For MZ SR:

For the Slovak Cardiology Society (hereinafter "SKS"):

For the Slovak hypertensive Society (hereinafter: "SHS'):

The aim of the workshop was to resolve the changes in clustering cardiac medicinal products of reference group The "C" mentioned in the Annex to the Decree MZ SR No 435/2011.

Director-General Department of Pharmacy and Drug Policy MZ SR MUDr. Hlôška welcomed representatives of the SKS, SHS and members of the Categorisation Commission for medicines. He told the audience prepared amendment Decree No. 435/2011, which should enter into force on 15.11.2012. Here The amendment will follow the Categorisation Committee for Medicinal Products on 1.4.2013. He has put forward a proposal for the clustering of the reference group "C" in the present. He informed that representatives of the Slovak Psychiatric Society and Slovak Neurological Society already representatives of the Pharmacy Section and drug policy of MZ SR discussed. He said they found a deal and clustering solved. This meeting today is supposed to resolve the changes in Classified cardiac medicinal products of reference group -C.

Doc. MUDr. Goncalves, CSc: She thanked and appreciated the possibility of involving experts in the process. She stated that the Government of Slovakia adopted a national programme to prevent heart and blood vessels disease, from which highlighted in particular the priorities, the philosophy of the programme as well as the European Charter The heart and WHO recommendations, with the main objective of the national programme being creating a socially efficient system of measures aimed at reduction in incidence and prevalence of the most serious cardiovascular risk factors as well as to reduce morbidity and mortality of ischaemic disease heart failure and sudden cardiac death. On the question the SKS is interested in reaching an agreement. It stressed that the effectiveness of prevention and treatment of cardiovascular diseases is from professional the need to promote medicines with the best medical evidence. These the priorities declared should be consistent with the concept of pharmaceutical policy governments.

Doc. MUDr. Filipová, CSc.: Agrees with the need for efficiency and Health inquiry but disagrees with the consequences of Decree No 435/2011, which has divided several medicines into payment groups (so-called clusters) by its application may jeopardise the effective provision of healthcare.

Prof. MUDr. Iveta Šimková, CSc. and MUDr. Dana Škultétyová, PhD.: The current order with the creation of clusters was drawn up without any professional public and discussions with it. They stressed that their statements could only be professional-medical. For a competent statement, the reimbursements and surcharges as doctors do not have the necessary education in the field of pharmaco-economics, and are neither competent to assess economic aspects. They consider it essential that each reimbursement group was at least one medicinal product with a zero supplement.

MUDr. Hlôška: Welcomes the approach of the representatives of the SKS and SHS. High priority there is a large number of patients with cardiovascular disease diseases. It is therefore necessary to find the most optimal solution. He said that the proposal of the representatives of the SKS and KHS is different from the proposal of the MZ SR, which divided clusters up to 11 credit transfers, thus creating an increase of 5 credit transfers groups of reference group C.

PharmDr. Mazag: informed as Vice-President of the Categorisation Commission for medicines, that the Commission's objective is the same as representatives of the professional company SKS and SHS, only roads to it differ. He pointed out that even members Categorisation panel in force in Decree 435/2011 gives rise to problems, but must respect also the economy of this state. He said he also welcomed the approach representatives of MZ SR amend this current decree as well as according to expert proposals.

Prof. Dr. Riečanský, CSc.: At the beginning of his entry he drew attention to the fact that he has not received any supporting documents for today's sitting.

Doc. MUDr. Filip, CSc.: It stressed that the decree in force was A disaster for patients, therefore, needs to be amended as soon as possible. She recalled that the need to amend this decree in favour of patients informed the public and Mr. Minister of Health of the Slovak Republic. Proposal submitted a sent to the SSC and the AEO in line with the conclusions of the meeting of 14 September 2012 made expressly on a professional basis, economics medically professional companies have no competence to examine.

Dr. Goncalves, CSc.: She said it was a mistake to do so meetings did not take place at the very beginning, i.e. when drafting the decree 435/2011.

