Increased delay from initial concern to diagnosis of autism spectrum disorder and associated health care resource utilization and cost among children aged younger than 6 years in the United States.

BACKGROUND: Prolonged delays between first caregiver concern and autism spectrum disorder (ASD) diagnosis have been reported, but associations between length of time to diagnosis (TTD) and health care resource utilization (HCRU) and costs have not been studied in a large sample of children with ASD. OBJECTIVE: To address these informational gaps in the ASD diagnostic pathway. METHODS: This retrospective, observational, single cohort analysis of Optum's administrative claims data from January 1, 2011, to December 31, 2020, included commercially insured children who had 2 or more claims for an ASD diagnosis (earliest diagnosis designated as the index date), were between the ages of older than 1.5 years and 6 years or younger at index date, and were continuously enrolled for up to 48 months before and for 12 months after the index date. Two cohorts (between the ages of older than 1.5 years and 3 years or younger and between the ages of older than 3 years and 6 years or younger at ASD diagnosis) were divided into shorter (less than median) and longer (greater than or equal to median) TTD around each cohort median TTD calculated from the first documented ASD-related concern to the earliest ASD diagnosis, because TTD may vary by age at diagnosis. This exploratory analysis compared all-cause and ASD-related HCRU and costs during a 12-month period preceding ASD diagnosis among children with shorter vs longer TTD. RESULTS: 8,954 children met selection criteria: 4,205 aged 3 years or younger and 4,749 aged older than 3 years at diagnosis, with median TTD of 9.5 and 22.1 months, respectively. In the year preceding ASD diagnosis, children with longer TTD in both age cohorts experienced a greater number of all-cause and ASD-related health care visits compared with those with shorter TTD (mean and median number of office or home visits were approximately 1.5- and 2-fold greater in longer vs shorter TTD groups; P < 0.0001). The mean all-cause medical cost per child in the year preceding ASD diagnosis was approximately 2-fold higher for those with longer vs shorter TTD ($5,268 vs $2,525 in the younger and $5,570 vs $2,265 in the older cohort; P < 0.0001 for both). Mean ASD-related costs were also higher across age cohorts for those with longer vs shorter TTD ($2,355 vs $859 in the younger and $2,351 vs $1,144 in the older cohort; P < 0.0001 for both). CONCLUSIONS: In the year prior to diagnosis, children with longer TTD experienced more frequent health care visits and greater cost burden in their diagnostic journey compared with children with shorter TTD. Novel diagnostic approaches that could accelerate TTD may reduce costs and HCRU for commercially insured children. DISCLOSURES: This study was funded by Cognoa, Inc. Optum received funding from Cognoa to conduct this study. Dr Salomon is an employee and holds stock options of Cognoa, Inc. Dr Campbell was an employee of Cognoa, Inc., at the time this study was conducted. Dr Duhig was an employee of Cognoa, Inc., at the time the study was conducted and holds stock options. Dr Vu, Ms Kruse, Mr Gaur, and Ms Gupta are employees and/or stockholders of Optum. Dr Tibrewal was an employee of Optum at the time the research for this study was conducted. Dr Taraman is an employee and holds stock options of Cognoa, Inc., receives consulting fees from Cognito Therapeutics, volunteers as a board member of the American Academy of Pediatrics California and Orange County Chapter, is a paid advisor for MI10 LLC, and owns stock options of NTX, Inc., and HandzIn.

Six-Month Use of Droxidopa for Neurogenic Orthostatic Hypotension.

BACKGROUND: Droxidopa is approved for adult patients with symptomatic neurogenic orthostatic hypotension (nOH); there is limited information regarding effects on symptoms, outcomes, and quality of life (QOL) beyond two weeks of treatment. OBJECTIVE: Examine the real-world experience of patients taking droxidopa after six months of treatment. METHODS: This non-interventional, US-based, prospective cohort study utilized a pharmacy hub, identifying patients who recently started droxidopa for nOH treatment. Questionnaires for fall frequency and other patient-reported outcomes (PROs) were completed at baseline and one, three, and six months following droxidopa initiation. RESULTS: 179 enrolled patients completed baseline surveys. Droxidopa continuation rates were high at months one, three, and six (87%, 79%, and 75%, respectively). From baseline to month one, there was significant reduction in the proportion of patients reporting falling at least once (54.1% vs. 43.0%; P = 0.0039), with similar observations at month three (52.9% vs. 44.5%; P = 0.0588) and month six (51.4% vs. 40.0%; P = 0.0339). Significant improvements from baseline to month one were observed and maintained at months three and six for most PROs, including the Orthostatic Hypotension Symptom Assessment Item 1, Short Falls Efficacy Scale-International, Sheehan Disability Scale, Physical Component of the 8-item Short-Form Health Survey, and Patient Health Questionnaire-9. CONCLUSIONS: In this non-interventional prospective study, fewer nOH patients reported falling after one, three, and six months of droxidopa treatment. Further, improvements reported in nOH symptoms, physical function, and QOL measures were maintained for six months following treatment initiation. Results from randomized clinical trials are required to validate the findings.

Relapse prevention: a cost-effectiveness analysis of brexpiprazole treatment in adult patients with schizophrenia in the USA.

OBJECTIVE: This study used a decision-analytic framework to assess the cost-effectiveness of brexpiprazole vs comparator branded therapies for reducing relapses and hospitalizations among adults with schizophrenia from a US payer perspective. METHODS: An economic model was developed to assess patients with stable schizophrenia initiating treatment with brexpiprazole (1-4 mg), cariprazine (1-6 mg), or lurasidone (40-80 mg) over a 1-year period. After 6 months, patients remained on treatment or discontinued due to relapse, adverse events, or other reasons. Patients who discontinued due to relapse or adverse events were assumed to have switched to other therapy, and those who discontinued due to other reasons were assumed to have received no therapy. Primary outcomes were incremental cost per relapse avoided and hospitalization avoided, and the secondary outcome was cost per quality-adjusted life-year (QALY) gained. Sensitivity and scenario analyses were also conducted. RESULTS: Brexpiprazole was associated with the highest per-patient clinical effectiveness (avoided relapses 0.637, avoided hospitalizations 0.719, QALYs 0.707) among comparators, followed by cariprazine (avoided relapses 0.590, avoided hospitalizations 0.683, QALYs 0.683) and lurasidone (avoided relapses 0.400, avoided hospitalizations 0.536, QALYs 0.623). Annual per-patient health-care costs were lowest for brexpiprazole ($20,510), followed by cariprazine ($22,282) and lurasidone ($25,510). Brexpiprazole was the least costly and most effective treatment strategy for all outcomes. Results were sensitive to relapse rates and daily cost of brexpiprazole. Limitations include data principally obtained from drug-specific randomized withdrawal studies and lack of direct-comparison trials. CONCLUSION: This analysis evaluated brexpiprazole treatment for the reduction of schizophrenia relapses and hospitalizations over a 1-year period compared to other recently available branded antipsychotics, and excluded generic antipsychotic treatments. Brexpiprazole treatment may lead to clinical benefits and medical cost savings, and provides a cost-effective treatment option for patients relatively to other branded second-generation antipsychotics.

The Current Status of Outcomes-Based Contracting for Manufacturers and Payers: An AMCP Membership Survey.

BACKGROUND: As the United States health care system shifts from traditional volume-based payments to value-based payments, outcomes-based contracts (OBCs) are gaining popularity among payers and manufacturers as a mechanism for the shift toward value. Under this model, stakeholders hope to align drug payment and value to real-world performance metrics (e.g., biomarkers and health care resource utilization). OBJECTIVE: To understand the experiences, perceptions, and needs of payers and manufacturers related to OBCs. METHODS: The Academy of Managed Care Pharmacy (AMCP) and Xcenda conducted an online survey with AMCP payer and manufacturer members. Participants were asked a series of questions regarding their use of OBCs, barriers to implementation, and elements required in establishing successful OBCs. The importance and urgency of specific impediments to successful OBC implementation were also assessed. RESULTS: The survey was fielded May 12, 2017, to June 7, 2017, yielding 65 responses (35 payers/30 manufacturers). While a minority of payers/manufacturers had at least 1 OBC in place (20%/33%), a majority had interest in future OBC use (71%/63%). Among those with at least 1 OBC in place, 86%/80% of payers/manufacturers had renewed at least 1 OBC in the past 5 years. All payers and 60% of manufacturers with OBCs included compliance measures. Improvement in clinical outcomes was also common (71%/70%) (e.g., reaching set laboratory values goals), and 71%/60% included avoidance of unnecessary medical resource use (e.g., hospitalization and emergency department visit). The barrier most frequently identified by payers in implementing OBCs was evidence that OBCs reduced pharmacy spending (60%), while manufacturers identified the inability to obtain accurate data/outcome measures (73%) as a major limiting factor. Payers/manufacturers endorsed the use of easily measurable outcomes (91%/100%) as most important in establishing successful OBCs. Manufacturers, and to a lesser extent payers, indicated that regulations and legal issues need to be addressed to make progress in OBC implementation (e.g., safe harbor for preapproval health care economic information [77%/46%] and exemption of OBCs for best-price requirements [83%/51%]). The only exception was the clarification of regulations for discussing information outside of an FDA-approved label, in which both manufacturers and payers indicated a very strong need (100%) to be addressed. CONCLUSIONS: Surveyed AMCP members are interested in OBCs and recognize their alignment to societal health goals and health care affordability, although actual use of these contracts has been somewhat limited to date. Results from this survey indicate that there is potential for OBC use to increase as barriers and limitations are addressed. DISCLOSURES: This research was sponsored by the Academy of Managed Care Pharmacy and Xcenda. Duhig, Kaufman, and Hughes are employed by Xcenda. Saha is employed by the Academy of Managed Care Pharmacy. Smith has nothing disclose. Study concept and design were contributed by Duhig, Kaufman, Saha, and Hughes. Kaufman and Hughes collected the data, and data interpretation was performed by all the authors. The manuscript was written by Saha, Smith, and Duhig, along with Kaufman and Hughes.

Nursing Home Use Across The Spectrum of Cognitive Decline: Merging Mayo Clinic Study of Aging With CMS MDS Assessments.

BACKGROUND/OBJECTIVES: Objective, complete estimates of nursing home (NH) use across the spectrum of cognitive decline are needed to help predict future care needs and inform economic models constructed to assess interventions to reduce care needs. DESIGN: Retrospective longitudinal study. SETTING: Olmsted County, MN. PARTICIPANTS: Mayo Clinic Study of Aging participants assessed as cognitively normal (CN), mild cognitive impairment (MCI), previously unrecognized dementia, or prevalent dementia (age = 70-89 years; N = 3,545). MEASUREMENTS: Participants were followed in Centers for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) NH records and in Rochester Epidemiology Project provider-linked medical records for 1-year after assessment of cognition for days of observation, NH use (yes/no), NH days, NH days/days of observation, and mortality. RESULTS: In the year after cognition was assessed, for persons categorized as CN, MCI, previously unrecognized dementia, and prevalent dementia respectively, the percentages who died were 1.0%, 2.6%, 4.2%, 21%; the percentages with any NH use were 3.8%, 8.7%, 19%, 40%; for persons with any NH use, median NH days were 27, 38, 120, 305, and median percentages of NH days/days of observation were 7.8%, 12%, 33%, 100%. The year after assessment, among persons with prevalent dementia and any NH use, >50% were a NH resident all days of observation. Pairwise comparisons revealed that each increase in cognitive impairment category exhibited significantly higher proportions with any NH use. One-year mortality was especially high for persons with prevalent dementia and any NH use (30% vs 13% for those with no NH use); 58% of all deaths among persons with prevalent dementia occurred while a NH resident. CONCLUSIONS: Findings suggest reductions in NH use could result from quality alternatives to NH admission, both among persons with MCI and persons with dementia, together with suitable options for end-of-life care among persons with prevalent dementia.

Direct medical costs and source of cost differences across the spectrum of cognitive decline: a population-based study.

BACKGROUND: Objective cost estimates and source of cost differences are needed across the spectrum of cognition, including cognitively normal (CN), mild cognitive impairment (MCI), newly discovered dementia, and prevalent dementia. METHODS: Subjects were a subset of the Mayo Clinic Study of Aging stratified-random sampling of Olmsted County, MN, residents aged 70 to 89 years. A neurologist reviewed provider-linked medical records to identify prevalent dementia (review date = index). Remaining subjects were invited to participate in prospective clinical/neuropsychological assessments; participants were categorized as CN, MCI, or newly discovered dementia (assessment date = index). Costs for medical services/procedures 1-year pre-index (excluding indirect and long-term care costs) were estimated using line-item provider-linked administrative data. We estimated contributions of care-delivery site and comorbid conditions (including and excluding neuropsychiatric diagnoses) to between-category cost differences. RESULTS: Annual mean medical costs for CN, MCI, newly discovered dementia, and prevalent dementia were $6042, $6784, $9431, $11,678, respectively. Hospital inpatient costs contributed 70% of total costs for prevalent dementia and accounted for differences between CN and both prevalent and newly discovered dementia. Ambulatory costs accounted for differences between CN and MCI. Age-, sex-, education-adjusted differences reached significance for CN versus newly discovered and prevalent dementia and for MCI versus prevalent dementia. After considering all comorbid diagnoses, between-category differences were reduced (e.g., prevalent dementia minus MCI (from $4842 to $3575); newly discovered dementia minus CN (from $3578 to $711)). Following the exclusion of neuropsychiatric diagnoses from comorbidity adjustment, between-category differences tended to revert to greater differences. CONCLUSIONS: Cost estimates did not differ significantly between CN and MCI. Substantial differences between MCI and prevalent dementia reflected high inpatient costs for dementia and appear partly related to co-occurring mental disorders. Such comparisons can help inform models aimed at identifying where, when, and for which individuals proposed interventions might be cost-effective.

Cost of post-traumatic stress disorder vs major depressive disorder among patients covered by medicaid or private insurance.

OBJECTIVE: To compare healthcare costs and resource utilization among patients with post-traumatic stress disorder (PTSD) vs control subjects with major depressive disorder (MDD) in populations covered by Medicaid or private insurance. STUDY DESIGN: Retrospective analysis of Medicaid and private insurance administrative claims data. METHODS: Patients with at least 2 PTSD diagnoses during or after 1999, and at least 1 PTSD diagnosis during or after 2003, were identified from deidentified Medicaid claims from Florida, Missouri, and New Jersey (1999-2007) and from a privately insured claims database (1999-2008). Patients had continuous eligibility 6 months before (baseline) and 12 months after (study period) the index date and were aged 18 to 64 years. Potential control subjects having MDD without PTSD diagnosis were identified using similar selection criteria. Control subjects with MDD were matched to patients with PTSD on age, sex, state or region, employment status (private insurance only), index year, and race/ethnicity (Medicaid only). Study period per-patient utilization and costs, calculated as reimbursements to providers for medical services and prescription drugs, were compared using univariate and multivariate analyses. RESULTS: Patients with PTSD had higher rates of other mental health disorders (eg, anxiety and bipolar disorder) and higher mental health-related resource use and costs than control subjects with MDD in both Medicaid and privately insured populations. The mean study period total direct healthcare costs were higher for patients with PTSD than for control subjects with MDD ($18,753 vs $17,990 for Medicaid and $10,960 vs $10,024 for private insurance, P <.05 for both). The difference in total direct costs was driven by higher mental health-related resource use for patients with PTSD. CONCLUSION: Patients having PTSD had 4.2% to 9.3% higher mean annual per-patient healthcare costs compared with matched control subjects having MDD among patients covered by Medicaid or private insurance.

Contingency management for smoking cessation: enhancing feasibility through use of immunoassay test strips measuring cotinine.

Contingency management (CM) is a powerful behavioral intervention shown to reduce the use of a variety of substances including tobacco. Use of CM techniques for smoking cessation has been restricted by the use of multiple daily measurements of breath CO as the objective indicator to reinforce abstinence. Cotinine, with its longer half-life, may be a better marker. We evaluated the use of urinary cotinine (determined using once-daily semiquantitative immunoassay test strips and verified using quantitative GC/HPLC techniques) as an abstinence indicator in treatment-seeking adult and adolescent smokers participating in a CM-based intervention program. Both techniques of determining urinary cotinine were highly sensitive and moderately specific at detecting abstinence, and they were highly concordant. However, specificity was somewhat lower during the first few days of a quit attempt and improved over time. The results were similar in adults and adolescent smokers, and suggest that during the first few days of a quit attempt it would be advisable to continue to use daily multiple CO measurements to verify abstinence. However, once abstinence is achieved, once-daily immunoassay test strips could be used for continued monitoring of urinary cotinine levels. Immunoassay testing can identify individuals who relapse to smoking, though this study cannot evaluate whether the strips can identify resumption of abstinence. These results suggest that the use of cotinine as an abstinence indicator, by reducing the number of daily appointments, could significantly enhance the feasibility and utility of CM-based interventions for smoking cessation.

Combining cognitive behavioral therapy with contingency management for smoking cessation in adolescent smokers: a preliminary comparison of two different CBT formats.

This pilot study evaluated the optimal format of cognitive behavioral therapy (CBT) to combine with contingency management (CM) in a four-week, high school-based smoking cessation program. Thirty-four adolescent smokers received a standard weekly version of CBT or a frequent brief behavioral intervention. Results indicate a trend toward a higher seven-day point prevalence end-of-treatment abstinence rate and percent days abstinent during treatment in the CBT condition. In addition, significantly more participants in the CBT group completed treatment. These preliminary results suggest that when combined with CM, the standard weekly format of CBT is more acceptable to adolescent smokers.

Laboratory and self-report assessments of impulsive behavior in adolescent daily smokers and nonsmokers.

This research compared adolescent daily smokers (n=25) and nonsmokers (n=26) on different measures of impulsivity. Assessments included question-based measures of delay (DDQ) and probability (PDQ) discounting, a measure of behavioral disinhibition (go-stop task), and a self-report measure of impulsivity (Barratt Impulsiveness Scale-Adolescent). Adolescent smokers were more impulsive on the DDQ and Barratt Impulsiveness Scale--Adolescent but not on the PDQ or the go-stop task. However, there was a significant interaction between smoking status and gender on the go-stop task, with male smokers performing less impulsively on this measure than male nonsmokers--an effect not observed with the female adolescents. These findings indicate that adolescents who smoke cigarettes are more impulsive with respect to some, but not all, types of impulsivity than are adolescents who do not smoke.

Characteristics of adolescent past-year gamblers and non-gamblers in relation to alcohol drinking.

A preliminary examination of mental health and gambling characteristics as a function of alcohol use in adolescents was conducted in a nationally representative sample of 16- and 17-year-olds using data from the 1998 Gambling Impact and Behavior Study. Adolescents were stratified by past-year alcohol use into abstainers/low-frequency (ALF) drinkers and moderate to high-frequency (MHF) drinkers as done previously [Desai, R. A., Maciejewski, P. K., Pantalon, M. V., & Potenza, M. N. (in press). Gender differences among recreational gamblers: Association with the frequency of alcohol use. Psychology of Addictive Behaviors]. A greater proportion of MHF drinkers reported past-year gambling than did ALF drinkers (66.1% vs. 38.2%). In the ALF drinking group but not the MHF one, past-year gambling was associated with dysphoria/depression (odds ratio for ALF: 1.94, odds ratio for MHF: 0.88) and drug use (odds ratio for ALF: 2.57, odds ratio for MHF: 0.49). A significant gambling-by-alcohol-use group interaction was observed for drug use (p<0.01). Among past-year gamblers, MHF drinkers were more likely than ALF ones to report frequent gambling. These results suggest a complex relationship between gambling alcohol use, drug use, and mental health in adolescents.

Behavioral impulsivity predicts treatment outcome in a smoking cessation program for adolescent smokers.

OBJECTIVE: To examine the relationship between impulsivity and smoking cessation treatment response among adolescents. METHODS: Thirty adolescent smokers participated in a high school based smoking cessation program combining contingency management and cognitive behavioral therapy. Self-report (Barratt impulsiveness scale (BIS-II); Kirby delay discounting measure (DDM)) and behavioral (experiential discounting task (EDT); continuous performance task (CPT)) measures of impulsivity were assessed at treatment onset. RESULTS: Sixteen participants (53%) were abstinent from smoking at completion of the four-week study. Compared to abstinent adolescents, those not achieving abstinence discounted monetary rewards more on the EDT and committed more commission errors on the CPT. Group differences were not observed on the BIS-II or DDM. CONCLUSIONS: These preliminary results suggest that specific behavioral measures of impulsivity may be associated with the ability to initiate and/or maintain abstinence from smoking among adolescent smokers.

Contingency management for smoking cessation in adolescent smokers.

This pilot study evaluated the use of contingency management (CM) procedures in combination with cognitive-behavioral therapy (CBT) for smoking cessation in adolescents. Twenty-eight treatment-seeking adolescent smokers participated in a 1-month, school-based smoking cessation program and were randomly assigned to receive either CM with weekly CBT or CBT alone. In the CM+CBT group, biochemical verification of abstinence was obtained twice daily during the first 2 weeks, followed by daily appointments during the 3rd week and once every other day during the 4th week. Participants were monetarily reinforced for abstinence on an escalating magnitude schedule with a reset contingency. At the end of 1 week and 1 month of treatment, abstinence verified using quantitative urine cotinine levels was higher in participants in the CM+CBT group (1 week: 76.7%; 1 month: 53.0%) when compared with the CBT-alone group (1 week: 7.2%; 4 weeks: 0%). These preliminary results provide a strong initial signal supporting the utility of CM techniques for smoking cessation in adolescents and demonstrate the feasibility of implementing such a program in a school setting.

Gender and weight concerns in adolescent smokers.

The aim of this study was to examine smoking-specific weight concerns in a well-characterized sample of adolescent daily smokers and the influence of gender, age, and body mass index (BMI). Adolescent smokers (n=103) were asked two smoking-specific weight concern questions: "How much do cigarettes help you control your weight?" and "How concerned are you about gaining weight as a result of quitting?" A significant positive relationship was found between average daily cigarette use and belief in smoking as a means to control weight and a significant negative relationship between the years of smoking and belief that smoking controls weight. There was no significant relationship between BMI and smoking to control weight for females, whereas for males, there was a positive relationship, indicating that heavier males were more likely to report smoking to control weight. Additionally, females who smoked more cigarettes reported more concern about gaining weight upon quitting, a pattern not seen in males. Results highlight potentially important gender differences in the relationship between weight concerns and smoking and the influence these concerns may have on quitting smoking.

Are fathers involved in pediatric psychology research and treatment?

BACKGROUND: Recently, there has been a growing awareness of the importance of the roles of fathers in understanding normative developmental processes. Increased attention has been given to the roles of fathers in the area of clinical child research and therapy. However, the presence of fathers in research and treatment in pediatric psychology has not been fully examined. OBJECTIVE: To explore the status of including fathers in both research and treatment in the area of pediatric psychology. METHOD: An extensive review of published research. RESULTS: The findings suggest that pediatric psychology research lags even farther behind clinical child research in including fathers in research designs and analyzing for maternal and paternal effects separately. There is also a concomitant lack of inclusion of fathers in family-based interventions in pediatric psychology. CONCLUSION: These patterns are discussed, with an emphasis on strategies to increase the inclusion of fathers in research and treatment of pediatric psychology issues. Future directions for researchers and clinicians are also included.

Daily patterns of alcohol, cigarette, and marijuana use in adolescent smokers and nonsmokers.

Timeline followback (TLFB) methodology was used to assess the daily use of cigarettes, alcohol, and marijuana in adolescent cigarette smokers and nonsmokers over the prior 30 days. Adolescent smokers reported more frequent daily use of both alcohol and marijuana than nonsmokers did. Of those smokers and nonsmokers who drank alcohol and used marijuana, smokers reported more frequent daily use of alcohol, but not marijuana. In examining daily use patterns, there were very few instances when adolescent smokers used alcohol but did not smoke cigarettes, and smokers used marijuana alone on more days than alcohol alone. One-fifth of the adolescent smokers used all three substances on the same day in the past month. There were no significant differences in the patterns of alcohol and marijuana use between female and male smokers, regardless of age. Implications for clinical interventions and future research are discussed.