AOTMiT: What will the Transparency Council address in June?

TRANSPARENCY COUNCIL MEETING NO. 22/2023 JUNE 5, 2023

Opdivo (nivolumabum)
Indication: under drug program B.141 "Treatment of patients with urothelial carcinoma (ICD-10: C61, C65, C66, C67, C68)"
Decision-making problem: preparation of a position paper on the evaluation of the drug

Lonsurf (Trifluridinum + Tipiracilum) CONDITIONAL
Indication: under drug program B.58. "Treatment of patients with advanced esophageal and gastric cancer (ICD-10: C15-C16)"
Decision problem: preparing a position paper on the evaluation of the drug

Koselugo (selumetinibum)
Indication: under the drug program "Treatment of patients with plexiform neurofibromas in the course of neurofibromatosis type 1 (NF1) (ICD-10 : Q85.0)"
Decision-making problem: preparing a position paper on the evaluation of the drug

"Subsidy for infertility treatment by in vitro fertilization method for residents of Zduńska Wola County for 2024-2026"
"Support for infertility treatment by in vitro fertilization method - in vitro for residents of the Silesian province for 2023-2026"
"Health policy program for early detection of vision defects in children, especially myopia, including in connection with the implementation of remote learning during the COVID-19 epidemic"
Decision-making problem: Preparation of opinions on draft health policy programs of local government units

COUNCIL MEETING TRANSPARENCY NO. 23/2023 JUNE 12, 2023

Inclusion of the product emicizumab in the treatment of patients with hemophilia A, within the framework of module 4 of the health policy program entitled National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019-2023
Decision-making problem: preparation of an opinion

Inclusion of Hemlibra in the PPZ module "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019 - 2023"
Indication: for use in the routine prophylaxis of bleeding episodes in patients with severe hemophilia A without factor VIII inhibitor, together with an indication of the inclusion criteria (if inclusion is warranted) Decision problem: preparation of an opinion

Assessment of the rationale for the introduction of prolonged-acting factor VIII within module 4 of the health policy program entitled "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019-2023"
Decision problem: preparation of an opinion

Polivy (polatuzumabum vedotinum) CONDITIONAL
Indication: under the drug program "Treatment of patients with diffuse large B-cell lymphoma and other B-cell lymphomas (ICD-10: C83, C85)"
Decision-making problem: preparing a position paper on the evaluation of the drug

Ryeqo (Relugolixum + Estradiolum + Norethisterone acetate) CONDITION
Indication: treatment of moderate to severe symptoms of uterine myomas in adult women of childbearing age
Decision problem: prepared positions on evaluation of drug

Toujeo (insulinum glargine) CONDITION
Indication: treatment of type 2 diabetes mellitus in adults
Decision problem: prepared positions on evaluation of the drug

Nexviadyme (avalglucosidasum alfa) CONDITIONAL
Indication: under the drug program "Treatment of patients with Pompe disease (ICD-10 E74.0) "Decision problem: prepared positions on the evaluation of the drug

Paxlovid (nirmatrelvirum; itonavirum) CONDITION
Indication: treatment of coronavirus 2019 (COVID-19) disease (confirmed by registered PCR or antigen test) in symptomatic (initiation of treatment within 5 days of symptom onset) adult patients who do not require oxygen therapy (resulting from COVID-19) and who are at increased risk of progression to severe COVID-19, defined as: 1) the presence of at least 3 risk factors among the following: Age ≥ 65 years; Obesity (BMI ≥ 35 kg/m2); Chronic lung disease (daily therapy required for asthma); Cardiovascular disease: myocardial infarction, stroke, transient ischemic episode (TIA), heart failure, angina, cardiomyopathy, status post: coronary artery bypass grafting, percutaneous coronary intervention, carotid endarterectomy, aortic bypass grafting; Diabetes mellitus; Chronic kidney disease; or 2) Diagnosis of immunodeficiency or chronic use of immunosuppressants: Systemic corticosteroids at a dose equivalent to ≥ 20 mg of prednisone per day for at least 14 consecutive days in the last 30 days; Biologic drugs, immunomodulatory drugs or anti-cancer drugs in the last 90 days; or 3) Active malignant neoplasm
Decision-making problem: preparing a position paper on drug evaluation.

Cabometyx (cabozantinibum)
Indication: under the drug program "Treatment of patients with differentiated thyroid cancer (ICD-10 C 73).
Decision problem: preparing a position paper on the evaluation of the drug

Lynparza (olaparibum)
Indication: under drug program B.9.FM. "Treatment of patients with breast cancer (ICD-10: C50)".

Decision-making problem: preparing a position on drug evaluation

Elvanse (lisdexamfetamini dimesilas)
Indication: treatment of activity and attention disorders
Decision-making problem: preparing a position paper on the appropriateness of issuing reimbursement approvals

"Health policy program for medical rehabilitation of residents of the municipality of Czarnia for 2023- 2028"
Decision-making problem: preparation of an opinion on the draft health policy program of local government units

"Diabetic retinopathy prevention program in Wielkopolska province - 2nd edition"
Decision-making problem: preparing an opinion on the draft health policy program co-financed by the EU under the ESF

"Preparation of opinions on recommended medical technologies, activities carried out within the framework of health policy programs and the conditions for their implementation in the field of fertility preservation in patients treated with oncology"
Decision problem: preparation of opinions on recommended medical technologies, activities carried out within the framework of health policy programs and the conditions for their implementation

COUNCIL MEETING TRANSPARENCY NO. 24/2023 JUNE 19, 2023

Introduction to the list of guaranteed services in the field of outpatient specialized care,health care benefit dedicated therapy for chronically ill patients, including in total:
administration of a drug, listed in the announcement of the Minister of Health on the list of reimbursed drugs, foodstuffs for special nutritional use and medical devices, in accordance with the conditions specified for individual drugs, issuance of a drug to continue chronic therapy at home, education on the administration of this drug at home, conditions for monitoring therapy.
Decision-making problem: preparation of a position on the introduction of a health care benefit to the list of guaranteed services in the field of outpatient specialized care

Assessment of the rationale for the introduction of prolonged-acting factor IX within module 4 of the health policy program entitled "National Program for the Treatment of Patients with Hemophilia and Related Hemorrhagic Diathesis for 2019-2023"
Decision problem: preparation of an opinion

Imbruvica (ibrutinib) CONDITIONAL
Indication: under drug program B.79. "Treatment of patients with chronic lymphocytic leukemia (ICD- 10: C91.1)"
Decision problem: preparing a position paper on the evaluation of the drug

TRANSPARENCY COUNCIL MEETING NO. 25/2023 JUNE 26, 2023

Preventive dental benefit for a child in the 3rd year of life
Indication: solutions currently in place for the indicated subject of the order and health problem (e.g., current standard therapy) and the possibility of using other solutions in relation to the proposed solution (e.g., alternative therapies).
Decision problem: preparation of a position paper on the assessment of the reasonableness of qualifying the health care benefit

Adaptive visit of a child in the 3rd and 4th year of life
Indication: solutions currently in place for the indicated subject of the order and health problem (e.g., current standard therapy) and the possibility of using other solutions in relation to the proposed solution (e.g., alternative therapies).
Decision problem: preparation of a position paper on the assessment of the reasonableness of the qualification of the health care service

Oramorph(morphinisulfas)CONDITIONAL
Indication: malignancies, chronic postherpetic neuralgia, multisymptomatic local pain syndrome type I - reflex sympathetic dystrophy and type II - causalgia.
Decision problem: preparing a position paper on the evaluation of the drug

Brukins (zanubrutinibum) CONDITIONAL
Indication: under drug program B.79. "Treatment of patients with chronic lymphocytic leukemia(ICD-10: C91.1)"
Decision problem: preparing a position paper on the evaluation of the drug

Vabysmo (farycymabum) - CONDITIONAL
Indication: under the drug program "Treatment of patients with retinal diseases (ICD-10: H35.3, H36.0)". Decision problem: preparation of a position on the evaluation of the drug.

Source: AOTMiT