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Biogen Update On European Access To Spinraza

Biogen update on European access to Spinraza

Below is an update on reimbursed access to Spinraza treatment in Europe and the Middle East. The news was provided to us today by Biogen in response to our request.

NOTE: An updated list can be viewed here.

Dear SMA Community,

In response to your request for an update, please find an update on access to SPINRAZA® (nusinersen) in Europe.

Access to reimbursed treatment

In Europe and across the region, significant progress continues to be made. For full details, please see the following table:

Access & Reimbursement Details by Country
AustriaReimbursed access – Types I, II and III
BelgiumNegotiations underway Types I, II and III
BulgariaPartner in place; preparing for reimbursement dossier submission
CroatiaReimbursed access – Type I, II, III (<18 yrs)
CyprusAccess through Individual Reimbursement
Czech RepublicReimbursed access – Types I, II and IIIa (subject to clinical criteria)
DenmarkReimbursed access – pre-symptomatic, Type I and II (subject to clinical criteria)
England & Wales Awaiting NICE Appraisal Committee decision
EstoniaNegotiations underway
FinlandReimbursed access for patients up to, and including, 17 years old, aligned with PALKO positive recommendation.
FranceNegotiations underway; current reimbursed access given to Types I, II and III through post-ATU
GermanyAMNOG process finalized. Reimbursed access in line with the label – 5q spinal muscular atrophy (SMA)
GreeceReimbursed access for pre-symptomatic, Types I and II; negotiations for Type III underway
HungaryBiogen & NEAK agreement signed. Final access decisions will be made by NEAK as per the Rare Disease Committee criteria in response to all individual applications
IcelandPartner in place; preparing for reimbursement dossier submission
IrelandNegotiations underway
IsraelReimbursed access – Types I, II and III
ItalyReimbursed access – Types I, II and III
KuwaitNegotiations underway; current access through a named patient programme
Latvia Partner in place; preparing for reimbursement dossier submission
LithuaniaAccess through individual reimbursement – Types I, II and III
LuxembourgReimbursed access – Types I, II and III
MacedoniaNegotiations underway
NetherlandsNegotiations underway Reimbursed access Type I, II and III (subject to clinical and age criteria)
Northern IrelandNegotiations underway
NorwayReimbursed access – Types I, II and III (0 to 18 years of age)
PolandNegotiations underway
PortugalNegotiations underway
QatarNegotiations underway; current access through a named patient programme
RomaniaSpinraza included in the national list of reimbursed medicines and therapeutic protocol published (Types I,II and III)
RussiaPartner in place; preparing for reimbursement dossier submission
Saudi ArabiaNegotiations underway; current access through a named patient programme
ScotlandReimbursed Access Type I (later-onset patients funded via the Individual Treatment Fund); negotiations for Type II and III in preparation
SerbiaAccess through a named patient programme
SlovakiaReimbursed access – Types I, II and IIIa as of August 1st 2018
SloveniaReimbursed access – Types I, II and III that are treated in paediatric centres
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) up to 20 years old; individual reimbursement for patients above 20
TurkeyNegotiations ongoing; current access through a named patient programme
UkrainePartner in place; preparing for reimbursement dossier submission
UAENegotiations underway; current access through a named patient programme

 

Thank you for the support we consistently receive from the entire SMA community.  We would not have made such progress without you, the families living with SMA, the physicians, health systems and government agencies who have supported the nusinersen program. We still have much work to do and we will continue to work tirelessly to ensure that patients who may benefit from nusinersen will receive access as quickly as possible.

We will continue to be available to provide updates in the future, when requested.

Best regards,

The SMA Biogen Team

We noted that access in some countries is more restricted that the table suggests. For instance, in France those with SMA type III as well as adults with any type are not likely to be allowed access. Access in a number of countries excludes those with SMA type 3b (those still able to walk independetly). In some countries, children have to fulfil strict age-related criteria.

TreatSMA campaigns for wide and unrestricted access to this treatment in the UK.

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