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
- Director and Head of the Service Office of the State Institute for Medicinal Products Control Pharm Dr. Jan Mazag
- Official of the Communication Department Mgr. Martina Lidinská
- Official of the Department of Classification, Pricing and Drug Policy Mgr. Jana Kernats, PhD.
For the Slovak Association of Sclerosis Multiplex:
- President of SZSM Jarmila Fajnor
- Member of the CoR of SZSM and Managing Director of SZSM Ing. Vlasta Krchniaková
The meeting took place at the request of representatives of the civic association Slovak Association of Sclerosis Multiplex (SZSM) regarding the availability of new treatment with Fampyra and petitions organised by partner citizens Hope for changing the indicative limitations of the incurably ill patients and the approval of a treatment for gait disturbance.
The meeting was launched by MUDr. Adam Hlôška Director General of the Department of Pharmacy and drug policy. He welcomed representatives of the Slovak Civil Association Sclerosis Multiplex Association and asked the president of the Association to give a presentation their requirements.
President Jarmila Fajnor:
She commented on petitions organised by the partner civil society associations Hope.
She reiterated that the civic association of the Slovak Association of Sclerosis the multiplex has officially resigned from the declared petition. Both representatives Civic Association of the Slovak Association of Sclerosis Multiplex resigned from petitions not only in their capacity but also as natural persons. Requested their prior consent to the petition confirmed by signature (They did not sign only were listed in the Petition Committee) abused even after their official resignation from the petition.
MUDr. Adam Dormouse:
It pointed out that Law No 85/1990 Coll. on petition law is not in the material scope of the section on pharmaceuticals and medicinal products policy and it is necessary in this matters to seek the opinion of a lawyer.
President Jarmila Fajnor:
She asked for information from the Ministry of Health the availability of new Fampyra treatment.
Presented results so far from monitoring patients who experienced to discontinuation within the current wording of the indication restrictions monitoring of the second group of patients already experienced in Fampyra, indicated for the improvement of walking in adults (from 18 years of age) and suffer from a walking disorder caused by multiple sclerosis.
The possibility of partially or fully paying Fampyra has been reported. is registered in Slovakia, but not yet categorized and the reasons not to include Fampyra in the list of categorised medicines.
PharmDr.
He stressed that the latest treatment for patients with diagnosis of multiple sclerosis. I. and II. treatment lines mainly depend on the efficacy and safety of medicines and evidence-based medicine.
He pointed out that the process of classifying medicinal products should also be taken into account the cost-effectiveness of treatment with the medicinal product and eliminate risks from possible treatment adverse reactions, especially if no clear evidence of the safety profile of the medicinal product in question.
He informed that Fampyra had not yet completed its registration process; registration is only conditional due to the requirement to submit additional clinical studies to identify patients for Best effect/risk profile. The benefit is only very Limited patient population and clinical trials were observed significant adverse reactions. Response to Treatment has been demonstrated in 55% and half of patients, respectively, 50% had a positive effect on treatment. We're talking 1⁄4 patients out of the total patients treated in clinical trials. It follows that is in the professional public and the manufacturer of the medicinal product to specify criteria on the basis of which treatment would be indicated for such a group only patients who benefit from effective and safe treatment.
He pointed out that there were other new medicines in the registration process, whose therapeutic effect is focused on early and sudden onset of disease multiple sclerosis, which will certainly benefit in treating a larger group patients with this type of disease manifestation.
It stressed that the classification of medicinal products should be carried out in such a way that the means managed by health insurance undertakings were sufficient to cover medicines covered by public health insurance and the need to ensure access to finance for other new types treatment.
President Jarmila Fajnor:
She noted that the rapid onset of the disease was not covered by the currently available in the treatment of multiple sclerosis. They therefore welcome information on new treatment options.
She informed that their civic association was monitoring the treatment situation multiple sclerosis also in surrounding countries and collects information regarding the effect of treatment with Fampyra.
She stressed that the view of the patient and the professional public in the evaluation effect of treatment diametrically different. Even minimal improvement in patient walking a meter or a short-term lift from a wheelchair is beneficial benefit the patient and improves his quality of life.
The patient was informed about the possibility of treatment with medicinal products in line II immediately, without prior medication I lines. Given the current situation the wording of the indication restrictions is not covered.
MUDr. Adam Dormouse:
He stressed that we were talking about a certain group of patients among all, sufferers of multiple sclerosis. The effect of Fampyra treatment is individual for each patient and therefore appropriate at this time individual treatment authorisation.
He warned the audience that there was a legal possibility of payment the non-categorized product by a health insurance undertaking.
On the basis of § 88 (7) and (8) of Act No 363/2011 Coll. on Scope and Conditions reimbursement of medicines, medical devices and dietetic foods based on public health insurance and amending certain laws may the health insurance undertaking, after prior authorisation to agree in justified cases, in particular where the medicinal product is supplied, taking into account the insured person's state of health with the only suitable option for the insured person in full; or Partial reimbursement of a medicinal product not included in the list categorised Not included in the list of officially indicated medicinal products price; payment is agreed by the health insurance company upon written request the provider.
Conclusion:
Continue monitoring patients for multiple sclerosis.
Inform patients and doctors about individual treatment options and reimbursement Fampyra based on objective and medically documented data.
Joint meeting of representatives of the Ministry of Health insurance companies, experts and representatives of the civil society association in March 2013 with possibility to reconsider the shift in new treatment information received patients with diagnosis of multiple sclerosis in Slovakia at the Ministry Health. (It was proposed by civil society to hold the meeting in question at the General Assembly of SZSM).
Mgr. Jana Kernats, PhD.
Approval: MUDr. Adam Hlôška, Director General of the Department of Pharmacy and Drug Administration
Policy, v.