Navigation Links
Added benefit of ingenol mebutate is not proven
Date:6/6/2013

The drug ingenol mebutate (trade name: Picato) has been approved in Germany since November 2012 as a gel for the treatment of certain forms of actinic keratosis in adults. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG) the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over diclofenac/hyaluronic acid gel. Such an added benefit cannot be derived from the dossier, however, as the drug manufacturer did not submit any relevant data: it did not cite any studies that directly compared ingenol mebutate with diclofenac/hyaluronic acid gel, and the method chosen by the manufacturer for an indirect comparison was unsuitable.

G-BA specified appropriate comparator therapy

Ingenol mebutate is approved for the treatment of flat, non-callous skin lesions. These are called non-hyperkeratotic and non-hypertrophic actinic keratoses. This disease can develop into a form of skin cancer (squamous cell carcinoma). The Federal Joint Committee (G-BA) specified diclofenac/hyaluronic acid gel as appropriate comparator therapy.

No direct comparative studies available

In its dossier, the manufacturer did not cite any randomized controlled trials (RCTs) that directly compared ingenol mebutate gel with diclofenac/hyaluronic acid gel. It therefore aimed for an indirect comparison. However, in the opinion of the manufacturer it was not possible to use a procedure appropriate for this, namely an adjusted indirect comparison with a common point of reference (intermediate comparator). It stated that the substances called vehicle gels that ingenol mebutate and diclofenac/hyaluronic acid were compared with in the available studies might differ in efficacy, and are therefore not comparable. These substances could therefore not be used as intermediate comparator.

Method of analysis unsuitable for indirect comparison

Instead, the pharmaceutical company used a method it called "chaining of direct comparisons". In such a comparison across several comparators it is indispensable, however, that direct comparisons exist for each link in the chain, i.e. for each pair of comparators. This condition was not fulfilled, however, as the manufacturer presented a non-adjusted comparison for one link in the chain. Hence the method of analysis was unsuitable, and its results could therefore not be used. An added benefit of ingenol mebutate is therefore not proven.

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.


'/>"/>

Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. No Added Cancer Risk From Hip Replacement Materials: Study
2. Tafamidis: Approval denotes proven added benefit
3. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
4. Abiraterone: Indication of considerable added benefit in certain patients
5. Collagenase for Dupuytrens contracture: Added benefit not proven
6. Added benefit of linagliptin is not proven
7. Added benefit of eribulin in breast cancer is not proven
8. Added benefit of fampridine is not proven
9. Belimumab for lupus erythematosus: Added benefit not proven
10. Keeping Up a Healthy Lifestyle Pays Off in Added Years: Study
11. Telaprevir: Added benefit in certain patients with hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. ... today that it has been recognized as one of the best small businesses for ... named as one of nine small businesses providing progressive benefits to new parents on ...
(Date:5/27/2016)... ... May 27, 2016 , ... In response to meager public ... unaware of the plight of aphasia. In collaboration with the American Aphasia Association, ... , The link between stroke and aphasia is relatively unknown, but through collaboration ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team of ... food industries. Aside from its GMP accreditation, Validation Center is also a registered ... products, services and staff. , Validation Center is ISO17025 accredited and only offers ...
(Date:5/26/2016)... ... 26, 2016 , ... Intalere, the healthcare industry leader in ... inaugural Member Conference at the Paris Hotel in Las Vegas, Nev., May 17-20, ... America’s healthcare providers. , The conference was highlighted by the announcement of the ...
(Date:5/26/2016)... ... May 26, 2016 , ... Cardiac arrhythmia is a ... on long-term patient survival, reports a team of UPMC researchers in the largest ... the Journal of Thoracic and Cardiovascular Surgery, provide critical information that will hopefully ...
Breaking Medicine News(10 mins):
(Date:5/27/2016)... , May 27, 2016  A new study highlights the necessity of health literacy ... Journal of the American College of Radiology , a majority of oncology patients undergo ... Photo - http://photos.prnewswire.com/prnh/20160527/373022 ... ... Medical Diagnostic Imaging Ampronix ...
(Date:5/27/2016)... , May 27, 2016 LabStyle ... Dario™ Diabetes Management Tool, today announced that the Company,s Chief ... Marcum MicroCap Conference being held June 1-2 in ... being held June 7-9 in Los Angeles, CA. ... discuss recent corporate and operational milestones, including the U.S. FDA ...
(Date:5/27/2016)... According to the 2016 report, ... ambulatory blood pressure monitoring system market growth. With aging, ... to respond to different pressure rates, leading to hypertension ... various cardiovascular disorders such as heart failure, stroke, coronary ... growing in prevalence each year. WHO estimates that 17 ...
Breaking Medicine Technology: