Pioneering access program begins in Brazil

 

 

The Brazilian Ministry of Health, working in collaboration with Biogen, has initiated an inaugural risk sharing agreement to assure broad access to all spinal muscular atrophy (SMA) individuals – with no age or type restriction. This type of agreement, which is still being finalized, has never occurred before in the country’s history, for any disease.


“We are so proud of our team in Brazil who are collaborating with the Ministry of Health to get this innovative agreement in place.  Enabling sustainable access to the first approved disease-modifying treatment for SMA meets clinical and social needs and we are proud to be part of this moment,” said Christiano Silva, General Manager at Biogen. “Also, as pioneers, Biogen is taking part in the development of this new public policy, that in the future might be the alternative route to patients’ access treatments, which can have a real impact for them and their families.”

 

 

Biogen is taking part in the development of this new public policy, that in the future might be the alternative route to patients access treatments.

— Christiano Silva

 

 

While Type 1 patients would follow the traditional access route, the risk sharing agreement would establish an alternative access route that would enable Type 2 and Type 3 SMA patients to get treatment while assuring the efficiency of public expenditures. Under the agreement, pre-determined real-life outcomes would be measured over the next three years. If patients meet or exceed them, SPINRAZA would be covered through the National Healthcare System as normal. If physicians, along with patients, determine patients are not sufficiently responding to treatment and make the decision to discontinue it, Biogen would be responsible for reimbursing the government. Despite the innovative approach to balance access and efficiency of public budget, the decision to stop treatment would be at the sole discretion of the patient and healthcare provider.


The risk sharing agreement remains under negotiation; details must still be defined. Over the next three years, the agreement would function as a pilot program, after which the government would decide on potentially updating clinical guidelines.


Learn more about our access programs.