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.

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.

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.

scholarly journals Cancer Drugs: An International Comparison of Postlicensing Price Inflation

2017 ◽  
Vol 13 (6) ◽  
pp. e538-e542 ◽  
Author(s):  
Philip Savage ◽  
Sarah Mahmoud ◽  
Yogin Patel ◽  
Hagop Kantarjian
Keyword(s):  
United States ◽  
Health Care ◽  
United Kingdom ◽  
The United States ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Price Inflation ◽  
Drug Prices ◽  
The United Kingdom ◽  
Price Increases

Purpose: The cost of cancer drugs forms a rising proportion of health care budgets worldwide. A number of studies have examined international comparisons of initial cost, but there is little work on postlicensing price increases. To examine this, we compared cancer drug prices at initial sale and subsequent price inflation in the United States and United Kingdom and also reviewed relevant price control mechanisms. Methods: The 10 top-selling cancer drugs were selected, and their prices at initial launch and in 2015 were compared. Standard nondiscounted prices were obtained from the relevant annual copies of the RED BOOK and the British National Formulary. Results: At initial marketing, prices were on average 42% higher in the United States than in the United Kingdom. After licensing in the United States, all 10 drugs had price rises averaging an overall annual 8.8% (range, 1.4% to 24.1%) increase. In comparison, in the United Kingdom, six drugs had unchanged prices, two had decreased prices, and two had modest price increases. The overall annual increase in the United Kingdom was 0.24%. Conclusion: Cancer drug prices are rising substantially, both at their initial marketing price and, in the United States, at postlicensing prices. In the United Kingdom, the Pharmaceutical Price Regulation Scheme, an agreement between the government and the pharmaceutical industry, controls health care costs while allowing a return on investment and funds for research. The increasing costs of cancer drugs are approaching the limits of sustainability, and a similar government-industry agreement may allow stability for both health care provision and the pharmaceutical industry in the United States.

OP440 Comparison Of Evidence Supporting Cancer Drug Approvals And Prices In The US And Brazil

2021 ◽  
Vol 37 (S1) ◽  
pp. 16-17
Author(s):  
Adriana Ivama Brummell ◽  
Huseyin Naci
Keyword(s):  
Overall Survival ◽  
Survival Benefit ◽  
Therapeutic Benefit ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Drug Benefits ◽  
Drug Prices ◽  
The Us ◽  
Drug Approvals ◽  
Overall Survival Benefit

IntroductionCancer drug prices are high on the policy agenda worldwide. Previous research found no association between cancer drug benefits and prices at the time of regulatory approval. Drugs approved in the US with uncertain benefits may have spill-over effects in other settings. Our objective was to compare the evidence supporting cancer drug approvals in the US and Brazil, and to examine the association between cancer drug prices and availability of added therapeutic benefit.MethodsWe matched all novel cancer drugs approved in the US from 2010–2019 to approvals in Brazil. We extracted data on pivotal study design characteristics and outcomes in the US and Brazil, and evidence supporting price approval in Brazil, including availability of added therapeutic benefit.ResultsFrom 2010–2019, fifty-six cancer drugs with matching indications were approved in US and Brazil and had their prices authorized in Brazil by December 2020. Drug were available in Brazil following a median 522 days after US approval (IQR: 351–932). In the US, thirty-four (60.7 percent) of the drugs had pivotal randomized controlled trials (RCTs) and Twelve (21.4 percent) had overall survival benefit. By the time of Brazilian approval, forty-one (73.2 percent) drugs had pivotal RCTs and twenty-two (39.3 percent) had overall survival benefit. A total of twenty-eight (50 percent) drugs did not demonstrate added therapeutic benefit over other authorized drugs for the same indication and had a median reduction from requested to approved price of 6.1 percent (IQR: 0–27.8 percent) in Brazil. The twenty-seven (48.2 percent) drugs with added therapeutic benefit had a median price reduction of 2.0 percent (IQR: 0–9.2 percent).ConclusionsHalf of new cancer drugs approved in Brazil failed to demonstrate added therapeutic benefit. The Brazilian pricing system secured considerable price reductions, ensuring that prices for medicines with no added therapeutic benefit were not higher than existing treatments for the same approved indication. Although evidence was more mature by the time of Brazilian review, pivotal studies often lacked randomization and overall survival endpoints.

