Sundheds- og Ældreudvalget 2019-20
SUU Alm.del Bilag 539
Offentligt
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9/10/2020
SPINRAZA: Global Pricing
and Reimbursement (P&R)
Status Update Report
Global Value & Access
August 3, 2020
FOR INTERNAL USE ONLY
Executive Summary
Updated: 03 August 2020
Guidance:
For external ‘high-level’ communications, please see the following
bullet points on the overview of reimbursement across major regions/geographies:
A. Licensed countries
(i.e. countries with regulatory approval):
o
o
29
countries with formal reimbursement in
Europe
41
countries with formal reimbursement at
Global
level
B. NPP and/or individual patient reimbursed countries:
o
o
6
countries in
Europe
17
countries at
Global
level
C. Total Access (Global)
o
58
countries world-wide where we have achieved formal reimbursement, individual
reimbursement, or a named-patient sales program
o
o
o
Formal reimbursement: 41 countries
Individual patient request reimbursement: 7 countries
Named-patient sales program (NPP): 10 countries
2
FOR INTERNAL USE ONLY
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 SUU, Alm.del - 2019-20 - Bilag 539: Henvendelse af 9/9-20 fra Biogen om hvorledes behandlingstilbud til børn og unge med SMA i Danmark adskiller sig fra andre lande
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9/10/2020
SPINRAZA – Summary of Reimbursement Status
Updated: 03 August 2020
P&R
Reimbursement Status
Full reimbursement
(as per label)
Countries (71)
[22] Germany, Italy, Luxembourg, Israel, Japan, Spain, Belgium,
Romania, Hong Kong, Portugal, Poland, Scotland, Slovenia,
France, UK (England/Wales), UK (N. Ireland), Qatar, UAE, Croatia,
Brazil, Netherlands
2
, Czech Republic
Broad reimbursement
(in line or
[16] USA, Greece, Sweden, Norway, Hungary, Switzerland,
Finland, Australia, Slovakia, Iceland, S. Korea, Argentina
9
, Austria,
broader than clinical trial data)
Canada
3
, Ireland, Bulgaria
Restricted Reimbursement
(whilst negotiations ongoing)
Individual Reimbursement
Named Patient Sales Program
(NPP)
Negotiations underway
[3] Denmark
1
, Latvia
5
, Taiwan
8
[7] Chile, Cyprus, Lithuania, Uruguay, Mexico
(private insurance)
6
,
Colombia, Russia
7
[10] Turkey, S. Arabia, Kuwait, Serbia, Macau, Montenegro, Egypt,
Oman, North Macedonia, Costa Rica
[5] Estonia, New Zealand, Bahrain, Singapore, China
4
[8] Ukraine, Algeria, Malaysia, Iraq, Ecuador, Guatemala, Panama,
Peru
Preparations underway
1
Pre-symptomatic,
Type I and Type II (≤4yrs disease duration);
2
Conditional reimbursement agreement for patients >9.5yo over 7-year period beginning Jan 2020;
3
See
Slide Notes;
4
Available via Self-Pay Patient Assistance Program in conjunction with China Primary Health Care Foundation;
5
Pre-symptomatic (2 or 3 SMN2 copies), Type I (2
SMN2 copies up to 6 months, 3 SMN2 copies up to 8 months), II & III (up to 12 years);
6
Preparations underway for reimbursement through public health system ;
7
Access
via individual reimbursement at the regional level (~25% of regions have made purchases as of Q2 2020), negotiations for national reimbursement ongoing;
8
SMA patient
Type 1, 2a OR pre-symptomatic of SMN 2 two copies, starting treatment before turning 7;
9
July 2020: Argentina regulatory label restricted to Type 1 & 2 SMA.
Reimbursement for Type 1, 2 and 3a (already on treatment). Restriction for new Type 3a & Type 4. Negotiations ongoing.
3
FOR INTERNAL USE ONLY
SPINRAZA – Europe MAP of Reimbursement Status
Updated: 03 August 2020
NORWAY
FINLAND
CANADA
(CADTH)
RUSSIA
SWEDEN
FINLAND
CANADA
(majority)*
ICELAND
SCOTLAND
ESTONIA
UK (ENGLAND/WALES)
UK (N. IRELAND)
NETHERLANDS
IRELAND
DENMARK
LATVIA
LITHUANIA
POLAND
GERMANY
BELGIUM
CZECH REPUBLIC
SLOVAKIA
AUSTRIA
HUNGARY
FRANCE
ROMANIA
SERBIA
BULGARIA
PORTUGAL
ITALY
SPAIN
Broad Reimbursement
(in line or broader than clinical trial data;
coverage of all ages up to 18 yrs +/- adults)
Limited Reimbursement
(more restrictive than clinical trial data,
and/or inconsistent coverage up to 18yrs)
Named Patient Sales
(pre-
approval)/Individual
Reimbursement
Preparations Underway /
Negotiations Ongoing
Under Assessment
*See slide notes for details
LUXEMBOURG
SWITZERLAND
SLOVENIA
CROATIA
GREECE
N. MACEDONIA
CYPRUS
TURKEY
4
FOR INTERNAL USE ONLY
MONTENEGRO
For further country-specific information,
please see local reimbursement protocols
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