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Biogen Update On European Access To Spinraza (Nusinersen)

Biogen update on European access to Spinraza (Nusinersen)

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 a request by TreatSMA in the UK.

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
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
Luxembourg Reimbursed access – Types I, II and III
Macedonia Negotiations underway
Netherlands Negotiations underway
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

TreatSMA 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 independently). In some countries, children have to fulfil strict age-related criteria.

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

SMAIreland campaign for wide and unrestricted access to this treatment in the Ireland.

Anton Mannering

Anton Mannering is step-father of Jordan Perez, a 10 year old boy with SMA type 2. They live in Co. Clare.

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