The introduction of generic risperidone in Medicare Part D.
ABSTRACT: The introduction of generic second-generation antipsychotics (SGAs), starting with risperidone in July 2008, could reduce antipsychotic spending and cost-related use barriers. This study examines associations between generic risperidone use and spending and adherence after introduction among Medicare Advantage (MA) beneficiaries.Historic cohort study.The study included MA beneficiaries receiving SGA treatment prior to July 2008. We examined antipsychotic spending using linear models, adherence (proportion of days covered ? 80%) using logistic models, and nonpersistence (time to first gap in antipsychotic use > 30 days) in 2009 using Cox proportional hazard models, comparing beneficiaries with versus without generic use, adjusting for individual and plan characteristics.Between July 2008 and December 2009, 22.8% of beneficiaries had ? 1 fill of generic risperidone: 73% of those previously using branded risperidone and 6.7% of those previously using other SGAs. Beneficiaries in private fee-for-service (FFS) versus health maintenance organization (HMO) plans had lower rates of generic use (hazard ratio [HR], 0.73 [95% CI, 0.56-0.96]); however, cost-sharing levels were not associated with generic use. Compared with beneficiaries who continued using other SGAs, those who switched from other SGAs to generic risperidone in 2008 had lower out-of-pocket spending (-$214; 95% CI, -$314 to -$115), higher adherence (odds ratio, 2.34; 95% CI, 1.62-3.40) and lower rates of nonpersistence (HR, 0.56; 95% CI, 0.46-0.69) in 2009.Generic use was concentrated among patients previously using branded risperidone. HMO plans appeared to be more effective at encouraging generic use than unmanaged private FFS plans; however, patient financial incentives had limited influence on switching. Additional opportunity remains to encourage greater generic SGA use, reduce spending, and potentially improve treatment adherence and outcomes.
Project description:Medicare Part D provides formulary protections for antipsychotics but does not exempt these drugs from cost-sharing. We investigated the impact of Part D coverage on antipsychotic drug spending, adherence, and clinical outcomes among beneficiaries with varying indications for use.We conducted a historical cohort study of Medicare Advantage beneficiaries who received antipsychotic drugs, with diagnoses of schizophrenia or bipolar disorder or with no mental health diagnoses (N=10,190). Half had a coverage gap; half had no gap because of low-income subsidies. Using fixed effects regression models, we examined changes in spending and adherence as beneficiaries experienced cost-sharing increases after reaching the gap. We examined changes in hospitalizations and emergency department visits using proportional hazard models.Across all diagnostic groups, total monthly expenditure on antipsychotic drugs decreased with cost-sharing increases in the gap compared with those with no gap (eg, schizophrenia: -$123 95% confidence interval [-$138, -$108]), and out-of-pocket spending increased (eg, schizophrenia: $104 [$98, $110]). Adherence similarly decreased, with the largest declines among those with schizophrenia (-20.6 percentage points [-22.3, -18.9] in proportion of days covered). Among beneficiaries with schizophrenia and bipolar disorder, hospitalizations and emergency department visit rates increased with cost-sharing increases (eg, schizophrenia: hazard ratio=1.32 [1.06, 1.65] for all hospitalizations), but did not among subjects without mental health diagnoses. Clinical event rates did not change among beneficiaries with low-income subsidies without gaps.There is evidence of interruptions in antipsychotic use attributable to Part D cost-sharing. Adverse events increased among beneficiaries with approved indications for use, but not among beneficiaries without such indications.
Project description:OBJECTIVES: To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. METHODOLOGY: We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. RESULTS: Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. CONCLUSIONS: Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.
Project description:To compare drug costs and adherence among Medicare beneficiaries with the standard Part D coverage gap versus supplemental gap coverage in 2006.Pharmacy data from Medicare Advantage Prescription Drug (MAPD) plans.Parallel analyses comparing beneficiaries aged 65+ with diabetes in an integrated MAPD with a gap versus no gap (n=28,780); and in a network-model MAPD with a gap versus generic-only coverage during the gap (n=14,984).Drug spending was 3 percent (95 percent confidence interval [CI]: 1-4 percent) and 4 percent (CI: 1-6 percent) lower among beneficiaries with a gap versus full or generic-only gap coverage, respectively. Out-of-pocket expenditures were 189 percent higher (CI: 185-193 percent) and adherence to three chronic drug classes was lower among those with a gap versus no gap (e.g., odds ratio=0.83, CI: 0.79-0.88, for oral diabetes drugs). Annual out-of-pocket spending was 14 percent higher (CI: 10-17 percent) for beneficiaries with a gap versus generic-only gap coverage, but levels of adherence were similar.Among Medicare beneficiaries with diabetes, having the Part D coverage gap resulted in lower total drug costs, but higher out-of-pocket spending and worse adherence compared with having no gap. Having generic-only coverage during the gap appeared to confer limited benefits compared with having no gap coverage.
