Real-world treatment modalities, health care resource utilization, and costs among commercially insured patients with newly diagnosed major depressive disorder in the United States.

BACKGROUND: In the United States, major depressive disorder (MDD) is one of the most prevalent mental health disorders. Treatment guidelines for MDD recommend pharmacologic and nonpharmacologic therapies tailored to the patient's disease severity, level of function, and comorbid health conditions. While previous studies examined real-world pharmacologic treatment patterns and costs among patients with MDD, few have examined the use of nonpharmacologic treatments and their association with health care resource utilization (HCRU) and cost. OBJECTIVE: To describe prevalence and associations between patient/provider characteristics and treatment modality and characterize HCRU and cost by treatment modality for patients with newly diagnosed MDD. METHODS: Commercially insured US patients, aged 18-62 years with newly diagnosed MDD between January 1, 2017, and September 30, 2019, were retrospectively identified from the Healthcare Integrated Research Database. Eligible patients were continuously enrolled in the health plan for 1 year before and 2 years after the first MDD diagnosis (index date). Those with co-occurring schizophrenia, bipolar disorder, postpartum depression, substance use disorder, and any prior MDD treatments were excluded. Treatment modalities assessed in the 2-year post-index period included antidepressant only (Rx-only), nonpharmacologic only (non-Rx-only), both antidepressant and nonpharmacologic (combination), and no treatment. HCRU and costs were assessed in the 2-year post-index period by treatment modality. Regression models identified associations between patient/provider characteristics and treatment modality, and the relationship between treatment modality and MDD severity changes. RESULTS: In total, 12,657 patients were included (mean age: 36 years; 60% female). During follow-up, 34% of patients received Rx-only, 25% received non-Rx-only, 28% received combination, and 13% received no treatment. MDD severity at diagnosis (26% mild, 54% moderate, 20% severe) was available for 51% of patients. Post-index inpatient hospitalizations were 11% for those with Rx-only, 10% for non-Rx-only, 16% for combination, and 29% for no treatment, whereas all-cause mean monthly total costs were $792, $633, $786, and $1,292, respectively. In multinomial logistic regression, age, sex, geographic region and urbanicity of patient residence, socioeconomic status, diagnosing provider specialty, and initial diagnosis location were significantly associated (P < 0.05) with treatment modality. In multivariable logistic regression, recipients of Rx-only (odds ratio = 2.03, P < 0.01) or combination (odds ratio = 3.26, P < 0.01) had higher odds of improving MDD severity than patients who received no treatment. CONCLUSIONS: In this real-world sample of commercially insured patients, we observed variations in outcomes by treatment modality and an association between treatment modality and disease severity. Further research is needed to explore the underlying causal relationships between treatment modality and patient outcomes. Study Registration: https://doi.org/10.17605/OSF.IO/YQ6B3 DISCLOSURES: Dr Grabner is an employee of Carelon Research, which received funding from the Innovation and Value Initiative for the conduct of the study on which this manuscript is based. Ms Pizzicato and Mr Yang were employees of Carelon Research at the time the study was conducted. Dr Grabner is a shareholder of Elevance Health. Drs Xie and Chapman are employees of the Innovation and Value Initiative.

Real-world treatment patterns and use of adjunctive pain and anti-inflammatory medications among patients with psoriatic arthritis treated with IL-17A inhibitors in the United States.

BACKGROUND: Much of the current research on treatment patterns and use of adjunctive pain and anti-inflammatory medications among patients living with psoriatic arthritis (PsA) predates the approval and uptake of IL (interleukin)-17A inhibitors. OBJECTIVE: To compare real-world treatment patterns and use of adjunctive pain and antiinflammatory medications between patients with PsA initiating the IL-17A inhibitors, ixekizumab and secukinumab, in a US-managed care population. METHODS: We conducted a retrospective cohort study using the HealthCore Integrated Research Database. Patients with a PsA diagnosis who initiated ixekizumab or secukinumab treatment between December 1, 2017, and November 30, 2019, were identified. Two cohorts were created based on which of the 2 medications was initiated (index date), and patients with prior use of either drug were excluded, as were patients with ankylosing spondylitis. Patients had to be continuously enrolled in the health plan for 6 months prior to (baseline) and 12 months after the index date (post-index). Inverse probability of treatment weighting was used to minimize confounding from baseline demographic and clinical differences between cohorts. Treatment patterns (dosing, persistence, discontinuation, and switching) and use of adjunctive pain/anti-inflammatory medications were assessed and compared between weighted cohorts using chi-square and t-tests. RESULTS: In total, 407 patients were identified in the ixekizumab cohort (mean age 51.6 years; 54% female) and 1,508 patients were identified in the secukinumab cohort (mean age 50.1 years; 59% female). Prior to weighting, presence of a psoriasis diagnosis code (ixekizumab: 60% vs secukinumab: 45%; standardized difference [std diff] = -0.30), specialty of the index prescriber (std diff = 0.38), and mean number of prior advanced therapies (2.0 vs 1.5; std diff = -0.33) were different between cohorts. Cohorts were well balanced after weighting. The majority of secukinumab patients (71%) received an index dose of 300 mg. Rates of persistence (ixekizumab: 40% vs secukinumab: 43%; P = 0.411) and switching (25% vs 20%; P = 0.072) were not statistically different between cohorts. Use of new adjunctive pain and anti-inflammatory medications was not statistically different between cohorts either (ixekizumab: 63% vs secukinumab: 58%; P = 0.187). CONCLUSIONS: Real-world treatment patterns and use of adjunctive pain and anti-inflammatory medications were similar in patients with PsA initiating ixekizumab and secukinumab in this US-managed care population. Further research examining reasons for discontinuation, switching, and use of adjunctive medications may help inform treatment decisions for patients living with PsA. DISCLOSURES: Ms Pizzicato, Ms Ketkar, and Dr Grabner are employees of HealthCore, Inc, which received funding from Eli Lilly and Company for the conduct of the study on which this manuscript is based. Ms Pepe was an employee of HealthCore, Inc., during the time the study was conducted. Dr Grabner is a shareholder of Elevance Health (legacy Anthem, Inc.). Dr Vadhariya, Dr Birt, and Ms Bolce are employees of Eli Lilly and Company, the manufacturer of ixekizumab (Taltz). Dr Birt and Ms Bolce are shareholders of Eli Lilly and Company. Dr Walsh is a paid consultant to Eli Lilly and Company and Novartis, the manufacturers of ixekizumab (Taltz) and secukinumab (Cosentyx), respectively. Additionally, Dr Walsh is a paid consultant for Pfizer, Janssen, AbbVie, and UCB and has contracts with Pfizer, AbbVie, and Merck.

Real-world treatment patterns, healthcare resource utilization, and cost among adults with pulmonary arterial hypertension in the United States.

Treatment for pulmonary arterial hypertension (PAH) has evolved over the past decade, including approval of new medications and growing evidence to support earlier use of combination therapy. Despite these changes, few studies have assessed real-world treatment patterns, healthcare resource utilization (HCRU), and costs among people with PAH using recent data. We conducted a retrospective cohort study using administrative claims from the HealthCore Integrated Research Database®. Adult members with claims for a PAH diagnosis, right heart catheterization, and who initiated PAH treatment (index date) between October 1, 2015 and November 30, 2020 were identified. Members had to be continuously enrolled in the health plan for 6 months before the index date (baseline) and ≥30 days after. Treatment patterns, HCRU, and costs were described. A total of 843 members with PAH (mean age 62.3 years, 64.2% female) were included. Only 21.0% of members received combination therapy as their first-line treatment, while most members (54.6%) received combination therapy as second-line treatment. All-cause HCRU remained high after treatment initiation with 58.0% of members having ≥1 hospitalization and 41.3% with ≥1 emergency room visit. Total all-cause costs declined from $15,117 per patient per month at baseline to $14,201 after treatment initiation, with decreased medical costs ($14,208 vs. $6,349) more than offsetting increased pharmacy costs ($909 vs. $7,852). In summary, despite growing evidence supporting combination therapy, most members with PAH initiated treatment with monotherapy. Total costs decreased following treatment, driven by a reduction in medical costs even with increases in pharmacy costs.

The implementation of opioid prescribing report cards in Medicaid managed care: a community quality collaborative.

