Updated trends in US brand-name and generic drug competition

Objective: To provide updated evidence on US trends in: market exclusivity periods (MEPs, time between brand-name drug launch and first generic competitors) for new molecular entities (NMEs); likelihood, timing and number of Hatch-Waxman Act Paragraph IV patent challenges; and generic drug penetration.

Methods: This study used IMS Health National Sales Perspectives^TM US data to calculate MEPs for the 288 NMEs experiencing initial generic entry between January 1995 and December 2014, the number of generic competitors for 12 months afterward (by level of annual sales prior to generic entry), and generic penetration rates. The likelihood, timing and number of Paragraph IV challengers were calculated using data from Abbreviated New Drug Approval (ANDA) letters, the FDA website, public information searches, and ParagraphFour.com.

Results: For drugs experiencing initial generic entry in 2013–2014, the MEP was 12.5 years for drugs with sales greater than $250 million (in 2008 dollars) in the year prior to generic entry ($250 million?+?NMEs), 13.6 years overall. After generic entry, brands rapidly lost sales, with their average unit share being 7% at 1 year for $250 million?+?NMEs, 12% overall. Ninety-four percent of $250 million?+?NMEs experiencing initial generic entry in 2013–2014 had faced at least one Paragraph IV challenge, an average of 5.2 years after brand launch (76% and 5.9 years for all NMEs). NMEs faced an average of 5.1 and 6.2 Paragraph IV challenges per NME, for all and $250 million?+?NMEs, respectively.

Limitations: Analyses, including Paragraph IV calculations, were restricted to NMEs where generic entry had occurred.

Conclusion: The average 2013–2014 MEP of 12.5 years for $250 million?+?NMEs, 13.6 overall remains consistent with prior research. MEPs are lower, and Paragraph IV challenges are more frequent and occur earlier for $250 million?+?drugs. Generic share erosion is also greater, and continues to intensify for both NME types.     

Economic evaluation of nivolumab for the treatment of second-line advanced squamous NSCLC in Canada: a comparison of modeling approaches to estimate and extrapolate survival outcomes

Background Lung cancer is the most common type of cancer in the world and is associated with significant mortality. Nivolumab demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) for patients with advanced squamous non-small cell lung cancer (NSCLC) who were previously treated. The cost-effectiveness of nivolumab has not been assessed in Canada. A contentious component of projecting long-term cost and outcomes in cancer relates to the modeling approach adopted, with the two most common approaches being partitioned survival (PS) and Markov models. The objectives of this analysis were to estimate the cost-utility of nivolumab and to compare the results using these alternative modeling approaches.

Methods Both PS and Markov models were developed using docetaxel and erlotinib as comparators. A three-health state model was used consisting of progression-free, progressed disease, and death. Disease progression and time to progression were estimated by identifying best-fitting survival curves from the clinical trial data for PFS and OS. Expected costs and health outcomes were calculated by combining health-state occupancy with medical resource use and quality-of-life assigned to each of the three health states. The health outcomes included in the model were survival and quality-adjusted-life-years (QALYs).

Results Nivolumab was found to have the highest expected per-patient cost, but also improved per-patient life years (LYs) and QALYs. Nivolumab cost an additional $151,560 and $140,601 per QALY gained compared to docetaxel and erlotinib, respectively, using a PS model approach. The cost-utility estimates using a Markov model were very similar ($152,229 and $141,838, respectively, per QALY gained).

Conclusions Nivolumab was found to involve a trade-off between improved patient survival and QALYs, and increased cost. It was found that the use of a PS or Markov model produced very similar estimates of expected cost, outcomes, and incremental cost-utility.     

Do they Know it’s CSR at all? An Exploration of Socially Responsible Music Consumption

Porter and Kramer (Harv Bus Rev 84(12):78–92, 2006; Harv Bus Rev 89(1/2), 62–77, 2011) introduced ‘shared value’ as a ‘new conception of capitalism,’ claiming it is a powerful driver of economic growth and reconciliation between business and society. The idea has generated strong interest in business and academia; however, its theoretical precepts have not been rigorously assessed. In this paper, we provide a systematic and thorough analysis of shared value, focusing on its ontological and epistemological properties. Our review highlights that ‘shared value’ has spread into the language of multiple disciplines, but that its current conceptualization is vague, and it presents important discrepancies in the way it is defined and operationalized, such that it is more of a buzzword than a substantive concept. It also overlaps with many other (related) concepts and lacks empirical grounding. We offer recommendations for defining and measuring the concept, take a step toward disentangling it from related concepts, and identify relevant theories and research methods that would facilitate extending the knowledge frontier on shared value.     

Valuing the benefits and costs of improved food safety and nutrition

Assuring the quality of food products, especially their safety and nutrition levels, is an increasing focus for governments, companies, and international trade bodies. In choosing quality assurance programs, public and private decision-makers must assess the benefits and costs of expected improvements in food safety and nutrition. This article discusses methods for measuring these benefits and costs as well as how these valuations are related to the mix of voluntary and mandatory quality management systems used in particular countries or trading blocs. These relationships are illustrated by a short case study of safety assurance systems for meat and poultry products.     

Combining Sources of Preference Data for Modeling Complex Decision Processes

We review current state-of-the-art practices for combining preference data from multiple sources and discuss future research possibilities. A central theme is that any one data source (e.g., a scanner panel source) is often insufficient to support tests of complex theories of choice and decision making. Hence, analysts may need to embrace a wider variety of data types and measurement tools than traditionally have been considered in applied decision making and choice research. We discuss the viability of preference-stationarity assumptions usually made when pooling data, as well as random-utility theory-based approaches for combining data sources. We also discuss types of models and data sources likely to be required to make inferences about and estimate models that describe choice dynamics. The latter discussion is speculative insofar as the body of literature on this topic is small.     

Food safety regulation: an overview of contemporary issues

This article discusses a number of issues that are influencing the evolution of food safety regulation in developed and, to a lesser extent, developing countries. Whilst not definitive, it aims to highlight those factors which are considered crucial to an understanding of contemporary food safety controls in both the public and private spheres. These issues include criteria applied to assess the need/justification for food safety regulation, relationships between public and private food safety control systems, alternative forms that public food safety regulation can take, strategic responses to food safety regulation, and the trade implications of national food safety controls. The article serves as an introduction to these issues, which are discussed at greater length in the other papers that make up this special issue of Food Policy.     

The role of debt and bankruptcy statutes in facilitating tacit collusion

Using a two‐period model this paper examines the quantity decisions of leveraged duopolists that are vulnerable to bankruptcy in the first period. When the firms have symmetric costs, a bankrupt firm reorganizes under Chapter 11. If a Chapter 11 firm experiences marginal cost relief, each firm produces a collusive output in period one in order to prevent its rival's financial demise. When the firms have asymmetric costs, the less efficient firm is liquidated under Chapter 7 upon bankruptcy. A predatory equilibrium exists, whereby the inefficient firm is driven from the market. Copyright © 1999 John Wiley & Sons, Ltd.     

Environmental Performance Focus in Private Family Firms: The Role of Social Embeddedness

The macro-level business ethics in Scholasticism contrasts with modern Anglo-Saxon Capitalism, which is very influential worldwide. Scholasticism, developed between the thirteenth and the mid-seventeenth centuries, deals with key elements of free market morality, including private property, contracts, profits, prices, and free competition. For over 500 years Scholasticism tried to understand economic phenomena and business activities and reflected on them from an ethical perspective. Scholasticism offered the crucial lesson of the centrality of justice and the role of practical wisdom in considering market morality. Justice is seen as both a virtue and a principle, and commutative justice (justice in exchanges) with the common good of society as the reference for the Scholastics, is regarded as being especially important.     

Concentration and decentralization: The new geography of freight distribution in US metropolitan areas

This paper examines the suburbanization of warehousing and trucking activity within US metropolitan areas between the 1980s and the present using Gini indices as a measure of concentration. While historical work exists on the relocation of transportation and warehousing activity to suburban locations, there has been little to document the most recent shifts in warehousing and logistics. This research does so via spatial analysis of Economic Census data, finding that while most US metropolitan areas have experienced decentralization in the spatial distribution of freight-related activity, there is also some growth in core counties, indicating that a more complex process is going on than simple suburbanization.