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Cut your price, Biogen told
Posted 26 February 2018
The PBAC has told Biogen that the price it wants for reimbursement of its spinal muscular atrophy drug Spinraza is too high and a "substantial reduction in the proposed price will be required" if the company's resubmission is to be successful when it is considered next week.
The PBAC met with spinal muscular atrophy stakeholders last month after Biogen's initial submission for reimbursement was rejected by the committee at its November 2017 meeting.
With Biogen immediately resubmitting the drug for reconsideration at the committee's March meeting next week, the committee held a stakeholder meeting in January to canvas issues with local and global Biogen representatives, the SMA Australia CEO, SMA health practitioners and a patient representative.
According to the PBS website, it is the seventh PBAC stakeholder meeting to be held in four years, although the previous meeting was in February 2016.
SMA stakeholders have run a high-profile media campaign in the past 12 months featuring children impacted by SMA and responding well to Spinraza. Biogen is seeking PBS reimbursement of the treatment for infantile-onset (Type I) and childhood-onset (Types II and III) SMA.
The PBAC said it rejected Biogen's first submission in November "due to uncertainty about the clinical effectiveness of nusinersen in terms of the extent and durability of response across the spectrum of SMA for which subsidy was sought".
"The PBAC acknowledged that there is a high and urgent clinical need for treatments for SMA, particularly for the most severe forms of the condition, and noted that the consumer input was strongly supportive of a broad PBS listing across all forms of SMA, including adult onset disease," the PBAC noted in its minutes of the January meeting.
"The PBAC considered that while the available evidence suggests patients may receive some benefit from nusinersen, the benefit needed to be better quantified.
"The PBAC considered that further information on the cost-effectiveness of treatment with nusinersen is necessary in order for it to be able to form a view on the appropriate PBS subsidy price, but that based on the information already available it is likely that a substantial reduction in the proposed price will be required."
PBAC Chair Professor Andrew Wilson said the committee acknowledged "the high clinical need for treatments for patients with SMA, particularly for young patients with the severest forms of the condition".
Information provided at the meeting would inform the PBAC's deliberations next month, Wilson said, while Biogen was also encouraged to use the information "in developing subsidy proposals for PBAC consideration".
Megan Brodie
Posted 26 February 2018
The PBAC has told Biogen that the price it wants for reimbursement of its spinal muscular atrophy drug Spinraza is too high and a "substantial reduction in the proposed price will be required" if the company's resubmission is to be successful when it is considered next week.
The PBAC met with spinal muscular atrophy stakeholders last month after Biogen's initial submission for reimbursement was rejected by the committee at its November 2017 meeting.
With Biogen immediately resubmitting the drug for reconsideration at the committee's March meeting next week, the committee held a stakeholder meeting in January to canvas issues with local and global Biogen representatives, the SMA Australia CEO, SMA health practitioners and a patient representative.
According to the PBS website, it is the seventh PBAC stakeholder meeting to be held in four years, although the previous meeting was in February 2016.
SMA stakeholders have run a high-profile media campaign in the past 12 months featuring children impacted by SMA and responding well to Spinraza. Biogen is seeking PBS reimbursement of the treatment for infantile-onset (Type I) and childhood-onset (Types II and III) SMA.
The PBAC said it rejected Biogen's first submission in November "due to uncertainty about the clinical effectiveness of nusinersen in terms of the extent and durability of response across the spectrum of SMA for which subsidy was sought".
"The PBAC acknowledged that there is a high and urgent clinical need for treatments for SMA, particularly for the most severe forms of the condition, and noted that the consumer input was strongly supportive of a broad PBS listing across all forms of SMA, including adult onset disease," the PBAC noted in its minutes of the January meeting.
"The PBAC considered that while the available evidence suggests patients may receive some benefit from nusinersen, the benefit needed to be better quantified.
"The PBAC considered that further information on the cost-effectiveness of treatment with nusinersen is necessary in order for it to be able to form a view on the appropriate PBS subsidy price, but that based on the information already available it is likely that a substantial reduction in the proposed price will be required."
PBAC Chair Professor Andrew Wilson said the committee acknowledged "the high clinical need for treatments for patients with SMA, particularly for young patients with the severest forms of the condition".
Information provided at the meeting would inform the PBAC's deliberations next month, Wilson said, while Biogen was also encouraged to use the information "in developing subsidy proposals for PBAC consideration".
Megan Brodie
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