Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia.

Background And Objectives: This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I).

Methods: Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018.

Network meta-analysis comparing the effectiveness of a prescription digital therapeutic for chronic insomnia to medications and face-to-face cognitive behavioral therapy in adults.

Objective: The purpose of this study was to compare the effectiveness of the only Food and Drug Administration-authorized prescription digital therapeutic (PDT) Somryst versus face-to-face cognitive behavioral therapy for insomnia (CBT-I), or FDA-approved prescription medications for insomnia.

Methods: A systematic literature review was undertaken to identify relevant studies. A Bayesian network meta-analysis (NMA) was conducted to examine (1) mean change in insomnia severity index (ISI); (2) proportional change in ISI remitters; (3) mean change in wake after sleep onset (WASO); and (4) mean change in sleep onset latency (SOL).

Real-World Reductions in Healthcare Resource Utilization over 6 Months in Patients with Substance Use Disorders Treated with a Prescription Digital Therapeutic.

Background And Aims: Substance use disorders (SUDs) affect approximately 40.3 million people in the USA, yet only approximately 19% receive evidence-based treatment each year. reSET is a prescription digital therapeutic (PDT) and the only FDA-authorized treatment for patients with cocaine, cannabis, and stimulant use disorders.

Reduced Healthcare Resource Utilization in Patients with Opioid Use Disorder in the 12 Months After Initiation of a Prescription Digital Therapeutic.

Background And Aims: reSET-O, an FDA-authorized prescription digital therapeutic (PDT) delivering cognitive behavioral therapy and contingency management to patients with opioid use disorder (OUD), may help improve clinical outcomes. One-year differences in healthcare resource utilization (HCRU) and costs post-PDT initiation were evaluated.

Methods: Retrospective analysis of healthcare claims data compared all-cause HCRU (across hospital facility encounters [sum of inpatient stays, treat-and-release emergency department [ED] visits, partial hospitalizations, and hospital outpatient department visits] and clinician services [procedure categories]) after PDT initiation (index) between reSET-O patients and controls.

Five-year budget impact of a prescription digital therapeutic for patients with opioid use disorder.

Background: Opioid use disorder (OUD) is associated with high healthcare resource utilization (HCRU) and costs. reSET-O is an FDA-cleared prescription digital therapeutic that delivers neurobehavioral therapy as an adjunct to treatment-as-usual (TAU; buprenorphine, face-to-face counseling, and contingency management).

Methods: A budget impact model was developed to evaluate reSET-O as an adjunct to TAU in OUD for a 1 million-member US mixed health plan over a 5-year time horizon.

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder.

Background: A prescription digital therapeutic (PDT) (reSET-O) may expand access to behavioral treatment for patients with opioid use disorder (OUD) treated with buprenorphine, but long-term data on effectiveness are lacking.

Objective: To compare real-world healthcare resource utilization (HCRU) among patients who engaged with reSET-O and buprenorphine compared to similar patients in recovery treated with buprenorphine who did not fill their reSET-O script or engage with the PDT beyond week one.

Methods: A retrospective analysis of facility and clinical service claims data was conducted in adults with PDT initiation and between 12 weeks and 9 months of continuous enrollment in a health plan after initiation.

Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder.

Purpose: To evaluate real-world prescription digital therapeutic (PDT) use and associated clinical outcomes among patients with opioid use disorder (OUD).

Patients And Methods: A real-world observational evaluation of patients who filled either a 12- or 24-week (refill) prescription for the reSET-O® PDT. The PDT content consists of 67 interactive lessons unlocked in sequence during use as well as the chance to earn rewards for progress and/or negative urine screens.

Cost-Effectiveness Analysis of a Prescription Digital Therapeutic for the Treatment of Opioid Use Disorder.

The lack of adequate treatment for many patients with opioid use disorder (OUD) has led to high medical costs ($90B in 2020). An analysis of the cost-effectiveness (cost-utility) of reSET-O, the first and only FDA-approved prescription digital therapeutic (PDT) for the treatment of OUD, is needed to inform value assessments and healthcare decision making. To evaluate the cost-utility of reSET-O in conjunction with treatment-as usual (TAU) compared to TAU alone.

Real-world changes in US health system hospital-based services following treatment with a prescription digital therapeutic for opioid use disorder.

Outcomes associated with buprenorphine therapy for the treatment of opioid use disorder (OUD) are suboptimal. reSET-O is an FDA-authorized prescription digital therapeutic (PDT) delivering neurobehavioral therapy via mobile devices to patients with OUD treated with buprenorphine. This analysis evaluated the net impact of reSET-O on medical costs among actively-engaged reSET-O patients using real-world observations.

Evaluation of the cost-utility of a prescription digital therapeutic for the treatment of opioid use disorder.

The opioid epidemic continues to generate a significant mental and physical health burden on patients, and claims the life of almost 150 Americans daily. Making matters worse, an increase in relapses and/or opioid-related deaths has been reported in more than 40 U.S.

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic.

Introduction: Buprenorphine medication assisted treatment (B-MAT) adherence for opioid use disorder (OUD) is suboptimal. reSET-O, an FDA-cleared prescription digital therapeutic, delivers neurobehavioral therapy (community-reinforcement approach+fluency training+contingency management) to B-MAT-treated OUD patients.

Methods: This retrospective claims study (10/01/2018-10/31/2019) evaluated healthcare resource utilization up to 6 months before/after reSET-O initiation.

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder.

Objectives: To evaluate patient engagement and usage of a prescription digital therapeutic (PDT) and associated outcomes of opioid use and treatment retention in a large real-world dataset of patients with opioid use disorder (OUD) treated with buprenorphine medication for opioid use disorder (MOUD). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials (RCTs), and authorized by the U.S.

Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.

Background: Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) seriously impairs health-related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with CRSwNP.

Methods: Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO).

Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: A pooled analysis of phase III clinical trials of eslicarbazepine acetate.

Background: Subjects who received eslicarbazepine acetate (ESL) as adjunctive therapy experienced significantly greater seizure frequency reduction (SFR) than placebo in three phase III, randomized, double-blind trials. This analysis compared changes in health-related quality of life (HRQOL) between treatment responders and non-responders across the pooled, per-protocol population (N=842) using the validated Quality of Life in Epilepsy Inventory-31 (QOLIE-31).

Methods: QOLIE-31 scores were calculated for Total Score (TS) and seven subscales; higher scores indicate better HRQOL.

Severity and burden of partial-onset seizures in a phase III trial of eslicarbazepine acetate.

Objective: The objective of this study was to compare posttreatment seizure severity in a phase III clinical trial of eslicarbazepine acetate (ESL) as adjunctive treatment of refractory partial-onset seizures.

Methods: The Seizure Severity Questionnaire (SSQ) was administered at baseline and posttreatment. The SSQ total score (TS) and component scores (frequency and helpfulness of warning signs before seizures [BS]; severity and bothersomeness of ictal movement and altered consciousness during seizures [DS]; cognitive, emotional, and physical aspects of postictal recovery after seizures [AS]; and overall severity and bothersomeness [SB]) were calculated for the per-protocol population.

Clinical and economic burden of breakthrough seizures.

Purpose: The purpose of this study was to measure health-care resource utilization and costs in treatment-adherent, previously seizure-free patients with epilepsy who were treated in the inpatient/emergency room (ER) setting for new-onset seizures, compared with matched controls.

Methods: The study used a retrospective case/control study design using administrative claims from the IMS PharMetrics™ database. We identified adult patients with epilepsy with 1+ ER visit/hospitalization with primary diagnosis of epilepsy between 1/1/2006 and 3/31/2011, preceded by 6months of seizure-free activity and antiepileptic drug (AED) treatment adherence (≥80% of days covered by any AED); the first observed seizure defined the "breakthrough" seizure/index event.

The effect of hepatitis C treatment response on medical costs: a longitudinal analysis in an integrated care setting.

Background: Studies suggest that chronic hepatitis C patients who achieve sustained virologic response (SVR) have lower risks of liver-related morbidity and mortality. Given the substantial costs and complexity of hepatitis C virus (HCV) antiviral treatment, post-treatment benefits are important to understand.  

Objective: To determine whether health care costs and utilization for up to 5 years after treatment differed between patients who achieved SVR and those who did not.

Will patients agree to have their literacy skills assessed in clinical practice?

If health providers are aware of their patients' literacy skills, they can more appropriately tailor their communication with patients. Few providers, however, assess patient's literacy skills for fear of offending patients, but no research has ever determined if patients object to such assessments. Our objectives were to determine the percentage of patients seen for routine health care that would agree to undergo literacy assessment and if satisfaction of patients differs in practices that perform literacy assessments versus practices that do not.