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The tables below provide an overview of access to Spinraza per country based on information received from Biogen and TreatSMA’s own sources.

Colour codes:

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

Date of last update: 18/10/2018

Europe

Austria Reimbursed access – all patients
Belarus Dossier not yet submitted
Belgium Reimbursed access – all patients who do not require permanent mechanical ventilation
Bulgaria Dossier not yet submitted
Croatia Reimbursed access – patients < 18 years old who are not on mechanical ventilation
Cyprus Individual reimbursement
Czech Republic Reimbursed access – patients with SMA type I, II and IIIa (subject to clinical criteria)
Denmark Reimbursed access – patients with SMA types I and II (subject to clinical criteria) as well as pre-symptomatic infants
England & Wales  HTA underway; access via Biogen’s humanitarian programme for children with SMA type I (80 patients; intake closed)
Estonia Pricing negotiations underway
Finland Reimbursed access – patients < 18 years old
France Reimbursed access – patients < 18 years old with SMA types I and II; negotiations for wider access underway
Germany Reimbursed access – all patients
Greece Reimbursed access – patients with SMA types I and II as well as pre-symptomatic infants; negotiations for reimbursed access in type III underway
Hungary Individual reimbursement – patients < 18 years old
Iceland Reimbursed access – patients < 18 years old
Ireland Pricing negotiations underway; access via Biogen’s humanitarian programme for children with SMA type I
Italy Reimbursed access – all patients
Latvia Dossier not yet submitted
Lithuania Individual reimbursement – patients with SMA types I, II and IIIa 
Luxembourg Reimbursed access – all patients
Macedonia Pricing negotiations underway
Netherlands Reimbursed access – patients < 9.5 years old (subject to restrictive clinical and age criteria)
Northern Ireland Pricing negotiations underway; access via Biogen’s humanitarian programme for children with SMA type I
Norway Reimbursed access – patients < 18 years old
Poland Reimbursed access – all patients
Portugal Reimbursed access – all patients
Romania Reimbursed access – all patients
Russia HTA underway
Scotland Reimbursed access – all patients
Serbia Access through a named-patient programme
Slovakia Reimbursed access – patients with SMA type I, II and IIIa
Slovenia Reimbursed access – patients with SMA type I, II and III who are treated in paediatric centres
Spain Reimbursed access – patients with SMA type I, II and III (subject to clinical criteria)
Sweden Reimbursed access – patients initiated below 18 years old with SMA types I, II and IIIa
Switzerland Reimbursed access – patients < 20 years old, including pre-symptomatic children; individual reimbursement for patients > 20
Ukraine Dossier not yet submitted

Middle East

Israel Reimbursed access – all patients
Kuwait Access for patients with SMA type 1 through a named-patient programme; pricing negotiations underway
Qatar Access for patients with SMA type 1 through a named-patient programme; pricing negotiations underway
Saudi Arabia Access for patients with SMA type 1 through a named-patient programme; pricing negotiations underway
Turkey Reimbursed access – all patients
UAE Access for patients with SMA type 1 through a named-patient programme; pricing negotiations underway

Asia and Australasia

Australia Reimbursed access – all patients
China Approval/HTA underway
Hong Kong Reimbursed access – all patients
Japan Reimbursed access (details missing)

North America

Canada Québec: Reimbursed access – all patients
Other provinces: Reimbursed access for babies with SMA type 1 below 6 months (subject to clinical criteria); repeated HTA underway for other patients; access via Biogen’s humanitarian programme for a limited number of most urgent cases of SMA type 2 and 3
United States Reimbursed access as approved by individual insurance providers (those rejected may access the treatment via Biogen’s humanitarian programme)
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