Economic modeling for the US of the cost-efficiency and associated expanded treatment access of conversion to biosimilar pegfilgrastim-bmez from reference pegfilgrastim

Abstract

Aims: For this economic analysis, we aimed to model: (1) the cost-efficiency of prophylaxis with biosimilar pegfilgrastim-bmez for chemotherapy-induced (febrile) neutropenia (CIN/FN) compared to reference pegfilgrastim, and (2) the expanded access to CIN/FN prophylaxis and anti-neoplastic treatment that could be achieved with biosimilar cost-savings on a budget-neutral basis.

Methods: In a hypothetical panel of 20,000 cancer patients receiving CIN/FN prophylaxis and using the average sales price (ASP) for the second quarter of 2019 for reference pegfilgrastim, we: conducted an ex ante simulation from the payer perspective of the cost-savings of 10–100% conversion from reference to biosimilar pegfilgrastim-bmez using drug price discounting ranging from 10–35%; estimated the budget-neutral expanded access to biosimilar pegfilgrastim-bmez enabled by these cost-savings; and estimated the budget-neutral expanded access to anti-neoplastic treatment with pembrolizumab. The simulations were replicated using fourth quarter 2019 wholesale acquisition cost (WAC) for reference pegfilgrastim and biosimilar pegfilgrastim-bmez in a post facto analysis.

Results: In ASP simulations, cost-savings of using pegfilgrastim-bmez over reference pegfilgrastim in a 20,000 patient panel range from $1.3?M (at 15% price discount) to $3?M (35%) at 10% conversion rate and from $6.4?M to $14.9?M, respectively, at 50% conversion. These savings could provide prophylaxis with pegfilgrastim-bmez to an additional 352 (15% discount) to 1,076 patients (35%) at 10% conversion or 1,764–5,384, respectively, at 50% conversion. Alternatively, savings could be reallocated for anti-neoplastic treatment with pembrolizumab to 3 (15% discount) to 9 (35%) patients at 10% conversion or 19–45, respectively, at 50% conversion. When utilizing WAC, cost-savings range from $4.6?M (10% conversion) to $23.1?M (50%) which could provide pegfilgrastim-bmez to an additional 1,174 (10% conversion) to 5,873 patients (50%).

Conclusions: Prophylaxis with biosimilar pegfilgrastim-bmez increases the value of cancer care by generating significant cost-savings that could be reallocated to provide expanded access to CIN/FN prevention and anti-neoplastic therapy on a budget-neutral basis.     

Benefits of a registration policy for microenterprise performance in India

This paper evaluates the effects of a voluntary registration policy with government authorities on financial performance of urban microenterprises in the Indian manufacturing sector. Using data from the 2006 World Bank survey of Indian microenterprises and applying the semi-parametric propensity score matching technique, we find that being registered leads to significant gains in sales per employee and value added per employee. Large gains are also noted for male-owned firms, those operating with or without paid labor and those operating outside of the owner’s home.     

Does conditionality in IMF-supported programs promote revenue reform?

This paper studies whether revenue conditionality in Fund programs had any impact on the revenue performance of 126 low- and middle-income countries during 1993–2013. The results indicate that such conditionality had a positive impact on tax revenue, with strongest improvement felt on taxes on goods and services, including the VAT. Revenue conditionality matters more for low-income countries, particularly those where revenue ratios are below the group average. Moreover, revenue conditionality appears to be more effective when targeted to a specific tax. These results hold after controlling for potential endogeneity, sample selection bias, and when revenues are adjusted for economic cycle.     

