AOTMiT Transparency Council: drug programs, off-label indications, health care services

The agenda includes:

Preparation of positions on the evaluation of drugs under drug program B.5. "Treatment of patients with hepatocellular carcinoma (ICD-10: C22.0) or biliary tract cancer (ICD-10: C22.1, C23, C24.0, C24.1, C24.8, C24.9)":

Imfinzi (durvalumabum)

Imjudo (tremelimumabum)

Preparation of a position paper on the qualification of the health care benefit "X-ray - pantomographic image with description 1 every 3 years" as a guaranteed benefit under general dental services for adults (over 18 years of age) for dental treatment.

Preparation of an opinion on the appropriateness of changing the reimbursement availability category for the active substance aflibercept from the drug program B.4. "Treatment of patients with colorectal cancer (ICD-10: C18-20)" to the catalog of reimbursed drugs in chemotherapy.

Preparation of an opinion on the draft health policy program of the local government unit "Prevention of hearing loss among elementary school students in Zawiercie County for 2026-2028".

Preparation of an opinion on the active substance octreotidum for an off-label indication:

C.45.b. pituitary (neoplasm of uncertain or unknown nature of endocrine glands) - for thyrotropinoma type tumors,

for the indication of corticotropinoma (ICD-10: D44.3).

Preparation of an opinion on the active substance anastrozole for the off-label indication: hormone-dependent and HER2-negative breast cancer in first-line hormone therapy used for advanced cancer (possible prior use of complementary hormone therapy for early breast cancer) - in cases other than in the SmPC.

Preparation of an opinion on the active substance exemestaneum in the off-label indication: hormone-dependent and HER2-negative breast cancer in first-line hormone therapy used for advanced cancer (possible prior use of complementary hormone therapy for early breast cancer) - in cases other than in the SmPC.

Preparation of an opinion on the active substance letrozolum in the off-label indication: hormone-dependent and HER2-negative breast cancer in first-line hormone therapy used for advanced cancer (possible prior use of complementary hormone therapy for early breast cancer) - in cases other than in the SmPC.

Preparation of an opinion on the active substance enoxaparinum natricum for off-label indications:

• Bridging therapy in patients requiring temporary discontinuation of chronic treatment with oral anticoagulants due to planned therapeutic and diagnostic procedures,
• Immobilization of the lower limb in a plaster dressing or orthosis due to isolated injuries to the lower limb (for the entire period of immobilization, if it is associated with an increased risk of venous thromboembolism),
• Prevention and treatment of venous thromboembolism in pregnant and postpartum women,
• Critical ischemia of the lower extremities - in the period preceding hospitalization, not more than 14 days (therapeutic doses).

Preparation of an opinion on the active substance nadroparinum calcicum in off-label indications:

• Bridging therapy in patients requiring temporary discontinuation of chronic treatment with oral anticoagulants due to planned therapeutic and diagnostic procedures,
• Immobilization of the lower limb in a plaster dressing or orthosis due to isolated injuries to the lower limb (for the entire period of immobilization, if it is associated with an increased risk of venous thromboembolism),
• Prevention and treatment of venous thromboembolism in pregnant and postpartum women,
• Critical ischemia of the lower extremities - in the period preceding hospitalization, not more than 14 days (therapeutic doses).

Source: AOTMiT