SMA Drug Zolgensma Health Insurance Denial
FDA Approved Zolgensma
The FDA approved Zolgensma® as a treatment for Children under the age of two who are living with Spinal Muscular Atrophy (“SMA”). SMA is a rare neuromuscular genetic disease that affects the control of voluntary muscle movement. It is the number one genetic cause of infant mortality. SMA involves the progressive loss of motor neurons in the spinal cord and brain. It leads to muscle weakness and muscle atrophy. Prior to Zolgensma, there was only one FDA-approved treatment for SMA, Spinraza (approved in December 2016). Whereas Spinraza requires numerous maintenance treatments for the life of the child living with SMA, Zolgensma is a potential “one-time” intravenous treatment. Also, the FDA approved Spinraza for treatment of all people living with SMA. However, Zolgensma’s approval is limited to children under the age of two. If you receive a Zolgensma health insurance denial, contact our firm. We may be able to help.
The FDA approval for Zolgensma follows data from an ongoing Phase 3 STR1VE trial, and a completed Phase 1 START trial that began in 2014 to evaluate the efficacy and safety of the drug when administered by intravenous infusion to children living with type 1 SMA, the most severe form, who were up to 6 months in age. Learn more about the medication Zolgensma here.
Zolgensma is Lifesaving And Expensive
While Zolgensma is a lifesaving, life changing and groundbreaking drug, it is also incredibly expensive. The single dose will have a cost in the millions. It is undoubtedly likely that health insurers will take measures to delay or deny coverage for its members. Denials even though it could mean the difference between a child’s life or their ability to walk for the rest of their life. A dose of Zolgensma is magnitudes more expensive than Spinraza. However parents of children with SMA have already seen issues with insurance denials or delays since the FDA approved it.
Our firm represented a child living with SMA and brought suit in the Los Angeles Superior Court. The suit alleged that his insurer Blue Shield of California unreasonably denied and delayed paying for Spinraza. And this led to his permanent physical injury. It also led to the emotional distress of his mother who had to watch him weaken and degrade during the delay.
If you have questions about Zolgensma or Spinraza or if you receive a Zolgensma health insurance denial, contact the Law Offices of Scott Glovsky for a free case evaluation.