2014, 61,478 in 2015, and 66,880 in 2016. The prevalence of anxiety/depression among PsO patients increased more than for matched controls, from 18.2% vs 12.2% in 2014 (p < 0.01) to 19.6% vs 13.1% in 2016 (p < 0.01). Prevalence of treated anxiety/depression followed the same trend, with increases from 14.5% vs 8.9% in 2014 (p < 0.01) to 15.9% vs 9.9% in 2016 (p < 0.01). For patients with moderate-to-severe PsO, unadjusted incremental all-cause healthcare costs associated with treated anxiety/depression were $8,077 (p < 0.01); 91% was due to utilization of medical services such as hospitalizations, ER visits, office visits, and other outpatient services (all p < 0.01).Conclusions: The prevalence of psychiatric disorders is higher among PsO patients than the general population, and the incremental burden of treated anxiety/depression is substantial. Further research is needed, but PsO treatments that improve psychiatric symptoms such as anxiety/depression may benefit patients and reduce their economic burden.

Using anxiolytics in a pediatric otolaryngology clinic to avoid the operating room.

INTRODUCTION: There is increasing concern regarding the risks associated with the use of general anesthesia in pediatric patients. Many otolaryngologic procedures performed under general anesthesia can also be performed in clinic. We hypothesize that anxiolytics can aid in performing common procedures in clinic thus avoiding the need to undergo general anesthesia in the OR. METHODS: We performed a retrospective review of patients undergoing inoffice procedures with anxiolytics in our pediatric otolaryngology outpatient clinic between February 2013 and January 2017. Charts were reviewed for age, past medical history, procedure type/duration, and outcome. These results were then compared to a cohort undergoing similar procedures in the OR. RESULTS: A total of 34 patients underwent an in-office procedure with an anxiolytic. The success rate was 97% (33/34). The average age was 6.2 years. Six children (17%) had a known history of chromosomal abnormalities and 2 children (6%) had autism. The four most common procedures performed were cerumen impaction removal (8), flexible laryngoscopy (6), ear canal foreign body removal (5), and septal cautery (4). Performing similar procedures in the OR resulted in an average additional cost of $822. CONCLUSIONS: Performing procedures with anxiolytics in a pediatric otolaryngology clinic is safe, expeditious, and cost-effective. Anxiolytics can provide an effective alternative to general anesthesia.

Consequences on economic outcomes of generic versus brand-name drugs used in routine clinical practice: the case of treating peripheral neuropathic pain or generalized anxiety disorder with pregabalin.

BACKGROUND: Discrepancies are seen between arguments in favor of and against prescribing generic versus brand-name drugs. OBJECTIVE: To provide real-world evidence on treatment persistence, economic and clinical outcomes of pregabalin, generic versus brand-name (Lyrica®, Pfizer), routinely used to treat neuropathic pain (NP) or generalized anxiety disorder (GAD). METHODS: Electronic medical records from subjects' first starting treatment with pregabalin between January-2015 and June-2016 were analyzed. Persistence, resources utilization, and costs were assessed, along with remitter and responder rates. RESULTS: A total of 4860 records were analyzed. Discontinuation was lower with brand-name than with generic in NP (adjusted hazard ratio [HR]: 0.70 [95% CI: 0.58-0.85], p < 0.001) and GAD patients (HR: 0.63 [0.45-0.84], p < 0.001). Adjusted mean total costs were lower with brand-name: €1500 [1428-1573] vs. €2003 [1864-2143] in NP and €1528 [1322-1734] vs. €2150 [1845-2454] in GAD (both p < 0.001). More patients were remitters/ responders with brand-name in NP (55.0% vs. 46.7% and 59.2% vs. 48.4%, respectively; p < 0.001) and GAD (58.6% vs. 48.7% and 64.6% vs. 47.2%, respectively; p < 0.001). CONCLUSIONS: As a consequence of higher persistence in routine practice, patients who first started therapy with pregabalin brand-name versus generic showed better pain or anxiety outcomes at a lower cost to payers in Spain.

Purchases of prescription drugs before an alcohol-related death: A ten-year follow-up study using linked routine data.

BACKGROUND: Physician's intention to prescribe drugs could potentially be used to improve targeting of alcohol interventions and enhanced disease management to patients with a high risk of severe alcohol-related harm within outpatient settings. METHODS: Comparison of ten-year incidence trajectories of 13.8 million reimbursed purchases of prescription drugs among 303,057 Finnish men and women of whom 7490 ultimately died due to alcohol-related causes (Alc+), 14,954 died without alcohol involvement (Alc-), and 280,613 survived until the end of 2007. RESULTS: 5-10 years before death, 88% of the persons with an Alc+ death had received prescription medication, and over two-thirds (69%) had at least one reimbursed purchase of drugs for the alimentary tract and metabolism, the cardiovascular system, or the nervous system. Among persons with an Alc+ death, the incidence rate (IR) for purchases of hypnotics, and sedatives was 1.38 times higher (95% confidence interval (CI):1.32,1.44) compared to those with an Alc- death, and 4.07 times higher (95%CI:3.92,4.22) compared to survivors; and the IR for purchases of anxiolytics was 1.40 times higher (95%CI:1.34,1.47) compared to those with an Alc- death, and 3.61 times higher (95%CI:3.48,3.78) compared to survivors. CONCLUSIONS: Using physician's intention to prescribe drugs affecting the alimentary tract and metabolism, cardiovascular system and nervous system could potentially be used to flag patients who might benefit from screening, targeted interventions or enhanced disease management. In particular, patients who are to be prescribed anxiolytics, hypnotics, and sedatives, and antidepressants may benefit from enhanced interventions targeted to problem drinking.

Do coverage mandates affect direct-to-consumer advertising for pharmaceuticals? Evidence from parity laws.

Direct-to-consumer advertising (DTCA) for prescription drugs is a relatively unique feature of the US health care system and a source of tens of billions of dollars in annual spending. It has also garnered the attention of researchers and policymakers interested in its implications for firm and consumer behavior. However, few economic studies have explored the DTCA response to public policies, especially those mandating coverage of these products. We use detailed advertising expenditure data to assess if pharmaceutical firms increase their marketing efforts after the implementation of relevant state and federal health insurance laws. We focus on mental health parity statutes and related drug therapies-a potentially ripe setting for inducing stronger consumer demand. We find no clear indication that firms expect greater value from DTCA after these regulatory changes. DTCA appears driven by other considerations (e.g., product debut); however, it remains a possibility that firms respond to these laws through other, unobserved channels (e.g., provider detailing).

Cost-effectiveness of interventions for treating anxiety disorders: A systematic review.

BACKGROUND: Anxiety disorders are highly prevalent mental disorders that constitute a major burden on patients and society. As a consequence, economic evaluations of the interventions have become increasingly important. However, no recent overview of these economic evaluations is currently available and the quality of the published economic evaluations has not yet been assessed. Therefore, the current study has two aims: to provide an overview of the evidence regarding the cost-effectiveness of interventions for anxiety disorders, and to assess the quality of the studies identified. METHODS: A systematic review was conducted using PubMed, PsycINFO, NHS-EED, and the CEA registry. We included full economic evaluations on interventions for all anxiety disorders published before April 2016, with no restrictions on study populations and comparators. Preventive interventions were excluded. Study characteristics and cost-effectiveness data were collected. The quality of the studies was appraised using the Consensus on Health Economic Criteria. RESULTS: Forty-two out of 826 identified studies met the inclusion criteria. The studies were heterogeneous and the quality was variable. Internet-delivered cognitive behavioural therapy (iCBT) appeared to be cost-effective in comparison with the control conditions. Four out of five studies comparing psychological interventions with pharmacological interventions showed that psychological interventions were more cost-effective than pharmacotherapy. LIMITATIONS: Comparability was limited by heterogeneity in terms of interventions, study design, outcome and study quality. CONCLUSIONS: Forty-two studies reporting cost-effectiveness of interventions for anxiety disorders were identified. iCBT was cost-effective in comparison with the control conditions. Psychological interventions for anxiety disorders might be more cost-effective than pharmacological interventions.

[Austrian expenditures on psychopharmaceutical drugs between 2006 and 2013]. / Analyse der Ausgaben für Psychopharmaka in Österreich von 2006 bis 2013.

OBJECTIVES: Health costs, which are increasing at a yearly rate of 4 %, represent 11% and thus a large share of Austria's gross domestic product (GDP). High expenditures derive frommental health care costs, including medication. In this article we investigate whether the costs and usage of psychopharmaceutic products in Austria are rising. METHOD: We did a descriptive analysis of the sales figures and number for packaging units of pharmaceutical products of ATC-classes N05 and N06 in all Austrian hospitals, pharmacies and medicine chests for the years 2006-2013. All data were provided free of charge by IMSHealth. RESULTS: The sales volume and number of prescribed packaging units of pharmaceuticals of ATC-classes N05 and N06 increased over the time period in question. In 2013, about 25% more packaging units were being sold than in 2006. Among the two ATC-classes, however, the indication subgroups developed differently. Expenditures increased a total of about 31%within the period of consideration. CONCLUSIONS: The increase in psycho-pharmaceutical sales exceeds the expansion rates of other health expenditures (17.8 %). During the 9 years of observation, 25% more psychopharmaceutical products were sold. This may result from increased prevalence of mental disorders, higher usage or an increment in prescriptions.

[Trends in the consumption of anxiolytic and hypnotic drugs in a Colombian population]. / Tendencias de consumo de medicamentos ansiolíticos e hipnóticos en una población colombiana, 2008-2013.

INTRODUCTION: In Latin America, psychotropic medications are the third most marketed drug group, especially antidepressants (35%) and anxiolytics (5%). The objective of this study was to determine the trends in the consumption and the costs of anxiolytic and hypnotic drugs in a population of patients enrolled in the Health System of Colombia. MATERIAL AND METHODS: A descriptive, observational study was performed using the data recorded inprescriptions for any anxiolytic or hypnotic drug prescribed to outpatients in the period between January 2008 and December 2013 in a population of 3.5 million people. Sociodemographic, pharmacological variables, overall costs, and cost per thousand inhabitants per day (CHD), were also recorded. RESULTS: The number of patients who received the drugs studied varied from 11,097 to 19,231 between 2008 and 2013. The most used drugs were clonazepam (44.1% of formulations), alprazolam (31.2%), and lorazepam (13.2%). The invoiced value of anxiolytics increased from US$ 207,673.63 in 2008 to US$ 488,977 in 2013, an increase of 135.4%. The CHD was US$ 0.31 for benzodiazepines, and US$ 0.02 for zaleplon, zolpidem and zopiclone (Z drugs) for 2008, and US$ 0.36 and US$ 0.02 in 2013 respectively. The CHD declined after 2010 following the introduction of generic drugs. CONCLUSIONS: Patients receiving benzodiazepines in Colombia are mostly women, average age 55 years, with very low frequency in defined daily doses per thousand inhabitants when compared with other countries.

The association of the use of opioid and psychotropic medications with workers' compensation claim costs and lost work time.

OBJECTIVE: To study the relationship between the use of psychotropic and opioid medications with workers' compensation disability and costs. METHODS: The study population included lost time claimants injured between 1999 and 2002 followed to closing in December 31, 2009. RESULTS: Controlling for age, sex, marital status, attorney involvement, and spinal surgeries, multivariate logistic regression revealed that odds ratios (95% confidence interval) of claim costs ≥$100,000 compared with claimants who were never prescribed opioids were 4.3 for short-acting opioids only; 8.6 for any use of long-acting opioids; 2.8 for any use of hypnotics; 2.6 for any use of antipsychotics; 1.6 for any use of anti-anxiety agents; and 2.9 for any use of antidepressants. CONCLUSIONS: The use of psychotropic and opioid medications was associated with high workers' compensation costs and prolonged disability.

Pregabalin: a review of its use in adults with generalized anxiety disorder.

Pregabalin (Lyrica(®)), a well established anxiolytic agent, has been approved in the EU for the treatment of generalized anxiety disorder (GAD) in adults. It has a distinct mechanism of action relative to other anti-anxiety agents (α2δ binding at presynaptic voltage dependent calcium channels leading to inhibition of excitatory neurotransmission), a rapid onset of effect (typically ≤1 week) and broad spectrum activity against both the psychic and somatic symptoms of GAD. In long-term studies, pregabalin maintained improvements in anxiety symptoms that occurred in response to short-term treatment and delayed the time to relapse of GAD compared with placebo. Common comorbidities of GAD, such as insomnia, gastrointestinal symptoms and subsyndromal depression, have no effect on the anxiolytic efficacy of, and moreover are specifically improved by, pregabalin. Treatment with pregabalin is generally well tolerated; the drug has an adverse event profile that includes dizziness, somnolence and weight gain. The potential for abuse of pregabalin is low; the risk of withdrawal symptoms is generally low when the drug is discontinued gradually (over 1 week). Alongside selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), pregabalin is considered a first-line agent for the long-term treatment of GAD by the World Federation of Societies of Biological Psychiatry. It should be stressed, however, that definitive head-to-head studies comparing pregabalin with SSRI/SNRIs, including in patients with GAD and co-morbid major depressive disorder, are currently lacking. Recently, a study of SSRI/SNRI augmentation with pregabalin yielded positive results, while another study of switching from long-term benzodiazepine therapy to pregabalin was inconclusive; further investigations on these topics are warranted.

