Professional development Vacancies

State health technology assessment: applications/dossiers, conclusions

08.02.2022 Updated 21.10.2026 70432 views

Date:
20.10.2026
INN:
Енфортумабу ведотин/Enfortumab vedotin
Claimed indication for medical use:
Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a programmed death receptor-1 inhibitor or a programmed death ligand-1 inhibitor.
Application:
Заява на проведення державної ОМТ лікарського засобу енфортумабу ведотин (ТН ПАДЦЕВ) (133 КБ) (Завантажено: 21.10.2026 12:59:46)
Conclusion:
Date:
29.09.2026
INN:
Semaglutide/Semaglutide
Claimed indication for medical use:
In insufficiently controlled type 2 diabetes mellitus, as an adjunct to diet and exercise in patients with obesity (BMI>30) and established atherosclerotic cardiovascular disease or very high cardiovascular risk, as an adjunct to one or two oral glucose-lowering medicinal products, including metformin.
Application:
Application for state health technology assessment for the purpose of including the medicinal product semaglutide (481 KB) (Uploaded: 01.10.2026 08:16:39)
Conclusion:
Date:
10.09.2026
INN:
Vosoritide / Vosoritide
Claimed indication for medical use:
Treatment of achondroplasia in patients aged 4 months and older whose epiphyses are not closed. The diagnosis of achondroplasia must be confirmed by appropriate genetic testing.
Application:
Application for state HTA of the medicinal product vosoritide (trade name VOXZOGO) (1.9 MB) (Downloaded: 11.09.2026 12:04:14)
Conclusion:
Date:
28.08.2026
INN:
Panitumumab/panitumumab
Claimed indication for medical use:
Indicated for the treatment of adults with left-sided metastatic colorectal cancer (mCRC) with wild-type RAS, primarily in combination therapy according to the FOLFOX6 regimen.
Application:
Application for state health technology assessment for the purpose of including the medicinal product panitumumab (819 KB) (Uploaded: 01.09.2026 13:37:40)
Conclusion:
Date:
16.07.2026
INN:
Vilanterol, umeclidinium bromide and fluticasone furoate
Claimed indication for medical use:
Indicated for maintenance therapy of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who do not receive an adequate effect from a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic receptor antagonist.
Application:
Application for state health technology assessment for the purpose of including the medicinal product vilanterol, umeclidinium bromide and fluticasone furoate. (1.3 MB) (Downloaded: 20.07.2026 06:14:17)
Conclusion:
Date:
03.06.2026
INN:
Vedolizumab/vedolizumab
Claimed indication for medical use:
Treatment of active moderate to severe ulcerative colitis in adult patients who have had an inadequate response, lost response, or were intolerant to standard therapy
Application:
Application for state HTA of the medicinal product vedolizumab (trade name ENTYVIO) (1.5 MB) (Downloaded: 04.06.2026 13:46:24)
Conclusion:
Date:
05.05.2026
INN:
Aztreonam/avibactam / aztreonam/avibactam
Claimed indication for medical use:
Treatment of infections caused by aerobic Gram-negative microorganisms in adult patients who have limited treatment options, including infections caused by carbapenem-resistant microorganisms and bacteria producing metallo-β-lactamases (MBL)
Application:
Application for state HTA of the medicinal product aztreonam/avibactam (trade name EMBLAVEO) (1.5 MB) (Uploaded: 11.05.2026 07:46:57)
Conclusion:
Date:
16.03.2026
INN:
Ivosidenib / Ivosidenib
Claimed indication for medical use:
In combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia with an isocitrate dehydrogenase (IDH-1) R132 mutation who are not eligible for standard induction chemotherapy
Application:
Application for state HTA of the medicinal product ivosidenib (trade name TIBSOVO) (296 KB) (Downloaded: 18.03.2026 12:28:29)
Conclusion:
Date:
19.02.2026
INN:
Empagliflozin/ empagliflozin
Claimed indication for medical use:
In adults, for the treatment of symptomatic chronic heart failure with reduced left ventricular ejection fraction
Application:
Application for state HTA of the medicinal product empagliflozin (trade name JARDIANCE) (1.5 MB) (Downloaded: 23.02.2026 14:10:54)
Conclusion:
Date:
20.01.2026
INN:
Crovalimab/crovalimab
Claimed indication for medical use:
Treatment of adults and children aged 12 years and older weighing 40 kg or more with paroxysmal nocturnal hemoglobinuria in patients with hemolysis with clinical symptom(s) indicating high disease activity
Application:
Application for state HTA of the medicinal product crovalimab (trade name PIASKY) (1.9 MB) (Downloaded: 09.09.2026 13:51:49)
Conclusion:
Conclusion of the state HTA on crovalimab of 03.09.2026 (744 KB) (Downloaded: 09.09.2026 13:51:56)
Date:
25.12.2025
INN:
Durvalumab/Durvalumab
Claimed indication for medical use:
IMFINZI is indicated for the treatment of adult patients with unresectable stage III NSCLC with PD-L1 expression ≥ 1%, whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
Application:
Application for state health technology assessment for the purpose of including the medicinal product durvalumab. (1.4 MB) (Uploaded: 26.12.2025 11:15:29)
Conclusion:
Conclusion of the state HTA on durvalumab of 21.08.2026 (731 KB) (Downloaded: 25.08.2026 13:42:54)
Date:
18.12.2025
INN:
Etelcalcetide /Etelcalcetide
Claimed indication for medical use:
For the treatment of secondary hyperparathyroidism in adult patients with chronic kidney failure who are on hemodialysis.
Application:
Application for state health technology assessment of the use of the medicinal product etelcalcetide/etelcalcetide. (1.3 MB) (Uploaded: 22.12.2025 07:58:16)
Conclusion:
Conclusion of the state HTA on etelcalcetide (PARSABIV) dated 14.09.2026 (878 KB) (Downloaded: 01.10.2026 06:47:32)
Date:
18.12.2025
INN:
Edoxaban/Edoxaban
Claimed indication for medical use:
Prevention of stroke in adult patients with non-valvular atrial fibrillation (NVAF) and one or more risk factors, such as congestive heart failure, arterial hypertension, diabetes mellitus, prior stroke or transient ischemic attack (TIA), age from 75 years.
Application:
Application for state HTA of the medicinal product edoxaban (trade name EDOXACORD) (2 MB) (Downloaded: 22.12.2025 07:55:46)
Conclusion:
Conclusion of the state HTA for the medicinal product edoxaban (trade name EDOXACORD) of 21.08.2026 (728 KB) (Downloaded: 27.08.2026 13:26:41)
Date:
15.12.2025
INN:
Vilanterol and umeclidinium bromide/Vilanterol and umeclidinium bromide
Claimed indication for medical use:
For maintenance bronchodilator therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) group B according to the GOLD classification.
Application:
Application for state HTA of the medicinal product vilanterol and umeclidinium bromide/vilanterol and umeclidinium bromide (1.5 MB) (Downloaded: 17.12.2025 06:52:00)
Conclusion:
Conclusion of the state HTA of the medicinal product vilanterol and umeclidinium bromide of 21.09.2026 (878 KB) (Uploaded: 21.09.2026 13:30:01)
Date:
19.11.2025
INN:
Darolutamide/Darolutamid
Claimed indication for medical use:
treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of developing metastases (PSA-DT < 10 months) in combination with ADT.
Application:
Application for state health technology assessment for the purpose of including the medicinal product darolutamide. (25 MB) (Uploaded: 21.11.2025 14:18:12)
Conclusion:
Conclusion of the state HTA on darolutamide of 17.07.2026 (783 KB) (Downloaded: 21.07.2026 14:16:50)
Date:
18.11.2025
INN:
Faricimab/Faricimab
Claimed indication for medical use:
Treatment of diabetic macular edema (DME).
Application:
Application for state HTA of the medicinal product faricimab (trade name VABYSMO) (2.1 MB) (Downloaded: 20.11.2025 07:01:33)
Conclusion:
State HTA conclusion on faricimab (VABYSMO) dated 14.08.2026 (17 MB) (Downloaded: 20.08.2026 13:59:56)
Date:
25.09.2025
INN:
Valsartan and sacubitril/(valsartan and sacubitril)
Claimed indication for medical use:
Treatment of chronic heart failure in adult patients with reduced left ventricular ejection fraction
Application:
Application for state health technology assessment of the medicinal product sacubitril/valsartan (Uperio) (19 MB) (Uploaded: 29.09.2025 13:51:51)
Conclusion:
State HTA conclusion on valsartan and sacubitril dated 23.06.2026 (639 KB) (Downloaded: 25.06.2026 11:08:13)
Date:
10.09.2025
INN:
Tobramycin
Claimed indication for medical use:
Treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
Application:
Application for state HTA of the medicinal product tobramycin (trade name BRAMITOB) (1.6 MB) (Downloaded: 16.09.2025 08:33:07)
Conclusion:
Conclusion of the state HTA on tobramycin of 03.06.2026 (760 KB) (Downloaded: 04.06.2026 13:45:23)
Date:
10.09.2025
INN:
Enfortumab vedotin
Claimed indication for medical use:
Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a programmed death receptor-1 inhibitor or a programmed death ligand-1 inhibitor.
Application:
Application for the state HTA of the medicinal product enfortumab vedotin (PADCEV) (1.5 MB) (Downloaded: 12.09.2025 10:45:31)
Conclusion:
In accordance with para. 17 of the Procedure for Conducting State Health Technology Assessment, approved by the Resolution of the Cabinet of Ministers of Ukraine of 23.12.2020 No. 1300, the application and dossier for the state HTA of the medicinal product enfortumab vedotin will be left without consideration
Date:
01.08.2025
INN:
Trastuzumab deruxtecan/trastuzumab deruxtecan
Claimed indication for medical use:
For the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2-based therapy regimens
Application:
Application for state health technology assessment of the use of the medicinal product trastuzumab deruxtecan (273 KB) (Downloaded: 08.08.2025 12:51:20)
Conclusion:
Conclusion of the state HTA on trastuzumab deruxtecan (ENHERTU) dated 27.02.2026 (884 KB) (Downloaded: 05.03.2026 09:32:54)
Date:
04.07.2025
INN:
Selumetinib/Selumetinib
Claimed indication for medical use:
As monotherapy for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric patients aged 3 years and older with neurofibromatosis type 1 (NF1)
Application:
Application for state HTA of the medicinal product selumetinib (trade name KOSELUGO) (1.5 MB) (Downloaded: 09.07.2025 08:33:03)
Conclusion:
State HTA conclusion on selumetinib (KOSELUGO) dated 09.04.2026 (691 KB) (Downloaded: 10.04.2026 09:37:04)
Date:
30.06.2025
INN:
Pembrolizumab / Pembrolizumab
Claimed indication for medical use:
Treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant therapy, followed by adjuvant monotherapy after surgery
Application:
Application for state HTA of the medicinal product pembrolizumab (trade name KEYTRUDA) (2.5 MB) (Downloaded: 01.07.2025 13:42:46)
Conclusion:
State HTA conclusion on pembrolizumab (KEYTRUDA) dated 01.06.2026 (936 KB) (Downloaded: 03.06.2026 05:58:54)
Date:
19.06.2025
INN:
Daratumumab
Claimed indication for medical use:
Use of the medicinal product Darzalex® as part of combination therapy with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one line of therapy.
Application:
Application for state health technology assessment of the medicinal product daratumumab (Darzalex) (1.5 MB) (Downloaded: 20.06.2025 12:40:07)
Conclusion:
Conclusion of the state HTA on daratumumab (trade name DARZALEX) dated 18.06.2026 (785 KB) (Downloaded: 22.06.2026 06:20:30)
Date:
29.05.2025
INN:
Emicizumab / Emicizumab
Claimed indication for medical use:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children from birth with hemophilia A (congenital factor VIII deficiency), with or without the formation of inhibitors to factor VIII
Application:
Application for state HTA of the medicinal product emicizumab (HEMLIBRA®) (2.1 MB) (Downloaded: 30.05.2025 13:22:30)
Conclusion:
State HTA conclusion on emicizumab (HEMLIBRA) dated 26.12.2025 (718 KB) (Downloaded: 26.12.2025 11:10:58)
Date:
10.04.2025
INN:
Papillomavirus (human types 16, 18)
Claimed indication for medical use:
CERVARIX™ vaccine is indicated for the prevention of persistent infection, precancerous lesions (of the cervix) and cervical cancer caused by certain oncogenic types of human papillomavirus (HPV) in girls from 11 years of age.
Application:
Application for state HTA of the medicinal product Papillomavirus (human types 16, 18), trade name CERVARIX. (1.3 MB) (Downloaded: 07.05.2025 12:39:40)
Conclusion:
Conclusion of the state HTA of the vaccine for the prevention of diseases caused by human papillomavirus types 16 and 18 dated 31.07.2026 (825 KB) (Uploaded: 17.08.2026 09:08:56)
Date:
09.04.2025
INN:
Pembrolizumab/Pembrolizumab
Claimed indication for medical use:
In combination with chemotherapy, indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as confirmed by a validated test.
Application:
Application for state HTA of the medicinal product pembrolizumab (KEYTRUDA) (2.1 MB) (Downloaded: 23.04.2025 06:12:38)
Conclusion:
Conclusion of the state HTA of the medicinal product pembrolizumab (KEYTRUDA) (775 KB) (Downloaded: 27.01.2026 13:48:07)
Date:
17.03.2025
INN:
Inclisiran/inclisiran
Claimed indication for medical use:
adult patients (over 18 years of age) with established atherosclerotic cardiovascular disease and primary non-familial hypercholesterolemia and with elevated LDL-C levels despite the use of the maximally tolerated dose of a statin. Within this indication, the population of patients with myocardial infarction is being considered to ensure coverage over the next 5 years
Application:
Application for state HTA of the medicinal product inclisiran (SIBRAVA) (1.4 MB) (Downloaded: 17.03.2025 14:52:55)
Conclusion:
Conclusion of the state HTA on inclisiran of 26.12.2025 (956 KB) (Downloaded: 26.12.2025 11:09:35)
Date:
06.03.2025
INN:
Agalsidase alfa/Agalsidase alfa
Claimed indication for medical use:
Long-term enzyme replacement therapy for patients with a confirmed diagnosis of Fabry disease (α-galactosidase deficiency)
Application:
Application for state HTA of the medicinal product agalsidase alfa (REPLAGAL) (271 KB) (Downloaded: 06.03.2025 15:19:23)
Conclusion:
Conclusion of the state health technology assessment of the medicinal product agalsidase alfa (REPLAGAL) of 12.12.2025 (764 KB) (Uploaded: 12.12.2025 18:55:50)
Date:
24.02.2025
INN:
Vigabatrin/Vigabatrin
Claimed indication for medical use:
Use of the medicinal product Sabril as monotherapy for infantile spasms (West syndrome), including those caused by tuberous sclerosis.
Application:
Application for state health technology assessment of the medicinal product SABRIL (Vigabatrin) (1.2 MB) (Uploaded: 25.02.2025 15:33:37)
Conclusion:
Conclusion of the state HTA on vigabatrin of 16.01.2026 (712 KB) (Downloaded: 19.01.2026 11:53:01)
Date:
20.02.2025
INN:
Velmanase alfa
Claimed indication for medical use:
Enzyme replacement therapy (ERT) for non-neurological manifestations of the disease in patients with mild to moderate alpha-mannosidosis.
