AOTMiT: What will the Transparency Council address in September?

TRANSPARENCY COUNCIL MEETING NO. 35/2023 SEPTEMBER 4, 2023

1. Strensiq (asfotasum alfa) CONDITIONAL Indication: under the drug program "Treatment of bone symptoms in the course of pediatric hypophosphatasia (HPP) (ICD-10 E83.3) with asfotasum alfa" Decision problem: preparation of a position paper on the evaluation of the drug

2. Tysabri (natalizumab) solution for injection CONDITIONAL Indication: under drug program B.29. "Treatment of patients with multiple sclerosis (ICD-10: G35)" Decision-making problem: preparing a position paper on the evaluation of the drug

3. phesgo (trastuzumab + pertuzumab) CONDITIONAL Indication: under drug program B.9.FM. "Treatment of patients with breast cancer (ICD-10: C50)". Decision-making problem: preparation of a position on the evaluation of the drug

4. Nilemdo (bempedoic acid) Indication: atherosclerosis Decision-making problem: preparation of a position on the appropriateness of granting reimbursement approval for a medicinal product

5. "Support of infertility treatment by in vitro fertilization - in vitro for residents of the Oświęcim district in 2024-2026". Decision-making problem: preparation of an opinion on the draft health policy program of local government units

TRANSPARENCY COUNCIL MEETING NO. 36/2023 SEPTEMBER 11, 2023

1. kymriah (tisagenlecleucelum) CONDITIONAL Indication: under the drug program "Treatment of patients with B-cell lymphoma (ICD-10: C82, C83, C85)". Decision-making problem: preparation of a position paper on the evaluation of the drug

2. Shingrix (hemiplegia vaccine, recombinant, with adjuvant) Indication: prophylaxis of hemiplegia and hemiplegic neuralgia in persons 65 years of age and older Decision problem: preparation of a position paper on the evaluation of the drug

VaxigripTetra (quadrivalent influenza vaccine (split virus)) 3. Indication: indicated for the prevention of influenza caused by two subtypes of influenza A virus and two types of influenza B virus, which are contained in the vaccine: - active immunization of adults, including pregnant women, and children from the age of six months, - passive immunization of infants from birth to less than six months of age after vaccination of pregnant women Decision problem: preparation of a position paper on the evaluation of the drug

4. dupixent (dupilumab) Indication: under the new drug program "Treatment of patients with rhinosinusitis with nasal polyps (ICD-10: J32, J33)". Decision-making problem: preparing a position paper on the evaluation of the drug

5. Entresto (sacubitrilum + valsartanum) Indication: in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction Decision problem: preparing a position paper on the evaluation of the drug

6. Rxulti (brexpiprazole) CONDITION Indication: for the treatment of schizophrenia in adult patients after ineffectiveness or poor tolerance, or in the case of contraindications to therapy with other second-generation antipsychotics Decision problem: preparing a position paper on the evaluation of the drug

7. vyvgart (efgartigimod alfa) CONDITIONAL INDICATION: under the drug program "Treatment of patients with generalized form of myasthenia gravis (G.70.0)". Decision-making problem: preparation of a position paper on the evaluation of the drug

8. opdualag (nivolumab + relatlimab) CONDITION Indication: treatment of patients with melanoma of the skin or mucous membranes Decision problem: preparation of a position paper on the evaluation of the drug

9. "Program of prevention of pneumococcal infections for adults of the Kuyavian-Pomeranian province". Decision-making problem: preparation of an opinion on the draft health policy program of local government units

TRANSPARENCY COUNCIL MEETING NO. 37/2023 SEPTEMBER 18, 2023

1. "Endodontic treatment of molars and premolars in adults (over 18 years of age) with biomechanical preparation of root canals and their final filling", "Closure of perforations of the chamber floor or root canal wall as a complication of endodontic treatment (people over 18 years of age.)", "Re-treatment of endodontic teeth in adults (over 18 years of age)", "Obturator in two-stage treatment of cysts and cystic tumors of the maxilla and/or mandible including necessary retaining elements (brackets)", "Repositioning and immobilization of a dislocated tooth or group of teeth and removal of a dental splint when replacing or completing treatment". Decision-making problem: preparation of positions on the assessment of the reasonableness of qualifying health care services

2. Sialanar (glycopyrronium bromide) CONDITIONAL INDICATION: symptomatic treatment of severe sialorrhea (chronic pathological salivation) in children and adolescents aged 3 years and older with cerebral palsy Decision problem: preparing a position paper on the evaluation of the drug

3. Forsteo Indication: hypoparathyroidism Decision-making problem: preparation of a position paper on the appropriateness of granting reimbursement approval for a medicinal product

4. "Program of prophylactic vaccination against pneumococcal infections for residents of Trzebownisko Municipality aged 55 years and older for 2023-2024". Decision-making problem: preparing an opinion on the draft health policy program of local government units

TRANSPARENCY COUNCIL MEETING NO. 38/2023 SEPTEMBER 25, 2023

1. Veltassa (calcium patiromer) CONDITIONAL INDICATION: for the treatment of hyperkalemia in the course of chronic kidney disease in patients using RAASi Decision problem: preparing a position paper on the evaluation of the drug

2. tecvayli (teclistamabum) solution for injection CONDITIONAL Indication: under drug program B.54. "Treatment of patients with plasmocytic myeloma (ICD-10: C90.0)" Decision-making problem: preparation of a position paper on the evaluation of the drug

3. imfinzi (durvalumabum) Indication: under the drug program "Treatment of patients with biliary tract cancer (ICD-10: C22.1, C23, C24.0, C24.1, C24.8, C24.9)". Decision-making problem: preparing a position paper on drug evaluation

4. "Program to improve the quality of life of diabetic patients and their families and caregivers titled "In time for the diabetic foot", "Program in the prevention of depression in children and adolescents in the city of Tychy" Decision-making problem: preparation of an opinion on the draft health policy program of local government units

Source: AOTMiT