MUDr. Table: Explained the principle of inclusion of medicinal products in reimbursements groups, the philosophy of clustering from three aspects namely: 1) the need for a patient (repayments), 2) need for doctors (professional criteria), 3) possibility for the state to pay treatment. He assured the audience that when drafting the new decree, they were Taken into account in particular low surcharges for medicines, expert opinions as well as the opinion of the Ministry of Finance - justification for clustering, State benefit.

PharmDr. Mazag: He stressed the need to consider not only formally, but also a point of view. He appealed again to the consensus. He said he didn't know expressing all aspects of the proposal submitted by the MZ SR, but is important both professional and economic.

PharmDr. Pullmann: He warned the audience that in the draft amendment Decrees do not change only clusters but also the possibility of group reimbursement other than calculated pursuant to paragraph 2) but not more than the third lowest the maximum cost of the medicine.

Prof. Dr. Murín, CSc.: He pointed out that a valid decree disrupted the activities of the CEC. About a quarter of medicines on the Slovak market is included in reimbursement groups on the basis of which diseases they are intended. Their reimbursement is determined by the cheapest treatment for the disease in question with the same the mechanism of action. Supplements for medicines are higher than before, therefore To find a compromise - to take account of patients' opportunities, to prepare a new one a decree so that it can be passed not only economically and professionally, but mostly to be or most accessible to patients. Agrees to split statins up to three groups in terms of effect.

Prof. MUDr. Riečanský, CSc.: Prof. Riečanský comprehensively evaluated complex aspects of the classification of reimbursements and surcharges of medicinal products as well as clustering; what he has been doing for the past five years. He noted that it was not possible to take a clear the opinion, but the financial capacity of the State must be taken into account. Early abandoned the negotiation due to other duties.

Representatives of the SKS and AEO: Patients with cardiovascular diseases are not treated many times professionally optimal medicines. They consider professional medical considerations to be paramount, taking into account the a knowledge of the economic capacity of the State, but it is necessary to take responsibility into consideration and financial burden of the patient. They do not agree to a new reallocation to and for reimbursement in Decree 435/2011 submit their own proposal. They stressed that this expert opinion should: be accepted in such a way that their declared priorities for pharmacotherapy cardiological medicinal products are transferred to the draft new decree. Alerted the fact that MZ has other instruments to adjust the reimbursement of medicinal products so that they are as a priority Supported substances with the strongest medical evidence (e.g. coefficients in payment groups).

MUDr. Hlôška: He appealed to the representatives of the SKS and SHS to make these negotiations rethink their attitudes. He said that MZ SR had three options: and it either cancel clusters, which is not passable (Ministry of Finance insists on continue clustering in other groups) or revise existing Order. A compromise needs to be made to be acceptable to patients.

Subsequently, all medicinal products listed in the reference group -C-C-C. Following the discussion, the content has been modified by consensus individual original reimbursement groups or on the basis of proposals from representatives The SKS and AEO have created new credit transfers groups (in Annex they are credit transfers groups) 5 to 15).

Conclusion:

Modified reference group The payment groups 5 to 15 were: incorporated into Annexes and forms part of that entry. Annex incorporated into the amendment of the Decree amending Decree No 435/2011 of MZ SR Coll. and with effect from 15.11.2012.

The meeting will be published on the Ministry's website Health SR.

She wrote: Jell-O

They verified: for
SKS: Doc. MUDr. Eva Goncalvesová, CSc., President of SKS, v.r.
Prof. MUDr. Iveta Šimková, CSc., future president of SKS, incl.

for SHS: Doc. MUDr. Slavomíra Filipová, CSc., President of SHS, v.r.
Dr. Dana Škultétyová, PhD., scientific secretary of AEO, v.r.

Approval: MUDr. Adam Hlôška,v.r.

Annex (included in this entry): modified reference group (Reserves groups 5 to 15)