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:3/29/2017)... and MINNETONKA, Minn. (PRWEB) , ... March 29, ... ... development of medical office buildings (MOBs) and other outpatient facilities, and who are ... to look exclusively at those questions, Revista and Healthcare Real Estate Insights (HREI) ...
(Date:3/29/2017)... Norwalk, CT (PRWEB) , ... March 29, 2017 , ... ... Valuing —on Thursday, April 20, 2017, at 1:00 PM ET. A recording of the ... of the Interactive Webinar Series. , Home health and hospice companies are still popular ...
(Date:3/29/2017)... ... March 29, 2017 , ... ... of Pittsburgh now have easier access to the robotic-assisted total-hip and partial-knee ... Network (AHN). Orthopaedic surgeons at Forbes Hospital and Jefferson Hospital recently started ...
(Date:3/29/2017)... ... March 29, 2017 , ... VisualSP has helped over 1.5 million SharePoint users ... for on-premises installation of its Help System for SharePoint was at the farm level. ... the entire tenant. , The company recently released a modified version of the ...
(Date:3/28/2017)... ... March 28, 2017 , ... India’s Chigurupati ... to directly address the resolution to globally reduce the harmful use of alcohol ... of FDA and TTB approved ingredients that when infused into alcohol, renders the ...
Breaking Medicine News(10 mins):
(Date:3/29/2017)... March 29, 2017 Varian Medical Systems (NYSE: ... for the second quarter of fiscal year 2017 following the ... news release will be followed by a teleconference available to ... and a link to the conference call webcast will be ... access the teleconference call and replay: ...
(Date:3/29/2017)... 2017  Spiral Therapeutics, Inc. today announced the ... S.L. for the worldwide exclusive rights to Bionure,s ... field of otolaryngology for aggregate payments of up ... agreement provides Spiral with the option to license ... profile. Under the terms of the agreement, Spiral ...
(Date:3/29/2017)... , March 29, 2017   Dynatronics Corporation ... the appointment of Cynthia L. McHenry ... be responsible for leading Dynatronics manufacturing, distribution, and ... report to Dynatronics, CEO Kelvyn H. Cullimore, ... an extensive search process conducted by the company ...
Breaking Medicine Technology: