CEE Workshops

Jinarc (tolvaptan) - Treatment of autosomal dominant polycystic kidney disease (ICD-10 Q 61.2) [en] (475.83 KB)

Zejula (niraparib) - Treatment of patients with ovarian cancer, fallopian tube cancer or peritoneal cancer (ICD-10 C56, C57, C48) [en] (450.23 KB)

Kymriah (tisagenlecleucel) - Treatment of B-cell acute lymphoblastic leukaemia with tisagenlecleucel (ICD-10 C91.0) [en] (420.22 KB)

Firazyr (icatibant) - Symptomatic treatment of acute, life-threatening attacks of hereditary angioedema in adolescents and children 2 years of age and over with C1 esterase inhibitor deficiency [en] (393.07 KB)

Kymriah (tisagenlecleucel) - Treatment of diffuse large B-cell lymphoma (ICD-10 C83, C85) with tisagenlecleucel [en] (426.97 KB)

Venclyxto (venetoclax) - Treatment of patients with chronic lymphocytic leukaemia with venetoclax in combination with rituximab (ICD-10 C91.1) [en] (433.04 KB)

Ozempic (semaglutide) - Type 2 diabetes, for patients using at least two oral hypoglycaemic agents or basal insulin in combination with at least one oral hypoglycaemic agent, with HbA1c ≥ 8%, with obesity defined as BMI ≥ 30 kg/m2 and with very high cardiovascular risk defined as: confirmed cardiovascular disease or damage to other organs manifested by: proteinuria or left ventricular hypertrophy, or retinopathy, or the presence of 2 or more major risk factors among the following: age ≥ 55 years for men, ≥ 60 years for women, dyslipidaemia, hypertension, smoking [en] (436.82 KB)

Lenvima (lenvatinib) - Treatment of advanced radioiodine-refractory thyroid cancer (ICD-10: C73) [en] (404.78 KB)

Farxiga drug (dapagliflozin) - Chronic heart failure in adult patients with reduced left ventricular ejection fraction (LVEF≤40%) and persistent symptoms of the disease in New York Heart Association classes II–IV despite the therapy based on ACEis (or ARBs) and beta blockers and, if indicated, mineralocorticoid receptor antagonists [en] (413.72 KB)

PKU GMPro - Phenylketonuria in patients over the age of 12 years [en] (366.39 KB)

Taltz (ixekizumab) -Treatment of active ankylosing spondylitis (AS) (ICD-10 M 45) [en] (365.48 KB)

Rybelsus (semaglutide) - Type 2 diabetes, in patients taking at least two oral hypoglycaemic agents or basal insulin in combination with at least two oral hypoglycaemic agents or basal insulin in combination with at least one oral hypoglycaemic agent, with HbA1c ≥ 8%, with obesity defined as BMI ≥ 30 kg/m2 and very high cardiovascular risk defined as: confirmed cardiovascular disease or damage to other organs manifested by: proteinuria or left ventricular hypertrophy, or retinopathy, or the presence of 2 or more major risk factors from among the following: age ≥ 55 of age for men, ≥ 60 of age for women, dyslipidaemia, hypertension, smoking [en] (368.56 KB)

Kineret (anakinra) -Treatment of active rheumatoid arthritis and aggressive course of juvenile idiopathic arthritis (ICD-10 M 05, M 06, M 08) [en] (409.11 KB)

Tysabri (natalizumab) - Treatment of multiple sclerosis [information protected as a trade secret] or primary progressive multiple sclerosis (ICD-10 G 35) [en] (366.02 KB)

Taltz (ixekizumab) - Treatment of patients with active spondyloarthropathy (SpA) without radiographic changes characteristic of AS (ICD-10 M46.8) [en] (351.99 KB)

Ofev (nintedanib) - Nintedanib treatment of systemic sclerosis-associated interstitial lung disease (ICD-10 M34+J99.1) [en] (381.67 KB)

Mavenclad (cladribine) - Information protected as a trade secret [en] (347.98 KB)

Gardasil, vaccine against human papillomavirus (HPV) (types 6, 11, 16, 18) - Prevention of: premalignant lesions of genital organs (uterine cervix, vulva and vagina), premalignant lesions of the anus, cervical cancer and anal cancer causally related to infection with certain oncogenic human papillomavirus (HPV) types; genital warts (condylomata acuminata) causally related to infection with specific HPV types in persons aged 9 and older [en] (365.13 KB)

Vitrakvi (larotrectinib) - Treatment of solid tumours that show the fusion of the neurotrophin tyrosine receptor kinase (NTRK) gene [en] (351.52 KB)

Sarclisa (isatuximab) - Treatment of patients with relapsed/refractory multiple myeloma (ICD-10 C90.0) with isatuximab [en] (434.94 KB)