Pivotal trial endpoints and prices of cancer drugs in the US and Europe.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2077-2077
Author(s):  
Kerstin Noëlle Vokinger ◽  
Paola Daniore ◽  
Thomas J Hwang ◽  
ChangWon C Lee ◽  
Aaron S Kesselheim
Keyword(s):  
Clinical Trial ◽  
Progression Free Survival ◽  
Treatment Costs ◽  
New Drugs ◽  
Cancer Drug ◽  
Pivotal Trial ◽  
Cancer Drugs ◽  
The Us ◽  
Trial Endpoints ◽  
Surrogate Measures

2077 Background: A key clinical outcome for new cancer drugs is improvement in overall survival (OS), defined as time from the date of randomization to the death from any cause. However, many cancer drugs are approved by regulators based on changes to surrogate measures of OS, such as progression-free survival or overall response rate. When surrogate measures are not validated, they can provide misleading information about drug efficacy. We categorized pivotal trial endpoints for recently-approved cancer drugs in the US and Europe as showing improvements in OS vs non-OS surrogates, and evaluated the correlation with drug prices. Methods: We identified new drugs FDA-approved between 2009 and 2018 that were indicated to treat solid and hematologic tumors in adults and that had also been approved by the EMA and Swissmedic by December 2019. Launch prices were extracted and adjusted to average sales prices for monthly treatment costs in the US and compared to currency-adjusted ex-factory monthly treatment costs in Germany, Switzerland, and England. Pivotal clinical trial primary endpoints were collected from the drug labeling and FDA medical reviews for the US, and the EMA public assessment reports for Europe, and categorized as OS in any trial vs. not. Pearson’s correlation tests assessed the association between launch prices and OS vs non-OS endpoints in each country. Results: 54 drugs were approved by the FDA, EMA, and Swissmedic during the study period. In the US, 30 (56%) were approved based on OS by contrast to 35 (65%) in the EMA. The number of cancer drugs approved by the FDA based on OS decreased in the past years. By contrast, the number of approved cancer drugs by the EMA based on OS were stable. There was no association for the US (p = 0.05), Germany (p = 0.13) and England (p = 0.12), while Switzerland revealed an association (p = 0.03) between OS endpoint and price. Conclusions: Reductions in use of OS endpoints as the basis for cancer drug approval in the US is concerning. Drug pricing should be better aligned with the benefit that drugs provide to patients, as measured by clinical trial outcomes such as OS.

scholarly journals Strategies that delay or prevent the timely availability of affordable generic drugs in the United States

Blood ◽  
2016 ◽  
Vol 127 (11) ◽  
pp. 1398-1402 ◽  
Author(s):  
Gregory H. Jones ◽  
Michael A. Carrier ◽  
Richard T. Silver ◽  
Hagop Kantarjian
Keyword(s):  
United States ◽  
Generic Drugs ◽  
The United States ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Timely Manner ◽  
Drug Prices ◽  
Cross Border ◽  
World Markets

Abstract High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.

scholarly journals Trends in Disability Among Adults 55-64 in the United States and England From 2002 to 2016

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 303-303
Author(s):  
HwaJung Choi ◽  
Robert Schoeni ◽  
Tsai-Chin Cho ◽  
Kenneth Langa
Keyword(s):  
Activities Of Daily Living ◽  
Daily Living ◽  
Income Group ◽  
The United States ◽  
Annual Change ◽  
Individual Level ◽  
Income Groups ◽  
The Us ◽  
Disability Prevalence ◽  
Over Time

Abstract The paper’s goal is to assess whether and, if so, the extent to which prevalence in disability of adults near retirement ages in the US increased over time compared to their peers in England and examine income group differences in the relative trends. This study uses 2002-2016 Health and Retirement Study (HRS) and English Longitudinal Study of Ageing (ELSA) focusing on adults aged 55-64. Annual percent changes over the period of 2002-2016 for limitations in instrumental activities of daily living (IADL) and activities of daily living (ADL) are estimated for each survey (HRS and ELSA) using multivariable logistic regressions to adjust for individual-level characteristics While disability prevalence of adults ages 55-64 in England improved over the years of 2002-2016 (annual % change= -2.01 for IADL; - 2.53 for ADL), disability prevalence of US adults has not improved and in fact even worsened in terms of IADL (annual % change= +1.35). There are substantial variations in the IADL/ADL trends by income groups. In the US, the adverse trends in disability were more pronounced among the lowest income groups (annual % change in IADL=1.76 for bottom 20% vs. -2.08 for top 20%; annual % change in ADL=1.08 for bottom 20% vs. -2.08 for top 20%). In England, the disability status improved over time for all but the lowest income group. We will examine further to identify specific factors contributing to divergent/convergent trends in disability between the US and England.

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.

