An overview of access to Spinraza per country based on information from Biogen and TreatSMA’s own sources.
Last updated on 23 August 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 – pre-symptomatic patients and patients with SMA types I, II and III, excluding all non-ambulant type III patients and all type IV (adult-onset) 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 | Reimbursed access – patients < 18 years old |
| Italy | Reimbursed access – all patients |
| Latvia | Reimbursed access (details missing) |
| 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 for patients < 9.5 years old (subject to clinical criteria); remaining patients have access via a managed access scheme |
| Northern Ireland | Reimbursed access – in line with access in England and Wales (see above) |
| 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 | Pricing negotiations under way; 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 via a managed access scheme |
| 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 – patients with SMA type I, II and IIIa (subject to clinical criteria) |
| 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) |
