Professional development Vacancies

Draft conclusions

16.01.2024 Updated 21.09.2026 30530 views

In accordance with the resolution of the Cabinet of Ministers of Ukraine of 22 December 2023 No. 1365 “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine of 23 December 2020 No. 1300 ‘On Approval of the Procedure for Conducting State Health Technology Assessment’”, from the date the draft conclusion of the authorized body is published on its website, the applicant, as well as other individuals or legal entities, have the right, within 14 calendar days, to submit comments on the draft conclusion of the authorized body regarding the declared medical technology to the postal address and/or the e-mail address dec@dec.gov.ua. All comments on the draft conclusion of the authorized body will be published

Date:
04.09.2026
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.
Draft conclusion:
Draft conclusion of the state HTA of umeclidinium bromide/vilanterol (ANORO ELLIPTA) of 02.09.2026 (872 KB) (Downloaded: 04.09.2026 10:47:57)
Comments received on the draft conclusion:
No comments received
Date:
25.08.2026
INN:
Etelcalcetide
Claimed indication for medical use:
For the treatment of secondary hyperparathyroidism in adult patients with chronic kidney failure who are on hemodialysis.
Draft conclusion:
Draft conclusion of the state HTA of etelcalcetide (PARSABIV) dated 25.08.2026 (878 KB) (Downloaded: 28.08.2026 10:25:52)
Comments received on the draft conclusion:
No comments received
Date:
19.08.2026
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 with hemolysis and clinical symptoms indicating high disease activity.
Draft conclusion:
Draft conclusion of the state HTA of the medicinal product crovalimab (PIASKY) dated 18.08.2026 (581 KB) (Downloaded: 19.08.2026 12:55:32)
Comments received on the draft conclusion:
No comments received
Date:
31.07.2026
INN:
Durvalumab/Durvalumab
Claimed indication for medical use:
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.
Draft conclusion:
Draft conclusion of the state HTA on durvalumab (IMFINZI) dated 31.07.2026 (722 KB) (Downloaded: 17.08.2026 08:59:19)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA on durvalumab (347 KB) (Downloaded: 25.08.2026 13:41:46)
Date:
07.08.2026
INN:
Edoxaban/edoxaban
Claimed indication for medical use:
Prevention of stroke in adult patients with non-valvular atrial fibrillation and one or more risk factors, such as congestive heart failure, arterial hypertension, diabetes mellitus, prior stroke or transient ischemic attack, age from 75 years.
Draft conclusion:
Draft conclusion of the state HTA of the medicinal product edoxaban (trade name EDOXACORD) of 05.08.2026 (721 KB) (Uploaded: 07.08.2026 12:31:21)
Comments received on the draft conclusion:
no comments received
Date:
29.07.2026
INN:
Faricimab/Faricimab
Claimed indication for medical use:
Treatment of diabetic macular edema involving the fovea center in adult patients with type 1 or 2 diabetes mellitus
Draft conclusion:
Draft conclusion of the state HTA on faricimab (VABYSMO) dated 28.07.2026 (904 KB) (Downloaded: 29.07.2026 14:09:13)
Comments received on the draft conclusion:
No comments received
Date:
07.07.2026
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.
Draft conclusion:
Draft conclusion of the state HTA of the vaccine for the prevention of diseases caused by human papillomavirus types 16 and 18 (trade name CERVARIX™) of 06.07.2026. (830 KB) (Downloaded: 08.07.2026 10:12:30)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of the vaccine for the prevention of diseases caused by human papillomavirus types 16 and 18 (trade name CERVARIX™) (439 KB) (Uploaded: 17.08.2026 09:07:51)
Date:
29.06.2026
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.
Draft conclusion:
Draft conclusion of the state HTA on darolutamide (NUBEQA) dated 26.06.2026 (777 KB) (Downloaded: 29.06.2026 08:16:24)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA on darolutamide (284 KB) (Downloaded: 21.07.2026 14:15:47)
Date:
09.06.2026
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.