Project description:To investigate whether differential influence on the QTc interval exists among four second generation antipsychotics (SGAs) in psychosis.Data were drawn from a pragmatic, randomized head-to-head trial of the SGAs risperidone, olanzapine, quetiapine, and ziprasidone in acute admissions patients with psychosis, and with follow-up visits at discharge or maximally 6-9 wk, 3, 6, 12 and 24 mo. Electrocardiograms were recorded on all visits. To mimic clinical shared decision-making, the patients were randomized not to a single drug, but to a sequence of the SGAs under investigation. The first drug in the sequence defined the randomization group, but the patient and/or clinician could choose an SGA later in the sequence if prior negative experiences with the first one(s) in the sequence had occurred. The study focuses on the time of, and actual use of the SGAs under investigation, that is until treatment discontinuation or change, in order to capture the direct medication effects on the QTc interval. Secondary intention-to-treat (ITT) analyses were also performed.A total of 173 patients, with even distribution among the treatment groups, underwent ECG assessments. About 70% were males and 43% had never used antipsychotic drugs before the study. The mean antipsychotic doses in milligrams per day with standard deviations (SD) were 3.4 (1.2) for risperidone, 13.9 (4.6) for olanzapine, 325.9 (185.8) for quetiapine, and 97.2 (42.8) for ziprasidone treated groups. The time until discontinuation of the antipsychotic drug used did not differ in a statistically significant way among the groups (Log-Rank test: P = 0.171). The maximum QTc interval recorded during follow-up was 462 ms. Based on linear mixed effects analyses, the QTc interval change per day with standard error was -0.0030 (0.0280) for risperidone; -0.0099 (0.0108) for olanzapine; -0.0027 (0.0170) for quetiapine, and -0.0081 (0.0229) for ziprasidone. There were no statistically significant differences among the groups in this regard. LME analyses based on ITT groups (the randomization groups), revealed almost identical slopes with -0.0063 (0.0160) for risperidone, -0.0130 (0.0126) for olanzapine, -0.0034 (0.0168) for quetiapine, and -0.0045 (0.0225) for ziprasidone.None of the SGAs under investigation led to statistically significant QTc prolongation. No statistically significant differences among the SGAs were found.
Project description:Purpose:Despite well-established concerns regarding adverse drug effects, antipsychotics are frequently prescribed for older adults. Our first objective was to identify trends in antipsychotic dispensations to older Nova Scotians. STOPP (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions) criteria identify antipsychotic use in those with a history of falls as potentially inappropriate. Our second objective was to identify trends, predictors, and adherence with this STOPP criteria by identifying continued antipsychotic dispensations following a fall-related hospitalization. Methods:A descriptive cross-sectional cohort study of Nova Scotia Seniors' Pharmacare Program (NSSPP) beneficiaries ? 66 years with at least one antipsychotic dispensation annually from April 1, 2009 to March 31, 2014 was completed. As well, unique beneficiaries with at least one antipsychotic dispensation in the four-year period between April 1, 2009 and March 31, 2013 were linked to fall-related hospitalizations recorded in the Canadian Institute for Health Information Discharge Abstract Database. The relationship of age, sex, fiscal year, days supply and length-of-stay were studied to identify predictors of continued antipsychotic dispensation post-discharge. Descriptive statistics and multivariate logistic analysis were performed. Odds ratios for the association of risk factors and adherence to STOPP criteria were calculated. Findings:We identified that in each year observed, there were 6% of eligible NSSPP beneficiaries that received at least one antipsychotic dispensation. Approximately 70% of antipsychotic dispensations were for second generation agents, primarily quetiapine and risperidone. Of the unique beneficiaries with at least one antipsychotic dispensation in the four-year period between April 1, 2009 and March 31, 2013 who survived a fall-related hospitalization over 75% were dispensed an antipsychotic in the 100 days following hospital discharge. Logistic regression showed no statistically significant association between potentially inappropriate therapy and potential predictors in multivariate analysis. Implications:In each year from 2009 to 2014, 6% of Nova Scotia Seniors' Pharmacare beneficiaries were dispensed at least one antipsychotic prescription. Over 75% of the older adults who received an antipsychotic dispensation in the 100 days prior to a fall-related hospitalization, continued the drug class after discharge. This demonstrates that despite the recommendations of quality indicators such as the STOPP criteria, antipsychotics are continued in individuals at a high risk of falling. Future investigations are needed to inform health team, system, and policy interventions to improve concordance with this antipsychotic specific STOPP criterion when appropriate.
Project description:Haloperidol, a typical antipsychotic, has been shown to inhibit cholesterol biosynthesis by affecting ?(7)-reductase, ?(8,7)-isomerase, and ?(14)-reductase activities, which results in the accumulation of different sterol intermediates. In the present work, we investigated the effects of atypical or second-generation antipsychotics (SGA), such as clozapine, risperidone, and ziprasidone, on intracellular lipid metabolism in different cell lines. All the SGAs tested inhibited cholesterol biosynthesis. Ziprasidone and risperidone had the same targets as haloperidol at inhibiting cholesterol biosynthesis, although with different relative activities (ziprasidone > haloperidol > risperidone). In contrast, clozapine mainly affected ?(24)-reductase and ?(8,7)-isomerase activities. These amphiphilic drugs also interfered with the LDL-derived cholesterol egress from the endosome/lysosome compartment, thus further reducing the cholesterol content in the endoplasmic reticulum. This triggered a homeostatic response with the stimulation of sterol regulatory element-binding protein (SREBP)-regulated gene expression. Treatment with SGAs also increased the synthesis of complex lipids (phospholipids and triacylglycerides). Once the antipsychotics were removed from the medium, a rebound in the cholesterol biosynthesis rate was detected, and the complex-lipid synthesis further increased. In this condition, apolipoprotein B secretion was also stimulated as demonstrated in HepG2 cells. These effects of SGAs on lipid homeostasis may be relevant in the metabolic side effects of antipsychotics, especially hypertriglyceridemia.
Project description:Movement disorders associated with antipsychotic medications are relatively common, stigmatising, and potentially disabling. Their prevalence in people with psychosis who are prescribed second-generation antipsychotics (SGAs) is uncertain, as is their level of recognition by clinicinas. We conducted meta-analyses of randomised controlled trials included in the Cochrane Database of Systematic Reviews on schizophrenia and schizophrenia-like psychoses to estimate the prevalence of new-onset dystonia, akathisia, parkinsonism, and tremor with SGAs (amisulpride, asenapine, aripiprazole, clozapine, olanzapine, paliperidone, quetiapine, risperidone, L-sulpiride, and ziprasidone) approved in Canada and the UK, comparing them with haloperidol and chlorpromazine. We used a random effects model because of the heterogeneity between-studies in drug dosage and method of ascertainment of movement disorders. Our systematic search yielded 37 Cochrane systematic reviews (28 for SGAs), which generated 316 informative randomised controlled trials (243 for SGAs). With respect to SGAs, prevalence estimates ranged from 1.4% (quetiapine) to 15.3% (L-sulpiride) for dystonia, 3.3% (paliperidone) to 16.4% (L-sulpiride) for akathisia, 2.4% (asenapine) to 29.3% (L-sulpiride) for parkinsonism, and 0.2% (clozapine) to 28.2% (L-sulpiride) for tremor. Prevalence estimates were not influenced by treatment duration, the use of a flexible or fixed dosing scheme, or whether studies used validated instruments for the screening/rating of movement disorders. Overall, we found high overlap on the prevalence of new-onset movement disorders across different SGAs precribed for established psychoses. Variations in prevalence figures across antipsychotic medications were observed for the different movement disorders. Differences in pharmacological properties, such as for the dopamine D2 R association rate and serotonin 5-HT2A antagonism, could contribute to this variation.
