Markups and Fixed Costs in Generic and Off-Patent Pharmaceutical Markets

2021 ◽  
pp. 1-28
Author(s):  
Sharat Ganapati ◽  
Rebecca McKibbin
Keyword(s):  
Market Power ◽  
Quality Standards ◽  
The United States ◽  
Fixed Costs ◽  
Free Entry ◽  
Pharmaceutical Markets ◽  
Drug Prices ◽  
The Us ◽  
Pharmaceutical Prices ◽  
Comparable Quality

Abstract There is wide dispersion in pharmaceutical prices across countries with comparable quality standards. Under monopoly, off-patent and generic drug prices are at least four times higher in the United States than in comparable Englishspeaking high income countries. With five or more competitors, off-patent drug prices are similar or lower. Our analysis shows that differential US markups are largely driven by the market power of drug suppliers and not due to wholesale intermediaries or pharmacies. Furthermore, we show that the traditional mechanism of reducing market power – free entry – is limited because implied entry costs are substantially higher in the US.

scholarly journals Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

2021 ◽  
Vol 61 (1) ◽  
Author(s):  
Gabriela Bittencourt Gonzalez Mosegui ◽  
Fernando Antõnanzas ◽  
Cid Manso de Mello Vianna ◽  
Paula Rojas
Keyword(s):  
Rheumatoid Arthritis ◽  
United States ◽  
Latin American ◽  
United States Of America ◽  
Purchasing Power Parity ◽  
The United States ◽  
Power Parity ◽  
Drug Prices ◽  
The Us ◽  
Latin American Countries

Abstract Background The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies’ databases. The pricing between countries was based on purchasing power parity (PPP). Results The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain’s price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusion The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.

Trajectories of Injectable Cancer Drug Costs After Launch in the United States

2018 ◽  
Vol 36 (4) ◽  
pp. 319-325 ◽  
Author(s):  
Noa Gordon ◽  
Salomon M. Stemmer ◽  
Dan Greenberg ◽  
Daniel A. Goldstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Steady Increase ◽  
Drug Prices ◽  
The Us ◽  
The Mean ◽  
Over Time

Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, −14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, −16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.

Clinical benefit and prices of cancer drugs in the United States and Europe.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6638-6638 ◽  
Author(s):  
Kerstin Noëlle Vokinger ◽  
Thomas J Hwang ◽  
Ariadna Tibau Martorell ◽  
Thomas J Rosemann ◽  
Aaron S Kesselheim
Keyword(s):  
Clinical Benefit ◽  
Rating Scales ◽  
The United States ◽  
Drug Costs ◽  
European Countries ◽  
Cancer Drug ◽  
Study Cohort ◽  
Cancer Drugs ◽  
Drug Prices ◽  
The Us

6638 Background: Given rising cancer drug costs, Medicare recently proposed to tie some US drug prices to average prices paid by comparable countries. To understand the potential scope of this policy, we assessed differences in cancer drug prices in the US and selected European countries. We also evaluated the correlation between drug prices and their clinical benefit, as measured by two value frameworks: the American Society of Clinical Oncology Value Framework v2 (ASCO VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale v1.1 (ESMO-MCBS). Methods: We identified all new drugs for adult solid and hematologic cancers, approved by the FDA from 2009-2017 and that have also been approved by the EMA by December 31, 2018. US average sales prices (and if not available, wholesale acquisition costs) were extracted as of February 1, 2019, and compared to comparable currency-adjusted ex-factory drug costs in England, France, Germany, and Switzerland. ASCO VF and ESMO-MCBS scores were assessed for pivotal trials supporting solid tumor drugs; in case of multiple trials, we focused on the highest score. Consistent with the developers of the rating scales, “high benefit” was defined as scores of A-B (neo/adjuvant setting) and 4-5 (palliative setting) on the ESMO-MCBS scale and scores≥45 on the ASCO VF. Linear regression models and non-parametric Kruskal-Wallis test and were used to assess the association between drug prices and benefit scores. Results: The study cohort included 63 drugs approved by the FDA and the EMA during the study period. 46 (73%) were approved for solid tumors, and 17 (27%) were approved for hematologic malignancies. Overall, median cancer drug prices in included European countries were 52% (interquartile range: 37-72%) lower than US prices. There was no statistically significant association between monthly treatment cost and ASCO-VF or ESMO-MCBS scores in any country. There was also no association between price differential between US and median European drug prices and either ASCO-VF (P = 0.599) or ESMO-MBCS (P = 0.321) scores. Conclusions: Cancer drug prices in the US were significantly higher than in the compared European countries. Drug prices of cancer drugs were not associated with clinical benefit in the US or in European countries.