Application:
Application for state health technology assessment of the medicinal product LAMZEDE (Velmanase alfa) (2 MB) (Uploaded: 21.02.2025 14:11:58)
Conclusion:
Conclusion of the state HTA on velmanase alfa dated 10.02.2026 (685 KB) (Downloaded: 12.02.2026 13:36:22)
Date:
23.12.2024
INN:
Tofacitinib citrate
Claimed indication for medical use:
Treatment of adult patients with active ankylosing spondylitis who have not achieved an adequate response to conventional therapy. In this population, initiating the medicinal product is considered for the first time for patients under 65 years of age.
Application:
Application for the state HTA of the medicinal product tofacitinib citrate (XELJANZ) (1.5 MB) (Downloaded: 08.01.2025 15:14:26)
Conclusion:
Conclusion of the state HTA of tofacitinib citrate (XELJANZ) dated 24.12.2025 (1023 KB) (Downloaded: 26.12.2025 08:49:14)
Date:
18.11.2024
INN:
formoterol, glycopyrronium bromide and budesonide
Claimed indication for medical use:
indicated as maintenance therapy for adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who do not respond adequately to therapy with a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic receptor antagonist
Application:
Application for state HTA of the medicinal product TRIXEO (1.2 MB) (Downloaded: 20.11.2024 14:54:36)
Conclusion:
Conclusion of the state HTA of the fixed triple combination of formoterol, glycopyrronium bromide, budesonide (Trixeo Aerosphere) dated 17.10.2025 (721 KB) (Uploaded: 21.10.2025 07:45:15)
Date:
17.12.2024
INN:
Acalabrutinib/acalabrutinib
Claimed indication for medical use:
Acalabrutinib as monotherapy for the treatment of adult patients with previously untreated chronic lymphocytic leukemia, poor performance status and intolerance/unsuitability of therapy with fludarabine in combination with cyclophosphamide and rituximab (FCR) and bendamustine in combination with rituximab (BR).
Application:
Application for state health technology assessment of the use of the medicinal product acalabrutinib (acalabrutinib) (1022 KB) (Uploaded: 19.12.2024 15:01:22)
Conclusion:
Conclusion of the state HTA on acalabrutinib (CALQUENCE) dated 16.09.2025 (848 KB) (Downloaded: 17.09.2025 12:37:40)
Date:
29.10.2024
INN:
Comb drug
Claimed indication for medical use:
For parenteral nutrition of adult patients for whom oral or enteral nutrition is impossible, insufficient or contraindicated and who are in the intensive care unit after surgery on the abdominal and digestive organs
Application:
Application for state health technology assessment of a three-chamber bag of emulsion for parenteral nutrition. (1.7 MB) (Uploaded: 04.11.2024 10:22:22)
Conclusion:
Conclusion of the state HTA of the medicinal product emulsion for parenteral nutrition comprising an amino acid solution with electrolytes, a lipid emulsion and a glucose solution with calcium (OLIMEL N7E) dated 22.07.2025 (674 KB) (Uploaded: 28.07.2025 14:45:48)
Date:
17.09.2024
INN:
Pertuzumab and trastuzumab
Claimed indication for medical use:
For use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Application:
Application for state health technology assessment of the medicinal product PHESGO (pertuzumab and trastuzumab). (880 KB) (Downloaded: 20.09.2024 13:12:12)
Conclusion:
Conclusion of the state HTA on pertuzumab/trastuzumab (PHESGO) dated 30.06.2025 (798 KB) (Downloaded: 01.07.2025 13:44:11)
Date:
09.09.2024
INN:
Ribociclib
Claimed indication for medical use:
Kisqali is indicated in combination with letrozole for the treatment of postmenopausal women with locally advanced or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-negative (human epidermal growth factor receptor type 2), as initial endocrine therapy or for the treatment of women who have previously received endocrine therapy.
Application:
Application for state health technology assessment of the medicinal product ribociclib (KISQALI) (3.9 MB) (Downloaded: 12.09.2024 14:10:46)
Conclusion:
Conclusion of the state HTA on ribociclib of 01.10.2025 (735 KB) (Downloaded: 03.10.2025 06:02:43)
Date:
09.09.2024
INN:
Ofatumumab
Claimed indication for medical use:
Ofatumumab for the treatment of adult patients with active relapsing-remitting multiple sclerosis who have previously received glatiramer acetate, interferon beta, or dimethyl fumarate but whose disease activity persists.
Application:
Application for state health technology assessment of the medicinal product ofatumumab (BONSPRI) (4 MB) (Downloaded: 12.09.2024 14:09:27)
Conclusion:
State HTA conclusion on ofatumumab (BONSPRI) dated 05.09.2025 (853 KB) (Downloaded: 09.09.2025 14:05:17)
Date:
09.08.2024
INN:
Acalabrutinib (acalabrutinib)
Claimed indication for medical use:
Calquence is indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior course of therapy.
Application:
Application for state health technology assessment of the medicinal product acalabrutinib (acalabrutinib). (915 KB) (Uploaded: 13.08.2024 13:39:33)
Conclusion:
Conclusion of the state HTA on acalabrutinib (CALQUENCE) dated 13.06.2025 (756 KB) (Downloaded: 16.06.2025 13:42:22)
Date:
09.07.2024
INN:
Ribociclib
Claimed indication for medical use:
In combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist for the treatment of pre- or perimenopausal women with locally advanced or metastatic breast cancer that is HR-positive (hormone receptor) and HER2-negative (human epidermal growth factor receptor type 2) as initial endocrine therapy, or for the treatment of women who have previously received endocrine therapy.
Application:
Application for state health technology assessment of the medicinal product ribociclib (KISQALI) (4 MB) (Downloaded: 10.07.2024 13:45:19)
Conclusion:
Conclusion of the state HTA on ribociclib (KISQALI) dated 07.07.2025 on 38 pp. (791 KB) (Downloaded: 08.07.2025 13:49:13)
Date:
18.06.2024
INN:
Atezolizumab
Claimed indication for medical use:
Non-small cell lung cancer. Adjuvant treatment as monotherapy after resection and platinum-based chemotherapy of adult patients with stage IIIIIA non-small cell lung cancer (NSCLC) with PD-L1 expression ≥ 1% of tumor cells
Application:
Application for state HTA of the medicinal product atezolizumab (TECENTRIQ) (1.4 MB) (Downloaded: 10.07.2024 13:47:21)
Conclusion:
Conclusion of the state HTA on atezolizumab (TECENTRIQ) dated 08.01.2025 (538 KB) (Downloaded: 08.01.2025 15:20:42)
Date:
18.06.2024
INN:
Polatuzumab vedotin
Claimed indication for medical use:
In combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
Application:
Application for the state HTA of the medicinal product polatuzumab vedotin (POLIVY®) (1.7 MB) (Downloaded: 19.06.2024 13:29:45)
Conclusion:
Conclusion of the authorized body on state HTA: polatuzumab vedotin of 22.04.2025. (1.1 MB) (Downloaded: 23.04.2025 14:15:42)
Date:
10.06.2024
INN:
Lanadelumab
Claimed indication for medical use:
For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Application:
Application for state HTA of the medicinal product lanadelumab (TAKHZYRO) (290 KB) (Downloaded: 12.06.2024 14:10:18)
Conclusion:
State HTA conclusion on lanadelumab (TAKHZYRO) dated 18.06.2025 (911 KB) (Downloaded: 19.06.2025 13:17:21)
Date:
10.06.2024
INN:
Ixazomib
Claimed indication for medical use:
In combination with lenalidomide and dexamethasone, indicated for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.
Application:
Application for state HTA of the medicinal product ixazomib (NINLARO®) (278 KB) (Downloaded: 12.06.2024 14:07:26)
Conclusion:
State HTA conclusion on ixazomib (NINLARO) dated 20.08.2025 (1003 KB) (Downloaded: 21.08.2025 13:54:34)
Date:
07.05.2024
INN:
Gilteritinib
Claimed indication for medical use:
As monotherapy for adult patients with relapsed or refractory acute myeloid leukemia with an FLT3 mutation.
Application:
Application for state HTA of the medicinal product gilteritinib (Xospata) (1.6 MB) (Downloaded: 09.05.2024 07:41:50)
Conclusion:
Conclusion of the state HTA on gilteritinib (trade name XOSPATA) dated 11.12.2025 (798 KB) (Downloaded: 12.12.2025 18:46:17)
Date:
16.04.2024
INN:
Palbociclib
Claimed indication for medical use:
Locally advanced or metastatic HR (+), HER2 (-) breast cancer in previously untreated (for metastases) postmenopausal patients, without life-threatening visceral involvement.
Application:
Application for state health technology assessment of the medicinal product palbociclib (palbociclib) (1000 KB) (Uploaded: 12.11.2024 16:12:34)
Conclusion:
State HTA conclusion on palbociclib (IBRANCE) dated 27.11.2024 (442 KB) (Downloaded: 28.11.2024 15:08:54)
Date:
02.04.2024
INN:
Fremanezumab
Claimed indication for medical use:
Preventive therapy for adult patients with chronic migraine after failure of two lines of preventive therapy
Application:
Application for state health technology assessment of the medicinal product AJOVY (fremanezumab) (1.3 MB) (Downloaded: 07.04.2024 06:33:24)
Conclusion:
State HTA conclusion on fremanezumab (AJOVY) dated 03.03.2025. (1.1 MB) (Downloaded: 03.03.2025 15:09:56)
Date:
19.03.2024
INN:
Pegvisomant
Claimed indication for medical use:
Treatment of acromegaly in adult patients in whom surgery and/or radiotherapy, and subsequent SSA therapy, have not produced an adequate effect (namely, normalization of serum IGF-1 levels) or were inappropriate
Application:
Application for state health technology assessment of the medicinal product SOMAVERT (pegvisomant) (1.3 MB) (Downloaded: 21.03.2024 14:46:13)
Conclusion:
State HTA conclusion on pegvisomant (SOMAVERT) dated 24.12.2024 (883 KB) (Downloaded: 25.12.2024 14:33:16)
Date:
13.03.2024
INN:
Brentuximab vedotin/ brentuximab vedotin
Claimed indication for medical use:
in combination with cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma
Application:
Application for state HTA of the medicinal product brentuximab vedotin (SAVL) (1.3 MB) (Downloaded: 15.03.2024 13:35:44)
Conclusion:
Conclusion of the state HTA on brentuximab vedotin (ADCETRIS) dated 20.12.2024. (515 KB) (Downloaded: 23.12.2024 14:57:45)
Date:
11.03.2024
INN:
Enzalutamide
Claimed indication for medical use:
Treatment of non-metastatic castration-resistant prostate cancer in adult men at high risk of progression.
Application:
Application for state health technology assessment of the medicinal product XTANDI (enzalutamide) (1.7 MB) (Downloaded: 13.03.2024 14:52:01)
Conclusion:
State HTA conclusion on enzalutamide (XTANDI) dated 08.01.2025 (828 KB) (Downloaded: 08.01.2025 15:20:08)
Date:
04.03.2024
INN:
Vedolizumab
Claimed indication for medical use:
Treatment of active moderate to severe ulcerative colitis in adult patients who have had an inadequate response, loss of response, or intolerance to standard therapy or tumor necrosis factor alpha (TNF-α) antagonists
Application:
Application for state health technology assessment for the purpose of including the medicinal product ENTYVIO (vedolizumab) (229 KB) (Uploaded: 06.03.2024 14:49:08)
Conclusion:
In accordance with para. 17 of the Procedure for Conducting State Health Technology Assessment, approved by Resolution of the Cabinet of Ministers of Ukraine of 23.12.2020 No. 1300, the application and dossier for state HTA of the medicinal product vedolizumab remain without consideration
Date:
23.01.2024
INN:
Inotuzumab ozogamicin
Claimed indication for medical use:
Treatment of adult patients with relapsed or refractory CD22-positive B-cell acute lymphoblastic leukemia. If patients have the Philadelphia chromosome-positive relapsed or refractory B-cell acute lymphoblastic leukemia, they must already be resistant to at least one tyrosine kinase inhibitor.
Application:
Application for state health technology assessment for the purpose of including the medicinal product inotuzumab ozogamicin. (321 KB) (Uploaded: 26.01.2024 12:07:36)
Conclusion:
Conclusion of the state HTA on inotuzumab ozogamicin (BESPONSA) dated 24.09.2024 (503 KB) (Downloaded: 27.09.2024 13:14:02)
Date:
12.01.2024
INN:
Enzalutamide
Claimed indication for medical use:
Treatment of metastatic castration-resistant prostate cancer in adult men with disease progression during or after chemotherapy that included docetaxel.
Application:
(1.5 MB) (Downloaded: 16.01.2024 11:30:41)
Conclusion:
Conclusion of the state HTA on enzalutamide (XTANDI). (813 KB) (Downloaded: 31.12.2024 13:09:17)
Date:
28.12.2023
INN:
Normal human immunoglobulin
Claimed indication for medical use:
Replacement therapy in adults with secondary immunodeficiencies (SID) in patients suffering from severe or recurrent infections, ineffective antimicrobial treatment, or in cases of proven specific antibody failure (PSAF*) or serum IgG level <4 g/L.
Application:
(271 KB) (Downloaded: 02.01.2024 14:54:08)
Conclusion:
Date:
14.12.2023
INN:
venetoclax (venetoclax)
Claimed indication for medical use:
in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic (lymphoid) leukemia (CLL)
Application:
(416 KB) (Downloaded: 18.12.2023 14:40:58)
Conclusion:
Conclusion of the state HTA on venetoclax (VENCLEXTA) dated 07.08.2024 (545 KB) (Downloaded: 08.08.2024 13:25:19)
Date:
08.12.2023
INN:
Antithymocyte immunoglobulin (rabbit)
Claimed indication for medical use:
Immunosuppression in transplantation: prevention of graft rejection (in kidney transplantation)
Application:
(586 KB) (Downloaded: 13.12.2023 14:50:38)
Conclusion:
Conclusion of the state HTA of rabbit anti-thymocyte globulin (THYMOGLOBULIN) dated 19.03.2025 (1 MB) (Downloaded: 20.03.2025 14:55:17)
Date:
28.11.2023
INN:
Cetuximab
Claimed indication for medical use:
Treatment of patients with RAS wild-type metastatic colorectal cancer expressing epidermal growth factor receptor EGFR in combination with irinotecan-based chemotherapy or prolonged infusions of 5-fluorouracil/folinic acid and oxaliplatin as first-line therapy
Application:
(7.9 MB) (Downloaded: 04.12.2023 14:44:33)
Conclusion:
State HTA conclusion on cetuximab (ERBITUX) dated 13.11.2024 (824 KB) (Downloaded: 12.12.2024 15:47:48)
Date:
23.11.2023
INN:
Formoterol and beclometasone
Claimed indication for medical use:
For the regular treatment of bronchial asthma where use of a combination product (inhaled glucocorticosteroid and long-acting beta2-agonist) is appropriate, in patients whose symptoms are not adequately controlled with inhaled glucocorticosteroids and rapid-acting beta2-agonists used as needed
Application:
(989 KB) (Downloaded: 28.11.2023 14:40:23)
Conclusion:
Conclusion of the state HTA on formoterol and beclometasone (FOSTER) dated 31.05.2024 (866 KB) (Downloaded: 03.06.2024 13:37:16)
Date:
23.10.2023
INN:
Normal human immunoglobulin
Claimed indication for medical use:
Guillain-Barré syndrome
Application:
Application for state health technology assessment of the medicinal product human normal immunoglobulin (BIOVEN) (253 KB) (Uploaded: 25.10.2023 13:38:28)
Conclusion:
Conclusion of the state HTA of human normal immunoglobulin dated 29.08.2025 (735 KB) (Downloaded: 01.09.2025 13:43:42)
Date:
20.09.2023
INN:
Nintedanib
Claimed indication for medical use:
Treatment of idiopathic pulmonary fibrosis (IPF) in adults
Application:
(1.6 MB) (Downloaded: 22.09.2023 07:27:18)
Conclusion:
Conclusion of the state HTA on nintedanib (OFEV) dated 27.05.2024 (941 KB) (Downloaded: 29.05.2024 13:36:43)
Date:
18.09.2023
INN:
Eptacog alfa activated
Claimed indication for medical use:
Treatment of bleeding in patients with congenital hemophilia (A or B) with coagulation factor VIII or IX inhibitor levels > 5 BU (Bethesda units)
Application:
Conclusion:
The application and dossier for the state HTA of the medicinal product eptacog alfa activated were withdrawn from consideration at the applicant's request on 17.05.2024
Date:
31.08.2023
INN:
Risdiplam
Claimed indication for medical use:
Treatment of 5q-associated spinal muscular atrophy (SMA) in patients aged 2 months and older
Application:
Application for state health technology assessment of the medicinal product EVRYSDI (risdiplam) (139 KB) (Uploaded: 05.09.2023 11:14:32)
Conclusion:
State HTA conclusion on risdiplam (EVRYSDI) dated 12.03.2024. (780 KB) (Downloaded: 14.03.2024 14:32:30)
Date:
03.08.2023
INN:
Rivaroxaban
Claimed indication for medical use:
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults
Application:
Application for state health technology assessment of the medicinal product XARELTO (rivaroxaban) (157 KB) (Downloaded: 04.08.2023 10:14:17)
Conclusion:
State HTA conclusion on rivaroxaban (XARELTO) dated 19.04.2024 (616 KB) (Downloaded: 22.04.2024 12:33:29)
Date:
29.06.2023
INN:
Ibrutinib
Claimed indication for medical use:
Imbruvica as monotherapy is used for the treatment of chronic lymphocytic leukemia in adult patients who have not previously received treatment
Application:
Application for state HTA of the medicinal product IMBRUVICA (ibrutinib) (3.3 MB) (Downloaded: 04.07.2023 05:59:31)
Conclusion:
Conclusion of the state HTA on ibrutinib of 26.12.2023 (566 KB) (Downloaded: 28.12.2023 14:41:25)
Date:
21.06.2023
INN:
Rivaroxaban
Claimed indication for medical use:
Xarelto® is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with a stroke risk according to the CHA2DS2-VASc score of ≥1 for men and ≥2 for women
Application:
Application for state health technology assessment of the medicinal product EVRYSDI (risdiplam) (143 KB) (Uploaded: 08.09.2023 08:32:40)
Conclusion:
Conclusion of the state HTA on rivaroxaban (XARELTO) dated 07.02.2024 (495 KB) (Downloaded: 09.02.2024 12:02:48)
Date:
08.06.2023
INN:
Pertuzumab
Claimed indication for medical use:
Metastatic breast cancer: the medicinal product Perjeta® is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease
Application:
Application for state HTA of the medicinal product PERJETA (pertuzumab) (2.7 MB) (Downloaded: 12.06.2023 12:47:30)
Conclusion:
State HTA conclusion on pertuzumab (PERJETA) dated 07.12.2023 (379 KB) (Downloaded: 11.12.2023 15:01:12)
Date:
06.06.2023
INN:
Normal human immunoglobulin
Claimed indication for medical use:
Treatment of the steroid-resistant population of patients with chronic inflammatory demyelinating neuropathy with ineffectiveness of/contraindications to plasmapheresis, for whom there is no treatment alternative other than placebo/medical rehabilitation
Application:
Application for state HTA of the medicinal product BIOVEN (human normal immunoglobulin) (1.4 MB) (Uploaded: 09.06.2023 06:06:05)
Conclusion:
Conclusion of the state HTA of human normal immunoglobulin dated 21.07.2025 (1.1 MB) (Downloaded: 28.07.2025 07:34:13)
Date:
01.06.2023
INN:
9-valent human papillomavirus vaccine (recombinant, adsorbed)
Claimed indication for medical use:
For active immunization of persons aged 9 years and older to prevent the following diseases caused by HPV precancerous conditions and cancer of the cervix, vulva, vagina and anal canal caused by the HPV types included in the vaccine
Application:
Application for state health technology assessment for the purpose of including the medicinal product GARDASIL® 9 (9-valent human papillomavirus vaccine (recombinant, adsorbed) (1.6 MB) (Downloaded: 05.06.2023 11:48:08)
Conclusion:
Conclusion of the state HTA of 9-valent human papillomavirus vaccine (recombinant, adsorbed) (GARDASIL® 9) dated 22.12.2023 (547 KB) (Uploaded: 27.12.2023 07:50:26)
Date:
23.05.2023
INN:
Dapagliflozin
Claimed indication for medical use:
Treatment of chronic kidney disease
Application:
Application for state health technology assessment for the purpose of including the medicinal product FORXIGA (dapagliflozin) (378 KB) (Uploaded: 25.05.2023 11:39:03)
Conclusion:
Conclusion of the state HTA: dapagliflozin dated 12.02.2024 (552 KB) (Uploaded: 13.02.2024 14:23:10)
Date:
23.05.2023
INN:
Trifluridine/tipiracil
Claimed indication for medical use:
Lonsurf® is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, as well as anti-VEGF and anti-EGFR agents.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Lansurf® (trifluridine/tipiracil) (3.1 MB) (Downloaded: 24.05.2023 07:35:09)
Conclusion:
Conclusion of the state HTA of trifluridine/tipiracil (LONSURF) dated 10.04.2024 (581 KB) (Downloaded: 12.04.2024 15:58:53)
Date:
03.05.2023
INN:
Ferric carboxymaltose
Claimed indication for medical use:
The medicinal product is indicated for patients in cases of insufficient efficacy, ineffectiveness or impossibility of oral intake of iron-containing products, for example due to intolerance of oral iron preparations or in the presence of gastrointestinal diseases (such as ulcerative colitis) where oral iron preparations may provoke an exacerbation of the disease, or in the case of iron deficiency resistant to therapy, when it is suspected that iron preparations are not being taken properly.
Application:
Application for state health technology assessment for the purpose of including the medicinal product ferric carboxymaltose (266 KB) (Uploaded: 04.05.2023 12:12:36)
Conclusion:
State HTA conclusion on ferric carboxymaltose dated 19.12.2023 (623 KB) (Downloaded: 25.12.2023 10:39:16)
Date:
14.04.2023
INN:
Tofacitinib citrate
Claimed indication for medical use:
Treatment of active polyarticular juvenile idiopathic arthritis (JIA) in adults and children weighing more than 40 kg.
Application:
Application for state health technology assessment for the purpose of including the medicinal product XELJANZ (tofacitinib citrate) (1.7 MB) (Uploaded: 17.04.2023 08:37:54)
Conclusion:
Conclusion of the state HTA of tofacitinib citrate (XELJANZ) dated 02.02.2024 (460 KB) (Downloaded: 05.02.2024 14:40:39)
Date:
23.03.2023
INN:
Emicizumab
Claimed indication for medical use:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A (congenital factor VIII deficiency) with the development of inhibitors to factor VIII.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Hemlibra® (emicizumab) (1.2 MB) (Uploaded: 28.03.2023 06:38:42)
Conclusion:
(712 KB) (Downloaded: 20.09.2023 11:15:40)
Date:
21.03.2023
INN:
Botulinum toxin type A (botulinum toxin)
Claimed indication for medical use:
for the symptomatic treatment of focal spasticity: dynamic equinus foot deformity in children aged 2 years and older with cerebral palsy.
Application:
Application for state HTA of the medicinal product DYSPORT 500 U (cerebral palsy) (2.4 MB) (Downloaded: 24.03.2023 08:42:47)
Conclusion:
Conclusion of the state HTA on botulinum toxin type A dated 10.11.2023 (807 KB) (Downloaded: 14.11.2023 14:22:47)
Date:
21.03.2023
INN:
Toremifene
Claimed indication for medical use:
Treatment of hormone-dependent metastatic breast cancer in postmenopausal women as a first-line drug.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Fareston (toremifene). (1.7 MB) (Downloaded: 24.03.2023 08:26:44)
Conclusion:
In accordance with para. 13 of the Procedure for conducting state health technology assessment, approved by Cabinet of Ministers of Ukraine resolution of 23.12.2020 No. 1300, the application and dossier for the state HTA of the medicinal product toremifene are left without consideration
Date:
16.03.2023
INN:
Pembrolizumab
Claimed indication for medical use:
Triple-negative breast cancer. Keytruda® in combination with chemotherapy is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10), as confirmed by a validated test.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Keytruda® (pembrolizumab) (1.8 MB) (Uploaded: 21.03.2023 07:58:51)
Conclusion:
Conclusion of the state HTA: pembrolizumab dated 10.11.2023 (445 KB) (Uploaded: 14.11.2023 14:40:46)
Date:
30.01.2023
INN:
Cladribine
Claimed indication for medical use:
Treatment of adult patients with relapsing forms of multiple sclerosis with high disease activity, established on the basis of clinical or imaging examinations
Application:
Application for state HTA of the medicinal product cladribine (6.9 MB) (Downloaded: 02.02.2023 10:33:08)
Conclusion:
State HTA conclusion on cladribine (MAVENCLAD) dated 14.08.2023 (964 KB) (Downloaded: 16.08.2023 09:00:08)
Date:
05.01.2023
INN:
Ocrelizumab
Claimed indication for medical use:
Treatment of adult patients with primary progressive multiple sclerosis
Application:
Application for state health technology assessment for the purpose of including the medicinal product OCREVUS® (ocrelizumab) (1.1 MB) (Uploaded: 10.01.2023 11:25:26)
Conclusion:
Conclusion of the state HTA: ocrelizumab dated 05.07.2023. (527 KB) (Uploaded: 06.07.2023 13:16:59)
Date:
03.01.2023
INN:
Agalsidase beta
Claimed indication for medical use:
Long-term enzyme replacement therapy for adults and children aged 8 years and older with confirmed Fabry disease (ICD code E75.2)
Application:
Application for state health technology assessment for the purpose of including the medicinal product FABRAZYME® (agalsidase beta) (414 KB) (Downloaded: 06.01.2023 09:04:15)
Conclusion:
Conclusion of the state HTA on agalsidase beta dated 09.10.2023 (845 KB) (Downloaded: 11.10.2023 09:06:06)
Date:
09.12.2022
INN:
Alemtuzumab
Claimed indication for medical use:
as a disease-modifying medicinal product for monotherapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS) who belong to the following group: patients whose disease remains highly active despite a full and adequate course of therapy with at least one disease-modifying medicinal product.
Application:
Application for state HTA of the medicinal product LEMTRADA (alemtuzumab) (388 KB) (Downloaded: 14.12.2022 09:30:43)
Conclusion:
(339 KB) (Downloaded: 21.08.2023 11:42:53)
Date:
02.12.2022
INN:
Olaparib
Claimed indication for medical use:
Ovarian cancer. Lynparza is indicated as monotherapy for: the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer with a BRCA1/2 mutation (germline and/or somatic) who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Application:
Application for state health technology assessment for the purpose of including the medicinal product LYNPARZA (olaparib) (243 KB) (Downloaded: 09.12.2022 13:14:03)
Conclusion:
Conclusion of the state HTA on olaparib of 12.07.2023 (491 KB) (Downloaded: 14.07.2023 06:34:47)
Date:
22.11.2022
INN:
Atezolizumab
Claimed indication for medical use:
First-line monotherapy treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (PD-L1-stained tumor cells ≥ 50% or PD-L1-stained tumor-infiltrating immune cells covering ≥ 10% of the tumor area) and without EGFR or ALK genomic tumor aberrations.
Application:
Application for state health technology assessment for the purpose of including the medicinal product atezolizumab (2.6 MB) (Uploaded: 25.11.2022 12:36:13)
Conclusion:
Conclusion of the state HTA on atezolizumab (TECENTRIQ) dated 05.07.2023 (660 KB) (Downloaded: 06.07.2023 10:45:35)
Date:
26.09.2022
INN:
Osimertinib
Claimed indication for medical use:
For use as monotherapy for the treatment of locally advanced or metastatic NSCLC with a positive EGFR T790M mutation status in adult patients
Application:
Application for state health technology assessment for the purpose of including the medicinal product TAGRISSO (osimertinib) (560 KB) (Uploaded: 29.09.2022 06:16:49)
Conclusion:
Conclusion of the state HTA: osimertinib dated 23.03.2023. (549 KB) (Uploaded: 24.03.2023 08:41:07)
Date:
09.09.2022
INN:
Bicyclol
Claimed indication for medical use:
Non-alcoholic steatohepatitis
Application:
Application for state health technology assessment for the purpose of including the medicinal product BICYCLOL (bicyclol) (5.8 MB) (Downloaded: 19.09.2022 06:48:23)
Conclusion:
In accordance with para. 13 of the Procedure for conducting state health technology assessment, approved by Cabinet of Ministers of Ukraine resolution of 23.12.2020 No. 1300, the application and dossier for the state HTA of the medicinal product Bicyclol are left without consideration
Date:
08.08.2022
INN:
Dapagliflozin
Claimed indication for medical use:
The medicinal product FORXIGA is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Application:
Application for state health technology assessment for the purpose of including the medicinal product FORXIGA (dapagliflozin) (354 KB) (Uploaded: 10.08.2022 06:33:39)
Conclusion:
Conclusion of the state HTA: dapagliflozin dated 18.01.2023 (647 KB) (Uploaded: 20.01.2023 07:19:15)
Date:
28.06.2022
INN:
Botulinum toxin type A
Claimed indication for medical use:
Dysport® is intended for the symptomatic treatment of focal spasticity of the upper limbs in adults.
Application:
Application for state health technology assessment for the purpose of including the medicinal product DYSPORT (botulinum toxin type A) (248 KB) (Downloaded: 01.07.2022 08:32:59)
Conclusion:
Conclusion of the state HTA on botulinum toxin type A dated 15.03.2023 (729 KB) (Downloaded: 20.03.2023 09:09:29)
Date:
03.12.2021
INN:
Lanreotide
Claimed indication for medical use:
Treatment of neuroendocrine tumors of the gastrointestinal tract or pancreas (GEP-NETs) of grade 1 differentiation and a subset of grade 2 differentiation tumors (Ki67 index up to 10%) originating in the midgut, pancreas or of unknown origin, excluding origin from the hindgut, in adult patients with unresectable locally advanced or metastatic tumors
Application:
Application for state health technology assessment for the purpose of including the medicinal product SOMATULINE AUTOGEL (resubmission). (2.1 MB) (Uploaded: 06.12.2021 15:33:02)
Conclusion:
Conclusion of the state HTA on lanreotide of 21.04.2022 (520 KB) (Downloaded: 25.04.2022 06:33:03)
Date:
04.02.2022
INN:
Nusinersen
Claimed indication for medical use:
Indicated for SMA caused by a mutation on chromosome 5q
Application:
Application for state health technology assessment for the purpose of including the medicinal product SPINRAZA (nusinersen) (1.7 MB) (Uploaded: 08.02.2022 07:22:42)
Conclusion:
Conclusion of the authorized body for state health technology assessment: nusinersen (508 KB) (Downloaded: 02.05.2023 06:11:15)
Date:
04.02.2022
INN:
Daratumumab
Claimed indication for medical use:
As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who had disease progression during the last therapy.
Application:
Application for state health technology assessment for the purpose of including the medicinal product DARZALEX® (daratumumab) (1.5 MB) (Uploaded: 07.02.2022 12:52:10)
Conclusion:
Conclusion of the state HTA on daratumumab of 30.05.2023 (474 KB) (Downloaded: 01.06.2023 09:41:04)
Date:
18.01.2022
INN:
Enzalutamide
Claimed indication for medical use:
Treatment of metastatic castration-resistant prostate cancer in adult men with disease progression during or after chemotherapy that included docetaxel.
Application:
Application for state health technology assessment for the purpose of including the medicinal product XTANDI (enzalutamide) (1.6 MB) (Uploaded: 20.01.2022 07:10:03)
Conclusion:
In accordance with para. 13 of the Procedure for conducting state health technology assessment, approved by CMU resolution of 23.12.2020 No.1300, the application and dossier for the state HTA of the medicinal product enzalutamide for the indication “treatment of metastatic castration-resistant prostate cancer in adult men with disease progression during or after chemotherapy that included docetaxel” are left without consideration.
Date:
11.01.2022
INN:
Lanreotide
Claimed indication for medical use:
Treatment of acromegaly with elevated levels of circulating growth hormone (GH) and insulin-like growth factor (IGF-1) after surgery and/or radiotherapy, or if surgery and/or radiotherapy are contraindicated
Application:
Application for state health technology assessment for the purpose of including the medicinal product SOMATULINE AUTOGEL (lanreotide) (3.7 MB) (Uploaded: 14.01.2022 08:54:44)
Conclusion:
Conclusion of the authorized body for state health technology assessment: lanreotide of 01.11.2022 (524 KB) (Downloaded: 03.11.2022 14:05:28)
Date:
08.12.2021
INN:
letermovir
Claimed indication for medical use:
For the prevention of cytomegalovirus (CMV) reactivation and CMV disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Application:
Application for state HTA for the purpose of inclusion of the medicinal product PREVYMIS® (955 KB) (Downloaded: 10.12.2021 07:08:57)
Conclusion:
Conclusion of the state HTA on letermovir of 29.06.2022 (499 KB) (Downloaded: 30.06.2022 12:28:24)
Date:
01.12.2021
INN:
Ceftazidime and avibactam
Claimed indication for medical use:
Treatment of ventilator-associated hospital-acquired pneumonia in adults
Application:
Application for state health technology assessment of the medicinal product: ZAVICEFTA (1.2 MB) (Uploaded: 06.12.2021 11:45:14)
Conclusion:
State HTA conclusion on ceftazidime/avibactam dated 27.06.2022. (539 KB) (Downloaded: 28.06.2022 10:48:29)
Date:
26.11.2021
INN:
Pegvisomant
Claimed indication for medical use:
Treatment of acromegaly in patients who had an inadequate response to surgery or radiotherapy or for whom these types of therapy are not appropriate.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Somavert® (1.8 MB) (Uploaded: 30.11.2021 10:11:25)
Conclusion:
Conclusion of the state HTA on pegvisomant of 22.02.2023 (371 KB) (Downloaded: 23.02.2023 12:51:23)
Date:
23.11.2021
INN:
Apixaban
Claimed indication for medical use:
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation who have one or more risk factors, such as: history of stroke or transient ischemic attack; age from 75 years; arterial hypertension; diabetes mellitus; symptomatic heart failure (at least class II according to the New York Heart Association classification).
Application:
Application for state health technology assessment for the purpose of including the medicinal product ELIQUIS (2.7 MB) (Uploaded: 29.11.2021 07:27:55)
Conclusion:
Conclusion of the state HTA on apixaban of 08.04.2022 (498 KB) (Downloaded: 11.04.2022 13:07:53)
Date:
16.11.2021
INN:
Palbociclib
Claimed indication for medical use:
Locally advanced or metastatic HR (+), HER2 (-) breast cancer in previously untreated (for metastases) postmenopausal patients, without life-threatening visceral involvement
Application:
Application for state health technology assessment for the purpose of including the medicinal product IBRANCE (palbociclib) (124 KB) (Downloaded: 17.11.2021 14:43:28)
Conclusion:
Conclusion of the state HTA on palbociclib of 01.09.2022 (829 KB) (Downloaded: 07.09.2022 09:38:28)
Date:
16.11.2021
INN:
Gemtuzumab ozogamicin
Claimed indication for medical use:
Newly diagnosed CD33-positive acute myeloid leukemia in adults.
Application:
Application for state health technology assessment for the purpose of including the medicinal product MYLOTARG (gemtuzumab ozogamicin) (71 KB) (Downloaded: 17.11.2021 14:44:21)
Conclusion:
State HTA conclusion on gemtuzumab ozogamicin dated 03.06.2022 (559 KB) (Downloaded: 07.06.2022 06:41:26)
Date:
03.11.2021
INN:
Ruxolitinib/Ruxolitinib
Claimed indication for medical use:
Treatment of splenomegaly-related disorders or symptoms of primary myelofibrosis (also known as chronic idiopathic myelofibrosis) in adult patients, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis
Application:
Application for the state health technology assessment (Ruxolitinib). (838 KB) (Downloaded: 04.11.2021 12:10:59)
Conclusion:
State HTA conclusion on ruxolitinib (JAKAVI) dated 29.05.2024 (630 KB) (Downloaded: 29.05.2024 13:31:22)
Date:
22.10.2021
INN:
Dabrafenib, trametinib
Claimed indication for medical use:
Dabrafenib is prescribed in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma whose cells have a BRAF V600 mutation.
Application:
Application for state health technology assessment of a combination of medicinal products: TAFINLAR® and MEKINIST. (901 KB) (Downloaded: 25.10.2021 08:06:14)
Conclusion:
Conclusion of the state HTA for dabrafenib, trametinib (TAFINLAR®, MEKINIST) of 04.11.2024 (522 KB) (Downloaded: 06.11.2024 11:46:31)
Date:
19.10.2021
INN:
Brigatinib
Claimed indication for medical use:
As monotherapy, it is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) positive for anaplastic lymphoma kinase (ALK) who have not previously been treated with an ALK inhibitor.
Application:
Application for state health technology assessment of the medicinal product ALUNBRIG® (brigatinib/brigatinib). (501 KB) (Downloaded: 19.10.2021 14:26:21)
Conclusion:
(471 KB) (Downloaded: 24.07.2023 13:34:30)
Date:
19.10.2021
INN:
Glecaprevir/Pibrentasvir
Claimed indication for medical use:
Treatment of chronic viral hepatitis C (CHC) of genotype 1 in adults who have previously been treated with regimens containing HCV NS5A protein inhibitors or NS3/4A protease inhibitors, but not drugs of both classes.
Application:
Application for the state health technology assessment (Glecaprevir/Pibrentasvir). (243 KB) (Downloaded: 19.10.2021 14:19:13)
Conclusion:
Conclusion of the state HTA on glecaprevir/pibrentasvir dated 11.07.2022 (503 KB) (Downloaded: 13.07.2022 06:31:02)
Date:
28.09.2021
INN:
Olanzapine
Claimed indication for medical use:
Olanzapine is indicated for the treatment of schizophrenia.
Application:
Application for state health technology assessment of the medicinal product ZOLAFREN (2.7 MB) (Uploaded: 28.09.2021 10:33:04)
Conclusion:
Conclusion of the state HTA on olanzapine of 10.06.2022 (403 KB) (Downloaded: 14.06.2022 12:28:58)
Date:
18.08.2021
INN:
dabigatran etexilate
Claimed indication for medical use:
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (hereinafter – NVAF) with one or more risk factors, such as: prior stroke or transient ischemic attack, age ≥75 years, heart failure (NYHA class ≥II), diabetes mellitus or arterial hypertension.
Application:
Application for state health technology assessment for the purpose of including the medicinal product PRADAXA® (2 MB) (Uploaded: 23.08.2021 11:57:28)
Conclusion:
State HTA conclusion on dabigatran etexilate dated 11.04.2022 (678 KB) (Downloaded: 11.04.2022 13:10:16)
Date:
21.07.2021
INN:
Triptorelin
Claimed indication for medical use:
Treatment of locally advanced or metastatic hormone-dependent prostate cancer
Application:
Application for state health technology assessment for the purpose of including the medicinal product DIFERELIN® (982 KB) (Uploaded: 23.07.2021 11:24:33)
Conclusion:
State HTA conclusion: triptorelin (445 KB) (Uploaded: 30.12.2021 08:12:37)
Date:
23.06.2021
INN:
Pembrolizumab
Claimed indication for medical use:
KEYTRUDA® is indicated for the treatment of patients with unresectable or metastatic melanoma.
Application:
Application for the state health technology assessment of the medicinal product KEYTRUDA® (1.3 MB) (Downloaded: 24.06.2021 11:57:14)
Conclusion:
Conclusion (812 KB) (Downloaded: 28.10.2021 14:18:45)
Date:
14.06.2021
INN:
Risdiplam/Risdiplam
Claimed indication for medical use:
Treatment of spinal muscular atrophy (SMA) in patients aged 2 months and older.
Application:
Application for the state health technology assessment of the medicinal product Evrysdi (2.2 MB) (Downloaded: 17.06.2021 07:09:56)
Conclusion:
Conclusion (1.2 MB) (Downloaded: 09.12.2021 14:29:09)
Date:
11.06.2021
INN:
Tiotropium bromide
Claimed indication for medical use:
Maintenance bronchodilator therapy in chronic obstructive pulmonary disease (COPD).
Application:
Application for state health technology assessment of the medicinal product SPIRIVA® (1.5 MB) (Uploaded: 15.06.2021 12:15:47)
Conclusion:
Conclusion (667 KB) (Downloaded: 25.11.2021 08:55:00)
Date:
04.06.2021
INN:
Nintedanib
Claimed indication for medical use:
The medicinal product OFEV® is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
Application:
Application for state health technology assessment of the medicinal product OFEV® (1.7 MB) (Downloaded: 09.06.2021 07:07:27)
Conclusion:
Conclusion of the authorized body: Nintedanib (435 KB) (Downloaded: 30.11.2021 14:00:34)
Date:
04.06.2021
INN:
Empagliflozin
Claimed indication for medical use:
Use of empagliflozin in addition to metformin (i.e., in combination with metformin), as a representative of standard therapy, for the treatment of adult patients with type 2 diabetes mellitus and a risk of cardiovascular disease, for glycemic control and reduction of the risk of cardiovascular complications.
Application:
Application for the state health technology assessment of the medicinal product JARDIANCE® (2.2 MB) (Downloaded: 09.06.2021 07:07:29)
Conclusion:
Conclusion (663 KB) (Downloaded: 11.11.2021 08:09:25)
Date:
27.05.2021
INN:
Venetoclax
Claimed indication for medical use:
The medicinal product Venclexta® in combination with rituximab is indicated for the treatment of adult patients with CLL who have previously received at least one line of therapy.
Application:
Application for state health technology assessment for the purpose of including the medicinal product VENCLEXTA® (1.6 MB) (Uploaded: 31.05.2021 14:00:26)
Conclusion:
Conclusion (647 KB) (Downloaded: 03.11.2021 14:54:12)
Date:
14.05.2021
INN:
Cabozantinib
Claimed indication for medical use:
Treatment of advanced renal cell carcinoma (RCC): - in adult patients who have not previously received treatment and have an intermediate or high risk.
Application:
Application for state health technology assessment for the purpose of including the medicinal product CABOMETYX® for the indication “Treatment of advanced renal cell carcinoma (RCC) in previously untreated adult patients with intermediate or high risk” (1.1 MB) (Uploaded: 19.05.2021 07:20:16)
Conclusion:
Conclusion (2 MB) (Downloaded: 20.10.2021 12:43:18)
Date:
14.05.2021
INN:
Cabozantinib
Claimed indication for medical use:
Treatment of advanced renal cell carcinoma (RCC): - in adult patients after prior treatment with agents that affect vascular endothelial growth factor (VEGF).
Application:
Application for state health technology assessment for inclusion of the medicinal product CABOMETYX® for the indication “Treatment of advanced renal cell carcinoma (RCC) in adult patients following prior therapy with agents targeting vascular endothelial growth factor (VEGF)” (2.3 MB) (Uploaded: 19.05.2021 07:21:36)
Conclusion:
Conclusion (1.2 MB) (Downloaded: 20.10.2021 12:43:38)
Date:
14.05.2021
INN:
Lanreotide
Claimed indication for medical use:
Treatment of grade 1 differentiated neuroendocrine tumors of the gastrointestinal tract or pancreas (GEP-NETs) and a subset of grade 2 differentiated tumors (Ki67 index up to 10%) originating from the midgut, pancreas, or of unknown origin, with exclusion of hindgut origin, in adult patients with unresectable locally advanced or metastatic tumors.
Application:
Applications for state health technology assessment for the purpose of including the medicinal product SOMATULINE AUTOGEL (2 MB) (Downloaded: 19.05.2021 07:22:52)
Conclusion:
Conclusion (2.1 MB) (Downloaded: 20.10.2021 12:44:12)
Date:
11.05.2021
INN:
alectinib
Claimed indication for medical use:
as monotherapy, indicated as a first-line medicinal product for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer.
Application:
Application for state health technology assessment for the purpose of including the medicinal product ALECENSA® in the Nomenclature of Medicinal Products under the category “Chemotherapeutic agents, radiopharmaceuticals, and supportive care agents for the treatment of oncology patients” (1.4 MB) (Uploaded: 14.05.2021 11:57:42)
Conclusion:
Conclusion of the state HTA on Alectinib of 30.12.2021 (668 KB) (Downloaded: 30.12.2021 14:42:17)
Date:
06.05.2021
INN:
brentuximab vedotin
Claimed indication for medical use:
treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression after autologous stem cell transplantation (ASCT).
Application:
Application for state health technology assessment for the purpose of including the medicinal product ADCETRIS® (177 KB) (Uploaded: 11.05.2021 07:15:10)
Conclusion:
Conclusion (3.1 MB) (Downloaded: 20.10.2021 12:42:09)
Date:
30.04.2021
INN:
pertuzumab
Claimed indication for medical use:
Early breast cancer: indicated for use in combination with trastuzumab and chemotherapy for neoadjuvant therapy of adult patients with HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence.
Application:
Application for state health technology assessment for the purpose of including the medicinal product Perjeta® in the nomenclature of medicinal products under the category “Chemotherapeutic drugs, radiopharmaceuticals and supportive care drugs for the treatment of cancer patients” (1.4 MB) (Uploaded: 07.05.2021 06:05:57)
Conclusion:
Conclusion of the state HTA on Pertuzumab of 15.12.2021 (858 KB) (Downloaded: 20.12.2021 14:11:00)
Date:
30.04.2021
INN:
obinutuzumab
Claimed indication for medical use:
in combination with bendamustine followed by obinutuzumab maintenance therapy, is indicated for the treatment of patients with follicular lymphoma who did not respond to treatment with rituximab or to combination therapy that included rituximab.
Application:
Application for state health technology assessment of the medicinal product trastuzumab deruxtecan (273 KB) (Uploaded: 05.08.2025 09:20:49)Application for state health technology assessment with a view to including the medicinal product Gazyva® in the nomenclature of medicinal products in the area “Chemotherapeutic agents, radiopharmaceuticals and supportive care medicines for the treatment of cancer patients” (1.9 MB) (Uploaded: 07.05.2021 06:06:00)
Conclusion:
Conclusion of the state HTA: obinutuzumab dated 16.12.2021 (835 KB) (Uploaded: 20.12.2021 14:10:00)

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