September, 2020
Dear members of SMA Europe,
In response to your request, please find an update on access to SPINRAZA (nusinersen).
Access to reimbursed treatment
There are now 29 European countries that have access to nusinersen via regular reimbursement.
Compared to the last report, you can find an updated situation in Switzerland.
As you can see from the table, there is a range of reimbursed access: in line with the label - 5q spinal muscular
atrophy (SMA); for Type I, II, III (excluding IV) and in some cases including age restrictions e.g. <18 yrs. Additionally,
in certain countries there are rare disease/ medical committees who apply further inclusion and exclusion clinical
criteria. For more details, please see the following table:
Access & Reimbursement Details by Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
England & Wales
Reimbursement Label varies by Region.
Reimbursed access in line with the European label - 5q spinal muscular atrophy
(SMA) - inclusion/ exclusion criteria may apply
Access through individual reimbursement and as of Jan 2020 national access -
Types I, II and III (<18 yrs.)
Reimbursed Access -Type I, II, III. No age limitations.
Access through individual reimbursement
Reimbursed access -Types I, II and III. No age limitations.
RESTRICTED Reimbursed access
–
presymptomatic, Type I & II up to app 6 years of
age. (Subject to clinical criteria)
The National Institute for Health and Care Excellence (NICE) has recommended
funding for SPINRAZA (nusinersen). The positive recommendation is for the
treatment of infants, children and adults with spinal muscular atrophy (SMA),
including pre-symptomatic and SMA types 1, 2 and 3, within the terms of the
Managed Access Agreement.
Negotiations underway
Reimbursed access - Types I, II and IIIa (<18 yrs.) Diagnosis before two years of age
and symptoms started before age 20 months aligned with PALKO positive
recommendation
Reimbursed access -Types I, II and III. No age limitations
Reimbursed access in line with the label
-
5q spinal muscular atrophy (SMA)
Reimbursed access for pre-symptomatic, Types I and II; Type III access via
exceptional funding and negotiations for Type III for formal access underway
Reimbursed access
–
Pre-symptomatics & Types I, II and III (<18 yrs.)
Reimbursed access
–
Types I, II, III under 18 years old
Reimbursed access -Pre-symptomatic & Types I, II and III up to 18 years
Reimbursed access - Types I, II and III
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
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