Registration from the meeting with representatives of the civic association House of Light Slovakia, Association for the Protection of Patients' Rights of the Slovak Republic, experts of MZ SR in the field of infectology and tropical medicine, health insurance companies and Ministry of Health of the Slovak Republic,

on the subject of supplemental pay for antiretrovirals medicines used to treat HIV patients and changes in legislation; and Guidelines governing these surcharges, held on 20.9.2016 at 10:00 on land Ministry of Health of the Slovak Republic.

For MZ SR:
director-General of the Pharmacy and Drug Policy Section PharmDr. PhDr. Matej Petrovich,
department of Classification, Pricing and Drug Administration Mgr. policy. Lucia Mišková,

For the civic association House of Light Slovakia:
Miloš Stefančík,

For the Association for the Protection of Patients' Rights:
PharmDr. Dominik Tomek, MPH, PhD,

For experts of MZ SR in the field of infectology and tropical medicine:
Prof. MUDr. Pavol Jarčuška,

For the GPP:
PharmDr. Lyudmila Krč-One.

The meeting was held on the initiative Ministry of Health of the Slovak Republic
(hereinafter referred to as "the Ministry') at the request of the citizen Association House of Light Slovakia addressed to the Minister for Health Slovak Republic by letter dated 23.6.2016, delivered to the Ministry 6.7.2016. From the point of view of professional competence, the Minister's office the application has resigned to the direct equipment of the pharmacy and pharmaceutical policy section. Representatives of the civic association House of Light Slovakia were invited by Section Pharmacies and drug policy for personal discussion of options and practices Ministry on legislative changes and regulatory guidelines supplemental antiretroviral therapy with other professionals; and representatives of all health insurance undertakings.

PharmDr. PhDr. Matej Petrovich,

1. He welcomed the participants and briefly presented the programme a working meeting.
2. He presented the current legislation that regulates the determination and review of health insurance contributions, in the sense of Act 363/2011 Coll. on the scope and conditions of reimbursement of medicinal products, aids and dietetic foods based on public health insurance; and on the amendment of certain laws and Decrees of the Ministry Health of the Slovak Republic 435/2011 Coll. on the method of determination the standard dose of the medicinal product and the maximum amount of reimbursement by the health insurance undertaking for normal dose. It also reported on the upcoming and proposed Legislative change and reassured all participants of consideration and review the initiatives presented in the process of legislative change.
3. He launched a debate on the Problems with the surcharges of antiretroviral medicinal products containing fixed combinations of medicinal products compared to the free combination of medicinal products containing these medicines (monotherapy) in HIV therapy, which is currently fully covered under public health insurance.

PharmDr. Dominik Tomek, MPH, PhD and Miloš Štefančík on behalf of patients
Patient representatives reported on complaints Patients treated with antiretroviral therapy, namely with a high supplement as one of the combinations used. Patients are aware of the availability of treatment co-administration with monotherapy, however, prefers treatment as the most optimal variant in terms of international standards. They alerted patients to both treatment and needs public health and relevant health policies. Patient representatives praised the constructive air and helpful attitudes of Ministry representatives Health and General Health Insurance, as well as support from a representative experts. From the explanations of the situation on the part of those present see patients in the current procurement situation over-the-counter purchases by a health insurance undertaking with the possibility of a price arrangement with the manufacturer at the optimal level. If necessary, they will be willing to provide synergies on national and international level through their patient organisations.

PharmDr. Lyudmila Krč-Only
The amount of the reimbursement of the medicinal products in question shall be determined in accordance with existing legislation. When determining the level of reimbursement of fixed combinations of medicinal products, is based on Law 363/2011 on the scope and conditions for reimbursement of medicinal products and on Decree MZ SR 435/2011 on how to determine the standard dose of the drug; and the maximum amount of health insurance cover for the standard dose of the drug:

The maximum amount of medical compensation for the standard dose of the active substance in the reference group in which the medicinal products are included Having a fixed formulation containing a combination of medicinal products, determination shall be made

(a) the sum of the maximum reimbursement amounts of the health insurance undertaking as the standard dose of the active substance in the reference groups in which they are included medicinal products containing the same quantities of these medicinal products in solid form, as contained in a medicinal product containing a combination of medicinal products

Supplement for fixed combinations (in question 2) medicines) does not limit the availability of the necessary combination-based treatment the active substances lamivudine, abacavir and dolutegravir. This treatment is current available by administration of a free combination of two or three concomitantly administered medicinal products containing the same active substances which are fully reimbursed health insurance.
We do not dispute the argument that a simpler dosage the use of fixed combinations is associated with a higher degree of adherence, However, the methodology for calculating the amount of compensation used for fixed combinations established by existing legislation is applied uniformly across all therapeutic areas. We consider that current is not possible (even Adverse Drug Reaction rules for determining the amount of compensation for fixed combinations.
Medical insurance (so-called "health insurance') central purchase), proposed by the AOPP SR representative, gives health an insurance undertaking's ability (not an obligation) to compete with more favourable pricing conditions; and eliminate the patient's surcharge, but also with these options Provision of reimbursement is neither in the options nor in the interest of the MSI to shop for everything that has a surcharge. These are time and logistically demanding A process that is limited by the internal standards of ABP and as a rule is used to ensure the availability of treatment for selected diseases with significant budgetary implications for which treatment is linked to centres. Due to the current availability of necessary antiretroviral therapy, allows infected people to survive a full life, we do not consider central purchase of a single-tablet combination as necessary.
For limited sources under funding We are in favour of a system of responsibility for ensuring availability of treatment for all necessary medicinal products that are or potentially may be included in a social intolerable surcharge scheme, transparently distributed among all participants in the drug chain. GPP promote the creation of legislative conditions that allow Registration holders/producers to participate in treatment costs patients.

The meeting was concluded by the Director General of the Pharmacy Section and PharmDr. PhDr. Matej Petrovič.