| 01.12.2021 |
Ceftazidime and avibactam |
Treatment of ventilator-associated
hospital-acquired pneumonia in
adults |
Application for state health technology assessment of the medicinal product:<br /> ZAVICEFTA (1.2 MB) (Uploaded: 06.12.2021 11:45:14) |
|
| 26.11.2021 |
Pegvisomant |
Treatment of acromegaly
in patients who have had
an inadequate response to
surgery or
radiotherapy, or for whom these types of therapy are not
suitable. |
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) |
|
| 23.11.2021 |
Apixaban |
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 for state health technology assessment for the purpose of including the medicinal product ELIQUIS (2.7 MB) (Uploaded: 29.11.2021 07:27:55) |
|
| 16.11.2021 |
palbociclib |
Locally advanced or metastatic HR (+), HER2 (-) breast cancer in previously untreated (for metastases) postmenopausal patients, without life-threatening visceral involvement |
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) |
|
| 16.11.2021 |
gemtuzumab ozogamicin |
Newly diagnosed CD33-positive acute myeloid leukemia in adults |
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) |
|
| 03.11.2021 |
Ruxolitinib/Ruxolitinib |
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 for the state health technology assessment (Ruxolitinib). (838 KB) (Downloaded: 04.11.2021 12:10:59) |
|
| 22.10.2021 |
Dabrafenib, trametinib |
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 for state health technology assessment of a combination of medicinal products: TAFINLAR® and MEKINIST. (901 KB) (Downloaded: 25.10.2021 08:06:14) |
|
| 19.10.2021 |
Brigatinib |
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 for state health technology assessment of the medicinal product ALUNBRIG® (brigatinib/brigatinib). (501 KB) (Downloaded: 19.10.2021 14:26:21) |
|
| 19.10.2021 |
Glecaprevir/Pibrentasvir |
Treatment of chronic hepatitis C virus (CHC) genotype 1 infection 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 for the state health technology assessment (Glecaprevir/Pibrentasvir). (243 KB) (Downloaded: 19.10.2021 14:19:13) |
|
| 28.09.2021 |
Olanzapine |
Olanzapine is indicated for the treatment of
schizophrenia. |
Application for state health technology assessment of the medicinal product ZOLAFREN (2.7 MB) (Uploaded: 28.09.2021 10:33:04) |
|
| 18.08.2021 |
dabigatran etexilate |
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 for state health technology assessment for the purpose of including the medicinal product PRADAXA® (2 MB) (Uploaded: 23.08.2021 11:57:28) |
|
| 21.07.2021 |
Triptorelin |
Treatment of locally advanced or metastatic hormone-dependent prostate cancer; Treatment of high-risk localized or locally advanced prostate cancer, in combination with radiotherapy |
Application for state health technology assessment for the purpose of including the medicinal product DIFERELIN® (982 KB) (Uploaded: 23.07.2021 11:24:33) |
|
| 23.06.2021 |
Pembrolizumab |
KEYTRUDA®
is indicated for
the treatment of patients with
unresectable or
metastatic
melanoma. |
Application for the state health technology assessment of the medicinal product KEYTRUDA® (1.3 MB) (Downloaded: 24.06.2021 11:57:14) |
Conclusion (812 KB) (Downloaded: 28.10.2021 14:18:45) |
| 14.06.2021 |
Risdiplam/Risdiplam |
Treatment of spinal muscular
atrophy (SMA) in patients aged
2 months and older. |
Application for the state health technology assessment of the medicinal product Evrysdi (2.2 MB) (Downloaded: 17.06.2021 07:09:56) |
Conclusion (1.2 MB) (Downloaded: 09.12.2021 14:29:09) |
| 11.06.2021 |
Tiotropium
bromide |
Maintenance bronchodilator therapy in chronic obstructive pulmonary disease (COPD). |
Application for state health technology assessment of the medicinal product SPIRIVA® (1.5 MB) (Uploaded: 15.06.2021 12:15:47) |
Conclusion (667 KB) (Downloaded: 25.11.2021 08:55:00) |
| 04.06.2021 |
Nintedanib |
The medicinal product OFEV® is indicated for the treatment of idiopathic pulmonary
fibrosis (IPF) in adults. |
Application for state health technology assessment of the medicinal product OFEV® (1.7 MB) (Downloaded: 09.06.2021 07:07:27) |
Conclusion of the authorized body: Nintedanib (435 KB) (Downloaded: 30.11.2021 14:00:34) |
| 04.06.2021 |
Empagliflozin |
Use of empagliflozin
as an add-on 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 the purpose of glycemic control and
reducing the risk of
cardiovascular complications. |
Application for the state health technology assessment of the medicinal product JARDIANCE® (2.2 MB) (Downloaded: 09.06.2021 07:07:29) |
Conclusion (663 KB) (Downloaded: 11.11.2021 08:09:25) |
| 27.05.2021 |
Venetoclax |
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 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 (647 KB) (Downloaded: 03.11.2021 14:54:12) |
| 14.05.2021 |
Cabozantinib |
Treatment of advanced
renal cell carcinoma
(RCC):
– in adult patients who have not previously
received treatment and have
intermediate or high risk. |
Application for state health technology assessment for the inclusion of the medicinal product CABOMETYX® for the indication “Treatment of advanced renal cell carcinoma (RCC) in treatment-naive adult patients with intermediate or<br /> high risk” (1.1 MB) (Uploaded: 19.05.2021 07:20:16) |
Conclusion (2 MB) (Downloaded: 20.10.2021 12:43:18) |
| 14.05.2021 |
Cabozantinib |
Treatment of advanced
renal cell carcinoma
(RCC):- in adult patients after
prior treatment with agents
that affect vascular endothelial
growth factor (VEGF). |
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 (1.2 MB) (Downloaded: 20.10.2021 12:43:38) |
| 14.05.2021 / 03.12.2021 |
Lanreotide |
Treatment of neuroendocrine
tumors of the gastrointestinal
tract or pancreas
(GEP-NETs) of grade 1
differentiation and a subset
of grade 2 tumors
differentiation (Ki67 index up to
10%) originating from the midgut,
pancreas or of
unknown origin, with
exclusion of origin from hindgut
sites, in adult
patients with unresectable
locally advanced or
metastatic tumors. |
Applications for state health technology assessment for the purpose of including the medicinal product SOMATULINE AUTOGEL (2 MB) (Uploaded: 19.05.2021 07:22:52) Application for state health technology assessment for the purpose of including the medicinal product<br /> SOMATULINE AUTOGEL (repeat). (2.1 MB) (Uploaded: 06.12.2021 15:33:02) |
Conclusion (2.1 MB) (Downloaded: 20.10.2021 12:44:12) |
| 11.05.2021 |
alectinib |
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 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) |
|
| 06.05.2021 |
brentuximab
vedotin |
treatment of adult patients with
CD30-positive Hodgkin
lymphoma at increased
risk of relapse or progression
of the disease after autologous
stem cell transplantation
(ASCT). |
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 (3.1 MB) (Downloaded: 20.10.2021 12:42:09) |
| 30.04.2021 |
pertuzumab |
Early breast cancer:
indicated for use in
combination with trastuzumab and
chemotherapy for the neoadjuvant
treatment of adult patients with HER2-
positive locally advanced, inflammatory, or
early-stage breast cancer at
high risk of recurrence. |
Application for state health technology assessment for the purpose of including the medicinal product Perjeta® in the nomenclature of medicinal products under the category<br /> “Chemotherapeutic drugs, radiopharmaceuticals, and supportive care drugs<br /> for the treatment of cancer patients” (1.4 MB) (Uploaded: 07.05.2021 06:05:57) |
|
| 30.04.2021 |
obinutuzumab |
in combination with bendamustine
followed by maintenance
therapy with obinutuzumab, 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 for state health technology assessment for the purpose of including the medicinal product Gazyva® in the nomenclature of medicinal products under the category<br /> “Chemotherapeutic drugs, radiopharmaceuticals, and supportive care drugs<br /> for the treatment of cancer patients” (1.9 MB) (Uploaded: 07.05.2021 06:06:00) |
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