Philadelphia, Pennsylvania, is an urban epicenter of the opioid epidemic, and inappropriate opioid prescribing remains a top concern. To help address this issue, the Philadelphia Medicaid Opioid Prescribing Initiative, a type of community quality collaborative, mailed thousands of local Medicaid providers an individualized prescribing report card in 2017 and 2018. The report card featured details of providers' opioid prescribing, including peer comparison measures and inappropriate prescribing measures like concomitant opioid and benzodiazepine prescribing. This case study describes the unique process of developing and distributing the opioid prescribing report cards, with a particular focus on the role of Medicaid managed care organizations. Using Medicaid pharmacy claims, the extensive variation in prescribing measures within and across specialties is also illustrated. The report card's implementation points to the potential value of collaborations between public health departments and Medicaid managed care organizations and can provide insight for other locally grown policies.

Legacies of the war on drugs: Next of kin of persons who died of opioid overdose and harm reduction interventions in Philadelphia.

BACKGROUND: Between the years 2017-2019 in Philadelphia, more than 70% of all deaths from opioid overdose occurred in a private residence. To learn more about home-based opioid use and overdose, researchers conducted qualitative interviews with next of kin of overdose victims to learn their perceptions about the decedent's drug use and their opinions about city-led harm reduction efforts, specifically naloxone administration and collaborative efforts to open an overdose prevention site. METHODS: In 2019, researchers conducted 35 qualitative interviews with next of kin of persons who died of opioid overdose in Philadelphia in 2017. Data were coded and analyzed using NVivo software. RESULTS: Data reveal that while persons who use drugs may benefit from enhanced harm reduction interventions that target their family members and caregivers including naloxone education and public health messaging about overdose prevention, these efforts may be up against other realities that Philadelphia families navigate-in particular structural inequalities exacerbated by decades of "War on Drugs" policies. CONCLUSION: Existing health disparities and structural barriers to care increase vulnerability to overdose and highlight the urgency to collaborate with impacted families and communities to design relevant harm reduction interventions. Without efforts to redress the consequences of war on drug policies, however, harm reduction interventions will not reach their full potential.

Adherence to buprenorphine: An analysis of prescription drug monitoring program data.

BACKGROUND: Although buprenorphine is an evidence-based treatment for opioid use disorder (OUD), many individuals discontinue treatment soon after starting. This study assesses predictors of buprenorphine adherence using Prescription Drug Monitoring Program (PDMP) data. METHODS: PDMP data for Philadelphia, Pennsylvania were used to measure 180-day adherence to buprenorphine among new initiates. Adherence was classified using percent days covered (PDC), and new initiates with PDC ≥ 0.80 were classified as adherent. Multivariable logistic regression was conducted to determine factors associated with buprenorphine adherence. RESULTS: Between January 2017 and December 2018, 10,669 Philadelphia residents initiated buprenorphine and 26.6 % remained adherent after 180 days. Demographic factors associated with greater odds of adherence included age category and female sex (aOR: 1.37; 95 % CI: 1.25-1.50). Those filling an opioid prescription, other than buprenorphine, during the follow-up period had lower odds of adherence than those who did not fill an opioid prescription (aOR: 0.62; 95 % CI: 0.50-0.77). Odds of adherence was greater for those on the film formulation (aOR: 1.37; 95 % CI: 1.25-1.50) than the tablet formulation. Those filling medium (aOR: 1.76; 95 % CI: 1.55-2.00) and high dose (aOR: 5.11; 95 % CI: 4.30-6.17) buprenorphine prescriptions had higher odds of adherence than those filling low dose prescriptions. CONCLUSIONS: Individual demographics, receipt of an opioid prescription, buprenorphine formulation, and buprenorphine dose were all associated with adherence to buprenorphine. Ongoing strategies to address OUD need to prioritize increasing retention in long-term evidence-based buprenorphine treatment while also encouraging providers to regularly consult the PDMP to ensure patient compliance.

Correlates of experiencing and witnessing non-fatal opioid overdoses among individuals accessing harm reduction services in Philadelphia, Pennsylvania.

Background: With the dramatic increase in overdose deaths in the United States, layperson overdose education and naloxone distribution (OEND) programs serve a critical role in preventing opioid overdose fatality. This study examines associations for witnessing an opioid overdose or experiencing a non-fatal opioid overdose to identify new opportunities for expansion of OEND programs. Methods: Cross sectional surveys were administered at the sole needle and syringe exchange program in Philadelphia, PA. Bivariate and multivariable logistic regression analyses were conducted to examine associations for witnessing an opioid overdose or experiencing a non-fatal opioid overdose in the previous 12 months. Results: In total, 370 individuals were identified as using opioids in the previous three months and included in the study. Factors associated with experiencing a non-fatal opioid overdose were unstable housing (aOR: 2.16; 95% CI: 1.12-3.99), recent incarceration (aOR: 2.34; 95% CI: 1.41-3.89), co-use of opioids and benzodiazepines (aOR: 2.04; 95% CI: 1.22-3.41), co-use of heroin and cocaine (aOR: 1.69; 95% CI: 1.04-2.75), drug injection (aOR: 4.25; 95% CI: 1.90-9.54), inpatient detoxification history (aOR: 2.33; 95% CI:1.27-4.43), and witnessing an overdose in the previous 12 months (aOR: 2.51; 95% CI: 1.02-6.13). Factors associated with witnessing an overdose were unstable housing (aOR: 5.14; 95% CI: 2.57-10.28), recent incarceration (aOR: 2.88; 95% CI: 1.24-6.74), and a history of being trained to use naloxone (aOR: 3.39; 95% CI: 1.63-7.04). Discussion: Findings presented here show characteristics of those most likely to witness an overdose or experience a non-fatal overdose who could be served by expansion of OEND programs.

Evaluating alcohol and marijuana use among emerging adult males via analysis of text messages.

Background: Advances in social technologies offer new tools for large scale data collection and analysis of peer influence and social networks on substance use attitudes and behaviors. Objective: The objective of this study was to determine if text message content can predict alcohol and marijuana use attitudes and behaviors. Methods: Text messages from 91 males ages 18-25 were monitored over a period of 6 months and examined for content related to alcohol and marijuana. Self-report data indicating alcohol and marijuana use attitudes and behaviors were used to determine relationships between text message content, social network structure, and substance use attitudes and behaviors. Results: In total, 23,173 text messages were analyzed with 166 text messages including alcohol related terms and 195 text messages including drug related terms. Individuals who sent text messages related to alcohol use were more likely to have problem alcohol use and positive attitudes toward alcohol use, and individuals who sent text messages related to marijuana use reported higher frequency of marijuana use and more positive attitudes toward marijuana use. Individuals with multiple daily marijuana use were in positions that had less control over network structure. Conclusions: The results of this study indicate that monitoring text message content and social network structure among emerging adult males can potentially predict alcohol and marijuana use attitudes and behaviors. Text message content analysis is a novel technique increasing our understanding of the role of peer influence and social network on substance use attitudes and behaviors.

Beyond the walls: Risk factors for overdose mortality following release from the Philadelphia Department of Prisons.

BACKGROUND: High overdose mortality after release from state prison systems is well documented; however, little is known about overdose mortality following release from local criminal justice systems (CJS). The purpose of this study was to assess overdose mortality following release from a local CJS in Philadelphia, PA. METHODS: We conducted a retrospective cohort study of individuals released to the community from a local CJS between 2010 and 2016. Incarceration records were linked to overdose fatality data from the Medical Examiner's Office and death certificate records. All-cause, overdose, and non-overdose mortality were examined. RESULTS: Of the 82,780 individuals released between 2010 and 2016, 2,522 (3%) died from any cause, of which 837 (33%) succumbed to overdose. Individuals released from incarceration had higher risk of overdose death compared to the non-incarcerated population (Standardized Mortality Ratio [SMR]: 5.29, 95% CI 4.93-5.65), and risk was greatest during the first two weeks following release (SMR: 36.91, 95% CI: 29.92-43.90). Among released individuals, black, non-Hispanic individuals (Hazard Rate [HR]: 0.17, 95% CI: 0.14-0.19) and Hispanic individuals (HR: 0.41, 95% CI: 0.34-0.50) were at lower risk for overdose than white, non-Hispanic individuals. Individuals released with a serious mental illness (SMI) were at higher risk of overdose (HR: 1.54, 95% CI: 1.27-1.87) than those without a SMI. DISCUSSION: Previously incarcerated individuals are at high risk of overdose death following release from a local CJS, especially in the earliest weeks following release. Prevention measures including behavioral health treatment and referral and take-home naloxone may reduce overdose mortality after release.

Correlates of viral suppression among HIV-infected men who have sex with men and transgender women in Lima, Peru.

In Peru, HIV is concentrated among men who have sex with men (MSM) and transgender women (TGW). Between June 2015 and August 2016, 591 HIV-positive MSM and TGW were recruited at five clinical care sites in Lima, Peru. We found that 82.4% of the participants had achieved viral suppression (VS; VL < 200) and 73.6% had achieved maximal viral suppression (MVS; VL < 50). Multivariable modeling indicated that patients reporting transportation as a barrier to HIV care were less likely to achieve VS (aOR = 0.47; 95% CI = 0.30-0.75) and MVS (aOR = 0.56; 95% CI = 0.37-0.84). Alcohol use disorders were negatively associated with MVS (aOR = 0.62; 95% CI = 0.30-0.75) and age was positively associated with achieving MVS (aOR = 1.29; 95% CI = 1.04-1.59). These findings underscore the need for more accessible HIV care with integrated behavioral health services in Lima, Peru.

Factors Associated with HIV Viral Suppression Among Transgender Women in Lima, Peru.

PURPOSE: Globally, transgender women (TGW) experience a high burden of adverse health outcomes, including a high prevalence of HIV and sexually transmitted infections (STIs) as well as psychiatric disorders and substance use disorders. To address gaps in HIV research in Peru focused specifically on TGW, this study presents characteristics of a sample of HIV-positive TGW and identifies factors associated with viral suppression. METHODS: Between June 2015 and August 2016, 50 HIV-positive TGW were recruited in Lima, Peru. Multivariable logistic regression was used to identify factors associated with viral suppression (<200 copies/mL) among the TGW. RESULTS: Among TGW, 85% achieved viral suppression. Approximately half (54%) reported anal sex with more than five partners in the past 6 months, 38% reported sex work, 68% had not disclosed their HIV status to one or more of their partners, and 38% reported condomless sex with their last partner. The prevalence of alcohol use disorders was high (54%), and 38% reported use of drugs in the past year. Moderate-to-severe drug use significantly reduced odds of achieving viral suppression (adjusted odds ratio 0.69; 95% confidence interval: 0.48-0.98). CONCLUSION: Our findings highlight the need for integrated treatment for substance disorders in HIV care to increase the viral suppression rate among TGW in Lima, Peru.

Active syphilis and its association with HIV and sexual risk behaviours in a multicity sample of men who have sex with men and transgender women in Peru.

Background Syphilis in Peru is heavily concentrated in men who have sex with men (MSM) and transgender women (TGW). The aim of the present study was to understand the risk factors for active syphilis infection among MSM and TGW in Peru. METHODS: Independent correlates suggestive of active syphilis infection were examined to better understand risk factors for syphilis in MSM and TGW, with separate analyses conducted based on location and among TGW. In 2011, 5101 MSM and TGW completed both self-report surveys and HIV and syphilis testing in five Peruvian cities. RESULTS: Overall, 261 (5.1%) MSM and TGW met the criteria for active syphilis, with higher prevalence in Lima than elsewhere (7.0% vs 3.0%) and in TGW than in MSM (10.7% vs 4.2%). Significant independent correlates of active syphilis infection differed greatly by location. In Lima, they included being HIV-infected (aware or unaware of status), being a TGW, being a high school graduate, engaging in receptive anal intercourse, no recent sex with a female partner and having had any symptomatic sexually transmissible infection, including syphilis, in the previous 6 months. Outside Lima, the independent correlates included being HIV-infected and unaware of status, engaging in recent sex work, no recent sex with a female partner and age 35-44 years. Among TGW, independent correlates of active syphilis included being HIV-infected (aware or unaware of status), a recent syphilis diagnosis in the previous 6 months and recent drug use. CONCLUSION: The findings of the present study support the need not only for combined HIV and syphilis screening, but also for increased screening and treatment of syphilis in MSM and TGW populations. Stratified analyses suggest different syphilis epidemics throughout the country and in TGW, yet being HIV-infected and aware were consistently associated with active syphilis, suggesting higher syphilis risk in HIV-infected MSM and TGW.