For MZ SR:

- Official of the Price and Drug Policy Classification Department: PharmDr. Linda Hrusiková,
- Official of the Price and Drug Policy Classification Department: Jana Kernats, PhD.

For the Expert Working Party (OPS) for FE KV and HZT:
- Member: doc. Tomáš Tesař, PhD., MBA

As signatories to the Memorandum:

For the NR SR Committee on Health:

For the Patient Rights Association:
- Vice President: PharmDr. Dominik Tomek, PhD., MPH.

For the Cancer League:
- President: Dr. Eva Siracká, DSc.

For Transparency International Slovakia:
- the project coordinator: Mgr. Zuzana Dančíková.

For the Institute of Financial Policy:
- Michaela Rubis, PhD.

For the General Health Insurance Institution:

For the Union Health Insurance Institution:
- MUDr. Ingrid Dúbravo.

For the Health Insurance Trust:

For GlaxoSmithKline:

For Merck Sharp & Dohme:

The meeting took place at the initiative of the signatories to the Memorandum, which advocates full paid vaccination against HPV from public health insurance in the Slovak Republic.

The meeting was opened by the State Secretary of the Ministry of MUDr. Mario Mikloši, PhD., who welcomed a wide range of experts from paediatrics, gynecology and legislators.
The theme of HPV vaccination is widely discussed in the Slovak Republic in relation to the scope of vaccination reimbursement in EU countries. Our vaccination is available and covered by public health insurance of 10% of the final price of the vaccine.
The Ministry's opinion on whether vaccination should be compulsory or recommended is unambiguous. The parent has the right to make a choice and therefore the Ministry wants to keep the vaccination as recommended. The questions that need to be answered are economic, with regard to the amount of reimbursement from public health insurance, how much we can increase the amount of reimbursement and its impact on the public health insurance budget, as the effectiveness of such a type of vaccination is different from that of infectious diseases. Is there also a need to answer the technical questions that relate to what we expect from this vaccination, how will health care be carried out in a group of vaccinated girls in terms of the frequency of paying for preventive examinations in a gynecologist? What will be the incidence of RKM in the vaccinated population, since the vaccine does not include all risk strains against HPV? There's still something left that we don't have vaccination against. The vaccine effect can be statistically evaluable in the population vaccinated by 11 to 12 year old girls up to 25 to 30 years.

Dr. Adam Hlôška,

  1. He welcomed the participants and presented the agenda of the meeting.
  2. He stressed that the topic resonated in drug policy for more than five years, we see it as a social problem.
  3. These are public sources that should be increased for HPV vaccination.
  4. The amount of the payment from the public health insurance is given by Decree No. 435/2011 Coll. on the method of determining the standard dose of the drug and the maximum amount of reimbursement from the health insurance company for the standard dose of the drug, as amended.
  5. We must maintain the sustainability of spending on medicines in the long term, setting up concepts that will not change and maintain continuity every 2-3 years.
  6. The topic deserves a large platform and transparent discussion with the participation of experts, patients, payers, legislators.
  7. The aim of the meeting is to conclude or recommend how to proceed.

Prof MUDr. Miroslav Borovský, PhD.

  1. He presented the challenge of six professional companies, in which they claim 100% reimbursement from public health insurance, as in other developed countries.
  2. He stressed that the Slovak Republic was the last one within the EU countries that did not fully replace HPV vaccination.
  3. He pointed out that HPV infection is not just a sexually transmitted disease but a cause of cancer.
  4. This is a local infection that can be prevented and destroyed, the vaccine discoverer is Nobel Prize winner, it's a breakthrough.
  5. We are talking about the prevention of RKM, we are not talking and we do not want to talk about the problem of sexuality.
  6. HPV infection is not only related to 200 deaths per year but also to the issue of conictions, the number of which is increasing, and the number of premature births and premature births in direct association. For the period 2003 to 2013, we see an 11-fold increase in the existing arrangements.
  7. The costs of society are increasing for treatment before cancer stages and their consequences.
  8. We've had protection from HPV for seven years and we've been using it to a minimum.
  9. A primary prevention system for vaccination should be established.
  10. The role of the state is to provide social security for children who are not economically active.
  11. At 12 years of age, vaccination against HPV is most effective, not related to juvenile sexuality.
  12. It is necessary to determine what should and should not be applied in gynecology.
  13. Whether increasing the reimbursement for HPV vaccine is primarily a political decision, gynecologists insist on 100% reimbursement.
  14. In the previous period, the company was conducting negotiations to review the pricing policy for the decision-holders on the registration of the vaccines in question or to participate in the project to vaccinate the population of e.g. 25 000 girls.
  15. This is a political issue.

