INFORMATION ABOUT INCLUDING SMA DRUGS WITHIN THE SCOPE OF REIMBURSEMENT

The Health Practice Communiqué was published stating that Risdiplam treatment was included in the scope of reimbursement; However, the established criteria show that many SMA patients cannot continue Nusinersen and Risdiplam treatments. According to the published Health Practice Communiqué;

In Spinal Musks Atrophy Type-1 disease; Nusinersen or Risdiplam treatments can be started in patients with an SMN2 copy number of at least 1, who are clinically diagnosed with SMA Type-1, and whose clinical signs and symptoms begin before 6 months.
However, during the treatment process, patients who need permanent invasive mechanical respiratory support (ventilator) for more than 3 weeks and more than 16 hours a day without interruption and are fed with a percutaneous gastrostomy tube (PEG) Treatment is discontinued in patients whose symptoms occur.
• During the treatment, it is necessary to monitor motor, cognitive, nutritional, respiratory, physical therapy, rehabilitation and orthopedic aspects, and standard evaluations should be made with age-appropriate and disease-specific criteria and should be stated in the medical board report.
Spinal Muscular Atrophy Type 2-3 in his disease;
• Nusinersen or Risdiplam treatments can be started in patients with an SMN2 copy number of at least 2, who are clinically diagnosed as SMA Type-2 or SMA Type-3, whose clinical signs and symptoms begin after 6 months, who do not require invasive/non-invasive mechanical respiratory support, and who have a normal swallowing reflex and can feed orally.
• During the treatment, it is necessary to monitor the motor, cognitive, nutritional, respiratory, physical therapy, rehabilitation and orthopedic aspects, and standard evaluations should be made with age-appropriate and disease-specific criteria and should be stated in the medical board report.
All gene-based treatments; [gene replacement therapy and SMN2 modifying treatments (nusinersen, risdiplam)] should not be used together.

In case of a switch between Nusinersen and Risdiplam for less than 1 year, the cost will not be covered by SSI. However, if there is a deterioration in functional evaluations or a significant life-threatening side effect occurs, the drug will be administered if stated in the new medical board report. can be changed.
Drugç In case of a change, if patients using nusinersen treatment continue their treatment with risdiplam, treatment with risdiplam is started if at least 4 months have passed since the last nusinersen application dose.
If patients using risdiplam treatment continue their treatment with nusinersen, treatment with nusinersen is started if at least 15 days have passed since the last risdiplam application dose.
With the Health Practice Communiqué published on 25 June 2023, treatment of type 1 patients was started regardless of whether they needed respiratory support or whether they were fed with PEG; Their treatments continued without respiratory, nutritional and physical therapy scoring. However, new criteria were introduced with the newly published Health Practice Communiqué, which necessitated the review of the criteria again."

You can access the relevant notification here.