MADDE 1 – 24/3/2013 tarihli ve 28597 sayılı Resmî Gazete’de yayımlanan Sosyal Güvenlik Kurumu Sağlık Uygulama Tebliğine 4.2.48 numaralı maddesinden sonra gelmek üzere aşağıdaki madde eklenmiştir.|||UNTRANSLATED_CONTENT_END|||
“4.2.49 – Spinal Muscular Atrophy Type-1 (SMA Type-1) disease nusinersen sodium principles of usage;
(1) Medicines used for the treatment of SMA Type-1 are prescribed separately for each application by the pediatric neurology specialist with the "Drug Use Approval" given by "Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency Evaluation Commission" based on 6-month medical board report for subsequent applications and 3-month medical board report for the first 4 applications where the pediatric neurology specialist takes part. If the "Drug Use Approval" is given at one time for the first 4 applications and separately for each subsequent application, the cost is covered by the Institution.
(2) In the event that the medicine containing the active ingredient, Nusinersen and Sodium, is used in the third level official health service providers determined by the Institution that has a registered newborn and pediatric intensive care service, including a pediatric neurologist, offers nutrition and dietetics, physical therapy and rehabilitationservices with a multidisciplinary approach, its cost is covered by the Institution.
(3) In case that the patients have the following criterias, cost is covered by the Institution.
ARTICLE 2 - The provisions of this Notification become valid 5 business days after its publication.
ARTICLE 3 - The provisions of this Notification are executed by the President of the Social Security Institution.