Information About SMA Drug Zolgensma and Health Insurance

Blog, Insurance and Healthcare Denials, Insurance Bad Faith
Information About SMA Drug Zolgensma and Health Insurance

The FDA just recently 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. SMA is the number one genetic cause of infant mortality. It involves the progressive loss of motor neurons in the spinal cord and brain, and leads to muscle weakness and muscle atrophy. Prior to Zolgensma there was only one FDA-approved treatment for SMA, Spinraza, a drug that has had approval only since December of 2016. However, whereas Spinraza requires numerous maintenance treatments for the life of the child living with SMA, Zolgensma is a potential “one-time” intravenous treatment. This being said, the FDA has approved Spinraza for treatment of all people living with SMA while the approval for Zolgensma is limited to children under the age of two.

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.

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 the treatment for its members 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 but parents of children with SMA have already seen issues with insurance denials or delays since the FDA approved it. Our firm currently represents a child living with SMA who has brought suit in the Los Angeles Superior Court alleging that his insurer Blue Shield of California unreasonably denied and delayed paying for Spinraza leading to his permanent physical injury and 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 your insurance company has denied or delayed access to these treatments then contact the Law Offices of Scott C. Glovsky for a free case evaluation.