AOTMIT: Transparency Council incl. on expanding the population and adding new drugs without assessing the effectiveness and budgetary impact

The agenda includes:

Preparation of an opinion on the introduction of a comprehensive change in the current description of the drug program B.54. "Treatment of multiple myeloma patients (ICD-10: C90.0)."

Preparation of an opinion on reimbursement of drugs containing active substances:

• octreotide in the indications: pituitary gland (a tumor of uncertain or unknown nature of the endocrine glands) - for tumors such as thyrotropinoma; corticotropinomas (ICD-10: D44.3),
• letrozole, anastrozole and exemestane in the indication: hormone-dependent and HER2-negative breast cancer in the first-line hormone therapy for advanced cancer (possible earlier use of adjuvant hormone therapy for early breast cancer) in cases other than those specified in the SmPC,
• enoxaparinum natricum, nadroparinum calcicum in the indications:
• bridging therapy in patients requiring temporary discontinuation of chronic treatment with oral anticoagulants due to planned therapeutic and diagnostic procedures - in cases other than those specified in the SmPC;
• immobilization of the lower limb in a plaster cast or orthosis due to isolated injuries of the lower limb (for the entire period of immobilization, as long as it is associated with an increased risk of VTE) - in cases other than those specified in the SmPC;
• prophylaxis and treatment of venous thromboembolism in pregnant women - other than those specified in the SmPC;
• Critical lower limb ischemia - in the period prior to hospitalization, no longer than 14 days (therapeutic doses) - other than those specified in the SmPC.

Introductory discussion of the problem of drug programs merging:

• the problem of expanding the population,
• adding new drugs without assessing the effectiveness and budgetary impact.

Source: AOTMiT