Continental Divide? The Attitudes of US and Canadian Oncologists on the Costs, Cost-Effectiveness, and Health Policies Associated With New Cancer Drugs

2010 ◽  
Vol 28 (27) ◽  
pp. 4149-4153 ◽  
Author(s):  
Scott R. Berry ◽  
Chaim M. Bell ◽  
Peter A. Ubel ◽  
William K. Evans ◽  
Eric Nadler ◽  
...  
Keyword(s):  
United States ◽  
Health Care ◽  
Cost Effectiveness ◽  
Health Care Systems ◽  
The United States ◽  
Drug Costs ◽  
Cancer Drug ◽  
Cancer Drugs ◽  
Care Systems ◽  
Effective Treatments

Purpose Oncologists in the United States and Canada work in different health care systems, but physicians in both countries face challenges posed by the rising costs of cancer drugs. We compared their attitudes regarding the costs and cost-effectiveness of medications and related health policy. Methods Survey responses of a random sample of 1,355 United States and 238 Canadian medical oncologists (all outside of Québec) were compared. Results Response rate was 59%. More US oncologists (67% v 52%; P < .001) favor access to effective treatments regardless of cost, while more Canadians favor access to effective treatments only if they are cost-effective (75% v 58%; P < .001). Most (84% US, 80% Canadian) oncologists state that patient out-of-pocket costs influence their treatment recommendations, but less than half the respondents always or frequently discuss the costs of treatments with their patients. The majority of oncologists favor more use of cost-effectiveness data in coverage decisions (80% US, 69% Canadian; P = .004), but fewer than half the oncologists in both countries feel well equipped to use cost-effectiveness information. Majorities of oncologists favor government price controls (57% US, 68% Canadian; P = .01), but less than half favor more cost-sharing by patients (29% US, 41% Canadian; P = .004). Oncologists in both countries prefer to have physicians and nonprofit agencies determine whether drugs provide good value. Conclusion Oncologists in the United States and Canada generally have similar attitudes regarding cancer drug costs, cost-effectiveness, and associated policies, despite practicing in different health care systems. The results support providing education to help oncologists in both countries use cost-effectiveness information and discuss drug costs with their patients.

History and Current Trends in the Electronic Cigarette Retail Marketplace in the United States: 2010–2016

2018 ◽  
Vol 22 (5) ◽  
pp. 843-847 ◽  
Author(s):  
Jennifer Cantrell ◽  
Jidong Huang ◽  
Marisa Greenberg ◽  
Jeffrey Willett ◽  
Elizabeth Hair ◽  
...  
Keyword(s):  
Tobacco Industry ◽  
The United States ◽  
Retail Market ◽  
Current Trends ◽  
Published Evidence ◽  
The Us ◽  
Industry Response ◽  
Market Trends ◽  
The Impact ◽  
Over Time

Abstract Introduction The US market for electronic nicotine delivery systems (ENDS) has grown rapidly in the last decade. There is limited published evidence examining changes in the ENDS marketplace prior to the US Food and Drug Administration’s (FDA) deeming rule in 2016. This study describes US ENDS retail market trends from 2010 to 2016. Methods National data were obtained from Nielsen retail scanners for five product types: (1) disposables, (2) rechargeables, (3) cartridge replacements, (4) e-liquid bottle refills, and (5) specialty vapor products. We examined dollar sales, volume, price, brand, and flavor. Results Adjusted national sales increased from $11.6 million in 2010 to $751.2 million in 2016. The annual rate of sales growth rapidly increased before slowing through 2015. The rate of growth spiked in 2016. Market share for menthol products and other assorted flavors increased from 20% in 2010 to 52.1% by 2016. NJOY’s early market dominance shifted as tobacco industry brands entered the market and eventually captured 87.8% of share by 2016. Rechargeables and accompanying products comprised an increased proportion of total volume sold over time while disposable volume declined. Specialty vapor products appeared at retail in 2015. Conclusions Findings show strong early growth in the ENDS retail market followed by considerable slowing over time, despite a slight uptick in 2016. Trends reflect shifts to flavored products, newer generation “open-system” devices, lower prices, and tobacco industry brands. This study provides a baseline against which to compare the impact of FDA’s 2016 deeming rule and future actions on the ENDS marketplace. Implications This study uses market scanner data from US retail outlets to describe trends in the ENDS retail market from 2010 to 2016, providing a baseline against which to compare the impact of FDA’s 2016 deeming rule and future actions on the ENDS marketplace. Understanding historical market trends is valuable in assessing how future regulatory efforts and advances in ENDS technology may impact industry response and consumer uptake and use.

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