Metachromatic leukodystrophy (MLD)
Metachromatic leukodystrophy (MLD) counts as a rare disease in Switzerland: Swissmedic has granted 1 orphan drug status for this indication. A medicine receives the status when no more than 5 in 10,000 people in Switzerland are affected by the life-threatening or chronically debilitating disease (Art. 4 para. 1 let. a decies TPA).
No medicine with a Swiss authorisation number is published for this indication yet: the status can be granted before the authorisation application is filed (Art. 4 para. 3 TPLO). 1 company holds the designation.
Orphan designations
Swissmedic publishes one row per medicine and orphan indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date. The table below reproduces those rows unchanged and links every indication to the matching rare disease in the directory.
| Orphan indication | Status granted | Status withdrawn |
|---|---|---|
| Behandlung der metachromatischen Leukodystrophie | 10/12/2020 | Status active |
Medicines
No authorised medicine yet
No medicine with an authorisation number is published for this designation in Switzerland. The status can be granted before the authorisation application is filed.
Reimbursement
Whether compulsory health insurance pays for this medicine depends on the FOPH specialities list (SL). Medicines that are not listed can be reimbursed case by case under Art. 71a-71d KVV.
Care in Switzerland
Switzerland concentrates rare-disease care in the centres recognised by kosek. Patient organisations are networked through ProRaris, and the Orphanet database maintains Swiss entries.
Frequently asked questions
Which medicines with orphan drug status are available in Switzerland for Metachromatic leukodystrophy (MLD)?
No medicine with a Swiss authorisation number is currently published for this indication. Only orphan drug designations exist, which means the status was granted while an authorisation application is still open or was withdrawn.
Does Swiss health insurance cover the treatment?
A medicine is reimbursed once it is on the FOPH specialities list (SL). Without an SL listing, or for use outside the limitation, reimbursement in an individual case under Art. 71a to 71d KVV is possible: the insurer decides after consulting its medical adviser, normally within two weeks.
Where are patients treated in Switzerland?
Care is delivered by the rare-disease centres recognised by kosek at the university and cantonal hospitals. Patient organisations are united in the ProRaris alliance, and diagnoses and reference centres are documented in Orphanet.
Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions