AOTMiT: The Transparency Council will evaluate drugs for UC, SMA and phenylketonuria, among others.

The agenda includes:

1 Prepare a position paper on the evaluation of the drug Ayvakyt (vapritinibum) under drug program B.115 "Treatment of patients with advanced forms of systemic mastocytosis".

2 Prepare a position paper on the evaluation of the drug Zolgensma (onasemnogenum abeparvovecum) under the drug program B.102.FM. "Treatment of patients with spinal muscular atrophy (ICD-10: G12.0, G12.1)".

3 Prepare a position paper on the evaluation of the drug Omvoh (mirikizumabum) under drug program B.55 "Treatment of patients with ulcerative colitis (UC) (ICD-10: K51)".

4 Prepare a position paper on the evaluation of the drug Ultomiris (ravulizumabum) under the drug program "Treatment of adult patients with generalized myasthenia gravis (GMG) (ICD-10 G70.0)"

5 Prepare a position paper on the examination of the legitimacy of issuing approvals for reimbursement of the medicinal product Kuvan (sapropterinum) for the indications: atypical form of phenylketonuria - tetrahydrobiopterin (BH4) deficiency, including 6-pyruvyltetrahydrobiopterin synthase (6-PTPS) defect, guanosine triphosphate cyclohydrolase (GTP-CH) deficiency.

6 Prepare an opinion on the continuation of the inclusion in reimbursement of the active substance lanreotidum in the indication - hyperinsulinism caused by another cause than specified in the SmPC.

7 Prepare an opinion on the continuation of the inclusion in reimbursement of the active substance octreotidum in the indications: hyperinsulinism due to a cause other than that specified in the SmPC and symptoms of hypersecretion occurring in the course of neuroendocrine tumors other than those specified in the SmPC.

8 Prepare an opinion on the continuation of reimbursement coverage of the active substance sulfasalazinum in the indication: autoimmune diseases other than those specified in the SmPC.

Source: AOTMiT