Adherence,persistence, and inpatient utilization among adult schizophrenia patients using once-monthly versus twice-monthly long-acting atypical antipsychotics

Aims: This study compared healthcare resource utilization (HRU), healthcare costs, adherence, and persistence among adult patients with schizophrenia using once-monthly (OM) vs twice-monthly (TM) atypical long-acting injectable (LAI) antipsychotic (AP) therapy.

Materials and methods: A longitudinal retrospective cohort study was conducted using Medicaid claims data from six states. Patients initiated on aripiprazole or paliperidone palmitate were assigned to the OM cohort; risperidone-treated patients were assigned to the TM cohort. HRU and healthcare costs were assessed during the first 12 months following stabilization on the medication. Adherence was measured using the proportion of days covered (PDC) during the first year of follow-up. Persistence to the index medication was measured during the first 2 years following the index date. Comparison between the cohorts was achieved using multivariable generalized linear models, adjusting for demographic and clinical characteristics.

Results: Patients in the OM LAI cohort had lower inpatient HRU and medical costs when compared with patients in the TM cohort. Higher medical costs in the TM LAI cohort offset the higher pharmacy costs in the OM LAI cohort. Mean PDC during the first 12 months of follow-up was higher in the OM cohort than in the TM cohort (0.56 vs 0.50, p?<?.01). Median persistence was longer in the OM cohort than in the TM cohort (7.5 months vs 5.5 months), as was the hazard of discontinuing the index medication (hazard ratio?=?0.83, p?=?.01). Kaplan-Meier rates of persistence at 1 year were higher for OM patients than for TM patients (37.6% vs 29.6%, p?<?.01).

Limitations: This was a Medicaid sample with few aripiprazole LAI patients (5.4% of OM cohort). Medication use was inferred from pharmacy claims.

Conclusions: Among Medicaid patients in these six states, OM AP treatment was associated with lower HRU, better adherence and persistence, and similar total costs compared to patients on TM treatment.     

The impact of low cost airline entry on competition, network expansion, and stock valuations

We conduct event studies and statistical analysis to explore the impact of low cost carriers’ entry on legacy airline stock prices. Oligopoly structures, entry barriers, and high fixed costs make the airline industry highly susceptible to competitive and network expansion impact of low cost airlines’ entry. Positive stock returns are observed, which we interpret as the spillover effects of network expansion. Thus, rising passenger traffic and improved connectivity increase the revenues of legacy airlines to sufficiently offset the low cost carriers’ competitive threats.     

The economic burden of psoriasis with high comorbidity among privately insured patients in the United States

Objective: To evaluate the impact of comorbidities on healthcare resource use (HRU), and direct and indirect work-loss-related costs in psoriasis patients.

Methods: Adults with psoriasis (≥2 diagnoses, the first designated as the index date) and non-psoriasis controls (no psoriasis diagnoses, randomly generated index date) were identified in a US healthcare claims database of privately-insured patients (data between January 2010 and March 2017 were used). Psoriasis patients were stratified based on the number of psoriasis-related comorbidities (0, 1–2, or ≥3) developed during the 12?months post-index. All outcomes were evaluated during the follow-up period, spanning the index date until the end of continuous health plan eligibility or data cut-off. HRU and costs per-patient-per-year (PPPY) were compared in psoriasis and non-psoriasis patients with ≥12?months of follow-up.

Results: A total of 9,078 psoriasis (mean age?=?44?years, 51% female) and 48,704 non-psoriasis (mean age?=?41?years, 50% female) patients were selected. During the 12?months post-index, among psoriasis vs non-psoriasis patients, 71.0% vs 83.0% developed no psoriasis-related comorbidities, 26.3% vs 16.0% developed 1–2, and 2.6% vs 1.0% developed ≥3 psoriasis-related comorbidities. Compared to non-psoriasis patients, psoriasis patients had more HRU including outpatient visits (incidence rate ratios [IRRs]?=?1.52, 2.03, and 2.66 for 0, 1–2, and ≥3 comorbidities, respectively [all p?p?p?p?Conclusions: HRU and cost burden of psoriasis are substantial, and increase with the development of psoriasis-related comorbidities.     

Transparency and trust in the European pharmaceutical sector: outcomes from an experimental study

Many European pharmaceutical regulators have committed to a more open, inclusive, and transparent model of regulatory decision-making in recent years. Yet, based on little empirical evidence, they have overwhelmingly adopted ‘fishbowl’ transparency measures, ‘the full disclosure of information without explanatory information or contextualization’ (e.g. heightening access to raw data). This paper conveys recent findings from an open-ended questionnaire with 200 face-to-face interviews carried out in the UK and the Netherlands. The study provides evidence on how members of the public are likely to react to ‘fishbowl’ transparency policies and receiving decontextualized data. After showing respondents raw data from a periodic safety update report that regulators are proposing to proactively release, the survey found they were shocked, concerned, and more worried, while many said they would reconsider taking their medicines and seek further advice. Based on these findings, the authors argue that enhancing ‘transparency’ needs to be integrated with effective, evidence- and science-based benefit/risk communication.     

Mutual fund trades and the value of contradictory private information

We investigate the performance of mutual funds that trade using private information. These funds are uniquely identified from a set of 2730 funds with 44,315 fund-periods between 1994 and 2005. We compare the alignment of fund trades with brokers’ recommendations, which we regard as “public information” in the universe of informed and uninformed mutual funds. Funds that systematically trade counter to the public information form a homogenous subset of the privately informed funds. By using private information that contradicts the public information, these funds exhibit a superior average performance. After we control for serial correlation in fund returns, we assess this advantage as being an economically significant 1.7% per annum. We also show empirically that smaller funds are better able to capture the benefit of private information.     

Medicines transparency at the European Medicines Agency (EMA) in the new information age: the perspectives of patients

The concept of transparency has gained widespread appeal in the European pharmaceutical domain, not least at the European Medicines Agency (EMA). Agency policies have two main objectives: (1) to enable the reuse of data (e.g. clinical study reports) and (2) to empower patients to directly and indirectly make more informed decisions on medicines. Past research has almost exclusively focused on the perspectives of external researchers intending to reanalyse data made publically available. Few studies, however, have explored what can be learnt from the perspectives of other actors (e.g. health care professionals, patients, the regulators themselves, industry and others). This empirical study explores the EMA’s transparency policies from the perspectives of patients. After presenting the results of a survey (N = 1010) with a sample of individuals diagnosed with five specific medical conditions (HIV/AIDS, multiple sclerosis, rheumatoid arthritis, osteoporosis and idiopathic pulmonary fibrosis) from four EU countries (Germany, Spain, France and the UK), the authors argue that EMA’s transparency policies do not adequately address the real-world complexities of communicating with patients. In turn, the paper concludes that the perspective of patients provides an essential contribution to understanding the full net effects (positive, negative and/or limited) of EMA’s transparency policies.     

Cost per median overall survival month associated with abiraterone acetate and enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer

Objective: To calculate costs per median overall survival (OS) month in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate plus prednisone (AA?+?P) or enzalutamide. Methods: Median treatment duration and median OS data from published Phase 3 clinical trials and prescribing information were used to calculate costs per median OS month based on wholesale acquisition costs (WACs) for patients with mCRPC treated with AA?+?P or enzalutamide. Sensitivity analyses were performed to understand how variations in treatment duration and treatment-related monitoring recommendations influenced cost per median OS month. Cost-effectiveness estimates of other Phase 3 trial outcomes were also explored: cost per month of chemotherapy avoided and per median radiographic progression-free survival (rPFS) month. Results: The results demonstrated that AA?+?P has a lower cost per median OS month than enzalutamide ($3231 vs 4512; 28% reduction), based on the following assumptions: median treatment duration of 14 months for AA?+?P and 18 months for enzalutamide, median OS of 34.7 months for AA?+?P and 35.3 months for enzalutamide, and WAC per 30-day supply of $8007.17 for AA?+?P vs $8847.98 for enzalutamide. Sensitivity analyses showed that accounting for recommended treatment-related monitoring costs or assuming identical treatment durations for AA?+?P and enzalutamide (18 months) resulted in costs per median OS month 8–27% lower for AA?+?P than for enzalutamide. Costs per month of chemotherapy avoided were $4448 for AA?+?P and $5688 for enzalutamide, while costs per month to achieve median rPFS were $6794 for AA?+?P and $7963 for enzalutamide. Conclusions: This cost-effectiveness analysis demonstrated that costs per median OS month, along with costs of other Phase 3 trial outcomes, were lower for AA?+?P than for enzalutamide. The findings were robust to sensitivity analyses. These results have important implications for population health decision-makers evaluating the relative value of therapies for mCRPC patients.     

Key research themes on governance and sustainable urban mobility

ABSTRACT

This article discusses the governance of sustainable urban development and in particular assesses the role of policy instruments to promote soft forms of governance associated with persuasion and coordination. These instruments are critically examined in terms of how they might help to promote greater policy integration and more sustainable development. Five types of strategies for promoting more sustainable transport policies are discussed: (1) policy indicators and targets, (2) benchmarking, (3) policy transfer and best practices, (4) policy experimentation/innovation, and (5) visioning/envisioning. The article is divided into four main parts. First, it presents an overview of recent trends in the governance of urban transport. Second, it examines the notion of policy integration, a central theme in discussions about sustainable transport and governance. Third, it considers how selected types of policy instruments might contribute to policy integration and sustainable urban development. Fourth, alongside the conclusions, suggestions are made for new research related to policy instruments and soft forms of governance in relation to urban transport.     

Cost-effectiveness of direct-acting antiviral regimen ombitasvir/paritaprevir/ritonavir in treatment-naïve and treatment-experienced patients infected with chronic hepatitis C virus genotype 1b in Japan

Objective: This study compared the cost-effectiveness of chronic hepatitis C virus (HCV) genotype 1b (GT1b) therapy ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) vs daclatasvir?+?asunaprevir (DCV/ASV) and no treatment in patients without cirrhosis. Cost-effectiveness analyses (CEAs) that compared OBV/PTV/r against DCV/ASV and sofosbuvir/ledipasvir (SOF/LDV) in Y93H mutation-negative, GT1b patients with and without cirrhosis were also included.

Methods: A health state transition model was developed to capture the natural history of HCV. A CEA over a lifetime horizon was performed from the perspective of the public healthcare payer in Japan. Costs, health utilities, and rates of disease progression were derived from published studies. Sustained virologic response (SVR) rates of OBV/PTV/r and DCV/ASV were extracted from Japanese clinical trials. Analyses were performed for treatment-naïve and -experienced patients. Alternative scenarios and input parameter uncertainty on the results were tested.

Results: OBV/PTV/r exhibited superior clinical outcomes vs comparators. For OBV/PTV/r, DCV/ASV, and no treatment, the lifetime risk of decompensated cirrhosis in treatment-naïve patients without cirrhosis was 0.4%, 1.4%, and 9.2%, and hepatocellular carcinoma was 6.5%, 11.4%, and 49.9%, respectively. Quality-adjusted life years (QALYs) were higher in treatment-naïve and -experienced patients without cirrhosis treated with OBV/PTV/r (16.41 and 16.22) vs DCV/ASV (15.83 and 15.66) or no treatment (11.34 and 11.23). In treatment-naïve and -experienced patients without cirrhosis, the incremental cost-effectiveness ratios (ICERs) of OBV/PTV/r vs DCV/ASV were JPY 1,684,751/QALY and JPY 1,836,596/QALY, respectively; OBV/PTV/r was dominant compared with no treatment. In scenario analysis, including GT1b patients with and without cirrhosis who were Y93H mutation-negative, the ICER of OBV/PTV/r vs DCV/ASV was below the Japanese willingness-to-pay threshold of JPY 5 million/QALY, while the ICER of SOF/LDV vs OBV/PTV/r was above this threshold; thus, OBV/PTV/r was cost-effective.

Conclusion: OBV/PTV/r appears to be a cost-effective treatment for chronic HCV GT1b infection against DCV/ASV. OBV/PTV/r dominates no treatment in patients without cirrhosis.