Draft conclusion:
Draft conclusion of the authorized body on the state HTA of valsartan and sacubitril of 08.06.2026 (633 KB) (Uploaded: 09.06.2026 10:54:20)
Comments received on the draft conclusion:
No comments received
Date:
03.06.2026
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.
Draft conclusion:
Draft conclusion of the state HTA of daratumumab (DARZALEX) dated 02.06.2025 (780 KB) (Downloaded: 03.06.2026 06:33:44)
Comments received on the draft conclusion:
No comments received
Date:
19.05.2026
INN:
Tobramycin/Tobramycin
Claimed indication for medical use:
Treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis
Draft conclusion:
Draft conclusion of the state HTA on tobramycin (BRAMITOB) dated 19.05.2026 (712 KB) (Downloaded: 20.05.2026 14:29:20)
Comments received on the draft conclusion:
No comments received
Date:
14.05.2026
INN:
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
Draft conclusion:
Draft conclusion of the state HTA of pembrolizumab (KEYTRUDA) dated 12.05.2025. (928 KB) (Downloaded: 15.05.2026 10:03:26)
Comments received on the draft conclusion:
No comments received
Date:
27.02.2026
INN:
Selumetinib/Selumetinib
Claimed indication for medical use:
The medicinal product Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform 2 neurofibromas (PN) in pediatric patients aged 3 years and older with neurofibromatosis type 1 (NF1).
Draft conclusion:
Draft conclusion of the state HTA of selumetinib (KOSELUGO) dated 25.02.2026 (668 KB) (Downloaded: 27.02.2026 12:14:53)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA on selumetinib (KOSELUGO) with justification of their acceptance or reasons for non-acceptance (412 KB) (Downloaded: 10.04.2026 09:36:03)
Date:
12.02.2026
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 therapy regimens based on anti-HER2 agents
Draft conclusion:
Draft conclusion of the state HTA of trastuzumab deruxtecan (ENHERTU) dated 09.02.2026 (874 KB) (Downloaded: 12.02.2026 13:38:02)
Comments received on the draft conclusion:
No comments received
Date:
27.01.2026
INN:
Velmanase alfa (velmanase alfa)
Claimed indication for medical use:
Enzyme replacement therapy for non-neurological manifestations of the disease in patients with mild to moderate alpha-mannosidosis.
Draft conclusion:
Draft conclusion of the state HTA of velmanase alfa (LAMZEDE) dated 26.01.2026 (681 KB) (Downloaded: 27.01.2026 12:05:26)
Comments received on the draft conclusion:
No comments received
Date:
31.12.2025
INN:
Vigabatrin/Vigabatrin
Claimed indication for medical use:
As monotherapy for infantile spasms (West syndrome) in first-line treatment.
Draft conclusion:
Draft conclusion of the state HTA on vigabatrin (SABRIL) dated 31.12.2025 (705 KB) (Downloaded: 02.01.2026 08:32:02)
Comments received on the draft conclusion:
No comments received
Date:
29.12.2025
INN:
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.
Draft conclusion:
Draft conclusion of the state HTA of pembrolizumab (KEYTRUDA) dated 29.12.2025 (767 KB) (Downloaded: 30.12.2025 10:50:47)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of pembrolizumab (KEYTRUDA) (422 KB) (Downloaded: 27.01.2026 13:49:20)
Date:
12.12.2025
INN:
Emicizumab/Emicizumab
Claimed indication for medical use:
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients older than 12 years with severe hemophilia A without inhibitors to factor VIII and with difficult venous access.
Draft conclusion:
Draft conclusion of the state HTA of emicizumab (HEMLIBRA) dated 12.12.2025. (709 KB) (Downloaded: 12.12.2025 18:50:00)
Comments received on the draft conclusion:
No comments received
Date:
27.11.2025
INN:
Agalsidase alfa/Agalsidase alfa
Claimed indication for medical use:
Long-term enzyme replacement therapy for patients with a confirmed diagnosis of Fabry disease (alpha-galactosidase deficiency).
Draft conclusion:
Draft conclusion of the state HTA of the medicinal product agalsidase alfa (REPLAGAL) of 27.11.2025. (768 KB) (Downloaded: 27.11.2025 14:09:27)
Comments received on the draft conclusion:
No comments received
Date:
27.11.2025
INN:
Inclisiran
Claimed indication for medical use:
For the treatment of adult patients with established atherosclerotic cardiovascular disease and primary non-familial hypercholesterolemia and with elevated LDL-C levels despite the use of the maximum tolerated dose of a statin.
Draft conclusion:
Draft conclusion of the state HTA on inclisiran (SIBRAVA) dated 27.11.2025 (941 KB) (Downloaded: 27.11.2025 14:05:00)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of inclisiran (SIBRAVA) (520 KB) (Downloaded: 26.12.2025 11:08:46)
Date:
26.11.2025
INN:
Gilteritinib (gilteritinib)
Claimed indication for medical use:
As monotherapy for adult patients with relapsed or refractory acute myeloid leukemia with an FLT3 mutation.
Draft conclusion:
Draft conclusion of the state HTA of gilteritinib (XOSPATA) dated 26.11.2025 (791 KB) (Downloaded: 26.11.2025 13:10:11)
Comments received on the draft conclusion:
Date:
20.11.2025
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.
Draft conclusion:
Draft conclusion of the state HTA of tofacitinib (XELJANZ) dated 20.11.2025 (1 MB) (Downloaded: 21.11.2025 14:21:22)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of the medicinal product tofacitinib citrate (XELJANZ) (550 KB) (Downloaded: 26.12.2025 08:46:36)
Date:
25.09.2025
INN:
Formoterol, glycopyrronium bromide and budesonide
Claimed indication for medical use:
Trixeo Aerosphere is indicated as maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated 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 antagonist.
Draft conclusion:
Draft conclusion of the state HTA of formoterol, glycopyrronium bromide and budesonide (TRIXEO) dated 25.09.2025 (714 KB) (Downloaded: 25.09.2025 14:16:03)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of the fixed triple combination of formoterol, glycopyrronium bromide, budesonide (Trixeo Aerosphere) (285 KB) (Downloaded: 21.10.2025 07:44:10)
Date:
17.09.2025
INN:
Ribociclib
Claimed indication for medical use:
Ribociclib 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.
Draft conclusion:
Draft conclusion of the state HTA on ribociclib (KISQALI) dated 16.09.2025 (727 KB) (Downloaded: 17.09.2025 12:35:49)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of ribociclib (KISQALI) (197 KB) (Downloaded: 03.10.2025 06:01:44)
Date:
01.09.2025
INN:
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).
Draft conclusion:
Draft conclusion of the state HTA of acalabrutinib (CALQUENCE) dated 01.09.2025 (844 KB) (Downloaded: 02.09.2025 13:44:16)
Comments received on the draft conclusion:
No comments received
Date:
20.08.2025
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.
Draft conclusion:
Draft conclusion of the state HTA on ofatumumab (BONSPRI) dated 20.08.2025. (846 KB) (Downloaded: 21.08.2025 13:51:36)
Comments received on the draft conclusion:
No comments received
Date:
04.08.2025
INN:
Normal human immunoglobulin
Claimed indication for medical use:
Guillain-Barré syndrome
Draft conclusion:
Draft conclusion of the state HTA of human normal immunoglobulin (BIOVEN) dated 04.08.2025 (730 KB) (Downloaded: 05.08.2025 09:36:10)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of human normal immunoglobulin (BIOVEN) (317 KB) (Uploaded: 01.09.2025 13:42:24)
Date:
04.08.2025
INN:
Ixazomib
Claimed indication for medical use:
Ixazomib in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have previously received at least 2 prior lines of therapy and have retained sensitivity to lenalidomide.
Draft conclusion:
Draft conclusion of the state HTA on ixazomib (NINLARO) dated 04.08.2025 (1001 KB) (Downloaded: 05.08.2025 09:36:56)
Comments received on the draft conclusion:
No comments received
Date:
23.06.2025
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
Draft conclusion:
Draft conclusion of the state HTA of human normal immunoglobulin (BIOVEN) dated 23.06.2025 (1.1 MB) (Downloaded: 24.06.2025 13:46:44)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of human normal immunoglobulin (BIOVEN) (291 KB) (Uploaded: 28.07.2025 07:28:22)
Date:
20.06.2025
INN:
emulsion for parenteral nutrition, comprising an amino acid solution with electrolytes, a lipid emulsion, and a glucose solution with calcium/comb drug
Claimed indication for medical use:
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.
Draft conclusion:
Draft conclusion of the state HTA of an emulsion for parenteral nutrition comprising an amino acid solution with electrolytes, a lipid emulsion and a glucose solution with calcium (OLIMEL N7E) dated 20.06.2025 (663 KB) (Uploaded: 20.06.2025 13:13:23)
Comments received on the draft conclusion:
Comments received on the draft opinion on 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) (456 KB) (Downloaded: 28.07.2025 14:43:39)
Date:
20.06.2025
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.
Draft conclusion:
Draft conclusion of the state HTA on ribociclib (KISQALI) dated 20.06.2025 (786 KB) (Downloaded: 20.06.2025 12:48:12)
Comments received on the draft conclusion:
No comments received
Date:
12.06.2025
INN:
Pertuzumab/trastuzumab
Claimed indication for medical use:
Pertuzumab and trastuzumab in combination with docetaxel are indicated for 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
Draft conclusion:
Draft conclusion of the state HTA of pertuzumab/trastuzumab (FESGO) dated 12.06.2025 (791 KB) (Downloaded: 13.06.2025 12:35:22)
Comments received on the draft conclusion:
No comments received
Date:
02.06.2025
INN:
Lanadelumab
Claimed indication for medical use:
For routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older
Draft conclusion:
Draft conclusion of the state HTA for lanadelumab (TAKHZYRO) of 02.06.2025 on 47 pages (903 KB) (Downloaded: 02.06.2025 13:33:22)
Comments received on the draft conclusion:
No comments received
Date:
28.05.2025
INN:
Acalabrutinib (acalabrutinib)
Claimed indication for medical use:
Indicated as monotherapy for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one course of therapy.
Draft conclusion:
Draft conclusion of the state HTA of acalabrutinib (CALQUENCE) dated 26.05.2025 (773 KB) (Downloaded: 28.05.2025 07:40:20)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for acalabrutinib (CALQUENCE) (224 KB) (Uploaded: 16.06.2025 13:41:11)
Date:
07.04.2025
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)
Draft conclusion:
Draft conclusion of the state HTA on polatuzumab vedotin (POLIVY) dated 04.04.2025 (1.1 MB) (Downloaded: 07.04.2025 13:56:50)
Comments received on the draft conclusion:
No comments received
Date:
28.02.2025
INN:
Rabbit antithymocyte globulin
Claimed indication for medical use:
Immunosuppression in transplantation: prevention of graft rejection (in kidney transplantation)
Draft conclusion:
Draft conclusion of the state HTA of rabbit anti-thymocyte globulin (THYMOGLOBULIN) of 28.02.2025 (1.1 MB) (Downloaded: 03.03.2025 15:18:52)
Comments received on the draft conclusion:
No comments received
Date:
31.01.2025
INN:
Fremanezumab
Claimed indication for medical use:
Preventive therapy for adult patients with chronic migraine after failure of two lines of preventive therapy
Draft conclusion:
Draft conclusion of the state HTA of fremanezumab (AJOVY) dated 30.01.2025 (547 KB) (Downloaded: 31.01.2025 07:41:12)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of fremanezumab (AJOVY) (411 KB) (Downloaded: 06.03.2025 10:40:03)
Date:
24.12.2024
INN:
Enzalutamide
Claimed indication for medical use:
Treatment of non-metastatic castration-resistant prostate cancer in adult men at high risk of progression.
Draft conclusion:
Draft conclusion of the state HTA on enzalutamide (XTANDI) dated 23.12.2024 (821 KB) (Downloaded: 24.12.2024 13:39:15)
Comments received on the draft conclusion:
No comments received
Date:
24.12.2024
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.
Draft conclusion:
Draft conclusion of the state HTA on atezolizumab (TECENTRIQ) dated 23.12.2024. (531 KB) (Downloaded: 24.12.2024 13:32:52)
Comments received on the draft conclusion:
No comments received
Date:
04.12.2024
INN:
Brentuximab vedotin
Claimed indication for medical use:
In combination with cyclophosphamide, doxorubicin and prednisone (CHP), indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).
Draft conclusion:
Draft conclusion of the state HTA of brentuximab vedotin (ADCETRIS) dated 03.12.2024 (509 KB) (Downloaded: 04.12.2024 14:39:33)
Comments received on the draft conclusion:
No comments received
Date:
26.11.2024
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.
Draft conclusion:
Draft conclusion of the state HTA of pegvisomant (SOMAVERT) dated 25.11.2024 (604 KB) (Downloaded: 26.11.2024 10:25:28)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of pegvisomant (SOMAVERT) (403 KB) (Downloaded: 25.12.2024 14:34:53)
Date:
22.11.2024
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
Draft conclusion:
Draft conclusion of the state HTA on enzalutamide (XTANDI) dated 20.11.2024 (521 KB) (Downloaded: 22.11.2024 09:59:54)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of enzalutamide (XTANDI) (501 KB) (Downloaded: 19.12.2024 15:05:25)
Date:
12.11.2024
INN:
Palbociclib
Claimed indication for medical use:
Advanced breast cancer (hereinafter – BC) HR(+), HER2(-), stage IV, without life-threatening visceral involvement. Postmenopausal patients who have not received prior treatment for metastases.
Draft conclusion:
Draft conclusion of the state HTA on palbociclib (IBRANCE) dated 11.11.2024 (738 KB) (Downloaded: 12.11.2024 16:09:53)
Comments received on the draft conclusion:
No comments received
Date:
29.10.2024
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.
Draft conclusion:
Draft conclusion of the state HTA on cetuximab (ERBITUX) dated 28.10.2024 (819 KB) (Downloaded: 12.12.2024 15:47:28)
Comments received on the draft conclusion:
No comments received
Date:
08.10.2024
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.
Draft conclusion:
Draft conclusion of the state HTA of dabrafenib, trametinib (TAFINLAR®, MEKINIST) of 08.10.2024 (516 KB) (Uploaded: 08.10.2024 13:47:35)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for dabrafenib, trametinib (TAFINLAR®, MEKINIST) (502 KB) (Uploaded: 06.11.2024 11:45:09)
Date:
26.08.2024
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.
Draft conclusion:
Draft conclusion of the state HTA of inotuzumab ozogamicin (BESPONSA) dated 26.08.2024 (616 KB) (Downloaded: 27.08.2024 13:53:08)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for inotuzumab ozogamicin (Besponsa) (200 KB) (Uploaded: 27.09.2024 13:09:26)
Date:
11.07.2024
INN:
Venetoclax
Claimed indication for medical use:
In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic (lymphoid) leukemia (CLL)
Draft conclusion:
Draft conclusion of the state HTA of venetoclax (VENCLEXTA) dated 11.07.2024 (532 KB) (Downloaded: 11.07.2024 13:24:35)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for venetoclax (VENCLYXTO) (170 KB) (Uploaded: 08.08.2024 13:24:19)
Date:
13.05.2024
INN:
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
Draft conclusion:
Draft conclusion of the state HTA of ruxolitinib (JAKAVI) dated 13.05.2024 (620 KB) (Downloaded: 13.05.2024 13:19:18)
Comments received on the draft conclusion:
No comments received
Date:
01.05.2024
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.
Draft conclusion:
Draft conclusion of the state HTA for formoterol and beclometasone (FOSTER) of 01.05.2024 (759 KB) (Downloaded: 02.05.2024 13:41:35)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of formoterol and beclometasone (FOSTER) (385 KB) (Downloaded: 03.06.2024 13:35:37)
Date:
26.04.2024
INN:
Nintedanib
Claimed indication for medical use:
Treatment of idiopathic pulmonary fibrosis (IPF) in adults
Draft conclusion:
Draft conclusion of the state HTA on nintedanib (OFEV) dated 25.04.2024 (557 KB) (Downloaded: 26.04.2024 10:30:24)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for nintedanib (OFEV) (321 KB) (Downloaded: 29.05.2024 13:37:35)
Date:
25.03.2024
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.
Draft conclusion:
Draft conclusion of the state HTA of rivaroxaban (XARELTO) dated 22.03.2024 (605 KB) (Downloaded: 25.03.2024 14:27:36)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of rivaroxaban (XARELTO) (444 KB) (Downloaded: 22.04.2024 12:32:37)
