(Press-News.org) Contact information: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Aflibercept in macular oedema: Added benefit not proven
Neither the new drug nor the comparator therapy was used in accordance with their approvals in the studies
For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG) dealt with the drug aflibercept. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute now examined whether aflibercept (trade name: Eylea) offers an added benefit over the appropriate comparator therapy in visual impairment due to macular oedema following occlusion of the central retinal vein. An added benefit could not be derived from the dossier because in the studies cited by the drug manufacturer, both aflibercept and the comparator therapy were not used in accordance with their approvals.
Indirect comparison between aflibercept and ranibizumab
Macular oedema is a retention of fluid in the macular area of the eye, which leads to blurring in the field of vision. If this is caused by occlusion of the central retinal vein, it can be attempted to improve visual acuity by injecting growth factor inhibitors like aflibercept. ´
The Federal Joint Committee (G-BA) specified either a dexamethasone intravitreal implant or the drug ranibizumab, another growth factor inhibitor, as appropriate comparator therapy. In its dossier, the pharmaceutical company presented three randomized controlled trials, on the basis of which it conducted an indirect comparison between aflibercept and ranibizumab: In two studies, aflibercept was compared with sham injections, and in the third study, sham injections were compared with ranibizumab.
Patients did not receive approval-compliant treatment
However, both drugs were not used in accordance with their approvals in the studies. The Summaries of Product Characteristics of aflibercept and ranibizumab are unambiguous: After the first injection, treatment is to be continued at monthly intervals until the functional and morphological assessment or visual acuity is stable for three consecutive monthly assessments performed while on treatment. If needed, treatment can then be continued at larger intervals. If there is no improvement over the course of the first three injections, however, continued treatment is not recommended.
Extent of deviation from approval could not be estimated
All three studies used different approaches: Independent from the changes in the individual outcomes, six planned injections were administered in 20 weeks. The data submitted also contained no information on the proportion of patients who received injections despite stable outcomes or who did not respond to treatment, i.e. in whom there was no improvement after the first three injections. It therefore remains unclear how many patients received injections that were unnecessary either because of stable improvement or because of treatment failure and that therefore contravened the approval. ´
On the basis of these data it cannot be estimated to what extent treatment in the studies deviated from the stipulations of the approval. Hence the indirect comparison conducted in the dossier was unsuitable for proving an added benefit.
G-BA decides on the extent of added benefit
The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G‑BA then decides on the extent of the added benefit, thus completing the early benefit assessment.
An overview of the results of IQWiG's benefit assessment is given by a German-language executive summary. In addition, the website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on aflibercept.
The G-BA website contains both general English-language information on benefit assessment pursuant to §35a Social Code Book (SGB) V and specific German-language information on the assessment of aflibercept in macular oedema.
### END
Aflibercept in macular oedema: Added benefit not proven
Neither the new drug nor the comparator therapy was used in accordance with their approvals in the studies
2014-01-07
ELSE PRESS RELEASES FROM THIS DATE:
Increased risk of prostate cancer in African American men; implications for PSA screening
2014-01-07
Increased risk of prostate cancer in African American men; implications for PSA screening
New Rochelle, NY, January 7, 2014—African American men have an increased risk of prostate cancer and are two times more likely than Caucasian American ...
Sugar-burning in the adult human brain is associated with continued growth, and remodeling
2014-01-07
Sugar-burning in the adult human brain is associated with continued growth, and remodeling
Research published in the journal Cell Metabolism shows that hotspots of fuel consumption in the adult brain also show key characteristics of developing brain regions
SEATTLE, ...
A CNIO research team discovers new regulators of the most prevalent liver disease
2014-01-07
A CNIO research team discovers new regulators of the most prevalent liver disease
AP-1 proteins modulate fat accumulation in the liver, a disease termed fatty liver disease (FLD); the pharmacological manipulation of these proteins might help treating ...
Teriflunomide in multiple sclerosis: Added benefit not proven
2014-01-07
Teriflunomide in multiple sclerosis: Added benefit not proven
Regarding side effects, there are both positive and negative effects in comparison with beta interferon 1a
Teriflunomide (trade name: Aubagio) has been approved in Germany ...
