Notice of initiation of own-initiative administrative proceedings concerning a change in the inclusion of a medicinal product in the list of medicinal products and medicinal products fully or partially covered by public health insurance

Č.

Subject /ATC- name of the active substance

Amendment

Reason for action

1.

Reference groups containing a combination of medicinal products already included in the list of medicinal products

Adjust the maximum amount of payment for the standard dose of the medicinal product in the reference group to the sum of the maximum reimbursements for the individual components, according to the amount of reimbursements in force on 1.4.2011.

§ 2 paragraph 8 of Decree MZ SR No 723/2004 Z. z., which regulates the details of the procedure for determining the standard dose of the medicinal product and the maximum amount of reimbursement by the health insurance undertaking for the standard dose of the medicinal product as amended.

2.

B01AE07-dabigatran etexilate 2 DF

B01AX05-fondaparinux parent. 1DF

10 mg

For antithrombotic agents in the heparin group, adjust SZP/ŠDL to the standard SZP/ŠDL height as for low molecular weight heparins 1.94 €, leaving the fondaparinux reimbursement without increase and taking into account the oral drug form by 30% for dabigatran etexilate and rivaroxaban.

Unification of reimbursement for medicinal products with comparable effect with benefit of oral formulation.

3.

B01AC04 - Clopidogrel p.o. 75 mg

B01AC05 - Ticlopidine p.o. 0,5 g                     

B01AC06 - acetylsalicylic acid p.o. up to 30 mg 1DF                                

B01AC06 - Acetylsalicylic acid. > 30 mg to 100 mg                           

B01AC10- indobufen p.o. 0,3 g

10mg, 10 mg

B01AC22-prasugrel p.o           

B01AC30 - combinations p.o. dipyridamol and ASA cps. 2DF               

For antithrombotic agents in the group of platelet aggregation inhibitors, adjust SZP/SDL so that the SZP/SDL is based on the mean SZP/SDL values u k. acetylsalicylicyl at 1.4.2011 at 0.029350 €.

For each active substance, set the SZP/SDL by increasing the compensation against k. acetylsalicylic acid as follows:

for clopidogrel 20%, SZP/ŠDL 0.03520, ticlopidine 10% SZP/ŠDL 0.032285, indobufen 10%, SZP/ŠDL 0.032285, prasugrel 30%, SZP/ŠDL 0.03815, dipyridamol+ASA 10% SZP/ŠDL 0.032285.

Alignment of reimbursement of medicinal products with comparable indications to the proposal for subsidy according to the efficacy and safety of the medicinal product.

4.

C09AA04 - Perindopril arginine

The amount of payment for perindopril arginine to decrease to 0,1353 €. The amount of reimbursement is based on the UZP/ŠDL for perindopril tert-butylamine plus 10% increase.

The current amount is unfounded. In terms of dosage and efficacy, the two salts of perindopril are comparable.

5.

A10BA02 - Metformin prolonged-release

For all strengths of the XR formulations determine the uniform amount of reimbursement according to the classic metformin formulation 0.1344 € per SDL.

Both formulations are comparable in terms of dosage and efficacy.

6.

M01AB05 - Diclofenac potassium salt

M01AB05 - diclofenac epolamine

Reduce payment to 0,0986 € for SDL. Due to the rate of onset of action compared to diclofenac sodium, the reimbursement is increased by 10%.

Equal treatment of comparable medicinal products.

7.

M01AB16 -aceclofenak.

Determine the payment of 0.0986 € per SDL. Given the speed of onset of effect, determine the reimbursement for diclofenac sodium with a 10% increase and the simultaneous abolition of the PO.

Equal treatment of comparable medicinal products.

8.

M01AB55 -diclofenac, combinations with misoprostol 50mg

M01AB55 - diclofenac, combinations with misoprostol 75mg

Re-evaluate the amount of credit transfer. The amount of compensation shall be fixed as the sum of the reimbursement for the active substance diclofenac and the misoprostol component, to be paid up to the maximum amount applicable to proton pump inhibitors.

For the 50 mg strength to determine the payment of 0.1213 € per SDL and 75 mg the power of payment of 0.1437 € per SDL. 

Align the reimbursements of comparable medicines.

9.

M05BA06 - ibandronic acid 150mg

Determine the amount of compensation at riseddronic acid level 35mg worth 0.4100 € per SDL.

Align the reimbursements of comparable medicines.

10.

M05BA06 - ibandronic acid IV 3mg/3ml

Due to the different dosing interval (three months) after compared to the oral formulation (monthly interval), set the reimbursement amount at €51.66 per 4 mg active substance, which includes a 5% increase over the p.o. pharmaceutical form.

Taking into account the dosage of the medicinal product.

11.

M05BA07-risedronic acid p.o. 75 mg

For 35 mg and 75 mg strength to determine the uniform reimbursement for both forces of €0.4100 per SDL. 

A comparable efficacy of 35 mg and 75 mg strengths.

12.

M05BA08 - Zoledronic acid parent. Sol. f.

Determine the amount of reimbursement up to a maximum of 35 mg for riseddronic acid. Take into account the annual dosing interval compared to weekly/monthly pharmaceutical forms by increasing the reimbursement by 20% - the payment for 1 DF is 179,58 €.    

Alignment of reimbursements, taking into account the possibility of 1x per year.

13.

Protocols on initiation and control of treatment with medicinal products

In cooperation with the expert companies, submit new versions of the protocol on the initiation and control of treatment with medicinal products approved by reviewers, accompanied by data and for the purpose of their electronisation. 

The change will allow more effective approval and processing of protocols by review doctors, review of standard therapeutic procedures, evaluation of the effectiveness of treatment, further processing and evaluation of data with outputs for both professional companies and health insurance companies will contribute to the rational use of public health insurance resources.

14.

J06BB16 - Palivizumab parent. 100 mg

Palivizumab parent. 50 mg

Split the wording of the indication restrictions:

Treated treatment may be indicated for the prevention of severe lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease:

For:

(a) children born at or before the 32nd week of pregnancy and who did not reach the sixth month of life at the beginning of the RSV season,

b)        

Castle treatment can be indicated in workplaces:

 a) neonatal with resustitative care 

university Hospital Bratislava - Ružinov,

at Trenčín Faculty Hospital,

at the Faculty Hospital Nitra,

at Trnava University Hospital,

in the Faculty Hospital Žilina,

the Rimavská Sobota intensive and resuscitation care unit,

hospital A. Leňa Humenné, n.o,

at Poprad Hospital,

 b) in peri-natal centres

at the University Hospital in Bratislava,

in Children's Faculty Hospital with Polyclinic, Bratislava,

in the Faculty Hospital with the New Castle Polyclinic,

university Hospital Martin,

in the Faculty Hospital with Polyclinic F. D. Roosevelt Banská Bystrica,

children's Faculty Hospital Košice,

in the Faculty Hospital with the Polyclinic J. A. Reimana Prešov,

Neonatologist and paediatric pneumologist for:

c) At the beginning of the RSV season, children born at 33 to 35 weeks of gestation did not reach the sixth month of life and have any of the following risk factors:

- a history of severe respiratory distress such as: IRDS, the need for artificial pulmonary ventilation, adrenal pneumonia, sepsis, aspiration of meconium, persistent pulmonary hypertension, tracheo-oesophageal fistula, pneumothorax or congenital developmental defects of lower respiratory organs including diaphragmatic hernia,

- prenatal hypotrophy below 5 percentiles,

- neuromuscular disease,

Castle treatment may be indicated in workplaces:

 a) neonatal with resustitative care 

university Hospital Bratislava - Ružinov,

at Trenčín Faculty Hospital,

at the Faculty Hospital Nitra,

at Trnava University Hospital,

in the Faculty Hospital Žilina,

the Rimavská Sobota intensive and resuscitation care unit,

hospital A. Leňa Humenné, n.o,

at Poprad Hospital,

 b) in peri-natal centres

at the University Hospital in Bratislava,

in Children's Faculty Hospital with Polyclinic, Bratislava,

in the Faculty Hospital with the New Castle Polyclinic,

university Hospital Martin,

in the Faculty Hospital with Polyclinic F. D. Roosevelt Banská Bystrica,

children's Faculty Hospital Košice,

      at the Faculty Hospital with the Polyclinic J. A. Reimana Prešov

c) at the Children's Pneumology Clinic of the University Hospital Bratislava, Children's Pulmonary

      the Danube Biskupice ambulance,

in the Children's Pulmonary Ambulance Nitra,

in the Children's Faculty Hospital Banská Bystrica,

at the Children's Clinic and the Graduation of the University Hospital, Martin,

in the Hospital with the Polyclinic,

children's Faculty Hospital in Košice,

Children's pneumologist for:

d) Children up to 2 years of age who continue to experience X-ray changes due to bronchopulmonary dysplasia and for whom treatment with bronchopulmonary dysplasia with continuous oxygen therapy, bronchodilator therapy, diuretic therapy or corticosteroid therapy was required in the last 6 months prior to the start of the RSV season,

Castle treatment may be indicated in workplaces:

at the Children's Pneumology Clinic of the University Hospital Bratislava

      the Danube Biskupice ambulance,

in the Children's Pulmonary Ambulance Nitra,

in the Children's Faculty Hospital Banská Bystrica,

at the Children's Clinic and the Graduation of the University Hospital, Martin,

in the Hospital with the Polyclinic,

children's Faculty Hospital in Košice,

Paediatric Cardiologist for:

(e) children up to 2 years of age with haemodynamically significant congenital heart disease (Q 20 Q 26).

Castle treatment may be indicated in workplaces:

at the National Institute of Cardiovascular Diseases a.s.

Treated treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 23 in Part J of the Model of Protocols on initiation and control of treatment.

Precise definition of indications for individual expertise so that the physician-specialist does not also indicate to the physician the non-relevant indications.

15.

J07AL02 - Pneumococcal vaccine, purified polysaccharide conjugated

parent antigen. 13-valent

J07AL52 - Pneumococcal vaccine, purified polysaccharide conjugated

parent antigen. 10-valent

Part B indication limits

Delete text:

The vaccine as a covered treatment is indicated as part of the recommended vaccination according to § 9 §. 2

decrees

(a) in children up to the age of the second year of life according to annex 3 to the decree

chronic respiratory disease (J 45 Asthma, J 47 Bronchiectasia, Q 32-33 Congenital trachea, bronchial and pulmonary defects, P 23-28 Peripheral respiratory disorders), Chronic cardiovascular disease (Q 20-25 Congenital heart defects), chronic metabolic disorders (E 10 Diabetes mellitus type 1, E 70, E 71, E 72, E 75, E 76 E 77, E 78, E 79 Metabolism disorders amino acid, lipid, purine and pyrimidine, E 84 Cystic fibrosis),

chronic renal impairment (N 04 Nephrotic syndrome, N 18-19 Renal failure), chronic immune disorders (A 39-41 Post-Perulent Meningitis or Septicaemia, B 20-24 Human immunodeficiency virus (HIV) disease, C 00-97 All malignancies requiring comprehensive protocol therapy, D 55-59 Haemolytic anaemia, D 70 Agranulocytosis, D 71 Functional disorders of polymorphonuclear leukocytes, D 72 Other disorders of white blood cells, D 73 Spleen disease, D 76 Diseases affecting lympho reticulary tissue and reticuloistiocytes, D 80 Immune insufficiency with predominance of antibody disorders, D 81 Combined immune deficiency, D 84 Other immunodeficiency, H 66 Nasal and unspecified otitis media (min. 3x requiring ORL intervention), P 05-07 Low birth weight (up to 2500 g), pre-maternity (GV 37 weeks), Q 89 Congenital spleen defects, Q 90-91 Down syndrome, Edwards, Patau syndrome)

The recommended vaccination in children up to the age of the second year of life on 1.7.2011 will not be up to date due to vaccination rates in this age group by introducing mandatory pneumococcal vaccination in the first year of life from 1.1.2009.

16.

L01AD05 - Fotemustine parent.

Amend the wording of the indication limit:

This may be indicated in malignant melanoma (including CNS metastases) and malignant gliomas

The current wording is not in line with the SPC, malignant glioma is indicated in labelling limitations beyond those indicated in the SPC

17.

L01AX03 - Temozolomide p.o. fixed LF,

Temozolomide p.o. children fixed LF

Amend the wording of the indication limit:

The primary treatment may be indicated in patients with diagnosis of malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, meduloblastoma or other mixed malignant glioma, low grade glioma) and ependymoma

a) Following surgery with complete or incomplete resection simultaneous radiotherapy in patients with Karnofsky score ≥ 70 (75 mg/m2 per day simultaneous with RAT, followed by 200 mg/m2 per day for five days every 28 days), followed by monotherapy for up to 6 cycles

b) second-line chemotherapy (resistance or intolerance to standard first-line therapy) in patients with Karnofsky score 70 ≥70

The condition for continued paid treatment is stabilisation or remission of the tumour after two cycles of treatment. Further treatment is not controlled in case of disease progression (clinical deterroration or tumour enlargement by more than 25%).

It is not indicated for the treatment of brain metastases of solid tumours.

The castle treatment can be indicated in the National Cancer Institute Bratislava, in the Oncology Institute of St. Elizabeth s. r. o., in the Eastern Slovak Cancer Institute, a. s. Košice, in the oncology department of the Faculty Hospital with the Polyclinic F. D. Roosevelt Banská Bystrica, at the onconeurological workplace of the University Hospital Bratislava - the hospital akad. L. Dérera, in the oncology department of the Hospital with the policlinic Žilina, in the oncology department of the Children's Faculty Hospital with the Polyclinic, Bratislava, in the Children's Faculty Hospital with the Policlinic, Banská Bystrica, in the cancer department of the Children's Faculty Hospital, Košice, in the department of clinical oncology of the Facultal Hospital Trenčín.

The castle treatment is subject to prior approval by the review physician

The dosage is specified in the SPC. Reference to 6 treatment cycles due to the tendency to administer the product until progression, i.e. more than 6 cycles.

Technical modification of the symbol larger/equal

18.

L01BC05 - Gemcitabine parent.

Amend the wording of the indication limit:

In non-small cell lung cancer (first and second lines), ovarian cancer (second and third lines), rehabilitating breast cancer resistant to other therapies, isolated renal pulmonary metastases, advanced pancreatic cancer, advanced and metastatic bladder cancer and urotel

In the current line of treatment, they are not aligned with the SPC:

launch a second line in lung cancer because the SPC defines it as the 1st line of treatment;

delete the third line in ovarian cancer because the SPC defines it as treatment after first-line platinum treatment;

in breast cancer, a change in the wording of – relaxing breast cancer and not resistant to other therapies;

delete the text of the "isolated pulmonary metastases kidney adenocarcinoma'.

19.

L01BC53 - Tegafur/Uracil p.o.

Abolish indicating restriction/disable medication from the list of medicines:

Treated therapy may be indicated in patients with metastatic colorectal cancer in combination with folinate.

Check the validity of the registration of medicinal products (codes 35455 and 354544).

20.

L01CD01 - Paclitaxel parent.

Amend the wording of the indication limit as follows:

This may be indicated in

a) ovarian cancer

1 in monotherapy or in combination with cisplatin for the treatment of advanced ovarian cancer,

2. in combination with cisplatin in the primary treatment of ovarian cancer in patients with advanced disease or tumour residue greater than one cm after prior laparotomy,

3. for the secondary treatment of ovarian cancer in metastatic ovarian cancer after failure of standard therapy,

b) breast cancer; in the treatment of metastatic breast cancer after failure of standard therapy, or in combination with trastuzumab in patients with HER-2 overexpression at 3+, detected immunohistochemically and for whom anthracycline treatment is not appropriate,

Justification: aligning the wording of the indication restrictions in breast cancer therapy with docetaxel, this combination is listed in the IO

in the adjuvant treatment of metastatic breast cancer into node after previous standard combination therapy (anthracyclines, cyclophosphamide),

b) non-small cell lung cancer in patients in whom radical treatment (surgical performance and/or exposure) in combination with cisplatin cannot be performed primarily,

c) secondary treatment of Kaposi's sarcoma in AIDS patients

Delete point 1 for duplicate wording with points 2 and 3.

The harmonisation of the wording of the indication restrictions for the treatment of breast cancer with docetaxel is indicated in the indication limit.

21.

L01DB01-Doxorubicin parent

Amend the wording of the indication limit:

In acute and chronic haemoblastoses, Kaposi' s sarcoma in AIDS patients, advanced ovarian cancer after failure of platinum-resistant or refractory first-line chemotherapy for previous platinum therapy, metastatic breast cancer in patients at increased cardiovascular risk, and progressive multiple myeloma in patients who have received at least one prior treatment and who have received or are not eligible for bone marrow transplantation.

The castle treatment is subject to prior approval by the review physician

Alignment to SPC - acute and chronic haemoblastoses are not included in the SPC; treatment for ovarian cancer is defined as the second line of treatment.

22.

L01XC03 - Trastazumab parent. plv.

Amend the wording of the indication limit:

The primary treatment may be indicated

a) in HER2 overexpressing metastatic breast cancer 3+ by immunohistochemical assay (standard Hercept-test) or determined FISH/CISH in first or second line treatment,

b) for adjuvant treatment of patients following early breast cancer surgery at an average tumour size of at least 1 over 0.5 cm with HER2 overexpression grade 3+ by immunohistochemical assay (standard Hercept-test) or by FISH/CISH method.

The castle treatment can be indicated in the National Cancer Institute, Bratislava, in the Oncology Institute of St. Elizabeth s. r. o., in the oncology department of the Faculty Hospital with the Polyclinic F.D.Roosevelt, Banská Bystrica and the East Slovakian Cancer Institute. s., Košice.

Treated treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 2 in Part J of the Model of Protocols on initiation and control of treatment 

Alignment with the SPC. 

23.

L01XC04 - Alemtuzumab parent. Liquid LF

Amend the wording of the indication limit:

This may be indicated in CLL

a) alkylating and fludarabine resistant,

b) patients for whom chemotherapy in combination with and fludarabine is not appropriate, and the condition for the paid treatment is cytogenetic examination with detection of chromosome deletion 17p.

Castle treatment can be indicated in the National Cancer Institute, Bratislava, on the Oncology Institute of St. Elizabeth s. r. o., at the Hematological Clinic of the University Hospital Bratislava - Hospital of St. Cyril and Methodius, at the Faculty Hospital of Children with Polyclinic Bratislava, at the Haematological Clinic of the University Hospital L. Pasteur Košice, at the Haematological Department of the Faculty Hospital with the Polyclinic of F. D. Roosevelt, Banská Bystrica, at the Clinic of Haematology and Transfuziology of the University of Comenius, Martin, at the University Hospital, Martin and at the Faculty Hospital with the Polyclinic of J. A. Reiman Prešov.

The castle treatment is subject to prior approval by the review physician

Technical adjustment.

24.

L01XC06 - Cetuximab parent.

Amend the wording of the indication limit:

This may be indicated in patients with

a) locally advanced squamous cell carcinoma of the head and neck in combination with radiotherapy and/or in combination with platinum-based chemotherapy in recurrent and/or metastatic disease,

(b) metastatic colorectal cancer of wild (unmutated) KRAS gene type expressing the epidermal growth factor receptor as part of systemic therapy as initial therapy, or treatment after the first, maximal second progression.  

The pre-paid treatment under (b) is the evidence of the presence of the non-mutated KRAS gene.

If the patient shows evidence of progression, further treatment is not covered.

The castle treatment can be indicated in the National Cancer Institute, Bratislava, in the Oncology Institute of St. Elizabeth s. r. o., in the East Slovak Cancer Institute a. s., Košice and in the oncology department of the Faculty Hospital with the Polyclinic F.D.Roosevelt, Banská Bystrica.

Treated therapy is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to Model 4 (for the treatment of colon cancer) or No 5 (for the treatment of head and neck cancer) listed in Part J of the Models of Protocols on the Initiation and Control of Treatment" 

Alignment with the SPC.

25.

L01XC07 - Bevacizumab parent.

Amend the wording of the indication limit:

This may be indicated in patients with

a) metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine-based chemotherapy as part of systemic therapy as initial therapy, or treatment after first progression, at most second progression,            

b) first-line metastatic breast cancer in combination

        paclitaxel or docetaxel in HER-2 negative patients;

covered treatment in patients with metastatic cancer of the colon or rectum and patients with metastatic breast cancer can be indicated in the National Cancer Institute, Bratislava, the Oncology Institute of St. Elizabeth s.r.o., the East Slovakian Cancer Institute, Košice and the oncology department of the Faculty Hospital F.D. Roosevelt, Banská Bystrica,

(c) first line metastatic, unresectable or recurrent

              non-small cell, excluding epidermoid (squamous cell) cancer

              lungs in combination with a platinum derivative (cisplatin or carboplatin);

paid treatment in patients with non-small cell lung cancer can be indicated at the National Cancer Institute, Bratislava, at the Oncology Institute of St. Elizabeth s.r.o., at the East Slovak Cancer Institute, Košice, at the oncology department of the Faculty Hospital with the Polyclinic F. D. Roosevelt, Banská Bystrica, at the onco-pneumological department of the University Hospital Bratislava, at the Special Hospital of St. Svorada Zobor, Nitra.

Good performance status of the patient (Karnofsky score more than 80 or ECOG 1) is a condition for the paid treatment.

If the disease progresses after three months of treatment or as continued therapy, further treatment is not reimbursed. Evaluation of tumour status shall be performed every three months. Growth in existing or emerging metastases is considered as evidence of progression.

Treated treatment is subject to prior approval by a review physician based on the submitted protocol on initiation and control of treatment according to Model No 2 (for breast cancer) or No 3 (for lung cancer) or No 4 (for colon cancer) listed in Part J of the Models of Protocols on the Initiation and Control of Treatment –

The SPC only lists clinical trials in line 1 and 2 of treatment.

26.

L04AB01 - Etanercept parent.

Amend the wording of the indication limit:

In point (b), insert a sentence

(b) dermatovenerologist or paediatric dermatovenerologist

1. adult patients with severe chronic generalised psoriasis in whom other treatments have not worked well enough have contraindications or intolerance to other systemic therapies, including retinoids, cyclosporine, methotrexate and PUVA;

foreground treatment can be indicated at the dermatovenerological clinic of the University Hospital with a Polyclinic Bratislava – Old Town, dermatovenerological clinic of the University Hospital of L. Pasteur , Košice, dermatovenerological clinic of the Martin Faculty Hospital, Martin, dermatovenerological department of the Faculty Hospital with the Polyclinic F.D.Roosevelta, Banská Bystrica, dermatovenerological department of the Faculty Hospital in Nitra and the dermatovenerological department of the Faculty Hospital with the policlinic, Prešov,

2. children and adolescents from the age of 8 years with severe chronic plaque psoriasis who are inadequately responsive or intolerant to other systemic therapies or phototherapy;

fortified treatment can be indicated at the dermatovenerological clinic of Children's Faculty Hospital with Polyclinic, Bratislava, in Children's Faculty Hospital, Banská Bystrica, in the clinic pediatrics of Faculty Hospital with Polyclinic A. Reimana, Prešov and in Children's Faculty Hospital with Polyclinic, Košice.

Treated treatment is subject to prior approval by the review physician based on the submitted treatment initiation and control protocol according to model No 14 in Part J of the Models of Protocols on Initiation and Control of Treatment

Further treatment is not covered by treatment if no therapeutic effect occurs after twelve weeks of administration of the active substance etanercept.

Once remission has been achieved - PASI 0 .

Alignment with the original wording of the SPC in the English language where this condition is stated.

27.

L04AB02 - Infliximab parent. plv.inf

Amend the wording of the indication limit:

Insert the following sentence in point (a):

Chest treatment may be indicated after prior pneumological and Quanto Feron TB tests 

a) gastroenterologist in

1. severe and fistulating form of Crohn's disease, not responding to conventional therapy,

2. moderate to severe active ulcerative colitis, if an adequate therapeutic response to conventional therapy including corticosteroids or azathioprine has failed or failed to achieve contraindications or intolerance to these drugs;

paid treatment can be indicated at the Gastroenterological Clinic of the University Hospital Bratislava - Hospital of St. Cyril and Methodius, Gastroenterological Department of NOVAMED s.r.o. Banská Bystrica, I. internal clinic LF UP JŠ and FN L. P. Košice, Gastroenteropathological Centre THALION, Bratislava, at the V. Internal clinic LF UK University Hospital Bratislava, Ružinov, NZZ KM Management spol. Ltd. Gastroenterological Departments NZZ KM Management spol. s r.o., Nitra, at the Centre for the Treatment of IBD, II. Internal Clinic of the Faculty Hospital with the Polyclinic A. Reimann, Prešov, at the Department of Gastroenterological Diagnostics of the Internal Clinic of the University Hospital Martin and in the gastroenterological practice of the Internal Clinic of the Faculty Hospital with the Polyclinic, Trenčín; 

Castle treatment is indicated in patients where surgery (e. g. in ulcerative colitis) is contraindicated.

the paid treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 15 in Part J of the Model of Protocols on initiation and control of treatment,

The surgery has a stabilising effect in treating the disease and it is not immediately necessary to proceed to second line treatment.

28.

L04AB04 -Adalimumab parent.

Amend the wording of the indication limit:

In point (b), insert the following sentence:

Chest treatment may be indicated after prior pneumological and QuantiFeron TB tests in patients 

b) a gastroenterologist in severe active Crohn's disease and to maintain remission in patients who have not responded to, or who are intolerant to, or are contraindicated to treatment despite full and adequate treatment with a corticosteroid or immunosuppressant. Initial treatment Adalimumab should be administered in combination with corticosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued corticosteroid therapy is inappropriate;

paid treatment can be indicated at the Gastroenterological Clinic of the University Hospital in Bratislava, the hospital of St. Cyril and Methodius, the Gastroenterological Department of NOVAMED s.r.o. Banská Bystrica, I. internal clinic LF UP JŠ and FN L. P. Košice, Gastroentero-pathological centre THALION, Bratislava, at the V. Internal clinic LF UK University Hospital Bratislava, Ružinov, Gastroenterological departments NZZ KM Management spol. s r.o., Nitra, at the Centre for the Treatment of IBD, II. Internal Clinic of the Faculty Hospital with the Polyclinic A. Reimann, Prešov, at the Department of Gastroenterological Diagnostics of the Internal Clinic of the University Hospital Martin and in the gastroenterological practice of the Internal Clinic of the Faculty Hospital with the Polyclinic, Trenčín;

Treatment is indicated in patients where surgery (e.g. in ulcerative colitis) is contraindicated.

the paid treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 15 in Part J of the Model of Protocols on initiation and control of treatment,

The surgery has a stabilising effect in treating the disease and it is not immediately necessary to proceed to second line treatment.

29.

S01LA03 - Pegaptanib loc.

Amend the wording of the indication limit:

Insert as follows:

Treated therapy may be indicated in patients with subretinal neovascular membrane with age-related macular degeneration, with baseline visual acuity in the range 20/40-20/200 and not indicated for photodynamic treatment with verteporfin.

The castle treatment can be indicated at the I. Očka clinic of the Faculty Hospital with the Polyclinic Bratislava Hospital Ružinov, at the I. Očná clinic of the Slovak Medical University of the Faculty Hospital with the Polyclinic Bratislava Hospital with St. Cyril and Methodius, at the Očka clinic of the Faculty Hospital with the Polyclinic F.D. Roosevelt, Banská Bystrica, at the Očka department of Hospital with the Polyclinic Žilina V. Spanyola 43, at the Očná clinic of the Faculty Hospital L. Pasteur Košice , at the Očka department of the Faculty Hospital with the Polyclinic J. A. Reimana Prešov, at the Očná clinic of the Faculty Hospital of Nitra and the Faculty German Department of Trenčín, in the OFTAL Očné centrum Zvolen, at the Ophthalmological department of the Faculty Hospital with the Nové Zámky, and at the Očliniclinickýmnica of the Bratislava Hospital of the Hospital of the University of the University of the.

The castle treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 9 in the E-formulae of the MEDICAL INITIATION AND CONTROL PROTOCOLs, supplemented by fluoroangiographic documentation.

Visual acuity conditions used in inclusion criteria for patients in clinical trials.

30.

S01LA04 - Ranibizumab intravitreal

Amend the wording of the indication limit:

Insert as follows:

 Treated therapy may be indicated for the treatment of the neovascular membrane in the moist form of age-related macular degeneration with baseline visual acuity in the range 20/40-20/200, which is subfoveal and is not indicated for photodynamic treatment with verteporfin.

Castle treatment can be indicated at the I. Očná klinika Faculty Hospital with Polyclinic Bratislava Hospital Ružinov, at the Očná klinika Faculty Hospital with Polyclinic Bratislava Hospital with St. Cyril and Methodius, at the Očka clinic of the Faculty Hospital with the Polyclinic F.D. Roosevelt, Banská Bystrica, at the Očka department of Hospital with the Polyclinic Žilina V. Spanyola 43, at the Očka clinic of the Faculty Hospital L. Pasteur Košice, at the Očka department of the Faculty Hospital with the Polyclinic J. A. Reiman Prešov, at the Očná klinika Faculty Hospital Nitra and Faculty Nemcnica Trenčín, Oftal s. r. o. Specialized hospital in the field of ophthalmology, Zvolen, at the Ophthalmological Department of the Faculty Hospital with the Polyclinic Nové Zámky and the Očený Department of the Central Military Hospital SNP Ružomberok, Očocné Department of the Ministry of Defence of the Slovak Republic, Bratislava, the Očec Department of the FN L. Pasteur Košice - the workplace Rastislavova 43, the Očocná Department of the Hospital with the Polyclinic Prievidza located in the Bojnice Department of the Hospital with the Policlinic, Poprad and the Oče Department of the Hospital with the Policlinic Trebišov, a.s. and the Department of the Martin Faculty Hospital, Martin.

The castle treatment is subject to prior approval by the review physician based on the submitted protocol on initiation and control of treatment according to model No 9 in the E-formulae of the MEDICAL INITIATION AND CONTROL PROTOCOLs, supplemented by fluoroangiographic documentation.

