AOTMiT: What will the Transparency Council address in July?

TRANSPARENCY COUNCIL MEETING NO. 26/2023 JULY 3, 2023

1. vabysmo (farycymabum) Indication: under the drug program "Treatment of patients with retinal diseases (ICD-10: H35.3, H36.0)". Decision-making problem: preparing a position paper on the evaluation of the drug

2. Ryeqo (relugolixum estradiolum norethisterone acetate) - CONDITIONAL Indication: in the indication resulting from the submitted reimbursement application Decision problem: preparation of a position on the evaluation of the drug

3. polivy (polatuzumabum vedotinum) 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

4. imbruvica (ibrutinibum) Indication: under drug program B.79. "Treatment of patients with chronic lymphocytic leukemia (ICD10: C91.1)" Decision-making problem: preparing a position paper on the evaluation of the drug

5. lynparza (olaparibum) Indication: under drug program B.50. "Treatment of patients with ovarian cancer, fallopian tube cancer or peritoneal cancer (ICD-10: C56, C57, C48)." Decision-making problem: preparation of a position paper on the evaluation of the drug

6. Calcort (deflazacort) Indication: nephrotic syndrome Decision problem: preparation of a position on the appropriateness of granting reimbursement approval for the medicinal product

7. "Expanding the availability of robotically assisted functional diagnosis and rehabilitation of children and young adults with cerebral palsy and other paraplegia syndromes in the Wielkopolska Region" Decision problem: preparing an opinion on the draft health policy program co-financed by the EU under ESF

TRANSPARENCY COUNCIL MEETING NO. 27/2023 JULY 10, 2023

1. Paxlovid (nirmatrelvirum; itonavirum) Indication: treatment of coronavirus 2019 (COVID-19) disease (confirmed by registered PCR or antigen test) in symptomatic (initiation of treatment within 5 days 2 of onset of symptoms) adult patients who do not require oxygen therapy (resulting from COVID-19), and who have an 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 problem: preparing a position paper on the evaluation of the drug

2. Oramorph (morphini sulfas) Indication: treatment of patients with malignant tumors, chronic postherpetic neuralgia, multisymptomatic local pain syndrome type I - reflex sympathetic dystrophy and type II - causalgia Decision problem: preparation of a position paper on the evaluation of the drug

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

4. Epidyolex (cannabidiolum) CONDITIONAL Indication: under the drug program "Treatment with cannabidiol of epileptic seizures associated with tuberous sclerosis syndrome in patients 2 years of age and older" Decision problem: preparing a position paper on the evaluation of the drug

5. Epidyolex (cannabidiolum) CONDITIONAL Indication: under the drug program "Treatment of epileptic seizures in patients with tuberous sclerosis syndrome (ICD-10: G40.4)". Decision-making problem: preparing a position paper on the evaluation of the drug

6. rozlytrek (entrectinibum) CONDITIONAL Indication: under the drug program "Treatment of patients with solid tumors with fusion of the receptor tyrosine kinase gene for neurotrophins (NTRK)". Decision problem: preparing a position paper on the evaluation of the drug

7. Respreeza (alpha-1 proteinase inhibitor) CONDITIONAL Indication: under the drug program "Treatment with human alpha1-proteinase inhibitor of patients with severe alpha1-antitrypsin deficiency and emphysema (ICD10: J44.8 and E88.0)." Decision problem: preparing a position paper on the evaluation of the drug

8. "Health policy program on prevention of depressive disorders for people over 60 years of age from the Mazovian province", 3 "Subsidized infertility treatment by in vitro fertilization for residents of the city of Biala Podlaska" Decision-making problem: preparing opinions on draft health policy programs of local government units.

TRANSPARENCY COUNCIL MEETING NO. 28/2023 JULY 17, 2023

1 Evaluate the appropriateness of a comprehensive amendment to create a new content of the Annex to the chemotherapy catalog: C.82.a BEVACIZUMABUM Decision-making problem: preparation of an opinion 2. Darzalex (daratumumabum) 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. Venclyxto (venetoclaxum) - CONDITIONAL Indication: under drug program B.79. "Treatment of patients with chronic lymphocytic leukemia (ICD-10: C91.1)" Decision-making problem: preparing a position paper on the evaluation of the drug

TRANSPARENCY COUNCIL MEETING NO. 29/2023 JULY 24, 2023

1. Crysvita (burosumab) Indication: under the drug program "Treatment of X-chromosome-associated hypophosphatemia" Decision problem: preparing a position paper on the evaluation of the drug

2. "Infertility treatment by in vitro fertilization for residents of the Municipality of Polkowice for 2024-2026", "Infertility treatment by in vitro fertilization for residents of the Municipality of Starogard Gdański for 2023-2026".

Decision-making problem: preparing opinions on draft health policy programs of local government units.

Source: AOTMiT