After spending an estimated $16 million this fiscal year on Sovaldi, which holds promise for a cure for the liver-damaging disease, the state agency headed by Julie Hamos approved the restrictions July 10.
The rules limit the drug to sicker patients and bar it for anyone with a history of drug or alcohol abuse within the past year. Hepatitis C spreads today mostly among drug users sharing needles, although some people became infected before widespread screening of the blood supply through blood transfusions and transplants.
The restrictions prohibit doctors from using Sovaldi in ways that seem promising in preliminary research but haven't been approved by federal regulators. And a "once in a lifetime" rule will give Medicaid patients only one chance at the treatment.
Doctors who have seen Sovaldi wipe out the virus find the rules too restrictive. Dr. Steven Flamm of Northwestern University Feinberg School of Medicine said the constraints could eliminate all but 30 percent of the Medicaid patients he'd like to treat with Sovaldi.
"It's going to ratchet down the numbers and lead to significant outrage in the community and among patients," said Flamm, who is involved in research and accepts consulting fees from several drug companies.
The limit on early treatment is what bothers Dr. Nikunj Shah of Rush University Medical Center. He'd rather treat with Sovaldi before severe liver damage occurs. Treating earlier could prevent expensive liver transplants. "I think this would be much better investment of the money for the state," Shah said.
Like Illinois, most other states are restricting Sovaldi's use, according to a July 23 earnings call held by the drug's maker, California-based Gilead Sciences Inc. The company reported second-quarter profits of $3.66 billion, or a net margin of 56 percent.