Visual acuity conditions used in inclusion criteria for patients in clinical trials.

31.

A03AX13 LF Liquid Silicones

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

93500 SAB SIMPLEX

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

32.

H02AB07- Prednisone p.rect.

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

42591 RECTODELT 100 mg

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

33.

J01DC02 - Cefuroxime p.o. 125 mg fixed LF

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

34427 CEFURIM 125

91310 Cefuroximaxetil 125 mg

33201 CEROXIM 125 mg

15868 ZINNAT 125 mg

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

34.

J05AB01 - Acyclovir p.o. liquid LF

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

93191 ZOVIRAX (200mg/5ml)

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

35.

N05BA01 - Diazepam p.rect. up to 5 mg

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

69417 DIAZEPAM DESITIN RECTAL TUBE

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

36.

N05BA01 - Diazepam p.rect. over 5 mg

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

69418 DIAZEPAM DESITIN RECTAL TUBE

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

37.

R03CC02 - Salbutamol p.o. liquid LF

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

09961 VENTOLIN

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

38.

R03CC13 - Clenbuterol p.o. liquid LF

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

86889 SPIROPENT

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

39.

R05CB01 - Acetylcysteine.

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

69405 SOLMUCOL 200MG

69163 SOLMUCOL 100MG

18531 SOLMUCOL

79357 ACC powder for oral solution

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

40.

R05CB15 - Erdosteine p.o. cps.

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

87076 ERDOMED 300 MG

92757 ERDOMED 300 MG

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

41.

R05CB15 - Erdosteine p.o. liquid sir

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

28993 ERDOMED 3.5 %

87073 ERDOMED 225 mg granules

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

42.

R06AX27 -Desloratadine p.o. liquid LF

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

Aerius sol por

39738 Aerius salt por

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

43.

S02BA - Corticosteroids oc. dexamet.+ cinchok.

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

84575 OTOBACID N

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

44.

V03AB25 -Flumazenyl parent.

Expand for a selected group of medicines the limitation to prescription to paediatric emergency medicine.

93214 ANEXATE

Health insurance companies do not accept a prescription for such medicinal products re-scribed by doctors in the field of paediatric emergency medicine.

45.

Reference groups for which the accelerated procedure divided into specific groups of medicinal products with different maximum levels of reimbursement for the standard dose of the medicinal product in the classification process as of 1.4.2011.

Merge the line and unify the reimbursements of reference groups for which the accelerated procedure (CNR or CNA1R) has resulted in a division into specific groups of drug with different maximum reimbursements for the standard dose of the drug in the process of categorization to 1.4.2011 into one reference group.

The maximum payment for the standard dose of the drug should be set as the lowest maximum amount for the health insurance company for the standard dose of the drug.

Art. VI, paragraph 3 of SR expert guidance

on the application procedure for inclusion or withdrawal of a medicinal product in or from the list of medicinal products and medicinal products fully reimbursed or partially reimbursed on the basis of public health insurance and the price proposals for medicinal products No 16652/2009-OKCLP, as amended by Expert Guideline No 23710/2009-OKCLP

46.

Medicines obtained without a prescription

Re-evaluate on the list of medicines the relevance of inclusion of all medicines obtained without a prescription. Medicinal products whose inclusion in the list of medicinal products will be assessed as unjustified in terms of the efficient and efficient use of public health insurance funds will be removed from the list of medicinal products.

§ 17 (4) (b) (a) Act No. 577/2004 Coll. on the scope of healthcare paid on the basis of public health insurance and reimbursements for health care services, as amended.

47.

Anti-infectives for systemic use and antiparasitic agents

Adjust the maximum amount of reimbursement for the standard dose of the drug in the reference groups so that the premium paid by the insured person (expressed as a proportion of the final price of the cheapest drug in the reference group, in the calculation to the SDL, in the reference group) corresponds to the values below.

J01AA02 J01CE06 p.o. fixed LF 25%

J01AA02 J01CE06 p.o. liquid LF 25%

J01CR02 p.o. fixed LF 25%

J01CR02 p.o. liquid LF 25%

J01CR04 p.o. fixed LF 25%

J01CR04 p.o. liquid LF 25%

J01DA p.o. fixed LF 25%

J01DA p.o. liquid LF 25%

J01DA p.o. fixed LF 125 mg 25%

J01DB01 p.o. fixed LF 25%

J01DB01 p.o. liquid LF 25%

J01DB05 p.o. fixed LF 25%

J01DB05 p.o. liquid LF 25%

J01DC02 p.o. 125 mg fixed LF 25%

J01DC02 p.o. 250 mg fixed LF 25%

J01DC02 p.o. 500 mg fixed LF 25%

J01DC02 p.o. liquid LF 25%

J01DC04 p.o. over 250 mg fixed LF 25%

J01DC04 p.o. over 500 mg fixed LF 25%

J01DC10 p.o. fixed LF 25%

J01DC10 p.o. liquid LF 25%

J01DD08 p.o. fixed LF 25%

J01DD08 p.o. liquid LF 25%

J01DD14 p.o

J01EA01 p.o. fixed LF 25%

J01EE01 p.o. fixed LF 25%

J01FA01 p.o. fixed LF 25%

J01FA01 p.o. liquid LF 25%

J01FA02 p.o. fixed LF 25%

J01FA06 p.o. fixed LF 25%

J01FA09 p.o. 250 mg fixed LF 25%

J01FA09 p.o. 500 mg fixed LF 25%

J01FA09 p.o. SR fixed LF 25%

J01FA09 p.o. liquid LF 25%

J01FA10 p.o. 125 mg fixed LF 25%

J01FA10 p.o. 250 mg fixed LF 25%

J01FA10 p.o. 500 mg fixed LF 25%

J01FA10 p.o. 200 mg liquid LF 25%

J01FA10 p.o. up to 100 mg liquid LF 25%

J01FF01 p.o. fixed LF 25%

J01FF01 p.o. liquid LF 25%

J01MA01 p.o. up to 200 mg including 25%

J01MA01 p.o. over 200 mg 25%

J01MA02 p.o

J01MA03 p.o

J01MA06 p.o

J01MA12 p.o 

J01MA14 p.o 

25 per cent 

J02AC01 p.o. 50 mg fixed LF 25%

J02AC01 p.o. 100 mg fixed LF 25%

J02AC01 p.o. 100 mg fixed LF 28 tbl. 25%

J02AC01 p.o. 150 mg dose fixed LF 25%

J02AC01 p.o. over 150 mg fixed LF 25%

J02AC01 p.o. LF 5%

J02AC01 p.o. 500 mg liquid LF 5%

J02AC01 p.o. over 500 mg liquid LF 5%

J02AC02 p.o

J02AC02 p.o. pulse therapy 25%

J05AB p.o

J05AB01 p.o. 200 mg fixed LF 10%

J05AB01 p.o. 400 mg fixed LF 10%

J05AB01 p.o. liquid LF 10%

J05AB04 p.o. 10%

J05AB09 PO 250 mg 10%

J05AB09 PO 500 mg 10%

J05AB11 p.o. 10%

P01AB01 p.o. 25%

P01BA01 p.o. 25%

P01BA02 p.o. 25%

P01BA05 p.o. 25%

P01BB51 p.o. 25%

P02CA01 p.o. fixed LF 25%

P02CA03 p.o. fixed LF 25%

P02CA03 p.o. liquid LF 25%

Methodology for determining the daily compensation for defined benefit (SPP2)

for anti-infectives for systemic use and antiparasitic agents applied from 1.1.2011.

48.

Reference groups of medicinal products included in the list of medicinal products in which the medicinal product has been placed or the officially determined price of the medicinal product has changed.

Review the maximum amount of health insurance premiums for the number of SDLs in all reference groups included in the list of medicinal products for which the inclusion of a medicinal product, the proposed final price of which is converted into the standard dose of the medicinal product, is lower than the applicable reference price for the standard dose of the medicinal product in the relevant reference group and in all reference groups where the official price of the medicinal product has been changed.

§ 2 (5) of Decree No 723/2004 MZ SR Z. z., which regulates the details of the procedure for determining the standard dose of the medicinal product and the maximum amount of reimbursement by the health insurance undertaking for the standard dose of the medicinal product as amended.

49.

M05BA07 - Risedronic acid PO.

Re-evaluate SZP for SDL in relation to ibandronic acid p.o.

Principle of mutual therapeutic interchangeability.

50.

N06AG02 -Moclobemide 300 mg 

Reduce SZP for SDL to the value of 0.1234 €.

Basic therapeutic interchangeability in the N06A antidepressant group (moclobemide p.o.; mianserin p.o.; trazodone p.o.; mirtazapine p.o.; tianliptin p.o.

51.

N06AX03 - Mianserin PO.               

Reduce SZP for SDL to the value of 0.1234 €.

52.

N06AX05 - Trazodon PO.

Reduce SZP for SDL to the value of 0.1234 €.

53.

N06AX22 - Agomelatine p.o.               

Reduce SZP for SDL to 0.3440 €.

Basic therapeutic interchangeability in the other antidepressants group - N06AX (bupropion p.o.; venlafaxine p.o.; milnacipran p.o.; duloxetine p.o.; agomelatine p.o.).

54.

M01AE09 - Flurbifen p.o. retarded LF                            

Reduce SZP for SDL to a value of 0.1062 €.

Basically, therapeutic interchangeability in the M01AE group of propionic acid derivatives.

55.

L04AD02 - Tacrolimus p.o. cps. PLD 1 mg      

Rethink the amount of SZP for SDL to 9,87 €.

Basic therapeutic interchangeability in the L04AD-calcineurin inhibitor group.

56.

L04AD02 - Tacrolimus p.o. cps. PLD 5 mg

Rate the amount of SZP for SDL to 9,44 €.

Basic therapeutic interchangeability in the L04AD-calcineurin inhibitor group.

57.

L02AE 02 Þ Leuprorelin parent.

Unify DDD for all leuprorelins - L02AE02 "

76553 Lucrin depot

53714 Lucrin depot 

52852 Lucrin depot

to re-evaluate the level of SZP/DDD in relation to Eligard.

Principal therapeutic interchangeability in the L02AE02 group.