ANNOUNCEMENT ABOUT THE TREATMENTS OF SMA PATIENTS

As it is known, that is used in the treatment of SMA in conformity with the practice of health “if sodium nusiner” active item “spinraza” commercial titled The principles of clinical assessments of the effectiveness of the drug and drug use were established by the teams created within the Ministry of health as the ultimate decision to continue treatment and evaluation to be done “drugs in the treatment of personal Ministry of Health Turkish medicines and Medical Devices Agency for the evaluation of their use by the commission must be provided.

In the first stage of the treatment in question, as determined by the Ministry of health should use the medicine, patient, determined, and organized the first health board to be based upon the report of the first 4 doses applied as initial therapy, patients completed initial treatment, re-examination, that has been established for the effects of the drug “treatment of the personal Ministry of Health Turkish medicines and medical devices agency evaluation of medicines and their use in the approval of the Commission pursuant to Article 5-and post-dose maintenance therapy is applied.

By the Social Security Institution; "the people who were affected by the immune status of chronic disease as a consequence of infectious diseases of more severe because the possibility exists of watching these individuals as much as possible on the servers of the reduction of the health service references that are important in combating coronavirus disease to avoid delays in access to health care for our citizens, in order to reduce the risk of possible transmission application is started and it is still continuing," the health report based upon usage in the last met prescription dosage/quantity considering, 1 (one) month periods, not to exceed (setup 1 Orb protocol applied enough in medicine) pharmaceutical and/or the supply of medical supplies to be made and costs to be met by the authority of” the drug in question What is in the application in the hospital environment, intrathecal (into the spinal fluid) is implemented as if the patients report at least every time the regulation of other processes to be kept for long periods in the hospital environment, mainly in terms of treatment of SMA;date until 31 December 2021;

In terms of the first 4 doses of application, referred to as ”initial treatment“; In accordance with the report prepared by the ”Ministry of Health-Turkish Medicines and Medical Devices Agency Commission for Evaluating the Use of Drugs in Personal Treatment" for patients who have been approved for the use of drugs, treatments will be provided in accordance with the provisions of the SUT.

“Maintenance therapy” known as by determining the effects of the drug and the patient's treatment will be given of the application of the decision to continue dose of 5 th terms; health communication application 4.2.49-A(3) -(C) to report in the manner as described under subparagraph to be searched, and the next will be held for 5 th dose based on a report issued for subsequent doses, it will be the continuation of treatment, medical practice Announcement 4.2.49-A(3)-(C) as described under subparagraph will not be requested.In the current situation, in terms of patients who have had 6th and subsequent dose treatments, it is also; Patients who have been approved for drug use by the “Ministry of Health-Turkish Medicines and Medical Devices Agency Commission for Evaluating the Use of Drugs in Personal Treatment” for the last maintenance treatment without seeking the considerations specified in paragraph 4.2.49-A(3)-(ç) of the Health Application Communique will also be continued treatment based on the final report.

It has been stated that if an announcement is made by the Ministry of Health regarding the effects of the pandemic, this date will be re-evaluated.

It is announced with respect to the public.