Registration of the meeting of representatives of the civic association of the Club cystic fibrosis with representatives of MZ SR, health insurance companies with participation of the main expert of MZ SR for paediatric pneumology and phtizeology on 15.11.2012 at 10.00 am. at MZ SR

For MZ SR:

• Director-General of the Pharmacy and Drug Policy Section MUDr. Adam Dormouse
• Director of the Department of Classification, Pricing and Drug Policy, PharmDr. Rastislav Pullmann
• Mgr. Jana Kernatsová, PhD.

For the GPP:

• PharmDr. Lyudmila Krč-Only

For Union ZP:

• doc. Tomáš Tesař, PhD., MBA

For ZP Trust:

• PharmDr. Elizabeth Arvai

For cystic fibrosis club:

• Mr Andrea Pendant
• Mr Jaroslav Lexa

Representative for cystic fibrosis patients:

• principal expert in paediatric pneumology and phtizeology doc. Martin Brezina, CSc.

The meeting took place on the basis of the conclusions of the working meeting of interested parties held on 27th September 2012 at the MZ SR.

The meeting was launched by the Director General of the Department of Pharmacy and Drug Policy MUDr. Adam Hlôška. He welcomed all those involved and stressed that the role of the Ministry at this meeting was the role of mediator of opinion. This is an open discussion between health insurance companies as payers and a patient organisation that represents and defends the rights of cystic fibrosis patients for accessible healthcare.

PharmDr. Lyudmila Krč-Only

1. The VZP took a position on the requirement of a civic association with full seriousness at the level of the Board of Health Insurance.
2. The GPP specified the cost of mucolytics paid for the diagnosis of respiratory disease in 2011, which was made at the previous meeting.
3. In 2011, the GPP spent EUR 2.23 million on medicinal products and medical devices for cystic fibrosis patients. €, representing approximately € 8 851 per patient with cystic fibrosis. For illustration purposes only, the average annual cost of medicines and medical devices for one insured person in 2011 was EUR 233.
4. Cystic fibrosis is a multi-organ disease and symptomatic treatment is aimed at all affected organs not only at bronchopulmonary treatment, which should be borne in mind.
5. Patients with cystic fibrosis as a single patient group are already guaranteed full reimbursement of medicinal products indicated in both pancreatic insufficiency and antibiotic therapy.

• By taking the measure to grant collective exemptions in the form of reimbursement for acetylcysteine-containing medicinal products, the health insurance undertaking considers the favouritism of a particular group of patients.
• The current legislation does not allow for reimbursement of treatment, which is defined by decree as supporting or supplemental. At the same time, the classification of medicinal products should be carried out in such a way that public funds managed by health insurance undertakings are sufficient to cover the reimbursement of medicinal products covered by public health insurance.
• Existing legislation leaves the possibility for individual authorisation of reimbursement for a medicinal product which is not categorised only in medically justified cases.

PharmDr. Elizabeth Arvai

1. In 2011, the health insurance company Trust spent €385 938 on medicines and medical devices for cystic fibrosis patients.
2. The granting of consent to reimbursement of acetylcysteine containing medicinal products to a group of cystic fibrosis patients is not sufficiently justified to benefit one patient group in this way.
3. They agree to individual authorisation of reimbursement for a non-categorized medicinal product in accordance with § 88 of Act No. 363/2011 Coll. on the scope in medically justified cases.
   

doc. Tomáš Tesař, PhD., MBA

1. Health insurance In the present case, the Union takes the same view as the two insurance companies.
2. They agree to individual authorisation of reimbursement for a non-categorized medicinal product in accordance with § 88 of Act No. 363/2011 Coll. on the scope in medically justified cases.

Mr Jaroslav Lexa

1. The aim of the citizens' association's proposal to approve mass exemptions for cystic fibrosis patients was to relieve doctors from burdensome administrative work.
2. The fact that most families with cystic fibrosis are undersized has been repeatedly pointed out, they are socially weaker.
3. As mentioned above, cystic fibrosis is a multi-organ disease, so in addition to the basic treatment, a multiple supplemental treatment with essential amino acids, vitamins ...., which is fully covered by patients or family members.

• Many patients and their family members find themselves in a bad social situation because of illness or care for a sick patient. Everyone wants to be fully involved in the work process, they want to live. If health insurance companies paid full health care, there would be no social pressure.

doc. Tomáš Tesař, PhD., MBA

1. A fundamental question must be asked whether we are dealing with the medical aspect of treatment or social. The medicine carries not only a medical but also a social aspect.
2. Social aspects belong to the Ministry of Social Affairs and Family Labour.
3. Insurance companies have an interest in solving the problem, but they must also take into account other groups of seriously ill patients who are in a similarly bad social situation.

Dr Adam Hlôška
Health systems not only in Europe but all over the world cannot cover health care
care. From an economic point of view, supply is always greater than demand and funding is not sufficient to cover it.

Mr Jaroslav Lexa
The Civic Association is doing everything possible to reduce the cost of treating cystic fibrosis. By agreeing with ADOS, they reduced their patients' beds to a minimum.

doc. Martin Brezina, CSc.
A decrease in the total cost of cystic fibrosis treatment is only possible thanks to comprehensive outpatient treatment.

Mr Jaroslav Lexa

1. Lung cleansing is the foundation of the treatment. They see progress thanks to available treatment especially in contemporary children. Elderly patients who have not had such treatment are worse off.
2. It should be borne in mind that urgent care in ill-treated patients due to their insolvencies in co-operation can result in higher costs for health insurance companies.
3. They call for individual consideration of the social situation in families.

Mr Andrea Pendant
Social contributions are made to patients from MPSvR only for hygiene and diet.

Mr Jaroslav Lexa
He also drew attention to problems with social insurance, since parents of children with cystic fibrosis who provide or provide assistance do not include retirement years.

Conclusion:

1. The position of health insurance companies is clear.
2. They agree to individual authorisation of reimbursement for a non-categorized medicinal product in accordance with § 88 of Act No. 363/2011 Coll. on the extent in medically justified cases, as permitted by the applicable legislation.

• The scope and approval of reimbursements will be carried out in such a way that public funds managed by health insurance undertakings are sufficient to cover public health insurance medicines. Only the medical relevance of the authorised medicinal product treatment will be taken into account.
• The principal expert of the Ministry of Paediatric Pneumoniology and Ftizeology will inform the doctors of cystic fibrosis centres about the possibility of reimbursement of acetylcysteine containing medicinal products for an individual patient waiver with medical justification and justification.
• A subsequent working meeting will take place in June 2013 to review the state of granting exemptions for the reimbursement of acetylcysteine containing medicinal products by health insurance companies and the cost of the treatment thus indicated.

Based on the results of the stakeholder meeting, further solutions will be sought, as appropriate, in line with existing legislation.

Mgr. Jana Kernats, PhD.

Approval: MUDr. Adam Hlôška, Director General of the Department of Pharmacy and Drug Policy, v.r.