Registration from the working meeting of Slovak Crohn Club, AOPP Association for Patient Protection of the Slovak Republic, representatives of the Slovak Gastroenterological Society with representatives of MZSR at 11 a.m. at MZSR 21.11.2017

The expert working meeting was opened by the Director of Classification and Pricing. The subject of a working meeting initiated by patient organisations was the negotiation of increased patient supplements for medicinal products containing the active substance mesalazine valid from 1.10.2017 as a result of a review of the Ministry's reimbursements in order to find a common solution for the patient.

At the outset, the Director of the Department of Classification explained the procedure followed by the Ministry for the revision of reimbursements under the current legislation of Act No. 363/2011 Coll. on the scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods on the basis of public health insurance and on the amendment of certain laws and Decree No. 435/2011 Z.z. Order The Ministry of Health of the Slovak Republic on the method of determining the standard dose of the drug and the maximum amount of reimbursement of the health insurance company for the standard dose of medicines. The director said that public funds were spent on the treatment of Crohn's disease and ulcerative colitis last year in value eur 24 million. It is also necessary to mention the increase in new expensive biological medicines for the diseases in question included in the list of categorised medicines and fully covered by public health insurance recently. The role of the Ministry, as a regulator, is to ensure the sustainability of public resources. The Ministry, the insurance undertaking and the holder of the registration are parties to the review proceedings. The holder of the registration has the possibility to respond to the surcharge with reduced pricing proposals (which would reduce the total price and with the same proportion as the patient's surcharge).

Doctor. Huorka and Mr. Professor Jurgosh agreed, the continuity of treatment with the active substance mesalazine is essential for the patient. In case of discontinuation, up to 20% of patients relapse. The patient must then be hospitalized, operated or undergoing biological treatment (as representatives of the patient's organisation have seen, treatment may not always be successful).

Mr Docent Jurgoš said that not all patients on biological treatment are withdrawn with medicines containing the active substance mesalazine.
Medicinal products containing the active substance mesalazine from the marketing authorisation holder Ferring-Léčiv, a. s  chemo-protective effect, which are confirmed by quidelinum and clinical studies. Mr. Docent Jurgoš mentioned the extended indication wording in the SPC for Pentasa.

If the total price of the medicinal product containing the active substance mesalazine falls, the possible non-availability of the medicinal products in question should also be considered in advance (re-export).  Mr. Docent Jurgosš from his own experience of gastroenterological practice in the discussion I said that the socio-economic benefit is up to EUR 10 for patients of M.Crohn and Ulceroid colitis.

In similar cases, the AOPP suggests taking into account the opinion of medical experts and the opinion of patient organisations when deciding the Ministry. In the future, they would see a sense in inviting patients to the categorisation committees. What the Director said about such changes it is necessary to proceed conceptually and the main possible changes to the legislative anchor. The AOPP is proposing to address the allocation of the reference group to the separate reference group for Salofalk and the separate reference group for Pentasa.

Representatives of the Civil Association Slovac Crohn Club  detailed description of all patients with Crohn's disease involved and the intolerable amount of the additional charge for Crohn's disease patients as a medicinal product containing the active substance mesalazine with longitudinal release from the marketing authorisation holder Ferring-Léčiv, a.s.

The proposed solution of the CSF:

Based on expert arguments medical Working Group And the Ministry, in the light of the current legislation in force, will set the payment for the second cheapest medicinal product by the next review, taking into account the price proposals made by the marketing authorisation holders and the results of the procedure for comparing the official prices. The modified reimbursements will be valid from 1.4.2018, as soon as possible after the next meeting of the CEC. The Ministry has promised to inform the patients about the change in the payment.

AOPP proposal: In addition to reducing the surcharges as soon as possible, patient representatives expect lines to be redistributed, which would also enable the difficult situation of part of patients to be resolved by returning part of the unbearably high surcharges to those patients who comply with the law.

Conclusion: The participants in the expert meeting partially agreed to the proposed solution of the Ministry.