Dear members of the SMA community,
In response to your request for information, we would like to provide you with an update on Biogen’s
SMA360 Canada Patient Support Program and the next steps following Health Canada’s approval of
SPINRAZA™ (nusinersen).
The SMA360 Canada Patient Support Program has been developed to be available for patients and
families who have received a prescription for SPINRAZA from their doctor.
Although we understand that the name of both the Canadian and US programs are similar, the programs
are different, based on country specific regulations and guidelines and differences in health and
reimbursement systems.
With Health Canada approving SPINRAZA for the treatment of 5q SMA, the Canadian SMA 360 Patient
Support Program will endeavor to provide navigation assistance for reimbursement and support where
feasible with either private or provincial/territorial public drug insurance plans depending on plan
policies and local provincial regulations in place.
However, SPINRAZA has not been through the processes of health technology assessment review that
are required for new medicines approved by Health Canada to be available for provincial/territorial
public drug insurance. SPINRAZA will undergo review by the various health technology assessment
review bodies in Canada, notably the Common Drug Review (CDR) and L’Institut national d’excellence en
santé et en services sociaux in Québec (INESSS). Biogen anticipates that the resulting recommendations
will be publicly available towards the end of 2017 and early 2018. It is anticipated that the timing for
negotiations with the provincial drug programs through the Pan-Canadian Pharmaceutical Alliance
(pCPA) will follow depending on PCPA uptake and the CDR and INESSS recommendations.
Based on provincial jurisdiction plans and policies, public drug programs may consider individual patient
claim requests, but they may also deny these claims until formal formulary reimbursement is secured.
Biogen Canada’s goal is to work closely and urgently with our public drug programs to ensure SPINRAZA
is available for appropriate Canadian patients in need as soon as possible.
Biogen Canada is continuing to provide SPINRAZA for existing and new eligible infantile-onset (Type 1)
patients for a period of time to minimize the gap in time between Health Canada approval and
reimbursement of SPINRAZA.
We recognize that this is a period of apprehension and uncertainty for the SMA community and we want
to ensure everyone understands that we are working hard to bring SPINRAZA to Canadian patients in
need as quickly as possible.
