NOTICE ON RELATING AN ALTERATION IN THE RESCRIPT OF HEALTH IMPLEMENTATION SOCIAL SECURITY INSTITUTION

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.

1. a) Genetic (5qSMA; having homozygous gene deletion or homozygous gene mutation or compound heterozygous gene mutation and on condition that ithe number of SMN2 copies is shown to be at least 2) and there must be a "Approval of Drug Use" which will be given by "Ministry of Health Turkey pharmaceuticals and Medical Devices Agency Evaluation Commission of the Use of Drugs for Personal Treatment" by applying for drug use abroad based on decision of the council which is consisted of 3 specialist physicians, one of whom is a pediatric neurologist and having clinically diagnosed SMA Type-1.
2. b) Clinical signs and symptoms should have started when ≤6 months (180 days) in accordance with SMA Type-1.
3. c) During treatment (except during the first 4 doses) Treatmentshould be discontinued in children who need respiratory support due to SMA. Treatment is not interrupted in children who receive respiratory support due to circumstances as infection, etc. and who need respiratory support after the cause is eliminated.
4. d) After the first 4 dose drug application, according to the objective evaluation results, HammersmithInfantNeurologicalExamination (HINE) and / or Hammersmith Functional Engine Scale Expanded Neurological and motor, called (HFMSE) scale by "Ministry of Health Turkey Pharmaceuticals and Medical Devices Agency Evaluation Commission for the Use of Drugs for Personal Treatment", in case of the approval for each application separately by the same commission, following the evaluations to be made  for each patient the continuation of the treatment will be provided.
5. D) There shouldn't be Lumbarpuncture procedures, CSF circulation or a brain that could interfere with safety assessments, or spinal cord  disease or a history.
6. e) For CSF drainage implantedshuntor implanted a CSF catheter should not exist.
7. f) There shouldn't be bacterial meningitis or viralencephalitis disease or a history.
8. g) Hypoxicischemicencephalopathy have not been diagnosed and there should be no hypoxic neurological sequelae due to birth. "

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.