SMA Newsroom

Sep 9, 2020

Community update on access to Spinraza in Europe

In response to our request, Biogen has provided us with an update on access to SPINRAZA™ (nusinersen).

There are now 29 European countries that have access to nusinersen via regular reimbursement.

Since the last report, an updated situation can be found for 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 Reimbursement Label varies by Region
Belgium Reimbursed access in line with the European label - 5q spinal muscular atrophy (SMA) - inclusion/ exclusion criteria may apply
Bulgaria Access through individual reimbursement and as of Jan 2020 national access - Types I, II and III (<18 yrs.)
Croatia Reimbursed Access -Type I, II, III. No age limitations.
Cyprus Access through individual reimbursement
Czech Republic Reimbursed access -Types I, II and III. No age limitations.
Denmark Limited reimbursed access – presymptomatic, Type I & II up to app 6 years of age. (Subject to clinical criteria)
England & Wales 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.
Estonia Negotiations underway
Finland 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
France Reimbursed access -Types I, II and III. No age limitations
Germany Reimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
Greece Reimbursed access for pre-symptomatic, Types I and II; Type III access via exceptional funding and negotiations for Type III for formal access underway
Hungary Reimbursed access – Pre-symptomatics & Types I, II and III (<18 yrs.)
Iceland Reimbursed access – Types I, II, III under 18 years old
Ireland Reimbursed access -Pre-symptomatic & Types I, II and III up to 18 years
Italy Reimbursed access - Types I, II and III
Latvia Reimbursed access - Pre-symptomatic (2-3 SMN2 copies), TI (2 copies ≤6mo, 3 copies ≤8mo), II & III (≤12 years)
Lithuania Access through individual reimbursement
Luxembourg Reimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
North Macedonia Access through a named patient programme
Motenegro Access through a named patient programme
Netherlands Regular reimbursement for children up to 9.5 years (subject to clinical criteria) and conditional reimbursement for SMA patients older than 9.5 years as of January 2020 for at least 7 years.
Northern Ireland Northern Ireland follows NICE’s recommendation
Norway Reimbursed access -Types I, II and IIIa (<18 yrs.)
Poland Reimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
Portugal Reimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
Romania Reimbursed access in line with the European label - 5q spinal muscular atrophy (SMA)
Russia Mareting authorization was granted. Negotiation for Federal Access as of 2021 underway.
Scotland SMC has broadened Spinraza’s reimbursement, from Type 1 currently, to cover Types 2 & 3 (later onset)
Serbia Access through a named patient programme
Slovakia Reimbursed access -Types I, II and IIIa
Slovenia Reimbursed access Types I, II and III
Spain Reimbursed access - Types I, II and III
Sweden Reimbursed access – Paediatric (initiated below 18 years old) Types I, II and IIIa
Switzerland Reimbursed access - pre-symptomatic and Type I, II, III
Turkey Access through a named patient programme (Type I, II, III without age limitation)
Ukraine Marketing authorization received on January 11, 2020. Negotiations expected in H2