PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Many new oncology drugs approved in the EU lack proof of added benefit

Even medicines with no or limited added benefit recover R&D costs quickly

Many new oncology drugs approved in the EU lack proof of added benefit
2024-02-29
(Press-News.org) A new study conducted by researchers from Utrecht University sheds light on the dynamics of added benefit and revenues of oncology drugs approved by the EMA between 1995 and 2020. The findings, published today, reveal significant insights. The research team consisted of Francine Brinkhuis, Wim Goettsch, Aukje Mantel-Teeuwisse, and Lourens Bloem, affiliated with the Pharmacoepidemiology and Clinical Pharmacology division at Utrecht University.

The study aimed to evaluate the added benefit and financial outcomes of oncology drugs, while exploring different EMA approval pathways. Using data from various organizations and publicly available financial reports, the researchers identified 458 evaluations of added benefit for 131 oncology drugs and revenue data for 109 oncology drugs.

Fast-tracked drugs The researchers found that many of these drugs lack proof of added benefit. In fact, 41% of the 458 evaluations of added benefit were negative, indicating that no added benefit was (or could be) determined. This seemed particularly the case for medicines that were approved through special regulations called expedited pathways.

This is a system of regulations that facilitates a faster market entry for drugs intended for patients with an unmet medical need. To do so, less evidence is accepted at the moment of drug approval, provided that further studies are performed to gather additional evidence of efficacy and safety. This limited evidence can be one of the reasons that added benefit cannot be established.

Great need for new drug options The authors emphasize that approving drugs through these so-called expedited pathways is not necessarily a bad thing. “There is often a great need for new drugs”, says Lourens Bloem, one of the researchers who contributed to this study. “This is especially true in oncology, where the medical need is often high. Expedited approval may be a way to have patients benefit from a new drug but we question whether added benefit can eventually be proven, once additional data are available. Therefore, it is essential to continue to monitor the actual added benefit of these types of drugs, and assess the costs involved.”

Recovering R&D costs The study reveals that more than half of the oncology drugs, including those with minimal or no added benefit, are able to recover their research and development (R&D) costs within three years. According to the researchers, this challenges the pharmaceutical industry's claim that high drug prices are necessary to offset R&D expenses.

Added benefit and revenue The analysis shows that medicines with higher levels of added benefit generally lead to greater revenues. “While lower levels of added benefit might result in lower revenues, these are still sufficiently high to recover R&D expenses”, the research team writes in The BMJ.  This may diminish the pharmaceutical industry’s incentive to develop high value drugs, the researchers argue, “because pharmaceutical companies might be satisfied with the revenue generated from lower value drugs”.

Reimbursement processes Since global spending on oncology drugs is expected to rise significantly in the coming years, the authors argue that regulatory and reimbursement processes should be aligned better. This could help stimulate pharmaceutical companies to keep pursuing drugs that offer significant added benefits, and not settle for drugs that offer minimal added benefits but still generate an acceptable revenue.

“We urge policymakers to consistently reassess both ongoing and new initiatives aimed at ensuring fair, affordable, and sustainable patient access to innovative and expensive drugs”, the authors write in an opinion article, also published in The BMJ. “Additionally, we emphasise the importance of investigating and promoting the rational use of these drugs in clinical practice. This approach strives for a future where drug development and limited resources align more closely with real-world benefits to patients.”

 

[PUBLICATIONS]

Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study
Francine Brinkhuis, Wim G Goettsch, Aukje K Mantel-Teeuwisse, Lourens T Bloem
BMJ, 29 February 2024. DOI: 10.1136/bmj-2023-077391


High-cost oncology drugs without proof of added benefit are burdening health systems
Francine Brinkhuis, Wim G Goettsch, Aukje K Mantel-Teeuwisse, Lourens T Bloem
BMJ, 29 February 2024.

END

[Attachments] See images for this press release:
Many new oncology drugs approved in the EU lack proof of added benefit Many new oncology drugs approved in the EU lack proof of added benefit 2 Many new oncology drugs approved in the EU lack proof of added benefit 3

ELSE PRESS RELEASES FROM THIS DATE:

Could fiber optic cable help scientists probe the deep layers of the moon?

Could fiber optic cable help scientists probe the deep layers of the moon?
2024-02-29
An increasing number of seismologists are using fiber optic cables to detect seismic waves on Earth—but how would this technology fare on the Moon, and what would it tell us about the deep layers of our nearest neighbor in space? In Seismological Research Letters, Wenbo Wu of Woods Hole Oceanographic Institute and colleagues explore the idea of deploying a fiber seismic network on the Moon, discussing some of the challenges to overcome. They also test this hypothetical network using artificial seismograms created from data collected by seismometers placed on the Moon’s surface ...

How climate change risks increase at a national scale as the level of global warming increases

2024-02-29
A major research programme led by the University of East Anglia (UEA) has quantified how climate change risks to human and natural systems increase at a national scale as the level of global warming increases.  A collection of eight studies – all focusing on Brazil, China, Egypt, Ethiopia, Ghana and India - shows that the risks of drought, flooding, declines in crop yields, and loss of biodiversity and natural capital greatly increase for each additional degree of global warming.  The overarching picture for the accrual of climate risk across these ...

Optimising preventive measures to stop surgical infections – why are we doing what we are doing?

2024-02-29
*Please mention the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024, Barcelona, 27-30 April) if using this material* A new research review to be given at a pre-congress day for this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024, Barcelona, 27-30 April) will look at improving preventive measures to stop surgical infections. It will also ask why we are doing what we are doing, especially when some interventions lack quality evidence or in fact in some cases any evidence to back them. The presentation will be given by Professor Hilary Humphreys, RCSI University ...

Knowing when you can return to work or send your child back to school/nursery – personalised care for influenza and flu-like illness

2024-02-29
*Please mention the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024, Barcelona, 27-30 April) if using this material* A new research review to be given at a pre-congress day for this year’s European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2024, Barcelona, 27-30 April) will focus on a future of more personalised care for diseases such as influenza, so that patients and doctors can work more closely together and be able to more accurately determine when the infectious part of the illness has passed and it is safe for someone to return to work or send their ...

Odours hasten mortality and reproductive ageing – study finds

2024-02-28
Sensory cues from the opposite sex can influence how animals age, a University of Otago-led study has found.   Lead author Associate Professor Mike Garratt, of the Department of Anatomy, says research has previously shown interactions with the opposite sex can speed up ageing. This study has built on that by showing sensory cues alone can drive those effects.   “This provides an example of how information detected by our sensory systems – what we see, hear and smell – can have long term effects on our ...

Researchers use AI, Google street view to predict household energy costs on large scale

Researchers use AI, Google street view to predict household energy costs on large scale
2024-02-28
Low-income households in the United States are bearing an energy burden that is three times that of the average household, according to the U.S. Department of Energy. In total, more than 46 million U.S. households carry a significant energy burden — meaning they pay more than 6 percent of their gross income for basic energy expenses such as cooling and heating their homes. Passive design elements like natural ventilation can play a pivotal role in reducing energy consumption. By harnessing ambient energy sources like sunlight and wind, they can create a more comfortable environment at little or no ...

Building bionic jellyfish for ocean exploration

Building bionic jellyfish for ocean exploration
2024-02-28
Jellyfish can't do much besides swim, sting, eat, and breed. They don't even have brains. Yet, these simple creatures can easily journey to the depths of the oceans in a way that humans, despite all our sophistication, cannot. But what if humans could have jellyfish explore the oceans on our behalf, reporting back what they find? New research conducted at Caltech aims to make that a reality through the creation of what researchers call biohybrid robotic jellyfish. These creatures, which can be thought of as ocean-going cyborgs, augment jellyfish with electronics that enhance their swimming and a prosthetic ...

