Navigation Links
Perampanel for epilepsy: No proof of added benefit
Date:1/30/2013

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In an early benefit assessment according to the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether perampanel offers an added benefit over the previous standard therapy. However, no such added benefit can be derived from the dossier, because the manufacturer failed to present any relevant data in it for the comparison with the drugs lamotrigine or topiramate.

Lamotrigine and topiramate as appropriate comparator therapy

Fits that affect only a small part of the brain are called "focal" or "partial seizures". In this type of fit, the muscle twitches and spasms remain limited to isolated parts of the body. They may, however, spread over the entire body and this process is then called a "secondary generalization". Perampanel is approved as add-on therapy for the treatment of partial seizures with or without secondary generalization in people aged 12 years and older.

When the Federal Joint Committee (G-BA) specified the appropriate comparator therapy, it distinguished between two treatment situations: if the first-line (basic) anti-epileptic treatment does not contain lamotrigine, perampanel as add-on therapy should be compared with lamotrigine as add-on therapy. If, on the other hand, lamotrigine is already part of the basic treatment, then perampanel as add-on therapy should be compared with topiramate as add-on therapy.

Topiramate not considered in the dossier

However, in its dossier, the pharmaceutical company deviated from this specification of the G-BA and considered only lamotrigine. In those cases where lamotrigine was already contained in the basic treatment, the manufacturer stated that a comparison with topiramate was "not productive". But IQWiG does not accept this explanation from the manufacturer.

Comparisons with lamotrigine not adequate

In order to demonstrate the added benefit over lamotrigine, the manufacturer provided data on a direct and an indirect comparison. However, ultimately the former comparison was with a dummy drug (a placebo). Although in this case a placebo comparison can prove a benefit, it cannot prove an added benefit.

For various reasons, the indirect comparison is also inadequate. Amongst other things, perampanel was not tested here against lamotrigine (in each case as add-on therapy), but instead a combination of perampanel and lamotrigine against lamotrigine, in each case in addition to basic treatment, was tested.

Since neither the indirect nor the direct comparisons are suitable for answering the research question, no relevant study results are available for the benefit assessment. Hence there is also no proof of 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.


'/>"/>

Contact: Anna-Sabine Ernst
presse@iqwig.de
49-221-356-85153
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. No Proof That Gum Disease Causes Heart Disease, Experts Say
2. More Proof That Healthy Habits Fight Disease
3. More Proof Cranberry Juice Thwarts Infection
4. No proof that patients lose weight after joint replacement surgery
5. Vandetanib in thyroid cancer: No proof of added benefit
6. No Proof That Doping With EPO Gives Athletes an Edge: Review
7. Corporate Whistle Blower Center Now Urges Physicians, Medical Device or Drug Insiders With Proof A Company Knowingly Sold A Bad Product to Become a Whistleblower
8. Corporate Whistle Blower Center Now Urges Physicians to Become a Whistleblower if They Have Proof a Medical Device or a Drug Product was Defective-and it was Sold Anyway
9. Pesticides and Parkinsons: UCLA researchers uncover further proof of a link
10. Corporate Whistle Blower Center Now Urges Physicians Medical Device and Drug Industry Insiders To Step Up-If They Have Proof Of Serious Wrongdoing or Overbilling
11. No Proof Drugs Ease Kids Migraines: Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... ... 2016 , ... Christie Medical Holdings, Inc. presented the Baylor ... Vision vein finder for the nursing school simulation lab. This donation ... blood, combining technology with traditional technique. , “VeinViewer is a wonderful new addition ...
(Date:2/12/2016)... ... February 12, 2016 , ... According to an article ... account for a significant portion of hernia repairs throughout the United States. Commenting on ... Hernia Center notes that this trend has not only been expected, but it seems ...
(Date:2/12/2016)... ... 12, 2016 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... at its 10th anniversary Fashion Luncheon on Monday, February 8, 2016. The special ...
(Date:2/12/2016)... Los Angeles, CA (PRWEB) , ... February 12, 2016 , ... ... be. With a hectic schedule, a demanding job, and no time to decompress, Rabinowitz ... there, she dedicated herself to meditation for its impact on her life, implementing a ...
(Date:2/12/2016)... , ... February 12, 2016 , ... ... Service (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) into Cielo®, ... to offer real-time business intelligence (BI) to their small and medium business (SMB) ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... Mich. , Feb. 12, 2016  Diplomat Pharmacy, Inc. (NYSE: DPLO ) is pleased ... Pharmaceutical Account Management and Payor Strategies effective Jan. 23, 2016. ... ... ... Diplomat Specialty Pharmacy ...
(Date:2/12/2016)... - Demers Ambulances announces its first delivery in the state of ... Emergency Medical Services (EMS) consisting of four vehicles: ... Quality Emergency Vehicles in Lecanto, FL , ... is the latest in Demers, ongoing expansion of sales.  ... --> Benoit LaFortune , Executive Vice President at ...
(Date:2/12/2016)... --  HeartWare International, Inc . (NASDAQ: HTWR ) ... its financial results for the three and 12 months ... at 8:00 a.m. ET.  The company plans to release ... webcast.  On the conference call and webcast, management will ... quarter and business outlook.   --> ...
Breaking Medicine Technology: