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
Austria	Reimbursed access – Types I, II and III
Belgium	Negotiations underway Types I, II and III
Bulgaria	Partner in place; preparing for reimbursement dossier submission
Croatia	Reimbursed access – Type I, II, III (<18 yrs)
Cyprus	Access through Individual Reimbursement
Czech Republic	Reimbursed access – Types I, II and IIIa (subject to clinical criteria)
Denmark	Reimbursed access – pre-symptomatic, Type I and II (subject to clinical criteria)
England & Wales	Awaiting NICE Appraisal Committee decision
Estonia	Negotiations underway
Finland	Reimbursed access for patients up to, and including, 17 years old, aligned with PALKO positive recommendation.
France	Negotiations underway; current reimbursed access given to Types I, II and III through post-ATU
Germany	AMNOG process finalized. Reimbursed access in line with the label – 5q spinal muscular atrophy (SMA)
Greece	Reimbursed access for pre-symptomatic, Types I and II; negotiations for Type III underway
Hungary	Biogen & NEAK agreement signed. Final access decisions will be made by NEAK as per the Rare Disease Committee criteria in response to all individual applications
Iceland	Partner in place; preparing for reimbursement dossier submission
Ireland	Negotiations underway
Israel	Reimbursed access – Types I, II and III
Italy	Reimbursed access – Types I, II and III
Kuwait	Negotiations underway; current access through a named patient programme
Latvia	Partner in place; preparing for reimbursement dossier submission
Lithuania	Access through individual reimbursement – Types I, II and III
Luxembourg	Reimbursed access – Types I, II and III
Macedonia	Negotiations underway
Netherlands	Negotiations underway Reimbursed access Type I, II and III (subject to clinical and age criteria)
Northern Ireland	Negotiations underway
Norway	Reimbursed access – Types I, II and III (0 to 18 years of age)
Poland	Negotiations underway
Portugal	Negotiations underway
Qatar	Negotiations underway; current access through a named patient programme
Romania	Spinraza included in the national list of reimbursed medicines and therapeutic protocol published (Types I,II and III)
Russia	Partner in place; preparing for reimbursement dossier submission
Saudi Arabia	Negotiations underway; current access through a named patient programme
Scotland	Reimbursed Access Type I (later-onset patients funded via the Individual Treatment Fund); negotiations for Type II and III in preparation
Serbia	Access through a named patient programme
Slovakia	Reimbursed access – Types I, II and IIIa as of August 1st 2018
Slovenia	Reimbursed access – Types I, II and III that are treated in paediatric centres
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) up to 20 years old; individual reimbursement for patients above 20
Turkey	Negotiations ongoing; current access through a named patient programme
Ukraine	Partner in place; preparing for reimbursement dossier submission
UAE	Negotiations 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.