The cost effectiveness of pharmacological treatments for generalized anxiety disorder.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most prevalent anxiety disorders, with important implications for patients and healthcare resources. However, few economic evaluations of pharmacological treatments for GAD have been published to date, and those available have assessed only a limited number of drugs. OBJECTIVE: To assess the cost effectiveness of pharmacological interventions for patients with GAD in the UK. METHODS: A decision-analytic model in the form of a decision tree was constructed to compare the costs and QALYs of six drugs used as first-line pharmacological treatments in people with GAD (duloxetine, escitalopram, paroxetine, pregabalin, sertraline and venlafaxine extended release [XL]) and 'no pharmacological treatment'. The analysis adopted the perspective of the NHS and Personal Social Services (PSS) in the UK. Efficacy data were derived from a systematic literature review of double-blind, randomized controlled trials and were synthesized using network meta-analytic techniques. Two network meta-analyses were undertaken to assess the comparative efficacy (expressed by response rates) and tolerability (expressed by rates of discontinuation due to intolerable side effects) of the six drugs and no treatment in the study population. Cost data were derived from published literature and national sources, supplemented by expert opinion. The price year was 2011. Probabilistic sensitivity analysis was conducted to evaluate the underlying uncertainty of the model input parameters. RESULTS: Sertraline was the best drug in limiting discontinuation due to side effects and the second best drug in achieving response in patients not discontinuing treatment due to side effects. It also resulted in the lowest costs and highest number of QALYs among all treatment options assessed. Its probability of being the most cost-effective drug reached 75 % at a willingness-to-pay threshold of £20,000 per extra QALY gained. CONCLUSION: Sertraline appears to be the most cost-effective drug in the treatment of patients with GAD. However, this finding is based on limited evidence for sertraline (two published trials). Sertraline is not licensed for the treatment of GAD in the UK, but is commonly used by primary care practitioners for the treatment of depression and mixed depression and anxiety.

Modelling the cost-effectiveness of pregabalin versus usual care in daily practice in the treatment of refractory generalised anxiety disorder in Spain.

PURPOSE: To model the cost-effectiveness (CEA) of the use of pregabalin versus usual care (UC) in outpatients with refractory generalised anxiety disorder (GAD) treated in daily practice in mental health settings in Spain. METHODS: This CEA model used data extracted from a 6-month prospective non-interventional trial: the Amplification of Definition of ANxiety (ADAN) study, which was conducted to determine the cost-of-illness in GAD subjects. Refractory subjects were those who reported persistent symptoms of anxiety and showed suboptimal response in the Hamilton-anxiety scale (HAM-A ≥ 16) after a standard dose regimen of anxiolytics other than pregabalin, alone or in combination, over 6 months. The pregabalin arm was documented with data extracted from patients who received pregabalin in the study for the first time, added or replacing the existing therapy. In the UC arm, treatment might include one or more of the following: a serotonin selective reuptake inhibitor, a serotonin-norepinephrine reuptake inhibitor, other anti-depressants, a benzodiazepine or an anti-epileptic drug other than pregabalin. The time horizon of the modelling was 6 months in the base-case scenario, and the National Health System perspective was chosen to calculate costs. Effectiveness was expressed as quality-adjusted life years (QALYs) gained, which were derived using the EQ-5D questionnaire, at baseline and end-of-trial visits. Results of the CEA model was expressed as an incremental cost-effectiveness ratio (ICER) per QALY gained. Probabilistic sensitivity analysis using bootstrapping techniques was also carried out to obtain the cost-effectiveness plane and the corresponding acceptability curve. RESULTS: Data from a total of 429 subjects per arm (mean HAM-A score 25.7) meeting eligible criteria for inclusion in CEA modelling were extracted from the original trial. Compared with UC, pregabalin (average dose 218 mg/day) was associated with significantly higher QALY gain; 0.1209 ± 0.1030 versus 0.0994 ± 0.0979 (P = 0.003), but increased healthcare costs as well; 1,272 ± 1,240 versus 1,070 ± 1,177 (P < 0.069) and drug costs 525 ± 252 versus 219 ± 211 (P < 0.001), resulting in an ICER of 15,804/QALY (95 % CI 6,661; 37,186) for healthcare costs and 15,165/QALY (7,947; 31,754) when drug costs were considered alone. A total of 94 % of re-samples fell below the threshold of 30,000 per QALY. CONCLUSIONS: This evaluation modelling suggests that pregabalin may be cost-effective in comparison with UC in outpatients with refractory GAD treated in mental healthcare settings in daily practice in Spain.

