SSH Opposes States’ Efforts to Limit Access to LUXTURNA™
In the wake of the December 2017 approval by the U.S. Food and Drug Administration of voretigene neparvovec (LUXTURNA™) to treat vision loss in patients with biallelic RPE65 mutation associated retinal dystrophy, some states are moving to restrict patient access to this life-changing gene therapy treatment.
Both Oregon and Oklahoma have begun the process to limit access to treatment with LUXTURNA™.
In Oregon, the Oregon Health Authority (OHA) has proposed prior authorization requirements for voretigene neparvovecrzyl that might exclude patients who suffer from inherited retinal dystrophies and are in need of treatment by restricting coverage to certain disease subtypes, counter to the Food and Drug
Administration’s (FDA) approved indication.
In Oklahoma, the proposed prior authorization requirements for LUXTURNA™ would exclude
many individuals who suffer from life-altering vision loss due to RPE65 genetic mutation. The Oklahoma regulation would require a certain degree of blindness in an individual in order to “qualify” for treatment. FDA guidelines recommend treatment as early as possible for best outcomes.
As advocates for the IRD and LCA community, SSH is responding. Read SSH’s full letter to the Oklahoma Health Care Authority here.