November 6, 2015 — State Medicaid programs may be illegally restricting coverage for the hepatitis C drugs Sovaldi and Harvoni, federal officials warn.
The Centers for Medicare and Medicaid Services (CMS) wrote that some state may be “imposing conditions for coverage that may unreasonably restrict access,” according to the Wall Street Journal.
States may be violating federal laws that require Medicaid programs to pay for all “medically necessary” treatments for conditions approved by the FDA. However, coverage for Sovaldi and Harvoni varies widely across the nation.
Many states limit access to patients who have developed scarring (cirrhosis or fibrosis) due to advanced liver disease and abstained from drugs and alcohol.
Critics say such restrictions are not backed by the FDA. It can also take years for hepatitis C to reach that stage. In the meantime, patients can spread the disease and they may experience symptoms like chronic fatigue.
There was no cure for hepatitis C until 2013, when Gilead Sciences introduced Sovaldi and Harvoni. Each 12-week treatment is more than 95% effective at curing hepatitis C and with far fewer side effects than other drugs. However, with a $95,000 price-tag in the United States, very few people can afford treatment without relying on insurance.
In 2014, Medi-Cal denied coverage to 94% of hepatitis C patients in California who requested Harvoni or Sovaldi, the Los Angeles Daily News reports.
The situation is even more grim in Texas, which has the third-largest Medicaid population after California and New York. Texas was the only state to spend nothing on Sovaldi last year — “price was the biggest issue,” a spokeswoman told the Wall Street Journal.
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