Date:
11.03.2024
INN:
Trifluridine/tipiracil
Claimed indication for medical use:
Monotherapy treatment of adult patients with metastatic colorectal cancer who have previously been 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
Draft conclusion:
Draft conclusion of the state HTA of trifluridine/tipiracil (LONSURF) dated 08.03.2024 (561 KB) (Downloaded: 11.03.2024 14:51:18)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA for trifluridine/tipiracil (LONSURF) (109 KB) (Uploaded: 12.04.2024 15:56:57)
Date:
23.02.2024
INN:
Risdiplam
Claimed indication for medical use:
Treatment of 5q-associated spinal muscular atrophy (SMA) in patients aged 2 months and older
Draft conclusion:
Draft conclusion of the state HTA on risdiplam (EVRYSDI) dated 22.02.2024 (774 KB) (Downloaded: 23.02.2024 14:36:02)
Comments received on the draft conclusion:
No comments received
Date:
26.01.2024
INN:
Dapagliflozin
Claimed indication for medical use:
Treatment of chronic kidney disease
Draft conclusion:
Draft conclusion of the state HTA of dapagliflozin (FORXIGA) dated 25.01.2024 (547 KB) (Downloaded: 26.01.2024 11:29:03)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA (298 KB) (Downloaded: 13.02.2024 14:22:20)
Date:
19.01.2024
INN:
Rivaroxaban
Claimed indication for medical use:
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation at risk of stroke according to the CHA2DS2-VASc score ≥1 for men and ≥2 for women
Draft conclusion:
Draft conclusion of the state HTA of rivaroxaban (XARELTO) dated 19.01.2024 (581 KB) (Downloaded: 19.01.2024 13:43:01)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of rivaroxaban (XARELTO) (161 KB) (Downloaded: 09.02.2024 11:56:26)
Date:
16.01.2024
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
Draft conclusion:
Draft conclusion of the state HTA on tofacitinib citrate (XELJANZ) dated 15.01.2024 (449 KB) (Downloaded: 17.04.2024 11:08:38)
Comments received on the draft conclusion:
Comments received on the draft conclusion of the state HTA of tofacitinib citrate (XELJANZ) (121 KB) (Downloaded: 05.02.2024 14:38:38)
Date:
Date display error
INN:
INN display error
Claimed indication for medical use:
INN display error
Draft conclusion:
Draft conclusion of the state HTA of ixazomib (NINLARO) dated 04.08.2025 (1001 KB) (Uploaded: 05.08.2025 09:36:56)Draft conclusion of the state HTA of human normal immunoglobulin (BIOVEN) dated 04.08.2025 (730 KB) (Uploaded: 05.08.2025 09:36:10)
Comments received on the draft conclusion:

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List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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Latest Announcements

Competitive selection of members of the HTA Expert Committee: deadline for submitting documents – until 12 October 2026

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Updated! List of original (innovative) medicinal products registered in Ukraine as of 07.09.2026

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Attention to business entities engaged in retail trade of medicinal products on the market of Ukraine! We provide lists of over-the-counter medicinal products by their storage conditions

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ДЕЦ рекомендує включити подвійну комбінацію умеклідиніуму броміду та вілантеролу до Нацпереліку основних лікарських засобів 

ДЕЦ рекомендує включити подвійну комбінацію умеклідиніуму броміду та вілантеролу до Нацпереліку основних лікарських засобів 

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Representatives of the Center exchanged experience in the field of HTA with Swedish colleagues

Representatives of the Center exchanged experience in the field of HTA with Swedish colleagues

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Ukraine has updated approaches to the rational use of antimicrobial medicinal products in healthcare facilities

Ukraine has updated approaches to the rational use of antimicrobial medicinal products in healthcare facilities

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