Navigation Links
Fingolimod: 'Hint' of advantages in a small group of patients

This release is available in German.

The immunosuppressive drug fingolimod (trade name: Gilenya) is approved for the treatment of highly-active relapsing-remitting multiple sclerosis (RRMS) in adults. In an early benefit assessment pursuant to "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) assessed whether fingolimod offers an added benefit compared with the present standard therapy.

According to the findings of the assessment, patients with a rapidly progressive and severe course of disease who take fingolimod experience fewer flu-like symptoms. Under consideration of this advantage on the one hand and the uncertain evidence base on the other, IQWIG has concluded that the data provide a "hint" of a minor added benefit of fingolimod for this group of patients.

Due to a lack of evaluable data, an added benefit is not proven for two further groups of patients.

Separate assessment in three groups of patients

According to the different areas of application, IQWiG performed separate assessments of the drug in three groups of patients. Fingolimod was compared with glatiramer acetate in patients with highly active RRMS who had not responded to a complete and appropriate (usually at least one-year) cycle with beta-interferon (IFN-β).

In patients with highly active RRMS who had not received sufficient IFN-β therapy and in those with rapidly progressive severe RRMS, fingolimod was in each case compared with IFN-β 1a.

Evaluable data only for one group of patients

One relevant study was available for the early benefit assessment, an approval study on fingolimod (TRANSFORMS), which compared treatment with fingolimod versus IFN β 1a in adults with RRMS. However, the study only provided data for one of the three patient groups specified by the Federal Joint Committee (G-BA), namely for those with rapidly progressive severe RRMS.

The manufacturer dossier did not contain evaluable data for a benefit assessment in the other two groups, that is, patients with highly active RRMS who had already received a complete pre-treatment with IFN-β and patients with RRMS who had not received sufficient pre-treatment with IFN-β. An added benefit of fingolimod is therefore not proven for these therapeutic indications.

Fewer flu-like symptoms in some patients

The study results in patients with rapidly progressive severe RRMS did not indicate significant differences between treatment groups for the outcomes "relapse", "progression of disability" and "health-related quality of life". No data were reported for the outcomes "fatigue" and "activities of daily living" for this patient group, even though such data were collected in the study. Likewise, no significant difference was shown between treatment groups regarding the overall rate of side effects (adverse events), serious adverse events, and study discontinuations due to adverse events.

However, for the outcome "frequency of flu-like symptoms" the data provided an indication of less harm: patients treated with fingolimod experienced fewer such symptoms.

Only "hint" of added benefit due to inadequate data

It should be noted that conclusions on the group of patients with rapidly progressive severe RRMS are somewhat uncertain. For example, according to the approval status, this patient group is defined by several disease criteria, but the study participants for whom the manufacturer had presented data did not fulfil all of these criteria and can only be identified indirectly as a patient group in the study pool.

Under consideration of this uncertain evidence base on the one hand and the potential advantage on the other, in summary IQWiG concludes that there is a "hint" of a minor added benefit of fingolimod in patients with rapidly progressive severe RRMS treated with fingolimod compared with those treated with beta-interferon.

G-BA decides on the extent of added benefit

The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.

The following extract provides an overview of the results of the benefit assessment performed by IQWiG. The website, which is issued by IQWiG, provides easily understandable brief information.

The G-BA website contains both general information on benefit assessments pursuant to 35a Social Code Book V and specific information on the assessment of fingolimod.


Contact: Dr. Anna-Sabine Ernst
Institute for Quality and Efficiency in Health Care

Related medicine news :

1. Study supports urate protection against Parkinsons disease, hints at novel mechanism
2. Early Study Hints at Link Between Certain Sunscreens, Endometriosis
3. Mouse Study Hints at New Path for Diabetes Treatment
4. Online Pawn Shop Spreads Awareness About its Small Business Loans.
5. Small Babies Can Be Sign of Heart Problems in Mother
6. Smallest, Largest Fetuses at Higher Risk of Stillbirth
7. Standing at Work All Day While Pregnant Linked to Smaller Babies
8. Google Rolls Out Another Panda Algorithm Update – Small Businesses Plan for the Future of SEO
9. B2B e Trader is Addressing the Critical Needs of Local Businesses by Lauching the New Shop Small Business Directory
10. Blood test for pregnant women could predict risk of having dangerously small babies
11. Infants cant distinguish between large and small groups
Post Your Comments:
(Date:11/26/2015)... ... November 26, 2015 , ... ... wellness consultation, has collaborated with Women’s Web – an online resource for ... topics on mental and emotional well-being relationship, life balance, stress, professional development, ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday season is ... pleasing the palates of attendees is of the utmost importance. Whether you are ... get-together, give these recipes a try this holiday season. , Turkey Croquettes , ...
(Date:11/25/2015)... Vegas, NV (PRWEB) , ... November 25, 2015 , ... ... invites patients to learn more about hair loss treatment with the Capillus272™ Pro laser ... an effective solution for thicker and fuller hair, without the need for surgery, prescription ...
(Date:11/25/2015)... ... 2015 , ... According to an article published November 10th by ... heralded as a breakthrough for performing hernia repairs. The article explains that the biggest ... that it can greatly reduce the pain that a patient might otherwise experience after ...
(Date:11/25/2015)... Florida (PRWEB) , ... November 25, 2015 , ... ... testing for physicians and athletic programs, launches new Wimbledon Athletics Facebook ... of testing young athletes for unsuspected cardiac abnormalities. About 2,000 people under the ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)...  Amgen (NASDAQ: AMGN ) today announced the ... the United States (U.S.) Food and ... to Humira ® (adalimumab). Amgen believes this submission ... FDA and represents Amgen,s first BLA submission using the ... M.D., executive vice president of Research and Development at ...
(Date:11/25/2015)... 25, 2015  Linden Care, LLC, a retail specialty ... for patients suffering from chronic pain, said today that ... Restraining Order (TRO) enjoining Express Scripts from unilaterally terminating ... --> --> The company ... legal options. --> --> ...
(Date:11/25/2015)... -- On Tuesday, November 24, 2015, the jury ... Medical Technology, Inc. for product liability and misrepresentation ... device, awarded $11 million in favor of Plaintiff ... three days of deliberations, the jury found that ... and unreasonably dangerous, and that Wright Medical made ...
Breaking Medicine Technology: