Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') pursuant to § 18 of Act No 71/1967 Coll. on Administrative Procedure (administrative order), as amended
o f the

that the following administrative procedures are initiated on its own initiative with regard to the amendment of the inclusion of a medicinal product in the list of medicinal products and medicinal products fully or partially reimbursed on the basis of public health insurance pursuant to § 39 (2) of Act No. 577/2004 Coll. on the scope of health care paid on the basis of public health insurance and reimbursements for services related to the provision of healthcare as amended (hereinafter referred to as "the Act'):

Import duty Article 3218 - Table 1

NO. 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 1.7.2011. § 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. 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 process of classification of medicinal products and medicinal products on 1.7.2011. Merge the line and unify the reimbursements of the 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 as at 1.7.2011 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 the Technical Guidelines of the MZ SR on the procedure for applying for inclusion or withdrawal of a medicinal product in or from the list of medicinal products and medicinal products fully paid or partially paid on the basis of public health insurance and pricing proposals for medicinal products No 16652/2009-OKCLP as amended by the Expert Guideline No 23710/2009-OKCLP
3. 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.
4. 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 per cent J01AA02 J01CE06 p.o. liquid LF 25 per cent J01CR02 solid LF 25 per cent J01CR02 p.o. liquid LF 25 per cent J01CR04 p.o. solid LF 25 per cent J01CR04 p.o. liquid LF 25 per cent 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 per cent J01DB05 p.o. solid LF 25 per cent J01DB05 p.o. liquid LF 25 per cent J01DC02 p.o. 125 mg solid LF 25 per cent J01DC02 p.o. 250 mg solid LF 25 per cent J01DC02 p.o. solid LF 25 per cent J01DC02 p.o. liquid LF 25 per cent J01DC04 p.o. solid LF 25 per cent J01DC04 p.o. over 500 mg solid LF 25 per cent J01DC10 p.o. solid LF 25 per cent J01DC10 p.o. liquid LF 25 per cent J01DD08 p.o. solid LF 25 per cent J01DD08 p.o. liquid LF 25 per % J01DD14 p.o. 25 per cent J01EA0101 fixed LF 25 per cent J01EE01 p.o. fixed LF 25% J01FA01 p.o. fixed LF 25% J01FA01 p.o. liquid LF 25% J01FA02 solid LF 25 per cent J01FA06 p.o. fixed LF 25 per cent J01FA09 p.o. 250 mg fixed LF 25 per cent J01FA09 p.o. 500 mg fixed LF 25 per cent J01FA09 p.o. SR fixed LF 25 per cent J01FA09 p.o. liquid LF 25 per cent J01FA10 p.o. 125 mg fixed LF 25% J01FA10 p.o. 250 mg fixed LF 25% J01FA10 p.o. 500 mg solid 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. 25% J01MA03 p.o. 25% J01MA06 p.o. 25% J01MA12 p.o. 25% J01MA14 p.o. 25% J01XX49 p.o. 25% J02AC01 p.o. 50 mg fixed LF 25% J02AC01 p.o. 100 mg fixed LF 25% J02AC01 150 mg fixed LF 25% J02AC01 p.o. over 150 mg fixed LF 25% J02AC01 50 mg liquid LF 5% J02AC01 500 mg liquid LF 5% J02AC01 p.o. over 500 mg liquid LF 5% J02AC02 p.o. 25% J02AC02 p.o. pulse therapy 25% J05AB 10% J05AB01 p.o. 200 mg fixed LF 10% J05AB01 p.o. 400 mg fixed LF 10% J05AB01 LF 10% liquid J05AB09 p.o. 250 mg 10% J05AB09 p.o. 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. solid LF 25% P02CA03 p.o. solid LF 25% P02CA03 p.o. liquid LF 25% Methodology for determining compensation for daily defined dose (ZPP2) for anti-infectives for systemic use and anti-parasitic agents applied from 1.1.2011.
5. Reference groups of medicinal products in which the inclusion of the medicinal product or the change in the official price of the medicinal product has taken place. Re-evaluate the maximum amount of the health insurance cover for the SDL in the reference groups where a new medicinal product has been introduced or the officially determined price of the product already included has changed so as to maintain the ratio between the health insurance cover and the premium for the insured person. Paragraph 39 (2) of the Law. § 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.
6. A10BA02 metformin p.o. p.o. Determine the SDL reimbursement level for the fixed oral metformin formulation. The oral tablet and powder formulations are comparable in terms of clinical efficacy and safety.
