Retigabin (3) – Trobalt®

Patients with epilepsy who require individualised adjunctive antiepileptic therapy, provided this is medically indicated and provided there is no known drug resistance, intolerance or contraindications

• In its resolution of 3 May 2012, following the benefit assessment of the active ingredient (INN) retigabine in accordance with Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V), the G-BA determined that retigabine is deemed not proven to have demonstrated any additional benefit, as the pharmaceutical manufacturer, in the dossier it submitted on 14 November 2011, the pharmaceutical company had not provided the evidence required under Section 35a(1), third sentence, No. 3 of the SGB V regarding the additional benefit of retigabin in relation to the appropriate comparator therapy determined by the G-BA within the authorised therapeutic indication.
• No dossier was submitted by the pharmaceutical manufacturer at the relevant time. Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment has been carried out as to whether the active ingredient retigabin has any additional benefit, no additional benefit or a less benefit compared with the appropriate comparator therapy, and the additional benefit of retigabin in relation to the appropriate comparator therapy is deemed not proven.
• In summary, the additional benefit of retigabin is assessed as follows: as the required proof has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code).
• Approved therapeutic indication for retigabin (Trobalt®):
  • Retigabin (Trobalt®) is indicated as an adjunctive therapy for drug-resistant focal seizures with or without secondary generalisation in patients with epilepsy aged 18 years or older, in whom other suitable combinations of medicinal products have been ineffective or have not been tolerated.
• Appropriate comparator therapy:
  • The appropriate comparator therapy as adjunctive treatment for drug-resistant focal seizures with or without secondary generalisation in patients with epilepsy aged 18 years or older, in whom other suitable combinations of medicines have been insufficiently effective or have not been tolerated, is:
  • An individualised adjunctive antiepileptic therapy, provided it is medically indicated and provided that no drug resistance, intolerance or contraindications are known, with one of the following active ingredients (INN): tiagabine, valproic acid or vigabatrin; otherwise: Treatment at the doctor’s discretion, depending on the baseline and previous therapy(ies) and taking into account the reason for the change in treatment and any associated side effects. The relevant marketing authorisation for the medicinal products must be observed.
• Note:
  • Valproic acid is usually part of prior treatment; the appropriateness of its use as add-on therapy must be assessed in light of this (e.g. side effects of valproic acid).
• Requirements for a quality-assured application
  • The guidelines set out in the European Public Assessment Report (EPAR) – Summary of Product Characteristics (Annex I) must be taken into account.
  • This was based on the increased risk of pigment changes in the eye tissue, including the retina, following several years’ use of Trobalt®. Deterioration in vision was observed in some patients in association with this.
  • Consequently, a comprehensive ophthalmological examination should be carried out before the start of treatment and at least every six months thereafter, including a check of visual acuity, a slit-lamp examination and a fundus examination under mydriasis.
  • Furthermore, there have been reports of pigmentary changes in the skin, lips and nails, some of which were observed in conjunction with the pigmentary changes in the ocular tissues. Patients should be closely monitored during treatment with Trobalt®. In the event of changes in pigmentation or visual acuity, the benefits and risks of continuing treatment with Trobalt® should be reassessed.
  • The initiation of treatment and decisions regarding the management of the treatment must be carried out by a specialist in neurology or a specialist in neurology. The treatment must be monitored by a specialist with experience in the treatment of epilepsy.

Courtesy translation only, please refer to the German original.