Question 6628 — pharmacy and medications

Summary

Ms. Anne Le Hénanff draws the attention of the Minister to the Minister of Labor, Health, Solidarity and Families, responsible for health and access to care, to the failure to cover the treatment taken by people suffering from Smith Magenis syndrome. An orphan genetic disease, Smith Magenis syndrome is manifested by an intellectual deficit, severe behavioral disorders and an inversion of the circadian rhythm of the secretion of melatonin, making nighttime sleep almost impossible. This unique biological feature is very debilitating because the reversal of the biological clock keeps people awake at night and asleep during the day. It also accentuates learning difficulties and amplifies already severe behavioral problems. Families are constantly vigilant, particularly at night, in order to prevent domestic accidents and endangering the sick. Numerous studies have demonstrated over the past ten years that the introduction of sustained-release melatonin to patients greatly improves the duration and quality of sleep. A marketing authorization (AMM) was issued in 2021 for children aged 2 to 18, following a temporary recommendation for use (RTU) of Circadin between 2015 and 2021. However, no social security support solution exists today for patients suffering from Smith Magenis syndrome after they turn 18. Also, due to lack of resources, many patients are forced to interrupt a treatment that is essential to their life balance and that of their family. A request for the establishment of a post-marketing authorization cohort (CPC) was made in particular by the association “Step by Step with Alexia - Smith Magenis Solidarity France” in order to allow continuity of care for adult patients. She also wishes to know whether the Government intends to respond favorably to this request in order to guarantee continued care adapted to the specific needs of people suffering from Smith Magenis syndrome who have reached adulthood.

Machine translation from French. The official text remains authoritative.

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