Navigation Links
Added benefit of fampridine is not proven
Date:8/29/2012

Fampridine (trade name Fampyra) has been approved in Germany since July 2011 for adult patients suffering from a higher grade walking disability (grades 4 to 7 on the EDSS disability status scale), as a result of multiple sclerosis (MS). The German Institute for Quality and Efficiency in Health Care (IQWiG) has assessed the added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). According to the findings, there is no proof of added benefit, as the manufacturer's dossier contains no evaluable study data for the comparison between fampridine and the appropriate comparator therapy.

G-BA specifies physiotherapy as the appropriate comparator therapy

MS is a chronic incurable inflammatory disease, in which the patient's own immune system damages nerve tracts in the brain and spinal cord. In some patients, some muscles are in permanent spasm or are paralysed. If the disease is more advanced, patients may develop a walking disability.

The Federal Joint Committee (G-BA) has specified physiotherapy as the appropriate comparator therapy for the benefit assessment. This treatment must fulfil the requirements of the German Guideline on Remedies (Heilmittelrichtlinie). In addition, the patients must receive optimized standard therapy for MS.

Requirements for an indirect comparison not fulfilled

There are no studies that directly compare fampridine with physiotherapy. Instead, the pharmaceutical company presented data on an indirect comparison. These data originate from studies in which fampridine was compared with a placebo or in which physiotherapy was compared with "no treatment".

The legal ordinance on AMNOG explicitly specifies that it is possible to prove added benefit using indirect comparisons too. However, specific methodological conditions apply, which were not fulfilled by the manufacturer in the fampridine dossier.

Marked differences in the grade of disability

In addition, the studies on physiotherapy which the pharmaceutical company has evaluated cannot be used, as they also included patients with a markedly lower grade of disability (EDSS from 1.5) than in the studies on fampridine. Thus, the populations were not similar enough to allow a comparison between the results.

Finally, the manufacturer does not discuss in the dossier whether the physiotherapy tested in these studies was in accordance with the criteria of the Guideline on Remedies and, if this is not the case, why these studies would nevertheless allow conclusions about the situation in Germany. Moreover, the manufacturer does not mention whether the patients actually received optimized MS standard therapy. However, these two points are conditions specified by the G-BA for the appropriate comparator therapy.

Hence the manufacturer did not present evaluable studies on the appropriate comparator therapy for the assessment of the added benefit of fampridine, thereby also failing to present an evaluable indirect comparison. Thus there is no proof of added benefit of fampridine.

G-BA decides on the extent of added benefit.

The dossier assessment is part of the overall procedure for early benefit assessment conducted by the G-BA. After publication of the manufacturer's dossier and its assessment by IQWiG, the G-BA initiates a formal commenting procedure which provides further information and can 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: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

Related medicine news :

1. Added benefit of eribulin in breast cancer is not proven
2. Added benefit of linagliptin is not proven
3. Collagenase for Dupuytrens contracture: Added benefit not proven
4. Abiraterone: Indication of considerable added benefit in certain patients
5. Nurse Alert Provides Added Level of Senior Alert Care With New Nurse Triage Feature
6. Tafamidis: Approval denotes proven added benefit
7. No Added Cancer Risk From Hip Replacement Materials: Study
8. Exploring exercise benefits for breast cancer patients
9. Not all lung cancer patients who could benefit from crizotinib are identified by FDA-approved test
10. Circumcision Benefits Are Significant, Pediatricians Say
11. Teens Benefit by Spending More Time With Parents
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/28/2017)... ... June 28, 2017 , ... The Dianne Michael Insurance ... Cincinnati metropolitan area, is teaming up with the local chapter of the Ronald ... treatment in nearby hospitals. , Ronald McDonald House of Greater Cincinnati, one of ...
(Date:6/27/2017)... ... June 27, 2017 , ... Harbour , a DAO (decentralized ... the Ethereum blockchain, has released their technical specifications . , 2017 has seen ... little systematic approach for determining which offerings will garner the greatest ROI. Dean Eigenmann, ...
(Date:6/27/2017)... ... June 27, 2017 , ... From June 20-22, EarQ and Widex ... Syracuse, New York, where EarQ is headquartered. , Together, the organizations educate hearing ... today’s savvy consumer, and the latest in hearing technology. At the event, EarQ ...
(Date:6/27/2017)... ... June 27, 2017 , ... ... contribute to an upcoming case studies guidebook. This guidebook offers an excellent branding ... book will include articles, case studies and how-to’s that fall into the following ...
(Date:6/27/2017)... ... June 27, 2017 , ... Hammer Strength, the world’s leading ... named Javair Gillett of the Houston Rockets the NBSCA Strength & Conditioning Coach of ... decided by NBSCA members who vote to select the coach who embodies the highest ...
Breaking Medicine News(10 mins):
(Date:6/9/2017)... , June 9, 2017 More than 400 ... effort to help spread lessons learned from clinical research ... Diabetes Federation (IDF) and Eli Lilly and Company (NYSE: ... second phase of the Bringing Research in Diabetes to ... commitment to helping people with diabetes effectively manage their ...
(Date:6/7/2017)... , June 7, 2017  Novavax, Inc., (Nasdaq: ... of two Phase 2 trials of its RSV F protein ... child bearing age have been published in the journal ... have been shared in prior scientific conferences). The Company previously ... April 2014. Novavax is developing the RSV F Vaccine with ...
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq: ... care, today announced new findings demonstrating positive biochemical outcomes ... System One™. The data will be presented at ... Madrid, Spain . ... Improve Home Dialysis Network in Europe ...
Breaking Medicine Technology: