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       #Post#: 854--------------------------------------------------
       Fingolimod in MS: Indication of added benefit in certain patient
       s
       By: agate Date: July 8, 2015, 6:01 pm
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       From Medical News Today, July 7, 2015:
       [quote]Fingolimod in RRMS: Indication of added benefit in
       certain patients
       Reassessment based on new analyses; advantages now in 2 instead
       of only 1 patient group
       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) reassessed fingolimod (trade
       name: Gilenya), a drug for the treatment of adults with highly
       active relapsing remitting multiple sclerosis (RRMS). The
       Federal Joint Committee (G-BA) had limited its decision on the
       first assessment from 2012 to three years because it considered
       the certainty of the data as insufficient. This obliged the drug
       manufacturer to submit a second dossier.
       It did not submit any new studies, but reanalysed studies that
       were already available. On this basis, IQWiG reached different
       conclusions: From the data, an added benefit was now derived for
       two instead of only one of a total of three patient groups.
       IQWiG now found an indication where it had found a hint before.
       Indication instead of hint in severe course of disease
       One study - the approval study TRANSFORMS - was decisive also
       for the new dossier assessment. The manufacturer presented new
       analyses with a more detailed differentiation between subgroups
       for two patient groups.
       On the basis of the new analyses, there was an indication, and
       no longer a hint of an added benefit in patients with rapidly
       evolving severe RRMS. The extent of this added benefit depends
       on sex, however: It is considerable in women, and minor in men.
       While adverse events in the form of influenza-like symptoms are
       less frequent and certain adverse events (severe adverse events)
       occur more often in both sexes, only women have fewer relapses
       under fingolimod.
       Added benefit for further patient group
       The new analyses of TRANSFORMS showed that fingolimod has
       advantages for patients with highly active RRMS that has not
       been fully treated with interferon beta. In contrast, no added
       benefit had resulted from the first dossier.
       Since both the annualized relapse rate is lower and adverse
       events in the form of influenza-like symptoms occur less
       frequently, IQWiG sees an indication of considerable added
       benefit in comparison with the appropriate comparator therapy.
       Still no evaluable data for one group
       However, also the new dossier contained no evaluable data for
       patients with highly active RRMS who have already received full
       previous treatment with interferon beta (IFN-β1a). The
       results of an indirect comparison again presented by the
       manufacturer are still unsuitable because the majority of the
       patients in the studies on the appropriate comparator therapy
       had not been fully pretreated.
       Now added benefit for two thirds of the approval population
       Overall, the current assessment showed an added benefit for
       approximately two thirds of all patients for whom fingolimod was
       approved in 2011. However, this assessment only referred to the
       thera-peutic indication of the first approval from 2011, not to
       the indication "highly active RRMS with pretreatments other than
       interferon beta", which was also approved in 2014 and assessed
       according to AMNOG.
       G-BA decides on the extent of added benefit
       This dossier assessment is part of the early benefit assessment
       according to AMNOG supervised by the G-BA. After publication of
       the dossier assessment, the G-BA conducts a commenting procedure
       and makes a final decision on the extent of the added benefit.
       Adapted by MNT from original media release
       [/quote]
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