AOTMiT: Transparency Council on heart failure and chronic kidney disease, among others

Agenda

1. Prepare a position paper on the evaluation of the drug Jardiance (empagliflozinum) for the indication:
   
   • Chronic kidney disease in adult patients:
     • With eGFR in the range of ≥20 ml/min/1.73 m² to <45 ml/min/1.73 m², taking ACEi/ARB-based therapy for at least 4 weeks or with a contraindication to such therapy.
     • With an eGFR of ≥45 ml/min/1.73 m² to <90 ml/min/1.73 m² and albuminuria or proteinuria, taking ACEi/ARB-based therapy for at least 4 weeks or with a contraindication to such therapy.

1. Prepare a position paper on the evaluation of the drug Jardiance (empagliflozinum) for the indication:
   
   • Chronic heart failure in adult patients:
     • With preserved left ventricular ejection fraction (LVEF >50%) and persistent NYHA class II-IV disease symptoms, despite therapy based on ACEi (or ARB/ARNi), beta-blockers and diuretics (if indicated).

1. Prepare a position paper on the evaluation of the drug Jardiance (empagliflozinum) for the indication:
   
   • Type 2 diabetes in patients:
     • Using at least one hypoglycemic drug, with HbA1c ≥7%.
     • With very high cardiovascular risk, defined as:
       • Confirmed cardiovascular disease or damage to other organs (e.g., proteinuria, left ventricular hypertrophy, retinopathy).
       • Presence of 3 or more risk factors, such as age ≥55 years for men and ≥60 years for women, dyslipidemia, hypertension, smoking, obesity.

1. Preparation of a position on the qualification of the benefit:
   
   • HPV HR test with hrHPV genotyping including at least types 16 and 18, under the cervical cancer prevention program as a guaranteed benefit.

1. Preparation of a position paper on the evaluation of the drug Talzenna (talazoparibum) under drug program B.56:
   
   • Treatment of patients with prostate cancer (ICD-10: C61).

1. Preparation of a position paper on the examination of the appropriateness of reimbursement of the medicinal product Renastep for the indication:
   
   • Chronic renal failure in pediatric patients over 7 years of age.

1. Preparation of a position paper on the examination of the appropriateness of reimbursement of the medicinal product Flekainid for the indications:
   
   • Supraventricular arrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia, atrial premature excitation).
   • Ventricular arrhythmias (premature ventricular beats, ventricular tachycardia).

1. Preparation of an opinion on the draft health policy program of the local government unit:
   
   • "Health policy program for early detection of asthma and inflammatory changes in the respiratory system in children in the environment of air pollution in the context of the past COVID-19 pandemic" implemented by the City of Krakow.

1. Preparation of an opinion on changing the reimbursement availability category for the active substance budesonideum in the indication:
   
   • Viral laryngitis in children under 18 years of age.

Source: AOTMiT