Featured Research

from universities, journals, and other organizations

Aflibercept in macular oedema: Added benefit not proven

Date:
January 7, 2014
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Due to a lack of suitable data, it is not proven that visual impairment in macular oedema can be treated more effectively with aflibercept than with the appropriate comparator therapy.

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.

Related Articles


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.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Aflibercept in macular oedema: Added benefit not proven." ScienceDaily. ScienceDaily, 7 January 2014. <www.sciencedaily.com/releases/2014/01/140107135938.htm>.
Institute for Quality and Efficiency in Health Care. (2014, January 7). Aflibercept in macular oedema: Added benefit not proven. ScienceDaily. Retrieved December 17, 2014 from www.sciencedaily.com/releases/2014/01/140107135938.htm
Institute for Quality and Efficiency in Health Care. "Aflibercept in macular oedema: Added benefit not proven." ScienceDaily. www.sciencedaily.com/releases/2014/01/140107135938.htm (accessed December 17, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Wednesday, December 17, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

UN: Up to One Million Facing Hunger in Ebola-Hit Countries

UN: Up to One Million Facing Hunger in Ebola-Hit Countries

AFP (Dec. 17, 2014) Border closures, quarantines and crop losses in West African nations battling the Ebola virus could lead to as many as one million people going hungry, UN food agencies said on Wednesday. Duration: 00:52 Video provided by AFP
Powered by NewsLook.com
When You Lose Weight, This Is Where The Fat Goes

When You Lose Weight, This Is Where The Fat Goes

Newsy (Dec. 17, 2014) Can fat disappear into thin air? New research finds that during weight loss, over 80 percent of a person's fat molecules escape through the lungs. Video provided by Newsy
Powered by NewsLook.com
Why Your Boss Should Let You Sleep In

Why Your Boss Should Let You Sleep In

Newsy (Dec. 17, 2014) According to research out of the University of Pennsylvania, waking up for work is the biggest factor that causes Americans to lose sleep. Video provided by Newsy
Powered by NewsLook.com
Flu Outbreak Closing Schools in Ohio

Flu Outbreak Closing Schools in Ohio

AP (Dec. 17, 2014) A wave of flu illnesses has forced some Ohio schools to shut down over the past week. State officials confirmed one pediatric flu-related death, a 15-year-old girl in southern Ohio. (Dec. 17) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins