December 15th, 2015

Biogen Responds to CADTH’s updated recommendation regarding coverage for SPINRAZA

·Canadian Association of Drugs and Technologies in Health (CADTH) has expanded their recommendations for public reimbursement for SMA patients

·The recommendation, however, continues to limit access to treatment for many patients with SMA

·Provincial jurisdictions are the final decision makers on public reimbursement

MISSISSAUGA, Ontario, March 01, 2019 (GLOBE NEWSWIRE) -- Today, CADTH publicly released updated recommendations that could inform provincial jurisdictions’ decisions on the public reimbursement of SPINRAZA (nusinersen), the first and only approved treatment shown to be effective in the treatment of Spinal Muscular Atrophy (SMA). The updated recommendation has been expanded to include patients with:

Genetic documentation of 5q SMA homozygous gene deletion, homozygous mutation, or compound heterozygote.
Are pre-symptomatic with two or three copies of SMN2, or
Have had disease duration of less than six months, two copies of SMN2, and symptom onset after the first week after birth and on or before seven months of age, or
Are 12 years of age or younger with symptom onset after six months of age, and never achieved the ability to walk independently.
Patient is not currently requiring permanent invasive ventilation.

SMA is a debilitating neurodegenerative condition and the leading genetic cause of death among infants. Children with the most severe form of SMA rarely live to see their second birthday. SMA is a rare disease and it is estimated that 1 in 10000 live births are affected by it.

While the expanded CADTH recommendation will provide access to treatment for a larger subset of patients with SMA, it is disappointing that the clinical criteria in the recommendation continue to limit access to treatment for many patients with SMA who could potentially benefit from SPINRAZA, the only life-changing drug therapy available. Notably all patients over 12 years of age and all those who have reached the ability to walk independently (Type 3) are denied treatment.

“Biogen recognizes that CADTH has acknowledged the urgent need to provide greater access to SPINRAZA to Canadian patients, however, we continue to be extremely concerned for those patients with SMA who fall outside of CADTH’s updated, yet limiting, criteria,” said Marina Vasiliou, Managing Director of Biogen Canada. “CADTH has provided its recommendation and now the ultimate decision for public reimbursement lies with the provincial jurisdictions. We remain committed to partnering with provincial governments to ensure they can exercise their role and provide broad, sustainable coverage for all patients with SMA in Canada”.

Through Biogen’s extensive clinical development program, SPINRAZA has shown significant improvements in survival rates and motor function across a broad range of types and ages of SMA patients. Health Canada approved SPINRAZA in June 2017. CADTH and INESSS received the same clinical data as part of Biogen’s resubmission and, in December 2018, the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec released its updated recommendations to expand coverage to patients of all ages and with all types of SMA. The Government of Quebec on Dec 18th, 2018 stated in its press release “This announcement follows an agreement reached by members of the Pan-Canadian pharmaceutical Alliance, to which Quebec participated actively. This agreement allowed the provinces to obtain economic conditions favouring the inclusion of the drug.”

“Biogen believes that the benefits of SPINRAZA are clear for patients across the spectrum of the disease. Governments, regulators, payors and medical communities in more than 45 other countries and jurisdictions around the world, have recognized the broad benefit of SPINRAZA," added Vasiliou.  ‘We hope that the provincial jurisdictions will follow Quebec in providing broad access to all Canadian SMA patients and ensure equity of access to treatment across Canada.”

Statement from Cure SMA Canada:
“We at Cure SMA Canada are happy to hear that more of our patients will have the ability to access treatment.  For these patients and their families, there is hope for a better future with improved health and a longer life. We are very disappointed, however, that we have left some of our patients with no treatment options.  This was their only hope.  Imagine what it is like for these patients and their families, to know some patients are able to access this life changing and lifesaving treatment, but are not able to themselves.  We grieve with them, but we also promise that we will not give up our fight.  We do not accept this response.”
- Susi Vander Wyk, Executive Director, Cure SMA Canada

Statement from Lawrence Korngut, MD:
"The criteria recommended by CADTH will be concerning for many teenage and adult patients with spinal muscular atrophy, in particular, those who are or were able to walk independently at some point (i.e. type 3 SMA). In my experience, it is the priority of most patients with SMA, due to the inherent weakness and functional limitations, to preserve their mobility and independence as much as possible. It is unfortunate that Spinraza will now only be available to this important group of patients only if they live in Quebec but not elsewhere in Canada.”

Lawrence Korngut MD MSc FRCPC
Associate Professor (Neurology)
Director, Calgary Neuromuscular Program and EMG (Calgary Zone)
Clinical Neurosciences, South Health Campus

Statement from Craig Campbell, MD:
“Based on the current CADTH criteria, the group of type 3 SMA patients who are still ambulatory has been excluded from having access to treatment. Clinical judgement and Emerging evidence suggests that these patients may benefit significantly with nusinersen treatment to maintain their independent ambulation, and many Canadian clinicians feel it is imperative to treat this group of patients with Spinraza.”

Craig Campbell MD MSc FRCPC
Head Division of Pediatric Neurology
Deputy Chair Research, Paediatrics 
Children's Hospital LHSC
Associate Professor, Western University

For more information contact:

Thérèse Gagnon-Kugler
therese.gagnonkugler@biogen.com 

About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in Alzheimer’s disease and dementia, multiple sclerosis and neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

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