Cost-efficiency analyses for the US of biosimilar filgrastim-sndz,reference filgrastim,pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia

Aims: Guidelines recommend prophylaxis with granulocyte colony-stimulating factor for chemotherapy-induced (febrile) neutropenia (CIN/FN) based on regimen myelotoxicity and patient-related risk factors. The aim was to conduct a cost-efficiency analysis for the US of the direct acquisition and administration costs of the recently approved biosimilar filgrastim-sndz (Zarxio EP2006) with reference to filgrastim (Neupogen), pegfilgrastim (Neulasta), and a pegfilgrastim injection device (Neulasta Onpro; hereafter pegfilgrastim-injector) for CIN/FN prophylaxis.

Methods: A cost-efficiency analysis of the prophylaxis of one patient during one chemotherapy cycle under 1–14 days’ time horizon was conducted using the unit dose average selling price (ASP) and Current Procedural Terminology (CPT) codes for subcutaneous prophylactic injection under four scenarios: cost of medication only (COSTMED), patient self-administration (SELFADMIN), healthcare provider (HCP) initiating administration followed by self-administration (HCPSTART), and HCP providing full administration (HCPALL). Two case studies were created to illustrate real-world clinical implications. The analyses were replicated using wholesale acquisition cost (WAC).

Results: Using ASP?+?CPT, cost savings achieved with filgrastim-sndz relative to reference filgrastim ranged from $65 (1?day) to $916 (14 days) across all scenarios. Relative to pegfilgrastim, savings with filgrastim-sndz ranged from $834 (14 days) up to $3,666 (1?day) under the COSTMED, SELFADMIN, and HPOSTART scenarios; and from $284 (14 days) up to $3,666 (1?day) under the HPOALL scenario. Similar to the cost-savings compared to pegfilgrastim, filgrastim-sndz achieved savings relative to pegfilgrastim-injector: from $834 (14 days) to $3,666 (1?day) under the COSTMED scenario, from $859 (14 days) to $3,692 (1?day) under SELFADMIN, from $817 (14 days) to $3,649 (1?day) under HPOSTART, and from $267 (14 days) to $3,649 (1?day) under HPOALL. Cost savings of filgrastim-sndz using WAC?+?CPT were even greater under all scenarios.

Conclusions: Prophylaxis with filgrastim-sndz, a biosimilar filgrastim, was associated consistently with significant cost-savings over prophylaxis with reference filgrastim, pegfilgrastim, and pegfilgrastim-injector, and this across various administration scenarios.     

Comparative effectiveness of pegfilgrastim,filgrastim, and sargramostim prophylaxis for neutropenia-related hospitalization: two US retrospective claims analyses

Abstract

Objective:

Few studies have compared the effectiveness of filgrastim (FIL), pegfilgrastim (PEG), and sargramostim (SAR) to reduce the risk of febrile neutropenia (FN) associated with myelosuppressive chemotherapy (M-CT). Two large commercial database analyses were separately conducted to examine the incidence of neutropenia-related and all-cause hospitalizations associated with FIL, PEG, and SAR prophylaxis for patients receiving M-CT for non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, or solid tumors.     

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.     

The effects of the external debts of Mexico,Brazil, Argentina,Venezuela, and the Philippines on the United States

The external debts of developing countries have become a major issue recently, prompting debate among both academicians and policy markers. In this paper, the author describes the origins and history of debt problem, summarizes proposals for policies for creditor nations, and estimates the effects of debt-related austerity in five major debtor nations on US imports, exports, net exports, and output in 1985. He concludes that debt-related austerity was responsible for 11.0% of the US merchandise trade deficit in that year, caused decreases in US net trade in 40 to 61 non-service industries studied and decreases in output in 46 industries, and caused a decrease of 0.5% in GNP.

Neither a borrower nor a lender be;

For loan oft loses both itself and friend,

And borrowing dulls the edge of husbandry.

William Shakespeare (Hamlet, I. iii. 75)     

Specialization,product development,evolution of the institution of the firm,and economic growth

This paper considers the effects of the division of labor on economic growth and welfare in a general equilibrium environment where changes in individual specialization and product development can proceed simultaneously. The nature of the dynamic equilibrium is shown to depend on the interaction of transaction efficiency, economies of specialization, and economies of complementarity. Where the dynamic equilibrium involves evolution in the division of labor, this will be associated with increased per capita real income and hence economic growth. It is also shown that the emergence of firms is an aspect of the evolution of division of labor if transaction efficiency for a producer good is lower than that for labor used to produce this good.     

Uncertainty,trust, and the regulation of the banking industry

This paper suggests that, in presence of uncertainty, individual choices are made on the basis of subjective evaluations, and the transmission of information is too expensive, so that the decision-making process must largely be based on other agents’ knowledge. Banks operate by developing a network of personal relationships, based on trust, that allows agents to make use of the subjective knowledge of others. The deregulation process of the financial industry of the 1990s was based on the principle that information disclosure would make the market for securities more efficient, increasing risk diversification, and making the financial system safer. Many innovative financial contracts, however, were not backed by trust and reputation mechanism as traditional banking activities. The shadow banking system emerging from these market-based transactions was thus much more risky and fragile than the traditional one, based on private information and unwritten rules of conduct.     

Information, Evolution of the Institution of the Firm, and the Optimal Decision Horizon

This paper introduces an information problem into Yang and Ng's model of the firm, to study the process of social searching for the efficient structure of residual rights. The analysis adopts the concept of Walrasian sequential equilibrium developed in the literature of endogenous specialization to model this searching process. The main finding is that more organizational patterns will be experimented with, and therefore an efficient organizational pattern is more likely to be achieved as the pricing efficiency increases. The problem of determining the optimal decision horizon is solved by specifying a tradeoff between the benefits and calculation costs from longer decision horizons.     

Factor Endowment,the Choice of Technology,and the Volume of Trade

Abstract

This paper studies impacts of factor endowment on international trade in a general equilibrium model in which firms choose their technologies endogenously. Although countries only differ in factor endowment ex ante, countries may also differ in their chosen technologies. If industries choose different capital-labor intensities in equilibrium, the Heckscher–Ohlin theorem, factor price equalization theorem, the Rybczynski theorem, and the Stolper–Samuelson theorem hold. If industries choose the same capital-labor intensity in equilibrium, the volume of trade is zero. None of the four theorems applies.     

中国的宪政、"三个代表"与法治

由于植根于本国的意识形态和宪政观念,西方的评论家常常误解中国的意识形态、宪政和法治的发展."三个代表"思想不仅能够充当中国共产党执政地位的意识形态基础,而且能够充当国家政治和意识形态权力的合法性来源.因此,它不仅仅是一种意识形态,而且能够推动中国宪政理论和实践的发展.     

Crony capitalism,the party-state,and the political boundaries of corruption

We build a model that puts together crony capitalism, the hierarchy of the Chinese communist party-state, and the decision-making process inside the Party Center. We show that inefficient economic institutions create local corruption that raises realized productivity, while generating rents that flow along the party-state hierarchy up to the provincial level, threatening the Center’s control in potential crises. Although both stronger crisis control and higher economic performance help the Center’s goal to stay in power, we show that given a general fat-tailed risk of crisis, the Center will maximize crisis control at the expense of the economy when choosing its tolerance of local corruption. Power structure and corruption within the Center and reciprocal accountability between central and provincial leaders are also analyzed. Our analysis suggests conditions under which China’s communist regime will or will not deal with the existential threat presented by corruption.     

Sraffa,Okun, and the theory of the imperfectly competitive firm

Piero Sraffa's Production of Commodities by Means of Commodities is wedded to Arthur Okun's Prices and Quantities to bring out important implications for the theory of the imperfectly competitive firm. The implications relate to firm objectives and to firm behavior in both the ‘vertical’ environment (relations with suppliers) and the ‘horizontal’ environment (relations with customers and competitors).     

Taxes,Risk Aversion,and the Size of the Underground Economy

Non‐parametric regression analysis was used to investigate the relationship between the effective tax rate and the relative size of the underground economy, using New Zealand data. The underlying theoretical framework is established, and it suggests an ambiguous prediction regarding the sign of the relationship we are studying. However, our non‐parametric empirical analysis, which also allows for the non‐stationarity of the time‐series data, produces a positive and ‘S‐shaped’ relationship, and this supports earlier empirical studies that imposed such functional forms. The estimated model is used to simulate the effects of hypothetical tax changes on the size of the New Zealand underground economy, and to draw policy conclusions.     

Commitment, Exchange Autonomy, and the Boundary of the Hierarchical Firm

In this article, I present a theory of the boundary of the firmthat accounts for some important characteristics of real-worldmultidivisional firms: operative decisions are in the handsof middle managers who are rewarded based on the performanceof their units, managers' decisions are subject to approvaland intervention by the top management of the firm, and managersare better informed regarding the affairs of their divisions.In this setup, the integration of an intermediate input supplierand its buyer as separate divisions within a single firm isdesirable, as long as the choice of trading partners can becredibly delegated to the divisions' managers. I show that thisis satisfied not only under the assumption of full commitmentby the general office of the firm but also, remarkably, if ithas no commitment power whatsoever. An explanation of the boundaryof the firm emerges only if the general office retains somelimited commitment power. I show that the general office mandatesinternal trades in more instances than would have been optimalwith full commitment, adversely affecting the levels of investmentundertaken by the divisions' managers. In such cases, it canbe optimal to have the trade conducted between nonintegratedparties.     

The farm, the city, and the emergence of social security

We study the social, demographic and economic origins of social security. The data for the U.S. and for a cross section of countries suggest that urbanization and industrialization are associated with the rise of social insurance. We describe an OLG model in which demographics, technology, and social security are linked together in a political economy equilibrium. In the model economy, there are two locations (sectors), the farm (agricultural) and the city (industrial) and the decision to migrate from rural to urban locations is endogenous and linked to productivity differences between the two locations and survival probabilities. Farmers rely on land inheritance for their old age and do not support a pay-as-you-go social security system. With structural change, people migrate to the city, the land loses its importance and support for social security arises. We show that a calibrated version of this economy, where social security taxes are determined by majority voting, is consistent with the historical transformation in the United States.     

Taxation, growth, and the spirit of capitalism

This paper uses a general two-sector model of endogenous growth to examine how the spirit of capitalism affects the relation between public finance and growth. The spirit of capitalism is defined as acquisitive personal objectives. We find that if the spirit of capitalism is present, an increase in the share of government spending in output reduces the long-run growth rate. The negative relationship between fiscal spending and growth is consistent with empirical evidence.     

Climate,diseases, and the origins of corruption

It has been commonly observed that tropical countries tend to suffer from intense corruption and underdevelopment. This study provides an explanation for this long-standing disparity across the world based on variation in the intensity of ultraviolet radiation (UV-R). The central hypothesis is that UV-R is positively associated with the (historical) prevalence of eye diseases, which significantly shortens work-life expectancy as a skilled worker. This helps shape the worldwide distribution of corruption by affecting the incumbents' window of opportunity. Using data for up to 139 countries, I consistently find empirical support for the positive relationship between UV-R and corruption. The main findings withstand accounting for numerous alternative explanations for international differences in corruption levels. Employing individual-level data from the World Values Survey, I document suggestive evidence that exposure to UV-R is linked to surveyed respondents' tolerance towards corrupt activities. Furthermore, a subnational analysis for China lends credence to the cross-country evidence.     

Education, corruption, and the distribution of income

We examine how the interaction between education and corruption affects institutional reform and economic development. While corruption reduces average income and education, education increases not only output and hence potential corruption rents, but also produces more informed electorates that better monitor government actions. We find that economies with intermediate levels of education remain in a poverty trap since the level of skills creates sufficient corruption rents but not enough monitoring. Economies with low or high levels of education can escape the poverty trap, and inequality plays a key role in determining whether this occurs through a change in institutions or an expansion of education.