Piqray (alpelisib) - To use in combination with fulvestrant in patients with progressive or recurrent breast cancer during or after completion of hormonal treatment with an aromatase inhibitor, under the B.9. drug programme "Treatment of patients with breast cancer (ICD-10 C50) [en] (342.29 KB)

Calquence (akalabrutynib) - Treatment of chronic lymphocytic leukaemia (ICD 10: C.91.1) [en] (427.93 KB)

Phesgo (pertuzumab + trastuzumab) - Treatment of patients with breast cancer (ICD-10 C50) [en] (373.49 KB)

Adcetris (brentuximab vedotin) - Treatment of patients with lymphoma CD30+ (ICD-10 C81; C84.5) [en] (325.83 KB)

Vyndaqel (tafamidis) - Treatment of transthyretin amyloid cardiomyopathy with tafamidis in adults (ICD-10 E85) [en] (326.63 KB)

Entyvio (vedolizumab) - Treatment of Crohn's disease (ICD-10 K50) [en] (357.86 KB)

Entyvio (vedolizumab) - Treatment of ulcerative colitis (UC) (ICD-10 K51) [en] (337.87 KB)

Cosentyx (secukinumab) - Information protected as a trade secret [en] (315.35 KB)

Evrysdi (risdiplam) - Treatment of spinal muscular atrophy with risdiplam (ICD-10 G12.0, G12.1) [en] (382.70 KB)

Erleada (apalutamide) - Treatment of castration- resistant prostate cancer (ICD-10 C61) [en] (361.83 KB)

Blincyto (blinatumomab) - Blinatumomab treatment in adults with minimal residual disease in acute lymphoblastic leukaemia [en] (404.08 KB)

L-carnitine (a foodstuff for particular nutritional uses) - Adjuvant therapy using L-carnitine in the following indications: 3-Methylcrotonylglycinuria – MCC, glutaric acidemia type 1 – GA I, isovaleric acidemia – IVA, methylmalonic acidemia – MMA, propionic acidemia – PA, long-chain fatty-acid oxidation disorders – LC-FAOD, medium-chain acyl-CoA dehydrogenase deficiency – MCADD, carnitine uptake defect – CUD, multiple acyl- CoA dehydrogenation deficiency – MADD (E 71.1, E 71.3, E 72.3) [en] (458.20 KB)

Nexavar (sorafenib) - Treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/oxyphilic – Hürthle cell) thyroid cancer, refractory to radioactive iodine (ICD10 C73) [en] (478.62 KB)

Valtricom (Amlodipinum + Valsartanum + Hydrochlorothiazidum) - In all indications registered as of the date of the Decision [en] (350.73 KB)

Kisqali (ribociclib) - Treatment of breast cancer (ICD-10 C50) [en] (423.81 KB)

Mevalia PKU Motion (a foodstuff for particular nutritional use) - Phenylketonuria [en] (443.65 KB)

Hizentra (human normal immunoglobulin) - Immunoglobulin infusion treatment in neurological disorders (ICD-10: G61.8, G62.8, G63.1, G70, G04.8, G73.1, G73.2, G72.4, G61.0, G36.0, M33.0, M33.1, M33.2) [en] (411.03 KB)

Signifor (pasireotide) - Treatment of Cushing’s disease (ICD-10 E24.0) [en] (419.42 KB)

Verzenios (abemaciclib) - Treatment of breast cancer (ICD-10 C50) [en] (409.10 KB)

Afstyla (onoctocog alfa ) - Prevention of bleeding episodes in children with haemophilia A and B (ICD-10 D 66, D 67) [en] (404.50 KB)

Egzysta (pregabalin) - Treatment of peripheral and central neuropathic pain in adults [en] (458.91 KB)

Repatha (evolocumab) - Treatment of patients with very high risk of cardiovascular disease in secondary prevention [en] (456.90 KB)

Bavencio (avelumab) - Treatment of Merkel cell carcinoma with avelumab (ICD-10 C44) [en] (426.02 KB)

Verzenios (abemaciclib) - Treatment of breast cancer (ICD-10 C50) [en] (449.78 KB)

Hyrimoz (adalimubab) - Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate [en] (473.02 KB)

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*Ladies and Gentlemen
We inform you that the materials and results of the discussions posted on the Agency’s website are the result of the conceptual work and analytical process carried out by the team of the Agency for Health Technology Assessment and Tariff System based on the EBM paradigm, including: search, selection, synthesis and interpretation of scientific evidence, or the data analysis carried out.
In connection with the above, we would like to inform you that the use of analytical material or the results of the discussion, in accordance with good practice, should be accompanied by information on the source in the form: [title of presentation / report], AOTMiT, Warsaw, June 2024]