O z n á m e n i e č. 2
opening the administrative procedure
(categorisation of medicinal products with expected efficacy at 1.10. 2011)
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 z n a m u j e,
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'):
Č. | Subject /ATC- name of the active substance | Amendment | Reason for action |
1. | J07AL02 Pneumococcal vaccine, purified polysaccharide conjugated Parent antigen. 13-valent J07AL52 Pneumococcal vaccine, purified polysaccharide conjugated Parent antigen. 10-valent | Delete the second sentence in the wording of the indication restrictions . | Do not extend the wording of the indication restriction because the indication of pneumococcal conjugate vaccines is limited by age in the sense of the SPC. Prevenar 13 is intended for children under 5 years of age, Synflorix for children not older than 24 months. |
2. | N05AX08 Risperidone parent 12.5 mg/ml depot, N05AX08 Risperidone parent. 18.75 mg/ml depot. a N05AX08 Risperidone parent. 25 mg/ml depot | Assess the currently valid method of payment and the amount of reimbursement based on public health insurance per unit of the standard dose of the drug N05AX08 Risperidone parent. 12.5 mg/ml depot, N05AX08 Risperidone parent. 18.75 mg/ml depot. and N05AX08 Risperidone Parent. 25 mg/ml depot. | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
3. | N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (1.4ml) N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (2.0ml) N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (2.7ml) | Assess current payment method and amount of reimbursement based on public health insurance per unit of standard drug dose for N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (1.4ml), N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (2.0ml) and N05AH03 Olanzapine pamoate Parent monohydrate. 150 mg/ml (2.7ml) | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
4. | N05AB02 Flufenazine parent. 25 mg/ml | Assess the current payment method and the amount of reimbursement based on public health insurance per unit of the standard drug dose for N05AB02 Flufenazine parent. 25 mg/ml | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
5. | N05AD01 Haloperidol parent. depot. 50 mg/ml | Assess current payment method and amount of reimbursement based on public health insurance per unit of standard drug dose for N05AD01 Haloperidol parent. depot. 50 mg/ml | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
6. | N05AF01 Flupentixol parent. 20 mg/ml | Assess the current payment method and the amount of reimbursement based on public health insurance per unit of standard drug dose for N05AF01 Flupentixol parent. 20 mg/ml | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
7. | N05AF05 Zuklopentixol parent. 200 mg/ml depot. | Assess current payment method and amount of reimbursement based on public health insurance per unit of standard drug dose for N05AF05 Zuklopentixol parent. 200 mg/ml depot. | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
8. | N05BA01 Diazepam parent. 5 mg/ml | Assess current payment method and amount of reimbursement based on public health insurance per unit of standard drug dose for N05BA01 Diazepam parent. 5 mg/ml | Given the nature of the medicinal product and its therapeutic effect, it is justified to determine the level of reimbursement of the health insurance undertaking per unit of the standard dose of the medicinal product in accordance with the methodology hp § 3 (2) (a). d) and e) Decree No 723/2004 of the Ministry of Health of the Slovak Republic Z.z., which regulates the details of the procedure for determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance undertaking for the standard dose of the drug. In accordance with this decree, according to the methodology of the ÞAÞ, the reimbursement for the standard dose of the active substance is provided if the medicinal product has to be administered in a healthcare facility by a healthcare professional or if, taking into account the nature of the patient's disease, the risk of deterioration of the medicinal product or the patient's disease does not guarantee the safe handling of the medicinal product by the patient. |
9. | N05AX08 Risperidone Parent depot | Align the IO text with the SPC. | Therapeutic indication for maintenance treatment of schizophrenia in patients currently stabilised on oral antipsychotics. |
According to § 33 of the Administrative Order, the Ministry calls on you to comment on the grounds of the decision within 3 days of receipt of the notification, or to propose evidence which, in your view, is important 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.