Sundheds- og Ældreudvalget 2019-20
SUU Alm.del Bilag 544
Offentligt
2244265_0001.png
September, 2020
Dear members of SMA Europe,
In response to your request, please find an update on access to SPINRAZA (nusinersen).
Access to reimbursed treatment
There are now 29 European countries that have access to nusinersen via regular reimbursement.
Compared to the last report, you can find an updated situation in Switzerland.
As you can see from the table, there is a range of reimbursed access: in line with the label - 5q spinal muscular
atrophy (SMA); for Type I, II, III (excluding IV) and in some cases including age restrictions e.g. <18 yrs. Additionally,
in certain countries there are rare disease/ medical committees who apply further inclusion and exclusion clinical
criteria. For more details, please see the following table:
Access & Reimbursement Details by Country
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
England & Wales
Reimbursement Label varies by Region.
Reimbursed access in line with the European label - 5q spinal muscular atrophy
(SMA) - inclusion/ exclusion criteria may apply
Access through individual reimbursement and as of Jan 2020 national access -
Types I, II and III (<18 yrs.)
Reimbursed Access -Type I, II, III. No age limitations.
Access through individual reimbursement
Reimbursed access -Types I, II and III. No age limitations.
RESTRICTED Reimbursed access
presymptomatic, Type I & II up to app 6 years of
age. (Subject to clinical criteria)
The National Institute for Health and Care Excellence (NICE) has recommended
funding for SPINRAZA (nusinersen). The positive recommendation is for the
treatment of infants, children and adults with spinal muscular atrophy (SMA),
including pre-symptomatic and SMA types 1, 2 and 3, within the terms of the
Managed Access Agreement.
Negotiations underway
Reimbursed access - Types I, II and IIIa (<18 yrs.) Diagnosis before two years of age
and symptoms started before age 20 months aligned with PALKO positive
recommendation
Reimbursed access -Types I, II and III. No age limitations
Reimbursed access in line with the label
-
5q spinal muscular atrophy (SMA)
Reimbursed access for pre-symptomatic, Types I and II; Type III access via
exceptional funding and negotiations for Type III for formal access underway
Reimbursed access
Pre-symptomatics & Types I, II and III (<18 yrs.)
Reimbursed access
Types I, II, III under 18 years old
Reimbursed access -Pre-symptomatic & Types I, II and III up to 18 years
Reimbursed access - Types I, II and III
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
1
SUU, Alm.del - 2019-20 - Bilag 544: Biogen, september 2020, oversigt over adgangen til Spinraza i europæiske lande
2244265_0002.png
Latvia
Lithuania
Luxembourg
North Macedonia
Montenegro
Netherlands
Northern Ireland
Norway
Poland
Portugal
Romania
Russia
Scotland
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Turkey
Ukraine
Reimbursed access - Pre-symptomatic (2-
SMN opies , TI
opies ≤6 o,
opies ≤8 o , II & III ≤ years
Access through individual reimbursement
Reimbursed access in line with the label - 5q spinal muscular atrophy (SMA)
Access through a named patient programme
Access through a named patient programme
Regular reimbursement for children up to 9.5 years (subject to clinical criteria) and
conditional reimbursement for SMA patients older than 9.5 years as of January
2020 for at least 7 years.
Northern Ireland follows
NICE’s re o
e datio .
Reimbursed access -Types I, II and IIIa (<18 yrs.)
Reimbursed access in line with the label
-
5q spinal muscular atrophy (SMA)
Reimbursed access in line with the label
-
5q spinal muscular atrophy (SMA)
Reimbursed access in line with the European label - 5q spinal muscular atrophy
(SMA)
Mareting authorization was granted. Negotiation for Federal Access as of 2021
underway.
SMC has broadened
Spi raza’s rei urse e t, fro Type urre tly, to over
Types 2 & 3 (later onset)
Access through a named patient programme
Reimbursed access -Types I, II and IIIa
Reimbursed access Types I, II and III
Reimbursed access - Types I, II and III
Reimbursed access
Pediatric (initiated below 18 years old) Types I, II and IIIa
Reimbursed access - pre-symptomatic and Type I, II, III
Access through a named patient programme (Type I, II, III without age limitation)
Marketing authorization received on January 11, 2020. Negotiations expected in H2
We will continue to be available to provide updates in the future, when requested.
Best regards,
The SMA Biogen Team
2