Ponesimod (1) – Ponvory®

• Clinical trials
  • In this RCT, ponesimod was compared with teriflunomide.

b) Adults with relapsing-remitting multiple sclerosis (RRMS) with highly active disease despite treatment with a disease-modifying therapy

• To assess the additional benefit of ponesimod in patient population a), the pharmaceutical manufacturer submitted the OPTIMUM study, which investigated adults with RMS and active disease.
• At the time the IQWiG was commissioned to carry out the benefit assessment, the active ingredient teriflunomide was not yet part of the appropriate comparator therapy.
• The benefit assessment published on 15 September 2021 is therefore unsuitable for decision-making under Section 35a(3) of Book V of the Social Code (SGB V), as it did not address the question of the additional benefit of ponesimod compared with the amended appropriate comparator therapy.
• Following the amendment to the appropriate comparator therapy, the IQWiG is therefore tasked, pursuant to Section 35a of the German Social Code, Book V (SGB V) in conjunction with Section 7(1) to (3) of the AM-NutzenV and Chapter 5, Chapter, Section 18 of the VerfO, to carry out, on the basis of the dossier received on 14 June 2021 at the registry of the Federal Joint Committee (G-BA) (G-BA) on 14 June 2021, to carry out, for patient population a), a new benefit assessment in accordance with Section 35a(2), first sentence, of SGB V.
• As, until the new benefit assessment pursuant to Section 35(2), first sentence, of SGB V has been submitted, a resolution by the G-BA pursuant to Section 35a(3), first sentence, of SGB V is not possible due to the lack of all the prerequisites for a substantive decision, the resolution on the benefit assessment of ponesimod for patient population a) is to be provisionally suspended for a period of 6 months.

b) Adults with relapsing-remitting multiple sclerosis (RMS) with highly active disease despite treatment with a disease-modifying therapy

• The additional benefit is not proven.
• The pharmaceutical manufacturer has not submitted any data for previously treated adults with highly active disease to assess the additional benefit of Ponesimod compared with the appropriate comparator therapy.
• For this patient group, the pharmaceutical manufacturer has not provided any data to assess the additional benefit of ponesimod compared with the appropriate comparator therapy.
• Appropriate comparator therapy
  • The G-BA has designated the active ingredients alemtuzumab, fingolimod or natalizumab as the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.