The cost-effectiveness of zuranolone versus selective serotonin reuptake inhibitors for the treatment of postpartum depression in the United States.

AIMS: The objective of this research is to evaluate the cost-effectiveness of zuranolone, the first oral treatment indicated for postpartum depression (PPD) in adults approved by the United States Food and Drug Administration. METHODS: Zuranolone and selective serotonin reuptake inhibitor (SSRI) trial-based efficacy was derived from an indirect treatment comparison. Long-term efficacy outcomes were based on a large longitudinal cohort study. Maternal health utility values were derived from trial-based, short-form 6-D responses. Other inputs were derived from literature and economic data from the US Bureau of Labor Statistics. We estimated costs (2023 US dollars) and quality-adjusted life-years (QALYs) for patients with PPD treated with zuranolone (14-day dosing) or SSRIs (chronic dosing). The indirect costs and QALYs of the children and partners were also estimated. RESULTS: The incremental cost-effectiveness ratio for zuranolone versus SSRIs was $94,741 per QALY gained over an 11-year time horizon. Maternal total direct medical costs averaged $84,318 in the zuranolone arm, compared to $86,365 in the SSRI arm. Zuranolone-treated adults averaged 6.178 QALYs compared to 6.116 QALYs for the SSRI arm. Costs and utilities for the child and partner were also included in the base case. Drug and administration costs for zuranolone averaged $15,902, compared to $30 for SSRIs over the studied time horizon. Results were sensitive to the model time horizon. LIMITATIONS: As head-to-head trials were not available to permit direct comparison, efficacy inputs were derived from an indirect treatment comparison which can be confounded by cross-trial differences. The data used are reflective of a general PPD population rather than marginalized individuals who may be at a greater risk for adverse PPD outcomes. The model likely excludes unmeasured effects for patient, child, and partner. CONCLUSIONS: This economic model's results suggest that zuranolone is a more cost-effective therapy compared to SSRIs for treating adults with PPD.

QUESTION: Is zuranolone cost-effective compared to selective serotonin-reuptake inhibitors for the treatment of postpartum depression (PPD) in adults in a United States (US) health care setting? FINDINGS: The model, which incorporated clinical trial data, long-term longitudinal cohort data, US Bureau of Labor Statistics data on compensation, and other peer-reviewed literature, projects that zuranolone is cost-effective compared to selective serotonin-reuptake inhibitors for the treatment of PPD at a willingness-to-pay threshold of $150,000 (USD).Meaning: For adults with PPD requiring pharmacological intervention, zuranolone may be a cost-effective treatment option with the potential to confer quality-of-life benefits for these patients and their families as well as economic benefits for society.

Economic burden and antidepressant treatment patterns among patients with major depressive disorder in the United States.

BACKGROUND: The prevalence of major depressive disorder (MDD) continues to rise year over year, resulting in significant economic implications. However, when patients are treated with contemporary standard-of-care antidepressant pharmacotherapies, a suboptimal response is often attained, resulting in frequent treatment changes. OBJECTIVE: To compare health care resource utilization (HCRU) and all-cause medical and pharmacy costs between commercially insured patients with an MDD diagnosis and matched non-MDD patients and explore treatment patterns among patients with MDD initiating antidepressant pharmacotherapy. METHODS: This was a retrospective, observational analysis of IBM MarketScan US commercial claims data. Adults aged 18 years and older with continuous enrollment 12 or more months before and after the patient's first MDD diagnosis from 2017 to 2018 were included in the analysis. HCRU and all-cause medical and pharmacy costs were compared among patients with MDD and a 1:1 exact-matched cohort of non-MDD patients during the same period (Objective 1). Treatment patterns (persistence, discontinuation, switch, combination, and augmentation) were analyzed for patients with MDD starting first-line antidepressant monotherapy for up to 12 months following their antidepressant initiation index date (Objective 2). Time to first treatment change or discontinuation was calculated and treatment patterns were graphically displayed in Sankey diagrams. RESULTS: 625,272 patients with MDD were matched 1:1 to a cohort of non-MDD patients in Objective 1. Patients with MDD had statistically significantly greater all-cause medical (20.4 vs 9.4; P < 0.0001), outpatient (19.5 vs 9.0; P < 0.0001), emergency department (0.51 vs 0.23; P < 0.0001), inpatient (0.35 vs 0.11; P < 0.0001), and any mental health-related (7.7 vs 0.58; P < 0.0001) visits compared with non-MDD patients. Mean all-cause medical costs were $6,809 (P < 0.0001) higher among patients with MDD than among patients without MDD ($13,183 vs $6,374, respectively). In Objective 2, 44,485 patients with MDD who received antidepressant monotherapy as their first-line MDD treatment were examined. Among the first treatment patterns observed following initiation, 19.3% of patients persisted with their first-line therapy, 56.2% discontinued antidepressant therapy, 24.5% experienced a treatment change (switching, adding a second antidepressant, or augmenting their existing therapy). The median days until first treatment change were 65 days for those discontinuing and 47 days for those switching antidepressants. Among the 24.5% of patients with a treatment change, 50.0% experienced another change in therapy within 30 days. CONCLUSIONS: The HCRU and costs accrued for patients with MDD is significantly greater than those for non-MDD patients. A large proportion of patients with MDD experienced treatment changes shortly after initiating their first-line antidepressant therapy. The results of this study highlight the need for reevaluation of the current MDD treatment paradigm. DISCLOSURES: Drs Zhu and Namjoshi are employees of Biogen Inc. and may hold stock. Dr Ferries and Ms Suthoff are employees of Sage Therapeutics, Inc., and may hold stock and/or stock options. Dr Bera has no potential conflicts of interest to disclose. This research was funded by Sage Therapeutics and Biogen. Manuscript editorial services were provided by Boston Strategic Partners, Inc., funded by Sage Therapeutics and Biogen. This work was supported by Sage Therapeutics, Inc., and Biogen. The authors had full editorial control of the manuscript and provided final approval on all content.

