Florida Adds Endari to Medicaid Preferred Drug List
The PDL, according to the Florida Agency for Health Care Administration (AHCA), is a listing of medications that are considered cost-effective, safe and clinically efficient. Importantly, medications on the PDL can be prescribed without prior authorization, which means a physician does not have to check with an insurer before prescribing certain medicines.
Essentially, being on the PDL means that physicians now may prescribe Endari to patients in Florida who are insured through Medicaid without first asking Medicaid for the go-ahead to do so. Medicaid is the federal government program that provides health insurance to low-income individuals in the U.S.
“This approval from the Florida AHCA exemplifies their belief that Endari provides valuable clinical benefits to patients who are experiencing effects of their sickle cell disease and adds Florida to the many other states that have eliminated any prior authorization criteria,” Yutaka Niihara, MD, chairman and CEO of Emmaus, said in a press release.
“This moves us another step closer to our goal of making Endari readily available to all professional health care providers and their sickle cell disease patients in need,” Niihara said.
Endari was added to the PDL in Texas last year.
SCD is caused by mutations that lead to the production of an abnormal form of hemoglobin, the protein that red blood cells use to ferry oxygen through the bloodstream, which causes them to take on a sickle-like shape that gives SCD its name. This abnormal hemoglobin also causes red blood cells to be more vulnerable to a type of cellular damage called oxidative stress, which is driven by an imbalance between the production of highly reactive oxygen-containing molecules and the body’s antioxidant defense mechanisms.
The active ingredient in Endari, L-glutamine, is an amino acid — one of the building blocks that cells use to assemble proteins. In SCD, damaged red blood cells can use this amino acid to help build antioxidant molecules, helping them to counteract the effects of oxidative stress.
The U.S. Food and Drug Administration approved Endari in 2017 to treat people with SCD, ages 5 and older. It was approved recently in the United Arab Emirates, and is currently up for potential approvals in Kuwait and Saudi Arabia.