NREL finds a new cellulose digestion mechanism by a fast-eating enzyme
2014-01-07
NREL finds a new cellulose digestion mechanism by a fast-eating enzyme
CelA digests cellulose faster than enzymes from commercial preparations
Researchers at the Energy Department's National Renewable Energy Laboratory (NREL) have discovered ...
MU researcher's study of African forest elephants helps guide research efforts in the US
2014-01-07
MU researcher's study of African forest elephants helps guide research efforts in the US
Study finds that human occupation of an area may not contribute to population decline of an endangered species
COLUMBIA, Mo. – Conservation of a protected or endangered ...
Story tips from the Department of Energy's Oak Ridge National Laboratory, January 2014
2014-01-07
Story tips from the Department of Energy's Oak Ridge National Laboratory, January 2014
To arrange for an interview with a researcher, please contact the Communications staff member identified at the end of each tip. For more information on ORNL and its research ...
Might more ravens -- aided by humans -- mean 'nevermore' for sage-grouse?
2014-01-07
Might more ravens -- aided by humans -- mean 'nevermore' for sage-grouse?
BOZEMAN (January 7, 2014) – A new study by the Wildlife Conservation Society, Idaho State University and the U.S. Geological Survey suggests that habitat fragmentation and the addition of ...
On-demand vaccines possible with engineered nanoparticles
2014-01-07
On-demand vaccines possible with engineered nanoparticles
Vaccines combat diseases and protect populations from outbreaks, but the life-saving technology leaves room for improvement. Vaccines usually are made en masse in centralized locations far removed from where they ...
Newly discovered 3-star system to challenge Einstein's theory of General Relativity
2014-01-07
Newly discovered 3-star system to challenge Einstein's theory of General Relativity
A newly discovered system of two white dwarf stars and a superdense pulsar--all packed within a space smaller than the Earth's orbit around the sun -- is enabling astronomers to probe ...
LAST 30 PRESS RELEASES:
Pink skies
Monkeys are world’s best yodellers - new research
Key differences between visual- and memory-led Alzheimer’s discovered
% weight loss targets in obesity management – is this the wrong objective?
An app can change how you see yourself at work
NYC speed cameras take six months to change driver behavior, effects vary by neighborhood, new study reveals
New research shows that propaganda is on the rise in China
Even the richest Americans face shorter lifespans than their European counterparts, study finds
Novel genes linked to rare childhood diarrhea
New computer model reveals how Bronze Age Scandinavians could have crossed the sea
Novel point-of-care technology delivers accurate HIV results in minutes
Researchers reveal key brain differences to explain why Ritalin helps improve focus in some more than others
Study finds nearly five-fold increase in hospitalizations for common cause of stroke
Study reveals how alcohol abuse damages cognition
Medicinal cannabis is linked to long-term benefits in health-related quality of life
Microplastics detected in cat placentas and fetuses during early pregnancy
Ancient amphibians as big as alligators died in mass mortality event in Triassic Wyoming
Scientists uncover the first clear evidence of air sacs in the fossilized bones of alvarezsaurian dinosaurs: the "hollow bones" which help modern day birds to fly
Alcohol makes male flies sexy
TB patients globally often incur "catastrophic costs" of up to $11,329 USD, despite many countries offering free treatment, with predominant drivers of cost being hospitalization and loss of income
Study links teen girls’ screen time to sleep disruptions and depression
Scientists unveil starfish-inspired wearable tech for heart monitoring
Footprints reveal prehistoric Scottish lagoons were stomping grounds for giant Jurassic dinosaurs
AI effectively predicts dementia risk in American Indian/Alaska Native elders
First guideline on newborn screening for cystic fibrosis calls for changes in practice to improve outcomes
Existing international law can help secure peace and security in outer space, study shows
Pinning down the process of West Nile virus transmission
UTA-backed research tackles health challenges across ages
In pancreatic cancer, a race against time
Targeting FGFR2 may prevent or delay some KRAS-mutated pancreatic cancers
[Press-News.org] Aflibercept in macular oedema: Added benefit not provenNeither the new drug nor the comparator therapy was used in accordance with their approvals in the studies