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Biogen widens Spinraza access
Posted 24 April 2018
Biogen has expanded its compassionate access program for paediatric patients with infantile- or childhood-onset Spinal Muscular Atrophy (SPA) eligible for the newly PBAC-recommended Spinraza.
Biogen has made its drug available to type 1 SMA patients - those with the most serious form of the disease - since 2016 but a surprise recommendation by the PBAC to back supporting its listing in three types has prompted the jubilant company to expand the program.
"In addition to the expanded access program for type I patients that Biogen has been running since 2016, the company has set up an additional compassionate access initiative for patients fulfilling the PBS criteria that will operate until the PBS listing takes effect," a Biogen spokesperson said.
The spokesperson said Biogen was now "working as quickly as possible with the government to meet their detailed processes and requirements to ensure Spinraza is made available on the PBS as soon as is feasible".
The March PBAC submission followed a November rejection and a subsequent stakeholder meeting in January at which Biogen was told to cut its price if it wanted the PBAC to back its next submission.
The company was asked to resubmit to the March meeting but in type 1 SMA only, however, it submitted for three types - most likely at a considerable price reduction to its original submission.
"Through Biogen's persistence in requesting the PBAC consider all 'urgent' types of SMA, Spinraza has now been recommended for reimbursement for SMA types I, II and IIIa," the Biogen spokesperson said.
SMA patient group head Julie Cini described the PBAC recommendation as "a phenomenal outcome, especially as Biogen was asked to resubmit to the March meeting for SMA type 1 only".
"When SMA Australia representatives were invited to the stakeholder meeting in January we highlighted the unmet need for urgent cases outside type 1 and we asked the PBAC to consider those families as well," she said.
Megan Brodie
Posted 24 April 2018
Biogen has expanded its compassionate access program for paediatric patients with infantile- or childhood-onset Spinal Muscular Atrophy (SPA) eligible for the newly PBAC-recommended Spinraza.
Biogen has made its drug available to type 1 SMA patients - those with the most serious form of the disease - since 2016 but a surprise recommendation by the PBAC to back supporting its listing in three types has prompted the jubilant company to expand the program.
"In addition to the expanded access program for type I patients that Biogen has been running since 2016, the company has set up an additional compassionate access initiative for patients fulfilling the PBS criteria that will operate until the PBS listing takes effect," a Biogen spokesperson said.
The spokesperson said Biogen was now "working as quickly as possible with the government to meet their detailed processes and requirements to ensure Spinraza is made available on the PBS as soon as is feasible".
The March PBAC submission followed a November rejection and a subsequent stakeholder meeting in January at which Biogen was told to cut its price if it wanted the PBAC to back its next submission.
The company was asked to resubmit to the March meeting but in type 1 SMA only, however, it submitted for three types - most likely at a considerable price reduction to its original submission.
"Through Biogen's persistence in requesting the PBAC consider all 'urgent' types of SMA, Spinraza has now been recommended for reimbursement for SMA types I, II and IIIa," the Biogen spokesperson said.
SMA patient group head Julie Cini described the PBAC recommendation as "a phenomenal outcome, especially as Biogen was asked to resubmit to the March meeting for SMA type 1 only".
"When SMA Australia representatives were invited to the stakeholder meeting in January we highlighted the unmet need for urgent cases outside type 1 and we asked the PBAC to consider those families as well," she said.
Megan Brodie
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