The role of integrated medical and prescription drug plans in addressing racial and ethnic disparities in medication adherence.

Medication nonadherence in the United States contributes to 125,000 deaths and 10% of hospitalizations annually. The pain of preventable deaths and the personal costs of nonadherence are borne disproportionately by Black, Latino, and other minority groups because nonadherence is higher in these groups due to a variety of factors. These factors include socioeconomic challenges, issues with prescription affordability and convenience of filling and refilling them, lack of access to pharmacies and primary care services, difficulty taking advantage of patient engagement opportunities, health literacy limitations, and lack of trust due to historical and structural discrimination outside of and within the medical system. Solutions to address the drivers of lower medication adherence, specifically in minority populations, are needed to improve population outcomes and reduce inequities. While various solutions have shown some traction, these solutions have tended to be challenging to scale for wider impact. We propose that integrated medical and pharmacy plans are well positioned to address racial and ethnic health disparities related to medication adherence. DISCLOSURES: This study was not supported by any funding sources other than employment of all authors by Humana Inc. Humana products and programs are referred to in this article.

Novel Approach Using Administrative Claims to Evaluate Trends in Oncology Multigene Panel Testing for Patients Enrolled in Medicare Advantage Health Plans.

PURPOSE: To develop an approach to identify and evaluate recent use of multigene panel testing over time. METHODS: We conducted a retrospective database analysis using medical and pharmacy claims data. Medicare Advantage Prescription Drug Plan members diagnosed with select malignant solid tumors were identified. The pattern of somatic genetic testing for each patient was evaluated from January 2016 through December 2018. Tests were classified by the number of genes tested in the panel: < 50 (small or medium) and ≥ 50 (large). RESULTS: An initial feasibility study using our novel approach for identifying panel tests resulted in 2.4 and 1.2 times more large and medium panels, respectively, identified compared with using procedure codes alone. A total of 121,675 eligible patients were identified, with 131,915 unique cancer cases. Overall, 5,457 (4.5%) patients received any panel test from 2016 to 2018. We found the number of tests performed each quarter increased from 238 in Q1 of 2016 to 755 in Q4 of 2018. The highest number of cases were genitourinary cancers; however, the highest proportion of cancer-related genetic testing was among patients with respiratory cancer. Across all tumor types, the proportion of large-panel tests performed as a function of all multigene panel tests increased from 20.7% of tests in Q1 of 2016 to 46.4% of tests in Q4 of 2018. The three cancer categories with the highest count of cancer-related panel tests, respiratory cancer, GI cancer, and female reproductive cancer, had a consistently greater proportion receiving a panel test at any point postindex. CONCLUSION: Across a variety of cancers, use of somatic, large-panel cancer-related genetic testing, as a proportion of all somatic cancer-related genetic testing, increased from 2016 to 2018, although testing overall was low.

FDA expedited approval and implications for rational formulary and health plan design.

DISCLOSURES: No funding supported this commentary. The authors are employed by Humana, Inc. Shrank reports board of directors work for GetWell Network and NCQA. The other authors have nothing to disclose.

Removal of prior authorization for medication-assisted treatment: impact on opioid use and policy implications in a Medicare Advantage population.

BACKGROUND: More than 30% of Medicare beneficiaries and 40% of patients dually eligible for Medicare and Medicaid use opioids. With an estimated 8%-12% of patients developing an opioid use disorder (OUD) after initiating opioids, opioid misuse is a significant public health challenge, especially among high-risk Medicare populations. Medication-assisted treatment (MAT) is the use of medications for the treatment of OUD and to prevent relapse to opioid use. MAT is the most effective treatment for OUD. There are a variety of barriers to MAT therapy that may delay access to treatment. OBJECTIVE: To study the impact of the removal of prior authorization requirements for MAT medications on MAT utilization, opioid utilization, and clinical outcomes, including emergency department visits, inpatient admission, relapse rates, behavioral health services, and nonopioid pain medication utilization, among opioid-using individuals with Medicare Advantage Prescription Drug (MAPD) coverage. METHODS: This retrospective, cross-sectional study used administrative medical, pharmacy, and enrollment data to identify chronic opioid users and a subset cohort initiating MAT use in 2017, when prior authorization requirements were in effect, and 2018 after removal of prior authorization requirements. Opioid and MAT utilization and clinical outcomes from emergency department visits were also examined before and after prior authorization requirements. A logistic regression analysis was conducted to examine the impact of the policy change on relapse rates, comparing relapse rates in 2017 and 2018, after controlling for potentially confounding demographic and clinical factors. RESULTS: This policy change was followed by a decrease in opioid utilization, an increase in MAT initiation, and a 4% decline in relapse rates. Patients initiating MAT after removal of prior authorizations had a 19% decrease in likelihood of relapse, and those with an OUD diagnosis were 47% less likely to relapse. The majority of MAT recipients were aged younger than 65 years, had a mental or behavioral health disorder diagnosis, and initially used relatively low doses (< 90 MME) of prescription opioids. There were no statistically significant differences in the use of behavioral health services or the use of nonopioid medications from 2017 to 2018. CONCLUSIONS: Utilization management policies should ensure appropriate MAT use, while minimizing impediments to access. Providing patients with evidence-based therapy effective for the treatment of OUD is essential to patient recovery and combating the consequences of the opioid epidemic. Further strides are needed to eliminate additional obstacles to OUD care. DISCLOSURES: No outside funding supported this study. All authors are or were employees of Humana, Inc., at the time of the study and have no other potential conflicts of interest to disclose.

Characteristics of Parkinson's Disease in Patients with and without Cognitive Impairment.

BACKGROUND: Characterizing patients with Parkinson's disease (PD) and cognitive impairment is important toward understanding their natural history. OBJECTIVE: Understand clinical, treatment, and cost characteristics of patients with PD pre- and post-cognitive impairment (memory loss/mild cognitive impairment/dementia or dementia treatment) recognition. METHODS: 2,711 patients with PD newly diagnosed with cognitive impairment (index) were identified using administrative claims data. They were matched (1:1) on age and gender to patients with PD and no cognitive impairment (controls). These two cohorts were compared on patient characteristics, healthcare resource utilization, and total median costs for 3 years pre- and post-index using Chi-square tests, t-tests, and Wilcoxon rank-sum tests. Logistic regression was used to identify factors predicting cognitive impairment. RESULTS: Comorbidity indices for patients with cognitive impairment increased during the 6-year study period, especially after the index. Enrollment in Medicare Advantage Prescription Drug plans vs. commercial (OR = 1.60), dual Medicare/Medicaid eligibility (OR = 1.36), cerebrovascular disease (OR = 1.24), and PD medication use (OR = 1.46) were associated with a new cognitive impairment diagnosis (all p < 0.05). A greater proportion of patients with cognitive impairment had hospitalizations and emergency department visits and higher median total healthcare costs than controls for each year pre- and post-index. CONCLUSION: In patients with PD newly diagnosed with cognitive impairment, comorbidity burden, hospitalizations, emergency department visits, and total costs peaked 1-year pre- and post-identification. These data coupled with recommendations for annual screening for cognitive impairment in PD support the early diagnosis and management of cognitive impairment in order to optimize care for patients and their caregivers.

Comparison of Medication Therapy Management Services and Their Effects on Health Care Utilization and Medication Adherence.

BACKGROUND: Medication therapy management (MTM) programs are designed to improve clinical outcomes and enhance appropriate medication use. Comprehensive medication reviews (CMRs) and targeted medication reviews (TMRs) are 2 broad interventions defined within MTM services. While MTM services have been extensively researched, there are few comparisons of CMR versus non-CMR interventions. Given the variability in MTM interventions and lack of a consistent TMR definition in the literature, this study sought to compare CMRs and TMRs that were clearly defined based on Centers for Medicare & Medicaid Services (CMS) criteria. OBJECTIVES: To (a) compare acute inpatient admissions and emergency department (ED) visits between patients participating in MTM services (CMR, TMR, or both) and eligible nonparticipating patients and (b) examine the effect of receiving TMR services on medication adherence. METHODS: This was a retrospective cohort study of patients with Medicare Part D coverage who received MTM services and a 1:1 propensity score-matched control group. Participants had to be eligible for MTM services in 2014 or 2015 based on CMS requirements. CMRs were offered to all MTM-eligible patients, while TMRs were completed based on clinical rules that helped identify medication-related problems (MRPs). The date of MTM intervention, or eligibility for the control group, was considered the index date. Participants had to be continuously enrolled in a Medicare Advantage plan that included prescription drug coverage during the study period and have at least 6 months of data before and after the index date. Medical and pharmacy claims were assessed to examine trend-adjusted inpatient admissions and ED visits from pre-index to post-index date for participants and matched controls. RESULTS: In 2014 and 2015, receipt of TMR interventions was associated with statistically significant reductions in acute inpatient admissions. In 2014, there were 55.2 fewer admits per 1,000 individuals (95% CI = 29-81) and 30.8 fewer admits per 1,000 individuals in 2015 (95% CI = 20-42). Receipt of CMR-only interventions was associated with fewer acute inpatient admissions only when coupled with preidentification of MRPs (36.8 [95% CI = 25-49] fewer admits per 1,000 individuals). In 2015, there were significant reductions in ED visits for participants receiving TMR-only interventions or TMR/CMR interventions (26.1 [95% CI = 11-41] and 12.0 [95% CI = 1-23] fewer ED visits per 1,000 individuals, respectively). In both years, a larger percentage (0.4% for oral diabetes medications; 7.7% for antihypertensives; 3.0% for statins) of MTM participants had greater improvements in medication adherence in the post-index period compared with controls. CONCLUSIONS: Receiving MTM services targeted at resolution of MRPs (TMR or CMR/TMR) resulted in positive reductions in health care utilization and increases in medication adherence. Given the importance of optimal medication utilization, this study highlights the need for additional focus on resolution of MRPs through TMRs and CMRs that can support improved clinical outcomes. DISCLOSURES: No outside funding supported this study. Researchers completed the work as part of their employment with Humana. All authors are or were employees of Humana at the time of the study. There are no other conflicts of interest to disclose. This study was previously presented at AMCP Nexus 2017 on October 16, 2017, in Dallas, TX.

The Prevalence of and Factors Associated With Receiving Concurrent Controlled Substance Prescriptions.

BACKGROUND: Controlled substance prescription (CSP) use and abuse in the United States has become a public health epidemic. One common and dangerous indicator of abuse involves obtaining CSPs concurrently. OBJECTIVE: The objective of this study was to identify the prevalence and factors associated with individuals receiving potentially inappropriate concurrent CSPs. METHODS: This was a retrospective, cohort analysis using data from the 2013-2014 Texas prescription drug monitoring program (PDMP). Descriptive statistics and a multiple logistic regression analysis were conducted to examine the individual-level and prescription utilization factors associated with individuals obtaining concurrent CSPs. RESULTS: Among Texas residents, 1,640,015 individuals (6.10% of all Texas residents and 15.99% of all CSP utilizers) were identified with at least one concurrent CSP combination. Concurrent opioid prescriptions were found to be the most prevalent concurrent use combination (n = 1,574,572). Having prescriptions for opioids, being ≥18 years of age, utilizing CSPs for >30 days, utilizing greater than one CSP, having a multiple provider episode, and traveling >25 miles to obtain CSPs were all statistically significant predictors of utilizing concurrent CSPs. CONCLUSION: The study findings indicate a high prevalence of individuals utilizing concurrent CSPs. This practice is concerning when considering that many overdose deaths result from the concurrent use of CSPs. Prescribers should utilize PDMPs to ensure that aberrant prescription drug behaviors, such as the use of concurrent opioids and benzodiazepines do not readily occur.