Testing for Oligopsony Power in the US Green Skin Avocado Market

2016 ◽  
Vol 14 (1) ◽  
Author(s):  
Edward Evans ◽  
Fredy H. Ballen
Keyword(s):  
United States ◽  
Dominican Republic ◽  
Empirical Evidence ◽  
Market Power ◽  
The United States ◽  
Dominant Position ◽  
The Us ◽  
The World ◽  
Supply Model ◽  
Oligopsony Power

AbstractThe United States is the main destination for Dominican Republic (DR) green skin avocado exports accounting for over 70 % of the total DR green skin avocado exports from 2004 to 2013. Given the US dominant position in the US-DR green skin avocado trade, the United States may have an incentive to deviate from the competitive markets model, and behave as an oligopsonist. The present study seeks to assess potential oligopsonistic behavior in the US green skin avocado import market. A residual supply model was specified and estimated. Findings indicate that despite its dominant position in the world avocado trade, there is no empirical evidence that indicates that the United States exercises market power over DR exports of green skin avocados.

scholarly journals Leveling the Playing Field: Industrial Policy and Export-Contingent Subsidies in India–Export Related Measures

2021 ◽  
pp. 1-17
Author(s):  
Swati Dhingra ◽  
Timothy Meyer
Keyword(s):  
United States ◽  
Trade Policy ◽  
Industrial Policy ◽  
Prescription Drugs ◽  
Generic Drugs ◽  
The United States ◽  
Playing Field ◽  
Enforcement Policy ◽  
The Us ◽  
Pharmaceutical Prices

Abstract In India–Export Related Measures, the United States challenged a range of Indian measures as prohibited export-contingent subsidies, and a WTO panel largely agreed. This article examines the factors at play in the United States’ decision to bring the challenge. At the level of policy, the United States case reflects India's graduation from the protections afforded developing nations’ export-contingent subsidies under the Agreement on Subsidies and Countervailing Measures. A closer examination, however, shows that India ramped up its export-contingent subsidies just as the SCM Agreement required it to wind those subsidies down. Moreover, the expanded Indian subsidies led to increased import competition with the politically influential metals and pharmaceutical sectors in the United States, which pushed the US challenge. We reflect on the larger implications of the challenge for the future of trade rules on industrial policy. In particular, we note that the United States pursued a trade enforcement policy that would have the effect of increasing pharmaceutical prices in the United States, by reducing subsidies for imported generic drugs, at a time when the Trump administration allegedly was trying to reduce the price of prescription drugs. This disconnect suggests the need for both greater transparency in trade policy and greater governmental coordination on the connection between trade policy and other policy priorities.

Launch prices and price developments of cancer drugs in the United States and Europe.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2006-2006
Author(s):  
Kerstin Noëlle Vokinger ◽  
Paola Daniore ◽  
ChangWon C Lee ◽  
Aaron S Kesselheim ◽  
Thomas J Hwang
Keyword(s):  
Solid Tumors ◽  
The United States ◽  
Treatment Costs ◽  
Cancer Drug ◽  
Study Cohort ◽  
Cancer Drugs ◽  
Price Changes ◽  
Drug Prices ◽  
The Us ◽  
Over Time

2006 Background: Cancer drug costs are rising in the US and Europe. While drug manufacturers set prices without restriction in the US, European countries have regulations that allow national authorities to directly negotiate drug prices at launch and over time. We analyzed and compared the launch prices and price developments of cancer drugs in the US, Germany, Switzerland and England. Methods: We identified new drugs indicated to treat solid tumors in adults that were FDA-approved between 2009 and 2019 and had also been approved by the EMA and Swissmedic by 31 December 2019. Launch prices and post-launch price changes as of 1 January 2020 were extracted and adjusted to average sales prices for monthly treatment costs in the US and compared to comparable currency-adjusted ex-factory monthly treatment costs in Germany, Switzerland, and England. A cross-sectional analysis was conducted to infer yearly trends in launch prices and post-launch price changes across the countries. Results: The study cohort included 42 drugs for solid tumors, of which 40 (95%) drugs were first approved in the US compared to Germany and England, and 41 (98%) to Switzerland. Average launch prices for monthly treatment costs per patient were $15,178 in the US vs $7,049 in Germany, $7,421 in Switzerland and $8,176 in England, i.e., 215% (interquartile range [IQR] 263%-187%), 205% (IQR 202%-185%) and 186% (IQR 166%-189%) higher in the US compared to Germany, Switzerland and England respectively. Post-launch prices of 36 (86%), 40 (95%), and 38 (90%) drugs decreased over time with total savings of monthly treatment costs for all drugs in the study cohort of $86,744, $44,936, and $1744 in Germany, Switzerland, and England respectively. By contrast, prices of 8 (19%) drugs decreased, while 34 (81%) increased post-launch in the US with total additional expenses of $128,192 for monthly treatment costs. Conclusions: Launch prices for cancer drugs are far higher in the US than in Germany, Switzerland, or England. These price disparities continue to increase substantially after market entry since cancer drug prices, in general, decrease over time in Europe and increase in the US. Spending on cancer drugs could be reduced in the US if it adopted the principles used to more effectively negotiate drug prices in Europe.

MARKET POWER AND THE AGGREGATE SAVING RATE

2018 ◽  
Vol 23 (06) ◽  
pp. 2269-2297
Author(s):  
Andrea Giusto ◽  
Talan B. İşcan
Keyword(s):  
United States ◽  
Market Power ◽  
The United States ◽  
Saving Rate ◽  
Complete Markets ◽  
Capital Income ◽  
Income Risk ◽  
The Us ◽  
Heterogeneous Agents Model ◽  
Distribution Of Income

Can increasing market power cause a decrease in the aggregate savings? We answer this question by using a heterogeneous agents model that features both idiosyncratic labor and capital income risk. Under complete markets, the saving rate does not depend on the degree of market power, but when markets are incomplete, higher markups substantially reduce the aggregate saving rate. This is due to endogenous changes in the distribution of income and wealth. A calibration of the model using the observed changes in market power in the United States since the 1970s closely matches the decline in the US saving rate. Furthermore, when market power increases, the model generates distributional changes that are consistent with the data.

Relation of Statistically Significant, Abnormal, and Typical WAIS-R VIQ-PIQ Discrepancies to Full Scale IQs

2000 ◽  
Vol 16 (2) ◽  
pp. 107-114 ◽  
Author(s):  
Louis M. Hsu ◽  
Judy Hayman ◽  
Judith Koch ◽  
Debbie Mandell
Keyword(s):  
Graphical Method ◽  
The United States ◽  
Full Scale ◽  
True Score ◽  
Absolute Value ◽  
Normative Population ◽  
The Us ◽  
The Mean ◽  
And Performance ◽  
Quadratic Models

Summary: In the United States' normative population for the WAIS-R, differences (Ds) between persons' verbal and performance IQs (VIQs and PIQs) tend to increase with an increase in full scale IQs (FSIQs). This suggests that norm-referenced interpretations of Ds should take FSIQs into account. Two new graphs are presented to facilitate this type of interpretation. One of these graphs estimates the mean of absolute values of D (called typical D) at each FSIQ level of the US normative population. The other graph estimates the absolute value of D that is exceeded only 5% of the time (called abnormal D) at each FSIQ level of this population. A graph for the identification of conventional “statistically significant Ds” (also called “reliable Ds”) is also presented. A reliable D is defined in the context of classical true score theory as an absolute D that is unlikely (p < .05) to be exceeded by a person whose true VIQ and PIQ are equal. As conventionally defined reliable Ds do not depend on the FSIQ. The graphs of typical and abnormal Ds are based on quadratic models of the relation of sizes of Ds to FSIQs. These models are generalizations of models described in Hsu (1996) . The new graphical method of identifying Abnormal Ds is compared to the conventional Payne-Jones method of identifying these Ds. Implications of the three juxtaposed graphs for the interpretation of VIQ-PIQ differences are discussed.

The Politics of Prophecy: The US Culture Wars and the Battle Over Public Education in the Left Behind Series for Kids

2009 ◽  
Vol 2 (1) ◽  
pp. 1-27
Author(s):  
Ann Abate Michelle
Keyword(s):  
Public Education ◽  
The United States ◽  
Culture Wars ◽  
Church History ◽  
Good News ◽  
Cultural Issues ◽  
School Prayer ◽  
Left Behind ◽  
Religious Books ◽  
The Us

This essay argues that in spite of their obvious Biblically-based subject matter, clear Christian content, and undeniable evangelical perspective, the Left Behind novels for kids are not simply religious books; they are also political ones. Co-authors Tim LaHaye and Jerry B. Jenkins may claim that their narratives are interested in sharing the good news about Jesus for the sake of the future, but they are equally concerned with offering commentary on contentious US cultural issues in the present. Given the books’ adolescent readership, they are especially preoccupied with the ongoing conservative crusade concerning school prayer. As advocates for this issue, LaHaye and Jenkins make use of a potent blend of current socio-political arguments and of past events in evangelical church history: namely, the American Sunday School Movement (ASSM). These free, open-access Sabbath schools became the model for the public education system in the United States. In drawing on this history, the Left Behind series suggests that the ASSM provides an important precedent for the presence not simply of Christianity in the nation's public school system, but of evangelical faith in particular.

The United States and the Iranian Nuclear Programme

2018 ◽  
Author(s):  
Steven Hurst
Keyword(s):  
United States ◽  
Decision Making ◽  
Domestic Politics ◽  
The United States ◽  
Nixon Administration ◽  
Comprehensive Plan ◽  
The Us ◽  
Nuclear Issue ◽  
The Relationship

The United States, Iran and the Bomb provides the first comprehensive analysis of the US-Iranian nuclear relationship from its origins through to the signing of the Joint Comprehensive Plan of Action (JCPOA) in 2015. Starting with the Nixon administration in the 1970s, it analyses the policies of successive US administrations toward the Iranian nuclear programme. Emphasizing the centrality of domestic politics to decision-making on both sides, it offers both an explanation of the evolution of the relationship and a critique of successive US administrations' efforts to halt the Iranian nuclear programme, with neither coercive measures nor inducements effectively applied. The book further argues that factional politics inside Iran played a crucial role in Iranian nuclear decision-making and that American policy tended to reinforce the position of Iranian hardliners and undermine that of those who were prepared to compromise on the nuclear issue. In the final chapter it demonstrates how President Obama's alterations to American strategy, accompanied by shifts in Iranian domestic politics, finally brought about the signing of the JCPOA in 2015.

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