New benefits and therapies in the evaluation of the AOTMiT Transparency Council

Agenda:

1. Preparation of a position paper on the qualification of the procedure for programming an intracranial brain neurostimulator as a guaranteed benefit.
2. Preparation of a position paper on monitoring of patients with an implanted intracranial brain neurostimulator as a guaranteed benefit.
3. Preparation of an opinion on the introduction of the medicinal product Hemlibra (emicizumab) to the PPZ "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2024-2028" for the indication: for patients with severe or moderate hemophilia A without an inhibitor.
4. Preparation of an opinion on the active substance anakinra in the off-label indication: other congenital autoinflammatory syndromes - TRAPS; polygenic autoinflammatory syndromes mediated by IL-1 - Schnitzler syndrome; secondary amyloidosis dependent on autoinflammatory lesions.
5. Preparation of an opinion on the active substance chloroquinum in the off-label indication: autoimmune diseases other than those specified in the SmPC; cutaneous porphyria late.
6. Preparation of an opinion on the active substance metforminum in the off-label indication: insulin resistance syndromes in cases other than in the course of diabetes.
7. Preparation of an opinion on the active substance venlafaxinum for the off-label indication: diabetic painful polyneuropathy.
8. Preparation of an opinion on the active substance stiripentolum in the off-label indication: malignant focal migratory infantile epilepsy.
9. Preparation of an opinion on the active substance abiraterone acetate in the off-label indication: C.87.b (treatment of adult patients with hormone-sensitive metastatic prostate cancer who do not meet the criteria for the registration indication listed in Annex C.XX.a, in combination with androgen deprivation as a stand-alone treatment or initially in combination with ongoing docetaxel-based chemotherapy for 18 weeks).

Source: AOTMiT