Benefit assessment: VMS and RMS agents only half and only slightly successful

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Written By Rivera Claudia

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Berlin. The Federal Joint Committee (G-BA) found some evidence of small additional benefits of fezolinetant in the treatment of vasomotor symptoms (VMS) associated with menopause.

In the case of ublituximab, which is used to treat adults with relapsing-remitting multiple sclerosis (RMS) with active disease, the committee, after examining the manufacturer’s documents, even sees an indication (of a slightly higher value) of a small additional benefit. But even with this active ingredient, the G-BA’s decision only affects a few patients.

In assessing the benefit of ublituximab, the study results presented by the manufacturer were considered in relation to two groups of patients: A) for adults with RMS who have not yet received any disease-modifying therapy and who do not have evidence of severe disease progression; and B) for patients with RMS who have not yet received disease-modifying therapy but for whom there is evidence of severe disease progression, as well as for adults who have active disease progression despite treatment.

Two-part decisions

Although the G-BA did not consider any additional benefit of ublituximab compared with appropriate comparator therapy (zvT) as demonstrated in the second group of patients, it concluded that for the first group there was at least an indication of a minor additional benefit. The reasons for this were that the study results showed advantages in terms of health-related quality of life and confirmed disease flares.

Two groups of patients were also considered for fezolinetant: first, postmenopausal women with moderate to severe vasomotor symptoms who are candidates for hormone therapy and who decided on hormone replacement therapy after an individual risk-benefit assessment; second, women in the same situation who are not eligible for hormone therapy or who decided not to take therapy after consideration.

Only for this last group did the G-BA determine that there were indications of a small additional benefit compared to zvT (watchful waiting). The reason for this was the advantages in reducing VMS and sleep disturbances as well as in health-related quality of life. (yuck)

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