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

BACKGROUND: The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy community expressed concerns of unintended consequences as a result of rescheduling. OBJECTIVES: This study examined physicians' intentions to prescribe HCPs after rescheduling using the framework of the theory of reasoned action (TRA). METHODS: A cover letter containing a link to the online questionnaire was sent to physicians of the Texas Medical Association who were likely to prescribe opioids. The questionnaire assessed physicians' intentions to prescribe HCPs after rescheduling. Predictor variables included attitude toward rescheduling, subjective norm toward HCP prescribing, and past prescribing behavior of schedule II prescriptions. All variables were measured on a 7-point, Likert-type scale. Intention to prescribe as a dependent variable was regressed over TRA variables and respondent characteristics. RESULTS: A total of 1176 usable responses were obtained, yielding a response rate of 13.3%. Mean (M) age was 53.07 ± 11 and most respondents were male (70%) and Caucasian (75%). Physicians held a moderately positive intention to prescribe HCPs (M = 4.36 ± 2.08), held a moderately negative attitude towards rescheduling, M = 4.68 ± 1.51 (reverse coded). Subjective norm was moderately low, M = 3.06 ± 1.78, and past prescribing behavior M = 2.43 ± 1.21. The linear regression analysis indicated that attitude (ß = 0.10; P = 0.006), subjective norm (ß = 0.35; P < 0.0001) and past prescribing behavior (ß = 0.59; P < 0.0001) were significant predictors of intention to prescribe HCPs after rescheduling. CONCLUSIONS: TRA was shown to be a predictive model of physicians' intentions to prescribe HCPs after rescheduling. Overall, physicians held a moderately positive intention to prescribe HCPs. Past behavior concerning schedule II prescribing was found to be the most significant predictor of intention. Understanding the impact of federal rule changes on pain management care and patient satisfaction is necessary to determine whether this change has produced the intended consequences without harming patients in need of HCPs.

Prevalence and Factors Associated with Multiple Provider Episodes in Texas: An Epidemiological Analysis of Prescription Drug Monitoring Program Data.

OBJECTIVE: Prescription drug abuse has reached epidemic levels, leading to overdose-related morbidity and mortality. Patient and regional-level factors are believed to contribute to higher rates of prescription drug abuse. The objective of this study was to determine the prevalence and factors associated with multiple provider episodes (MPEs) in Texas. METHODS: This was a retrospective cohort analysis of data from the Texas Prescription Drug Monitoring Program (PDMP) database, linked with Texas county census data. Descriptive statistics and a multilevel model regression analysis were employed to estimate the prevalence of MPEs and examine the association between individual controlled substance prescription (CSP) utilization and county factors associated with MPEs. RESULTS: Among the 10,381,532 Texas residents utilizing CSPs in 2013, prescription opioids were the most frequently dispensed CSP (38.64%). The prevalence of MPEs was 71.30 per population of 100,000. Of those with MPEs, 76.98% received CSPs for more than 150 days and 11.48% had an average daily morphine equivalent dose (MED) 100 mg/day or higher. Residing in metropolitan areas, traveling more than 100 miles to obtain and fill prescriptions, chronic use of CSPs, younger age, and high MED were all significantly associated with increased risk of MPEs. CONCLUSIONS: This study revealed that previous estimates of prescription drug abuse may be drastically underestimated. Prescription drug abuse is a major public health problem in Texas, especially in metropolitan areas. Therefore, prevention efforts need to be addressed at the individual level and through public health and policy legislation.

Educating Pharmacists on a Prescription Drug Monitoring Program.

OBJECTIVE: To provide education to community pharmacists regarding the registration and use of the Texas prescription drug monitoring program (PDMP) and to assess the impact of the education on pharmacists' perceptions of the PDMP. METHOD: The study design was a descriptive, pre and post, cross-sectional survey conducted among community pharmacists attending a PDMP education program. The program was designed to present the PDMP as a public health tool available to assist pharmacists with dispensing decisions related to controlled prescription drugs. RESULTS: Of the 24 pharmacists who completed the survey, 23 were already registered to use the PDMP. However, all 23 felt that the program successfully educated users regarding the PDMP and agreed that other community pharmacists would benefit from the program presented. After the program, 14 participants responded they would very likely use the PDMP in the next 30 days. Recognition of the use of PDMPs as a program for both pharmacists and physicians was increased from 12.5% (pre) to 73.9% (post). CONCLUSION: Pharmacists found the educational program beneficial and they were very likely to use the PDMP in the future. Perceptions of the Texas PDMP were changed from pre- to post-education program, with recognition that a PDMP can be a beneficial tool for pharmacy practice.