A new lawsuit seeks to force state Medicaid officials to revoke a policy limiting high-priced drugs to treat hepatitis C to only the sickest patients. After a similar suit last month, a private insurer changed its policy.
Two weeks after suing private insurers for improperly denying costly drugs to patients with hepatitis C infections, Seattle lawyers have expanded the fight to Washington state’s Medicaid provider.
A class-action lawsuit filed this week on behalf of two Apple Health clients — and nearly 28,000 others with the liver-damaging disease — seeks to force the Health Care Authority (HCA) to change a policy that limits the spendy drugs to only the sickest patients.
Two Medicaid patients, a 53-year-old Seattle woman and a 47-year-old Lakewood man, were prescribed the drug Harvoni to cure their hepatitis C infections. However, the prescriptions were denied because the drug is too expensive, according to the complaint filed in U.S. District Court in Western Washington.
The plaintiffs were not identified by name in the lawsuit.
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“It is unlawful to withhold prescription drugs that cure a disease from Medicaid beneficiaries based on the cost of those drugs,” the complaint filed by the firm Sirianni, Youtz, Spoonemore and Hamburger states. Co-filers include Columbia Legal Services and the Center for Health Law and Policy Innovation at Harvard Law School.
The HCA denied the lawyers’ written demand to remove the policy restricting access to the hepatitis C drugs.
“This is a complex situation and my client would like more time,” Angela Coats McCarthy, an assistant attorney general representing the HCA, wrote in a Feb. 12 response. “As you know, this is a national issue which many state and insurers are struggling with — my client is no different.”
An HCA spokeswoman said the agency hadn’t seen the lawsuit and couldn’t comment on pending or active litigation.
Harvoni is among the newest highly effective drugs that can halt the hepatitis C virus (HCV). It has a cure rate of 90 percent — but comes with a retail price tag of about $95,000 for a 12-week course of therapy.
Like dozens of state Medicaid programs across the nation, the HCA plan limits treatment with Harvoni and other direct-acting anti-viral drugs to patients with the most severe fibrosis, or liver scarring. Fibrosis is measured on a scale of F0 to F4, with the highest level indicating cirrhosis. Patients with high scores can develop liver cancer or require liver transplants.
In a letter sent to the U.S. Senate in September, Washington Medicaid Director MaryAnne Lindeblad estimated it would cost $242 million just to provide drugs for high-risk hepatitis C patients in fiscal 2016.
“If HCA were to pay for hepatitis C treatment for all Medicaid clients infected with hepatitis C, the cost would be three times the current total pharmacy budget,” she wrote. That budget is $1 billion a year.
Medical guidelines previously supported limiting the drugs to the sickest patients, but that changed last year. Experts with the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) updated their guidelines, saying that drugs such as Harvoni should be used to treat all patients with HCV, “including mild liver disease.”
Limits based on severity of illness are no longer supported by best medical practice, the lawsuit claims.
Two similar class-action lawsuits were filed late last month against private insurers Group Health Cooperative and BridgeSpan, a subsidiary of Regence BlueShield, for imposing similar limits. BridgeSpan last week updated its policy to provide the direct-acting anti-viral drugs to all hepatitis C patients, regardless of liver-fibrosis stage, a spokeswoman said.
Group Health has changed its policy to allow consideration of treatment for patients with fibrosis scores of F2 and higher rather than F3 and higher, a spokesman said.
In supplemental budget documents, HCA officials initially requested $77.7 million to expand treatment to patients with less severe liver disease, but later submitted an adjustment that would give back $44 million. The agency originally projected treating 3,600 Medicaid clients with HCV by June 2015, but actually treated about 1,200 clients.