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  • Zolgensma™

Zolgensma™

What is Zolgensma™?

Zolgensma, previously known as AVXS-101, is a gene replacement therapy developed to treat the genetic root cause of spinal muscular atrophy (SMA) type 1 in pediatric patients. The treatment was recently approved by the FDA as a single-dose intravenous treatment for infants.

In clinical trials, this one-time treatment has proven effective for the children and families affected by this life-threatening genetic disorder. Children’s Health is one of a few select locations in the U.S. able to provide this gene replacement therapy.

How can my child receive this treatment?

Children’s Health is not able to administer Zolgensma to patients unless their health insurer has authorized the gene therapy. We also cannot begin the process for authorization until your insurance carrier has issued coverage guidelines.

Once an authorization and payment from your insurance provider has been secured, they will work with the appropriate specialty pharmacy to obtain the Zolgensma therapy. The pharmacy will prepare and ship the Zolgensma treatment to Children’s Medical Center Dallas. From there, your Neurology provider will coordinate the plan and schedule therapy for your child. We do not have a set timeline for this process and expect that timelines will vary based on an individual’s insurance carrier’s procedures.

As of today, the following insurers has established coverage guidelines for Zolgensma. We are awaiting updates from all other insurance plans and are hopeful additional guidelines will be released soon. The table below provides links to coverage guidelines.

Commercial Insurance Carriers

Carrier: UnitedHealthcare
Guidelines: Medical Benefit Drug Policy 2019D0079A
Effective Date: May 29, 2019

Carrier: Anthem
Guidelines: Gene Therapy for Spinal Muscular Atrophy
Effective Date: June 13, 2019

Medicaid Insurance Carriers

Carrier: UnitedHealthcare Community Plan
Guidelines: Medical Benefit Drug Policy CS2019D0079A
Effective Date: May 29, 2019

If your insurer has not issued guidelines, here are two things you can do:

  1. We encourage you to contact your insurance carrier and advocate for your child to receive Zolgensma.
  2. If your insurance plan is through an employer, we also suggest you contact your employer’s HR personnel and ask them to also advocate for your child with contacts they may have at your insurance provider.

If your insurance plan has issued guidelines, and you are unsure if you meet the criteria, Children’s Health will work with your case manager and physician to submit a Letter of Medical Necessity to determine coverage and/or next steps.

If your insurance carrier has issued guidelines and you do not meet their criteria for Zolgensma, you may also:

  1. Contact your insurance company and advocate for your child.
  2. If your insurance plan is through an employer, we also suggest you contact your employer’s HR personnel and ask them to also advocate for your child with contacts they may have at your insurance provider.

We know this can be a timely and frustrating process as insurance guidelines are created. Children’s Health will continue to provide updated information to support our patient families in their efforts toward receiving Zolgensma.

If you have further questions after speaking with your insurance company, please contact our Managed Care team via email at zolgensma@childrens.com.

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