Page 10 - Mobility Management, July 2019

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Zolgensma Manufacturer: FDA Approval Is “Just the Beginning”
The U.S. Food & Drug Administration’s approval of Zolgensma, a drug that treats young children who have spinal muscular atrophy (SMA), is “just the beginning,” according to the drug’s manufacturer.
Zolgensma, manufactured by AveXis, a Novartis company, made mainstream news headlines when it was approved in May because of the drug’s high cost: $2.125 million per dose.
Nevertheless, news of FDA approval was celebrated by the SMA community, which has been raising funds for years to support research aimed at creating a treatment for SMA.
In a May 24 bulletin to stakeholders, AveXis said Zolgensma has been approved for children under age 2 who have SMA. It’s a one-time, intravenous dose that takes about 60 minutes to administer.
AveXis also recommends that children taking Zolgensma receive an oral corticosteroid the day before getting the treatment and continue taking
corticosteroids for at least 30 days afterward “to help manage elevated liver enzyme levels.”
Children who take Zolgensma should have liver enzyme levels monitored via blood tests for at least three months after receiving the drug, AveXis said. Physicians may gradually lower corticosteroid dosages based on blood test results.
AveXis said there are five ongoing Zolgensma clinical studies ongoing, with two more studies planned. As of May 2019, the company said 130 children with SMA have taken Zolgensma.
Due to the drug’s high cost, AveXis said that when a physician prescribes Zolgensma, “highly trained people from the OneGene Program, a dedicated resource from AveXis, can work closely with the patient’s insurance company to help obtain coverage.” The OneGene Program is also available to answer questions and provide guidance for families “during treatment and beyond.” m
Three American Universities Earn RESNA Accreditation
The assistive technology programs at three universities have earned accreditation under RESNA’s new program.
In a news announcement, RESNA said the schools earned accreditation from the Commission on Accreditation of Healthcare Education Programs (CAAHEP), a partnership that RESNA began last year.
The three programs now accredited are the University of Illinois/Chicago’s Department of Disability & Human Development; the University of Pittsburgh’s School of Health & Rehabilitation Sciences; and the University
of Wisconsin/Milwaukee’s College of Health Science’s Certificate in Assistive Technology & Accessible Design.
In the announcement, RESNA said, “Each of these newly approved programs has found the accreditation process valuable to their purpose of recruiting and training the next generation of AT \[assistive technology\] and RE \[rehabilitation engineering\] professionals by
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them offering assurance of educational excellence. Graduates of these accredited programs are ready for employment and prepared for assuming the role of an assistive technology professional (ATP) following their successful passage of the RESNA Certification exam.”
RESNA is seeking additional university programs that would like to be accredited.
The announcement comes at a time that the complex rehab technology industry is looking for its next genera- tion of professionals. At this year’s International Seating Symposium (ISS), hosted in March by the University of Pittsburgh, Mark Schmeler, Ph.D., OTR/L, ATP, the Director of the ISS when it’s held in the United States, noted
that ATPs are currently retiring from the industry faster than they’re being replaced. Schmeler added that the average age of today’s ATP — 52 years — is 10 years older than the average American worker. m
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