AI technique 'decodes' microscope images, overcoming fundamental limit

2024-02-28
Atomic force microscopy, or AFM, is a widely used technique that can quantitatively map material surfaces in three dimensions, but its accuracy is limited by the size of the microscope’s probe. A new AI technique overcomes this limitation and allows microscopes to resolve material features smaller than the probe’s tip. The deep learning algorithm developed by researchers at the University of Illinois Urbana-Champaign is trained to remove the effects of the probe’s width from AFM microscope images. As reported in the journal Nano Letters, the algorithm surpasses other methods in giving the first true three-dimensional ...

Exchange program research provides critical nutrition recommendations in Tanzania

Exchange program research provides critical nutrition recommendations in Tanzania
2024-02-28
FAYETTEVILLE, Ark. — Using a novel research methodology, researchers in the U.S. and Tanzania have identified new recommendations for reducing nutrient deficiency in the East African country. Brandon McFadden, professor of agricultural economics and agribusiness and the Tyson Endowed Chair in Food Policy Economics for the Arkansas Agricultural Experiment Station, said that a key recommendation from the study was for policymakers and public health officials in Tanzania to focus on education about zinc deficiency. “Zinc deficiency is a major health problem worldwide, particularly in developing countries, and a major health consequence is stunted growth ...

Q&A: Decline in condom use indicates need for further education, awareness

2024-02-28
New research from the University of Washington shows that condom use has been trending downward among younger gay and bisexual men over the last decade, even when they aren’t taking pre-exposure prophylaxis, or PrEP. The study, published Feb. 27 in AIDS and Behavior, measures changes in sex without condoms among HIV-negative gay and bisexual men who are not taking PrEP. Using data from the 2014-19 cycles of the American Men’s Internet Survey — a web-based survey of cisgender men ages 15 and older who have sex with men (MSM) — researchers found ...

LAST 30 PRESS RELEASES:

How can we reduce adolescent pregnancies in low- and middle-income countries?

When sun protection begets malnutrition: vitamin D deficiency in Japanese women

Cannabis use can cause chromosomal damage, increasing cancer risk and harming offspring

Survey finds many Americans apply misguided and counterproductive advice to combat holiday weight gain

New study reveals half a century of change on Britain’s iconic limestone pavements

Green flight paths could unlock sustainable aviation, new research suggests

Community partners key to success of vaccine clinic focused on neurodevelopmental conditions

Low-carbon collaborative dual-layer optimization for energy station considering joint electricity and heat demand response

McMaster University researchers uncover potential treatment for rare genetic disorders

The return of protectionism: The impact of the Sino-US trade war

UTokyo and NARO develop new vertical seed distribution trait for soybean breeding

Research into UK’s use of plastic packaging finds households ‘wishcycle’ rather than recycle – risking vast contamination

Vaccine shows promise against aggressive breast cancer

Adverse events affect over 1 in 3 surgery patients, US study finds

Outsourcing adult social care has contributed to England’s care crisis, argue experts

The Lancet: Over 800 million adults living with diabetes, more than half not receiving treatment, global study suggests

New therapeutic approach for severe COVID-19: faster recovery and reduction in mortality

Plugged wells and reduced injection lower induced earthquake rates in Oklahoma

Yin selected as a 2024 American Society of Agronomy Fellow

Long Covid could cost the economy billions every year

Bluetooth technology unlocks urban animal secrets

This nifty AI tool helps neurosurgeons find sneaky cancer cells

Treatment advances, predictive biomarkers stand to improve bladder cancer care

NYC's ride-hailing fee failed to ease Manhattan traffic, new NYU Tandon study reveals

Meteorite contains evidence of liquid water on Mars 742 million years ago

Self-reported screening helped reduce distressing symptoms for pediatric patients with cancer

Which risk factors are linked to having a severe stroke?

Opening borders for workers: Abe’s profound influence on Japan’s immigration regime

How skills from hospitality and tourism can propel careers beyond the industry

Research shows managers of firms handling recalls should review media scrutiny before deciding whether to lobby

[Press-News.org] Many new oncology drugs approved in the EU lack proof of added benefit
Even medicines with no or limited added benefit recover R&D costs quickly