Treatment patterns and costs in patients with generalised anxiety disorder: one-year retrospective analysis of data from national registers in Sweden.

PURPOSE: To investigate medication use, direct healthcare costs and comorbidities in patients with generalised anxiety disorder (GAD) within specialised care in Sweden 2006-2007. METHODS: A retrospective study was conducted using data from the National Patient Register and the Swedish Prescribed Drug Register. All patients with a primary GAD (ICD-10) diagnosis in 2006 were followed for 12 months to study medication use and health care consumption. Resource use was evaluated from the number of hospitalisation episodes, number of visits to outpatient care and medication dispensed. Costs were calculated by multiplying the number of visits and hospitalisation episodes with the corresponding unit costs. Descriptive statistics were used for all analyses. RESULTS: Three thousand seven hundred and one patients with a primary GAD diagnosis were included in the study. Thirty-four percent of the patients (n=1246) had at least one secondary comorbid diagnosis. SSRIs/SNRIs were the most commonly dispensed medications, followed by benzodiazepine-anxiolytics, hypnotics and antihistamines. The mean number of treatment days for all medications prescribed and dispensed was highest (1144 days) for elderly women aged 65 years or more (treatment days per patient could exceed 365 days due to multiple concomitant medication use). Elderly patients were frequently prescribed benzodiazepine-anxiolytics (n=92/117 men [79%]; n=238/284 women [84%]) and hypnotics (n=70 men [60%]; n=178 women [63%]) compared to the overall study population (n=612/1303 men [47%] and n=935/2398 women [39%], respectively). GAD-related direct costs accounted for 96% of all direct costs. Mean number of hospitalisation days and corresponding costs were high (19 days; SEK 92,156; n=358 [9.7%]) in relation to medication (SEK 5520; n=3352 [91%]) and outpatient costs (SEK 7698; n=3461 [94%]). CONCLUSIONS: The high rate of polypharmacy, significant psychiatric comorbidity and widespread use of benzodiazepine-anxiolytics and medications not indicated for GAD suggest that the disease burden is high. Total direct costs associated with the disease were high but still likely to be underestimated.

Discontinuation of reimbursement of benzodiazepines in the Netherlands: does it make a difference?

BACKGROUND: In an attempt to control chronic benzodiazepine use and its costs in the Netherlands, health care insurance reimbursement of this medication was stopped on January 1st 2009. This study investigates whether benzodiazepine prescriptions issued by general practitioners changed during the first two years following implementation of this regulation. METHODS: Registry study based on data from all benzodiazepine users derived from the Registration Network Groningen. This general practice-based research network collects longitudinal data on the primary care administered to about 30,000 patients. Based on the number of quarterly accumulated prescription days, a comparison was made of benzodiazepine prescriptions issued between 2007/2008 and 2009/2010. Also investigated was which type of user (i.e. short-term or long-term) showed the most change. RESULTS: Information on benzodiazepine prescriptions among 5,200 patients from 16 consecutive trimesters between 2007 and 2010 was available for analysis. A significant reduction in prescription days was observed between 2007/2008 and 2009/2010. Overall, an estimated 1.73 (CI:-1.94 to -1.53; p<0.001) days were less prescribed per trimester after the termination of reimbursement. In particular, short-term users experienced a reduction in prescription days in 2009 and 2010. The number of long-term users decreased by 2.3%, while the number of individuals that did not use increased by 4.2%. CONCLUSIONS: A total reduction of almost 14 prescription days was observed over eight trimesters after implementation of the regulation to terminate the reimbursement of benzodiazepines. Short-term users were mainly responsible for this reduction in prescription days in 2009 and 2010. Although long-term users did not alter their benzodiazepine use in 2009 and 2010, the number of long-term users decreased slightly.

Change in healthcare utilization and costs following initiation of benzodiazepine therapy for long-term treatment of generalized anxiety disorder: a retrospective cohort study.

BACKGROUND: Selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and benzodiazepine anxiolytics are used in the US to treat generalized anxiety disorder (GAD). While benzodiazepines typically provide rapid symptomatic relief, long-term use is not recommended due to risks of dependency, sedation, falls, and accidents. METHODS: Using a US health insurance database, we identified all persons with GAD (ICD-9-CM diagnosis code 300.02) who began a long-term course of treatment (≥ 90 days) with a benzodiazepine anxiolytic between 1/1/2003 and 12/31/2007, We compared healthcare utilization and costs over the six-month periods preceding and following the date of treatment initiation ("pretreatment" and "post-treatment", respectively), and focused attention on accident-related encounters (e.g., for treatment of fractures) and care received for other reasons possibly related benzodiazepine use (e.g., sedation, dizziness). RESULTS: A total of 866 patients met all study entry criteria; 25% of patients began treatment on an add-on basis (i.e., adjunctive to escitalopram, paroxetine, sertraline, or venlafaxine), while 75% of patients did not receive concomitant therapy. Mean total healthcare costs increased by $2334 between the pretreatment and post-treatment periods (from $4637 [SD=$9840] to $6971 [$17,002]; p<0.01); costs of accident-related encounters and other care that was possibly related to use of benzodiazepines increased by an average of $1099 ($1757 [$7656] vs $2856 [$14,836]; p=0.03). CONCLUSIONS: Healthcare costs increase in patients with GAD beginning long-term (≥ 90 days) treatment with a benzodiazepine anxiolytic; a substantial proportion of this increase is attributable to care associated with accidents and other known sequelae of long-term benzodiazepine use.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

BACKGROUND: Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. OBJECTIVES: To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). METHODS: Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR4) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. RESULTS: The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR4 = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. CONCLUSIONS: Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy.

Medicare Part D benzodiazepine exclusion and use of psychotropic medication by patients with new anxiety disorders.

OBJECTIVE: The Medicare Modernization Act (MMA) specifically excluded benzodiazepines from Medicare Part D coverage starting in 2006; however, benzodiazepines are an effective, low-cost treatment for anxiety. This study evaluated the effect of the Medicare Part D benzodiazepine coverage exclusion among patients with new anxiety disorders. METHODS: The authors used a quasi-experimental cohort design to study patients with new anxiety diagnoses from a large national health plan during the first six months of 2005, 2006, and 2007. Logistic and zero-truncated negative-binomial regression models using covered claims for behavioral, medical, and pharmaceutical care linked with eligibility files were used to estimate utilization and costs of psychotropic medication and health care utilization among elderly Medicare Advantage enrollees (N=8,397) subject to the MMA benzodiazepine exclusion and a comparison group of near-elderly (ages 60­64) enrollees (N=1,657) of a managed care plan. RESULTS: Medicare Advantage enrollees diagnosed in 2005 had significantly (p<.05) higher rates of covered claims for benzodiazepines and all psychotropic drugs, lower rates of covered claims for nonbenzodiazepines, and lower expenditures for psychotropic drugs than enrollees diagnosed in 2006 and 2007. There were no significant differences over time in utilization or expenditures related to psychotropic medication among the comparison group. There also were no significant changes over time in outpatient visits for behavioral care by either cohort. CONCLUSIONS: Among elderly patients with new anxiety diagnoses, the MMA benzodiazepine exclusion increased use of nonbenzodiazepine psychotropic drugs without substitution of increased behavioral care. Overall, the exclusion was associated with a modest increase in covered claims for psychotropic medication.

The cost of generalized anxiety disorder in primary care settings: results of the ANCORA study.

To assess the cost of illness of generalized anxiety disorder (GAD) in a primary healthcare setting in Spain. A cross-sectional, retrospective study was conducted. The sample comprised patients diagnosed with GAD according to ICD-10 criteria and a control group. Healthcare/non-healthcare resource utilization was recorded retrospectively for the 12 months prior to the study visit. Costs were estimated from a societal perspective. Two models have been produced to study the variables that influence the cost of the illness both, without and with controls. The study enrolled 456 patients [76.8 % women, 49.2 (17.0) years] with GAD and 74 controls without GAD [42.5 % women, 47.9 (16.7) years]. 67.8 % of subjects were on combination therapy (antidepressant + anxiolytic); 6 % were using 2 or more drugs to treat anxiety; and 23.4 % were on monotherapy. Total annual average costs were higher in the GAD group (€7,739 vs. €2,609), with mean costs attributable to GAD of €5,139 (healthcare costs: €1,329, indirect costs: 75 % of total cost, approximately). Age and health status measured by Hamilton Anxiety Rating Scale and clinical global impression were related to costs. The improvements in quality of life measured by EQ-5D index are associated to lower cost. GAD treated in Spanish primary healthcare settings generated considerable healthcare costs and, particularly, loss-of-productivity costs.