Retrospective Database Analysis to Explore Patterns and Economic Burden of Switchback to Brand After Generic or Authorized Generic Utilization.

Background: Despite demonstration of bioequivalence of generics to brands and the potential for reduced costs, some patients switch back from a generic to the brand. A prior retrospective analysis suggested that this switchback rate may be lower among patients that had initially switched to authorized generics (AG), often both produced and marketed by the brand company, compared to those initially switched to another generic. Objective: Explore switching patterns of brands, AGs, and generics, switchback rates, and the potential impact of switchbacks on healthcare costs. Methods: An analysis of the Pharmetrics Plus™ database (2007-2019), a United States (US) payer administrative database, was conducted to examine the use of Upjohn medications available as AGs across multiple therapeutic areas. Patients initiating treatment with brand medication in the 6 months prior to generic market entry were identified and switch rates to generics and AGs, as well as switchback rates, were evaluated. Costs were descriptively compared between patients who switched back to brand and those who remained on any generic. Results: Across 14 brand medications, more than half of the patients initiating treatment with the brand medication were switched to a generic. Generally, switching to AG, which ranged from 0.5 to 39.6%, was lower than switching to non-AG generics (16.7-79.9%). The comparison of switchback rates from AGs to brand and non-AGs to brand showed similar results (AG:1.3-7.5%; non-AG:1.4-12.9%); however, the most substantial differences were observed where non-AG switchbacks were higher. Patients that switched back to brand remained on AG or generic for an average of 1-3 months (32-88 days). The analysis showed a tendency towards increased medical costs in the period immediately preceding switchback for all medications except sildenafil in both indications (erectile dysfunction and pulmonary arterial hypertension). For the remaining medications, medical costs ranged from $63 to $1544 higher for the switchback population. Pharmacy costs similarly tended to be higher for patients who had a switchback, with the exception of sildenafil for pulmonary arterial hypertension and sirolimus. Conclusion: Patients receiving a brand medication are likely to be switched to a generic upon market availability. Some patients switch back to the brand medication, usually within 1-3 months; this may be associated with increased medical costs. Additional research is needed to understand switching, its potential disruption to patients, and the role of brands, generics, and AGs.

Provider and household costs of Plasmodium vivax malaria episodes: a multicountry comparative analysis of primary trial data.

OBJECTIVE: To determine household and health-care provider costs associated with Plasmodium vivax infection across a range of endemic settings. METHODS: We collected cost data alongside three multicentre clinical trials of P. vivax treatment in Afghanistan, Brazil, Colombia, Ethiopia, Indonesia, Philippines, Peru, Thailand and Viet Nam conducted between April 2014 to December 2017. We derived household costs from trial participant surveys administered at enrolment and again 2 weeks later to determine the costs of treatment and transportation, and the number of days that patients and their household caregivers were unable to undertake their usual activities. We determined costs of routine care by health-care providers by micro-costing the resources used to diagnose and treat P. vivax at the study sites. FINDINGS: The mean total household costs ranged from 8.7 United States dollars (US$; standard deviation, SD: 4.3) in Afghanistan to US$ 254.7 (SD: 148.4) in Colombia. Across all countries, productivity losses were the largest household cost component, resulting in mean indirect costs ranging from US$ 5.3 (SD: 3.0) to US$ 220.8 (SD: 158.40). The range of health-care provider costs for routine care was US$ 3.6-6.6. The cost of administering a glucose-6-phosphate-dehydrogenase rapid diagnostic test, ranged from US$ 0.9 to 13.5, consistently lower than the costs of the widely-used fluorescent spot test (US$ 6.3 to 17.4). CONCLUSION: An episode of P. vivax malaria results in high costs to households. The costs of diagnosing and treating P. vivax are important inputs for future cost-effectiveness analyses to ensure optimal allocation of resources for malaria elimination.

Cost-Effectiveness of Dolutegravir in HIV-1 Treatment-Naive and Treatment-Experienced Patients in Canada.

INTRODUCTION: The Antiretroviral Analysis by Monte Carlo Individual Simulation (ARAMIS) model was adapted to evaluate the cost-effectiveness of dolutegravir (DTG) in Canada in treatment-naive (TN) and treatment-experienced (TE) human immunodeficiency virus (HIV)-1 patients. METHODS: The ARAMIS-DTG model is a microsimulation model with a lifetime analytic time horizon and a monthly cycle length. Markov health states were defined by HIV health state (with or without opportunistic infection). DTG was compared to efavirenz (EFV), raltegravir (RAL), darunavir/ritonavir, rilpivirine (RPV), elvitegravir/cobicistat, atazanavir/ritonavir and lopinavir/ritonavir in TN patients and to RAL in TE patients. The initial cohort, the main efficacy data and safety data were derived from phase III clinical trials. Treatment algorithms were based on expert opinion. Costs normalized to the year 2013 included antiretroviral treatment cost, testing, adverse event, HIV and cardiovascular disease care and were derived from the literature. RESULTS: Dolutegravir was estimated to be the dominant strategy compared with all comparators in both TN and TE patients. Treatment with DTG was associated with additional quality-adjusted life-years that ranged from 0.17 (vs. RAL) to 0.47 (vs. EFV) in TN patients and was 0.60 in TE patients over a lifetime. Cost savings ranged from Can$1393 (vs. RPV) to Can$28,572 (vs. RAL) in TN patients and amounted to Can$3745 in TE patients. Sensitivity analyses demonstrated the robustness of the model. CONCLUSIONS: Dolutegravir is a dominant strategy in the management of TN and TE patients when compared to recommended comparators. This is mainly related to the high efficacy and high barrier to resistance. FUNDING: ViiV Healthcare.

An extreme bushfire smoke pollution event: health impacts and public health challenges.

AIMS: To determine the health impacts of smoke and the effectiveness of public health advisories during a severe bushfire smoke event in Albury, NSW. METHODS: The NSW Department of Environment and Climate Change provided PM(10) data. A computer-assisted telephone survey using random digit dialling was conducted following the smoke event to assess health impacts and the effectiveness of advisories. RESULTS: The smoke event lasted 38 days. The maximum daily PM(10) level was 415 microg/m(3). Public health advisories were based on alerts for air pollution issued by NSW Department of Health. From the survey, a total of 389 interviews were available for analysis. At least one health effect of the smoke was reported by 70% of respondents and 5% reported seeking medical treatment. Over 74% reported seeing, hearing or reading the health advisories. Behaviour change was significantly greater in this group (odds ratio = 2.74; 95% confidence interval 1.50-5.02). CONCLUSION: High rates of health effects may be experienced by populations exposed to bushfire smoke pollution. Public health advisories can support behaviour change to reduce exposure to bushfire smoke.

Further validation of an individualized migraine treatment satisfaction measure.

OBJECTIVE: To assess individualized satisfaction with migraine treatment, patient expectations, importance rankings, treatment outcomes, and overall satisfaction were combined using a four-part conceptual model. This article describes the measurement properties of the Migraine Treatment Satisfaction Measure (MTSM) using participants from a randomized controlled trial evaluating a Headache Management Program (HMP). METHODS: Participants completed the first two parts of the MTSM upon enrollment and the final two parts at 6 months. Internal consistency reliability was computed within each of the four modules. Discriminant validity was ascertained using Migraine Disability Assessment Survey (MIDAS), Patient Health Questionnaire-9, and MSFB scores. Convergent validity was established by hypothesized positive correlations between MTSM scores, Medical Outcomes Study Short-Form (SF-36), MIDAS, and Migraine Symptom Frequency Bother (MSFB). RESULTS: In total, 124 participants (mean age 45.4 years, 75% women, 59.7% Caucasian) enrolled. Internal consistency for expectations, importance rankings, outcomes, and satisfaction measures was 0.83, 0.95, 0.86, and 0.95, respectively. As the severity of depression increased, MTSM scores decreased significantly. ANOVA between MTSM scores and symptom bothersomeness and symptom frequency tertiles showed a significant decrease in satisfaction in the moderate-to-severe groups. MTSM scores showed expected associations with MSFB scores (-0.301; P < 0.01), MIDAS (-0.267; P < 0.01), general health (0.253; P < 0.05), mental health (0.217; P < 0.05), and vitality subscales of SF-36 (0.214; P < 0.05). Patients in the HMP reported significantly higher MTSM scores (43.2 vs. 31.4; P < 0.001). Patients on triptans reported a significantly higher satisfaction compared to patients on analgesics (39.5 vs. 32.9; P < 0.05). CONCLUSION: The MTSM is a valid and reliable patient-reported outcome that can be used to evaluate differences in treatment satisfaction associated with migraine therapies.

Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov, the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.