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

Date of last update: 15 May 2019.

Colour codes:

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

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  Reimbursed access – all patients
Estonia Pricing negotiations under way
Finland Reimbursed access – patients with types I and II < 18 years old
France Reimbursed access – all patients
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 under way
Hungary Individual reimbursement – patients < 18 years old
Iceland Reimbursed access – patients < 18 years old
Ireland Pricing negotiations under way; Biogen’s humanitarian programme in place 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
Malta Reimbursed access via a named patient programme
Netherlands Reimbursed access – patients < 9.5 years old (subject to restrictive clinical and age criteria)
Northern Ireland Pricing negotiations under way; Biogen’s humanitarian programme in place for children with SMA type I
North Macedonia Pricing negotiations under way
Norway Reimbursed access – patients < 18 years old
Poland Reimbursed access – all patients (including presymptomatic)
Portugal Reimbursed access – all patients
Romania Reimbursed access – all patients
Russia Dossier submitted; Biogen’s humanitarian programme in place for children with SMA type I under 2 years (max. 40 patients, subject to clinical criteria)
Scotland Reimbursed access – all patients
Serbia Access through a named-patient programme depending on funding availability
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 – all patients (subject to clinical criteria in type IIIb)
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 years old
Ukraine Dossier to be submitted in Q2 2019

Middle East

Israel Reimbursed access – all patients
Kuwait Pricing negotiations under way; a named-patient programme in place for patients with SMA type I
Qatar Pricing negotiations under way; a named-patient programme in place for patients with SMA type I
Saudi Arabia Pricing negotiations under way; a named-patient programme in place for patients with SMA type I
Turkey Reimbursed access – all patients
UAE Pricing negotiations under way; a named-patient programme in place for patients with SMA type I

Asia and Australasia

Australia Reimbursed access – patients below 18 years old
China Approval/HTA under way
Hong Kong Reimbursed access – all patients
Japan Reimbursed access – all patients
Korea Reimbursed access (details missing)
New Zealand Pricing negotiations under way; Biogen’s humanitarian programme in place for patients with SMA type I

North America

Canada Québec: 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 States Reimbursed access as approved by individual insurance providers (those rejected may access the treatment via Biogen’s humanitarian programme)
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