Germany’s drug pricing watchdog is now recommending Novartis’ multiple sclerosis pill Gilenya (fingolimod) to treat more patients after re-assessing its data.
IQWiG is evaluating the drug’s price in relation to its efficacy for relapsing remitting multiple sclerosis (RRMS) after Germany’s Federal Joint Committee (GBA) had in 2012 only allowed limited funding of the medicine.
For this second submission, Novartis did not present any new studies, but instead reanalysed trials that were already available.
On this basis, IQWiG reached different conclusions than it had three years ago: From the data, an added benefit has now been derived for two instead of only one of a total of three 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: IQWiG found that it was considerable in women while being minor in men.
The new analyses of Novartis’ TRANSFORMS study also showed that Gilenya 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 set of data from 2012.
But it was not all good news for Novartis as the new data contained no positive data for patients with highly active RRMS who have already received full previous treatment with interferon beta (IFN-β1a), meaning it cannot be recommended for this area.
The final decision as to what price and for what licences will be paid for the drug rests with the GBA, which will make a final decision in the next three months.