Role of Shopping Values and Web Atmospherics in E-Satisfaction and Repurchase Intention

Expected to touch US$55 billion in 2016, the e-commerce market in India presents an unprecedented growth opportunity for retailers. Existing studies have identified factors influencing shoppers’ online behaviour pertaining to the developed economies. Hence, it becomes pertinent to validate these antecedents for the economies like India. The article addresses this gap by examining the role of shopping values and web atmospherics, on e-satisfaction of Indian shoppers. Using multiple regression analysis, it also examines the influence of e-satisfaction on repurchase intention. The findings suggest that effectiveness of information content has the most significant impact on e-satisfaction. Web entertainment, utilitarian values and web informativeness are the other influencing factors. Contrary to the earlier studies, this study didn’t find any influence of hedonic shopping values on shoppers’ satisfaction. Also, e-satisfaction was found to have a positive influence on repurchase intention of e-shoppers. The article suggests select strategies that can be adopted by e-retailers.     

Ownership structures of U.S. joint ventures in the 1980S

A firm's choice between sole and joint ventures in a foreign market is subject to various market-specific and firm-specific influences. This study draws upon the transaction cost and bargaining power theoretical frameworks to identify and measure some of these influences. A logistic regression model was employed to examine the relative influences of the main and interaction effects of the independent factors on ownership structures employed for new foreign subsidiaries by U.S. firms in the 1980s.     

Leverage and growth: Effect of stock options

Previous literature documents a negative relationship between leverage and firm growth. This paper finds that once the incentives provided by stock options are accounted for, leverage does not affect firm growth. The paper also finds that the sensitivity of CEOs’ wealth to stock price (i.e. option delta) instead of leverage has a negative relationship with growth. These findings suggest that incentive contracts that tie managers’ wealth to firm value prevent managers from overinvesting. Thus in presence of options the role of debt as a disciplining mechanism has become less important.     

Sources of Real Exchange Rate Volatility in Africa: The Case of ECOWAS*

Abstract: This study examines the impact of (real) demand shocks, (aggregate) supply shocks, and monetary shocks on real exchange rates in 13 West African countries. We observe that the real demand shocks explain most of the fluctuations in real exchange rates in all these countries. Accordingly, policymakers should adopt a careful demand management strategy by controlling government expenditure and taxes.     

Optimal Returns Policy under Demand Uncertainty

Multiple categories of retail products suffer limited shelf life, demand uncertainty, and, in some cases, long lead times. To provide retailers with an incentive to increase the stocking quantity of such products, manufacturers may offer an option to return unsold items at wholesale or less than wholesale prices. This article extends the additive price-dependent demand model in three ways. First, partial returns are optimal for the manufacturer but do not induce higher stocking quantities compared with when the manufacturer offers no returns. Second, in terms of the effect of investment in demand-enhancing activities, when retailers invest, they set higher resale prices, but an optimal partial returns policy still does not induce higher stocking quantity, whereas when manufacturers invest, the optimal returns policy induces higher stocking quantity. Third, when the manufacturer and retailer have different expectations of demand uncertainty, the retailer's estimate influences the expected profits for both, whereas the manufacturer's estimate has a major impact on its profits only.     

A decision analytic approach for technology portfolio prioritization: aviation safety applications

A decision analytic approach for evaluating new aviation safety products and technologies is developed and demonstrated to consolidate five existing program assessment metrics to develop a unified metric that simultaneously considers the relative importance and contribution of each. This allows for a meaningful and objective evaluation and comparison of the National Aeronautics and Space Administration (NASA) Aviation Safety Program (AvSP) advanced aeronautical products and technologies. The resulting decision model is referred to as the Composite Program Assessment Score (CPAS). The CPAS includes the five existing metrics; technical development risk, implementation risk, fatal accident rate reduction, safety benefits and cost, and safety risk reduction, which are each defined and quantified by different sources. The CPAS involves the scaling and combination of these individual metrics. In this paper, two alternative combinatorial modeling approaches to calculate the CPAS are presented. The weighted sum model and an additive value theory model are compared and contrasted. The resulting CPAS metrics allow an overall comparison of all 48 of the NASA AvSP products and technologies. Currently CPAS is based on preliminary weight measures from subject matter experts to reflect the relative importance of each metric. Actual case studies of both linear and non‐linear value functions are demonstrated.