7. H05BA01 calcitonin salmon synthetic soaked. M05BX03 strontium ranelate p.o. M05BX04 denosumab parent. Determine SDL reimbursement at: calcitonin salmon synthetic SZP / SDL = 1,59534€ strontium ranelate SZP / SDL = 1,19016€ denosumab SZP/ ŠDL = 1,19016 € The active substances can be considered comparable in terms of efficacy and safety to the antiresorptive agents of the bisphosphonate group. Re-evaluation of health insurance premiums in relation to the re-evaluation of payments in the bisphosphonate group.
8. G04CA52 tamsulosin and dubasterid p.o. Adjust the maximum reimbursement for the standard dose of the drug in the reference group to the sum of the maximum reimbursements for the individual components (0,9600 EUR / ŠDL) § 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.
9. H01CA03 histrelin parent. L02AE02 leuprorelin parent. L02AE02 leuprorelin parent. 5 mg imp. Align the indicative limit H01CA03 of histerrelin parent. SPC. Re-evaluate: Abolition of the indication limit for histerelin parent. Align with the wording of the indication limit leuprorelin parent. 3.6 mg imp. and leuprorelin parent. 5 mg imp. as follows: Medicinal product subject to medical prescription. Consider setting a time limit of 3 years. Alignment of the indication limit with the SPC. Medicinal products containing leuprorelin parent 5 mg imp and 3.6 mg imp have the same indication as histrelin.
10. L02AE02 leuprorelin parent. Inj. 11.25 mg To define the wording of the indication limit: Castle treatment may be indicated in adult men with advanced prostate cancer (locally advanced, metastatic or recurrent after curative treatment), in patients with localised, low-differentiated prostate cancer in combination with radiotherapy; the maximum duration of paid treatment is three years in premenopausal and perimenopausal women with breast cancer in whom hormonal treatment is appropriate. To establish the text of the limitation: ONK, URO. Leuprorelin parent. Inj. 11,25 mg does not have the registered indication referred to in point (c) of the current version of the indication restriction (endometriosis and uterine myomatosis in cases of sterility or infertility). Re-evaluation of the prescription restriction in relation to indications of the medicinal product.
11. L02AE04 triptorelin parent. 0.1 mg To define the wording of the indication limit: The recommended treatment can be indicated according to the SPC for the given product for: (a) prostate cancer, (b) assisted reproduction, IVF and ET methodology The indication of assisted reproduction IVF and ET methodology is subject to prior approval by the review physician. Alignment of indication restrictions with the SPC. Different indications depending on the active substance content.
12. L02AE04 triptorelin parent 3.75 mg To define the wording of the indication limit: Medicinal product subject to medical prescription. Indication of assisted reproduction The IVF and ET methodology shall be subject to prior approval by the review physician. Alignment of indication restrictions with the SPC. Different indications depending on the active substance content.
13. L02AE04 triptorelin parent. 11.25 mg To define the wording of the indication limit: Medicinal product subject to medical prescription Alignment of indication restrictions with the SPC. Different indications depending on the active substance content.
14. L02AE04 triptorelin parent. 22.5 mg To define the wording of the indication limit: Medicinal product subject to medical prescription. Alignment of indication restrictions with the SPC. Different indications depending on the active substance content.
15. L02AE03 goserelin parent. depot. 3.6 mg To define the wording of the indication limit: Treated treatment can be indicated by oncourologists, urologists in prostate cancer, breast cancer in premenopausal women, endometriosis and myomatosis, assisted reproduction, IVF and ET methodology, chest treatment may indicate gynaecologist in endometriosis and myomatosis in uterine cases of sterility and infertility. Indication of assisted reproduction The IVF and ET methodology shall be subject to prior approval by the review physician. To establish the wording of the limitation: GYN, ONK, URO Alignment of indication limits and prescription restrictions with the SPC. Different indications depending on the active substance content.
16. L02AE03 goserelin parent. 10.8 mg To define the wording of the indication limit: Medicinal product subject to medical prescription. To establish the wording of the limitation: ONK, URO Alignment of indication limits and prescription restrictions with the SPC. Different indications depending on the active substance content.
17. J06BB16 Palivizumab Parent. 50 mg Palivizumab Parent. 100 mg A comprehensive review of the wording of the indication restriction. Re-evaluate the wording of the indication limit in view of the incidence of virus RSV, reduction of the risk of hospitalisation, reduction of mortality.