Project description:Previous evidence suggests modest improvements in antihypertensive medication adherence occurred from 2007 to 2012 among US adults ?65 years of age. Whether adherence improved over time among adults <65 years of age is unknown. We assessed trends in antihypertensive medication nonpersistence and low adherence among 379?658 commercially insured adults <65 years of age initiating treatment in 2007-2014 using MarketScan claims. Nonpersistence was defined as having no days of medication available to take during the final 90 days of the 365 days following initiation. Among beneficiaries who were persistent to treatment, low adherence was defined by having antihypertensive medication available to take for <80% of the days in the 365 days following initiation (ie, proportion of days covered <80%). In 2007 and 2014, 23.3% and 23.5% of patients were nonpersistent to treatment, respectively, and 42.3% and 40.2% had low adherence, respectively. The relative risks for nonpersistence and low adherence were lower among beneficiaries initiating treatment with an angiotensin-converting enzyme inhibitor (0.95; 95% CI, 0.94-0.97 and 0.97; 95% CI, 0.96-0.98, respectively), angiotensin receptor blocker (0.86; 95% CI, 0.85-0.88 and 0.99; 95% CI, 0.97-1.00, respectively), or multiclass regimen (0.82; 95% CI, 0.80-0.84 and 0.88; 95% CI, 0.86-0.89, respectively), prescribed 90-day versus 30-day prescriptions (0.67; 95% CI, 0.66-0.68 and 0.70; 95% CI, 0.69-0.71, respectively), or who received medications by mail versus at the pharmacy (0.93; 95% CI, 0.90-0.95 and 0.90; 95% CI, 0.88-0.92, respectively). In conclusion, several modifiable factors were associated with lower rates of both antihypertensive medication nonpersistence and low adherence among adults <65 years of age initiating treatment in 2007-2014.
Project description:During the past decade, the introduction of generic versions of newer antidepressants and the release of Food and Drug Administration warnings regarding suicidality in children, adolescents, and young adults may have had an effect on cost and quality of depression treatment.To examine longitudinal trends in health service utilization, spending, and quality of care for depression.Observational trend study.Florida Medicaid enrollees, between July 1, 1996, and June 30, 2006. Patients Annual cohorts aged 18 to 64 years diagnosed as having depression.Mental health care spending (adjusted for inflation and case mix), as well as its components, including inpatient, outpatient, and medication expenditures. Quality-of-care measures included medication adherence, psychotherapy, and follow-up visits.Mental health care spending increased from a mean of $2802 per enrollee to $3610 during this period (29% increase). This increase occurred despite a mean decrease in inpatient spending from $641 per enrollee to $373 and was driven primarily by an increase in pharmacotherapy spending (up 110%), the bulk of which was due to spending on antipsychotics (949% increase). The percentage of enrollees with depression who were hospitalized decreased from 9.1% to 5.1%, and the percentage who received psychotherapy decreased from 56.6% to 37.5%. Antidepressant use increased from 80.6% to 86.8%, anxiety medication use was unchanged at 62.7% and 64.4%, and antipsychotic use increased from 25.9% to 41.9%. Changes in quality of care were mixed, with antidepressant use improving slightly, psychotherapy utilization fluctuating, and follow-up visits decreasing.During a 10-year period, spending for Medicaid enrollees with depression increased substantially, with minimal improvements in quality of care. Antipsychotic use contributed significantly to the increase in spending, while contributing little to traditional measures of quality of care.
Project description:<h4>Objectives</h4>To determine the magnitude and mechanisms of response to Medicare Part D cost sharing by low-income subsidy (LIS) recipients using oral hypoglycemic agents (OHAs) and statins.<h4>Data sources</h4>Medicare data for a 5 percent random sample of beneficiaries with diabetes enrolled in fee-for-service Part D drug plans in 2008.<h4>Study design</h4>We evaluated the impact of differences between generic and brand cost sharing rates among cohorts of LIS and non-LIS recipients to determine if wider price spreads increased the generic dispensing rate (GDR) and reduced total drug use and cost.<h4>Principal findings</h4>We found little association between cost sharing and aggregate OHA and statin use. In adjusted analyses, non-LIS beneficiaries who paid 46 percent of total OHA costs had 2.5 percent fewer OHA days supply than full benefit dual eligibles who paid just 5 percent of their therapy costs. For statins, the difference in days supply between those facing the lowest and highest cost sharing was 4.6 percent. Higher cost sharing was associated with filling fewer but larger prescriptions for both generics and brands.<h4>Conclusions</h4>Higher generic and brand copays had little association with OHA and statin use among LIS recipients. This implies that modest changes in required cost sharing for these medicines would have very little substantive impact on generic dispensing or utilization patterns among LIS recipients and thus would have little effect on total program spending. At the same time, any increases in out-of-pocket costs would be expected to shift costs and place greater financial burden on low-income beneficiaries, particularly those in poor health.