Newborn tests to include four more diseases

Screenings will look for 35

Newborns in Arkansas would be tested for an additional four genetic diseases, including one screening mandated by the state Legislature this year, under regulations approved Thursday by the state Board of Health.

The regulation allows the Department of Health to begin checking blood samples from newborns for spinal muscular atrophy, X-linked adrenoleukodystrophy, Pompe disease and mucopolysaccharidosis Type I.

With those additions, Arkansas would test for 35 disorders recommended for screening by the U.S. Department of Health and Human Services.

Testing for spinal muscular atrophy, a disease causing muscle weakness and often fatal, was mandated by the Legislature under Act 58 of 2019.

According to a federal advisory panel recommending the screening, the disease affects about 1 out of every 11,000 people.

Nationwide screening would detect the disease in about 364 babies each year, prevent about 30 deaths, and keep 50 infants from needing a ventilator, according to a

summary of the panel’s recommendation.

“I think it’s wonderful,” Rep. Julie Mayberry, R-Hensley, who sponsored the state legislation, said of the Board of Health’s approval of the regulations.

She said she’s met families of children with spinal muscular atrophy through an organization she founded offering dance classes and other activities for disabled children.

“One family I know in particular, it took them many years to find out what was wrong with their daughter,” Mayberry said. “Had they known at birth, their daughter would be running

and playing instead of in a chair with a debilitating disease.”

The board’s approval came days after the Swiss drug company Novartis announced it earned $160 million off a drug for spinal muscular atrophy during its first full quarter of sales.

The drug, Zolgensma, costs $2.1 million for a oneshot treatment and has been described as the world’s most expensive drug.

The first drug for the disease was approved by the U.S. Food and Drug Administration in late 2016.

That drug, Spinraza, marketed by Biogen of Cambridge, Mass., costs about $750,000 for the first year’s worth of treatment and $250,000 for subsequent years, according to testimony

on Mayberry’s bill before the Arkansas House Committee on Public Health Welfare and Labor in January.

Arkansas Blue Cross and Blue Shield, Arkansas’ largest health insurer, covers Zolgensma and Spinraza, said Max Greenwood, a spokesman for the company.

Amy Webb, a spokesman for the state Department of Human Services, said she didn’t have information Thursday on the state Medicaid program’s coverage for the drugs.

The Health Department laboratory tests for genetic disorders using drops of blood collected from babies at hospitals on pieces of filter paper.

Adding the four tests would increase the cost of the testing by $10, to $131,

said Glen Baker, the laboratory’s director.

Most of the additional cost would come from the tests for spinal muscular atrophy, which would require an additional staff member and new equipment, he said. Hospitals pass along the charges to patients or their insurance plans.

The regulations adding the tests will go to Legislative Council subcommittees for review after a public hearing and 30-day public comment period, Health Department spokesman Meg Mirivel said. The changes will then be filed with the secretary of state and become final 10 days later, she said.

Mirivel said Baker expects to begin the new screenings soon after the rules become final.