18. N03AX14 Levetiracetam PO 250 mg PO 500 mg PO 1000 mg PO 100 mg/ml SOl. Por. Determine the payment for the SDL at the level of reimbursement for doses of 500 mg and 1000 mg. (EUR 3,5849 / SDL) Article 2 (2) 7) b) Point 2 of Paragraph 2 (6) (a). b) point 2 of Decree No 723/2004 of the Slovak Republic 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.
19. N06AX21 Duloxetine p.o. 30 mg Assess the modification of the wording of the indication limit: Preferred treatment may be indicated for laboratory or clinically documented diabetic polyneuropathy with neuropathic pain, as the first choice in major depressive disorder, as the second choice following lack of effect by SSRIs. Alignment of the indication limit for duloxetine with gabapentin. EMG is not a standard laboratory examination. Required for severe indications or for differential diagnosis.
20. A10BG03 Pioglitazone p.o. 30 mg A10BG03 Pioglitazone p.o. 45 mg Assess the modification of the wording of the indication limit: HbA1c may be indicated for the treatment of type 2 diabetes mellitus in motivated diabetics with HbA1c above 7% monotherapy when metformin is not tolerated or contraindicated, combination therapy with metformin or a sulphonylurea agent, unless it has resulted in metabolic compensation, triple combination with metformin and a sulphonylurea derivative with prior monotherapy, unless the combination therapy has led to metabolic compensation, combination with insulin in patients for whom metformin is inappropriate due to contraindications or intolerance. Use is indicated in obese patients without evidence of heart failure. If after six months of treatment HbA1c does not fall by 0.5% below 7%, further treatment is not covered. Technical alignment of the text with the wording of the other wording of the indication restrictions. If the patient has HbA1c at the start of treatment e.g. 9%, it is not possible to achieve a decrease in HbA1c by more than 2% within a half-year.
21. A10BD05 Pioglitazone and metformin p.o. 15 mg/850 mg Medicinal product subject to medical prescription. Use is indicated in obese patients without evidence of heart failure. If after six months of treatment HbA1c falls below 7% by no more than 0.5%, further treatment is not covered. Technical alignment of the text with the wording of the other wording of the indication restrictions. If the patient has HbA1c at the start of treatment e.g. 9%, it is not possible to achieve a decrease in HbA1c by more than 2% within a half-year.
22. M01AX21 Diacerein 50 mg Determine SZP as SDL at M01AX25 Chondroitin sulphate p.o. 400 mg and 800 mg Basic therapeutic interchangeability.
23. M01AC05 Lornoxicam 4 mg Determine SZP for SDL at the level of reimbursement for Lornoxicam p.o. 8 mg (0,089 € / SDL) Article 2 (6) (a) b) point 2 of Decree No 723/2004 of the Slovak Republic 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.
24. L03AA13 Pegfilgrastim parent. Determine the payment of the health insurance company for the standard drug benefit of EUR 50,9825. The SZP for SDL of EUR 50,9825 corresponds to the payment for Neulasta (code 41011) for which withdrawal from the Marketing Authorisation Holder has requested. The remaining formulation does not provide a better effect on clinically relevant target parameters.
25. N05AH03 Olanzapine PO. Re-evaluate and reduce SZP for P.O. pharmaceutical forms (tbl flm, tbl obd) in relation to p.o. oro (tbl oro) formulations Article 2 (2) 7) b) Point 2 of Paragraph 2 (6) (a). b) point 2 of Decree No 723/2004 of the Slovak Republic 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.
26. J07AJ52 Pertussis (acellular) vaccine, purified antigen, combined with toxoids parent. To assess the justification for the division of the reference group into two reference groups (5 components pertussis and 3 components pertussis) with the possibility of determining different conditions of categorisation for these reference groups. Professional assessment taking into account the effectiveness and effectiveness of public health insurance.

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According to § 33 of the Administrative Order, the Ministry calls on you to comment on the grounds of the decision within 5 days of receipt of the notification, or to propose evidence which, in your view, is relevant for the decision of the administrative body under Paragraph 39 (2) of the Act.
You can send your evidence and suggestions electronically to your email address medicines@health.gov.sk. Enter the text in the subject under the heading "Recast of the active substance'.
Mgr. Michaela Gajdoš, MPH
Director General of Pharmacy and Drug Policy Section
This notice of initiation is served by a public order and will be posted for 15 days on the official board of the Ministry and published on the website www.health.gov.sk.