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An overview of access to Spinraza per country based on information from Biogen and TreatSMA’s own sources.

Last updated on 23 August 2019.

Colour codes:

  • full/broad access
  • partial access
  • restricted access / procedures underway
  • no access / procedures not yet started

Europe

AustriaReimbursed access – all patients
BelarusDossier not yet submitted
BelgiumReimbursed access – all patients who do not require permanent mechanical ventilation
BulgariaDossier not yet submitted
CroatiaReimbursed access – patients < 18 years old who are not on mechanical ventilation
CyprusIndividual reimbursement
Czech RepublicReimbursed access – patients with SMA type I, II and IIIa (subject to clinical criteria)
DenmarkReimbursed access – patients with SMA types I and II (subject to clinical criteria) as well as pre-symptomatic infants
England & Wales Reimbursed access – pre-symptomatic patients and patients with SMA types I, II and III, excluding all non-ambulant type III patients and all type IV (adult-onset) patients
EstoniaPricing negotiations under way
FinlandReimbursed access – patients with types I and II < 18 years old
FranceReimbursed access – all patients
GermanyReimbursed access – all patients
GreeceReimbursed access – patients with SMA types I and II as well as pre-symptomatic infants; negotiations for reimbursed access in type III under way
HungaryIndividual reimbursement – patients < 18 years old
IcelandReimbursed access – patients < 18 years old
IrelandReimbursed access – patients < 18 years old
ItalyReimbursed access – all patients
Latvia Reimbursed access (details missing)
LithuaniaIndividual reimbursement – patients with SMA types I, II and IIIa 
LuxembourgReimbursed access – all patients
MaltaReimbursed access via a named patient programme
NetherlandsReimbursed access for patients < 9.5 years old (subject to clinical criteria); remaining patients have access via a managed access scheme
Northern IrelandReimbursed access – in line with access in England and Wales (see above)
North MacedoniaPricing negotiations under way
NorwayReimbursed access – patients < 18 years old
PolandReimbursed access – all patients (including presymptomatic)
PortugalReimbursed access – all patients
RomaniaReimbursed access – all patients
RussiaPricing negotiations under way; Biogen’s humanitarian programme in place for children with SMA type I under 2 years (max. 40 patients, subject to clinical criteria)
ScotlandReimbursed access – all patients via a managed access scheme
SerbiaAccess through a named-patient programme depending on funding availability
SlovakiaReimbursed access – patients with SMA type I, II and IIIa
SloveniaReimbursed access – patients with SMA type I, II and III who are treated in paediatric centres
SpainReimbursed access – all patients (subject to clinical criteria in type IIIb)
SwedenReimbursed access – patients initiated below 18 years old with SMA types I, II and IIIa
SwitzerlandReimbursed access – patients < 20 years old, including pre-symptomatic children; individual reimbursement for patients > 20 years old
UkraineDossier to be submitted in Q2 2019

Middle East

IsraelReimbursed access – all patients
KuwaitPricing negotiations under way; a named-patient programme in place for patients with SMA type I
QatarPricing negotiations under way; a named-patient programme in place for patients with SMA type I
Saudi ArabiaPricing negotiations under way; a named-patient programme in place for patients with SMA type I
TurkeyReimbursed access – all patients
UAEPricing negotiations under way; a named-patient programme in place for patients with SMA type I

Asia and Australasia

AustraliaReimbursed access – patients below 18 years old
ChinaApproval/HTA under way
Hong KongReimbursed access – all patients
JapanReimbursed access – all patients
KoreaReimbursed access – patients with SMA type I, II and IIIa (subject to clinical criteria)
New ZealandPricing negotiations under way; Biogen’s humanitarian programme in place for patients with SMA type I

North America

CanadaQuébec: Reimbursed access – all patients
Other provinces: Reimbursed access for babies with SMA type I below 6 months (subject to clinical criteria); a new HTA under way for other patients; Biogen’s humanitarian programme in place for a limited number of most urgent cases of SMA type II and III
United StatesReimbursed access as approved by individual insurance providers (those rejected may access the treatment via Biogen’s humanitarian programme)
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