News

The purpose of SMA Europe is to provide a framework to stimulate collaboration and accelerate translational research pathways in SMA and promote patient care.

  1. Community update on access to Spinraza in Europe

    Access to Spinraza in EuropeIn 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
    AustriaReimbursement Label varies by Region
    BelgiumReimbursed access in line with the European label - 5q spinal muscular atrophy (SMA) - inclusion/ exclusion criteria may apply
    BulgariaAccess through individual reimbursement and as of Jan 2020 national access - Types I, II and III (<18 yrs.)
    CroatiaReimbursed Access -Type I, II, III. No age limitations.
    CyprusAccess through individual reimbursement
    Czech RepublicReimbursed access -Types I, II and III. No age limitations.
    DenmarkLimited reimbursed access – presymptomatic, Type I & II up to app 6 years of age. (Subject to clinical criteria)
    England & WalesThe 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.
    EstoniaNegotiations underway
    FinlandReimbursed 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
    FranceReimbursed access -Types I, II and III. No age limitations
    GermanyReimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
    GreeceReimbursed access for pre-symptomatic, Types I and II; Type III access via exceptional funding and negotiations for Type III for formal access underway
    HungaryReimbursed access – Pre-symptomatics & Types I, II and III (<18 yrs.)
    IcelandReimbursed access – Types I, II, III under 18 years old
    IrelandReimbursed access -Pre-symptomatic & Types I, II and III up to 18 years
    ItalyReimbursed access - Types I, II and III
    LatviaReimbursed access - Pre-symptomatic (2-3 SMN2 copies), TI (2 copies ≤6mo, 3 copies ≤8mo), II & III (≤12 years)
    LithuaniaAccess through individual reimbursement
    LuxembourgReimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
    North MacedoniaAccess through a named patient programme
    MotenegroAccess through a named patient programme
    NetherlandsRegular 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 IrelandNorthern Ireland follows NICE’s recommendation
    NorwayReimbursed access -Types I, II and IIIa (<18 yrs.)
    PolandReimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
    PortugalReimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
    RomaniaReimbursed access in line with the European label - 5q spinal muscular atrophy (SMA)
    RussiaMareting authorization was granted. Negotiation for Federal Access as of 2021 underway.
    ScotlandSMC has broadened Spinraza’s reimbursement, from Type 1 currently, to cover Types 2 & 3 (later onset)
    SerbiaAccess through a named patient programme
    SlovakiaReimbursed access -Types I, II and IIIa
    SloveniaReimbursed access Types I, II and III
    SpainReimbursed access - Types I, II and III
    SwedenReimbursed access – Paediatric (initiated below 18 years old) Types I, II and IIIa
    SwitzerlandReimbursed access - pre-symptomatic and Type I, II, III
    TurkeyAccess through a named patient programme (Type I, II, III without age limitation)
    UkraineMarketing authorization received on January 11, 2020. Negotiations expected in H2

    For more information