PharmDr. Dominik Tomek, PhD., MPH.

  1. He thanked me for inviting him to the seminar.

MUDr. Pavol Trnovec

  1. He presented the theme "Prevention of cervical cancer caused by oncogenic HPV types under the conditions of the Slovak Republic'.
  2. He stressed the following facts:
  3. the risk of HPV infection is high after first intercourse;
  4. 80% of women can become infected during their lifetime;
  5. 50% of HPV infections are oncogenic;
  6. The risk of persistent HPV infection increases with age;
  7. around 600 diseases and 200 deaths per year;
  8. The RKM affects women 1 5 20 years earlier than other malignancies;
  9. The average shorter life expectancy of a woman with an RKM is over 17 years;
  10. He presented a solution to the problem of prevention of RBMs in the EU, which is education, screening, vaccination.
  11. He stressed that GlaxoSmithKline was a preventive vaccine, containing a new adjuvant system, antibody levels and persistence are higher than conventional adjuvant.
  12. The immunogenicity of the 2-dose schedule in 9 – 14 year-old girls is comparable to the 3-dose regimen.
  13. Bivalent vaccine offers up to 93% protection.
  14. Vaccination is a safe, efficient and cost-effective solution to prevent RKM.
  15. The maximum budgetary impact for vaccinated 25 to 27 000 girls at 40% or 70% of the vaccination rate is between 1.4 and 2.5 million. €.
  16. The solution to the problem of prevention of RBMs in the Slovak Republic is education, screening, 100% reimbursement of the reference vaccine.

Ing. Mirosalv Grandfather

  1. He presented the medical and pharmaco-economic benefits of Silgard at full reimbursement by health insurance companies.
  2. Human Papillomavirus (HPV) infection is considered to be an etiological factor for the entire number of cancers of the anogenital region, especially the cervix, vagina and vulva, rectum, penis and other skin and mucosal carcinomas in other locations.
  3. Protection against cervical cancer can be divided into two basic procedures - screening and vaccination.
  4. Anti-HPV vaccination and public reimbursement is currently in place in 23 EU countries.
  5. As the costs and effects of treatment will have a longer time horizon than the clinical trial, modelling through Markov's cohort model has been chosen.
  6. The budget impact of 40% vaccination for 26 500 girls is up to 1 million. € for full payment of vaccine.

doc. Tomáš Tesař, PhD., MBA

  1. It presented the opinion of OPS for FEK and HTA on the submitted pharmacovigilance analyses of Cervarix and Silgard vaccines.
  2. It noted that the clinical benefits are clearly addressed in the submitted pharmacovigilance analyses.
  3. However, pharmaceutical companies have not shown that this vaccination has saved the financial resources of health insurance companies.
  4. He stressed the importance of input data on the costs with which the analyses work. These need to be supplemented by pharmaceutical companies. The addition of input data is necessary to ensure the feasibility of cost data for the public health insurance system in the Slovak Republic and then the submitted pharmaco-economic analyses can be verified.
  5. He stated that only 40% of the vaccination rate and 100% of the reimbursement from public health insurance were 2 million. €.
  6. The budget is limited and payers must ensure the sustainability of the public health insurance system in the context of the debate on the increase in the costs associated with vaccination.

Dr. Richard Rashi, PhD., MPH

  1. He said that we are always making symbiosis with Europe, why is it otherwise in this case? Is this a problem of available resources?
  2. Did he ask what a cost reduction is when we prevent vaccination of HPV-associated diseases?
  3. The cost reduction may be higher than the expenditure presented.
  4. In regions outside Bratislava, 100 € is an obstacle that children are not vaccinated and end up with RKM.

Dr. Ladislav Andreánsky

  1. He stressed the cooperation of gynecologists with pediatricians who, at the age of the recommended vaccination, have more frequent contact with girls.
  2. He sees the problem in high payment for the vaccine, i.e. in its price.
  3. 100% reimbursement from public health insurance.

PhDr. Stefan Kuffa

  1. He stressed that health and our future were held in our own hands.
  2. It does not support the full payment of vaccination, as if something is free, we do not appreciate it. Many drugs end up in containers.
  3. Why vaccination since the age of 12 is related to the sex life of girls aged 16 and over?
  4. It calls for a change in lifestyle, sexual and premarital restraint.

Dr. Eva Siracká, DSc.

  1. The potential for vaccination is limited by its financial difficulty.

Prof. Dr. Pavol Jarčuška, PhD.

  1. He said that we were looking for a way not to pay for the vaccine and not to pay for it.
  2. 20 years of added life goes to antibiotics and vaccination, the investment has returned.
  3. He highlighted the conclusions of the Atlantic panel of experts, where vaccination must take place at some point in the fight against RBMs.
  4. Up to 80% of women experience this infection.
  5. He pointed out that in 30 years, as many people died from the Ebola epidemic in our RBMs as at present. Is that a low number?
  6. Consideration should be given to the question of how much will be saved by increased vaccination not only by the payer but by the state, but also to indirect costs. The Slovak Ministry of Finance would be requested here.

PharmDr. Lyudmila Krč-Only

  1. This is about the sustainability of public finances.
  2. The availability and level of reimbursement of healthcare is determined by current legislation. We do not want to bring a religious or sexual aspect to the payment of the vaccine.
  3. Vaccination is preventable and justified.
  4. The payer does not challenge vaccination, it is recommended not mandatory vaccination.
  5. The financial resources for 2015 are significantly limited, the demands for new, expensive molecules are increasing.
  6. Resources must be sufficient for legally guaranteed health care.
  7. This is a one-off investment in health by the patient.
  8. It is also about the willingness of a parent to invest in protecting the health of his child. It is a very good investment once in a lifetime.
  9. The GPP has very strongly supported preventive programmes. However, prevention in gynecology is only used at 30%, which is a question of the policyholder's personal approach.
  10. At present, compensation is an adequate public resource.
  11. The amount of compensation should not be an obstacle to the use of the vaccine.
  12. The analysis of total costs is under way, but the problem is immediate investment.
  13. He sees a logistical problem in the central purchase of vaccines because they are connected to the centres.

PharmDr. Monika Laincz

  1. They are for recommended vaccination and not mandatory.
  2. They did not count on cost increases.
  3. Already in previous years, part of the cost of HPV vaccine was able to be reimbursed retroactively under the above-standard products.
  4. From 2014 you can use the product 100 +100+100.
  5. They also reimburse their insured persons part of the cost of reimbursement up to 100 €.

MUDr. Ingrid Dúbravová

  1. They are not considering changing the reimbursement to HPV vaccine. They are in favour of keeping the vaccination as recommended.
  2. They motivate insured persons and invest in preventive inspections.
  3. In addition, they reimburse insured persons for part of the cost of reimbursement for HPV vaccine. It's not much of a benefit.

Mr Zuzana Dančíková

  1. She appreciated the possibility of this wider debate.

Ing. Michaela Rubis

  1. We lack an analysis of what such prevention would bring to us from a longer time perspective for health insurance companies and society.
  2. Such an analysis is necessary and necessary.

Prof. MUDr. Tibor Šagat, CSc.

  1. He expected the GZP to calculate by how much costs will be reduced.
  2. It's standard treatment.
  3. Other countries have carried out an analysis and are therefore paying a higher level of vaccination.
  4. It should be decided at today's meeting.
  5. It is a political decision. It has medical attributes that need to be covered.
  6. Preventive programmes reversed the development of a healthy population e.g. Finland.
  7. Savings will take place after four years.

Conclusion:
Until 15.5.2015 MZ SR awaits the submitted draft solution or opinion on the issue by the payer (health insurance companies) with an analysis of the costs and benefits of vaccination in the long term. Whether it is an efficient investment that can be made from own resources without the State's support. It is necessary to look for reserves, internal resources, e.g. from review activity or profit. If this solution is not found, we will look for another way.
After 15.5. 2015 MZ SR will initiate a meeting of representatives of Transparency international Slovakia, GlaxoSmithKline and Merck Sharp & Dohme regarding the offer of the acceptable price of the vaccine as agreed for the central procurement of HPV vaccine.

Mgr. Jana Kernats, PhD.
They verified: participants in the meeting
Approval: MUDr. Adam Hlôška, v.r.