Study: States Breaking Law in Limiting Hep-C Drug Medicaid Availability

Most US states appear to be violating federal law by putting restrictions on which Medicaid recipients can get the newer hepatitis C antivirals, a Brown University study found.

Writing in Annals of Internal Medicine Soumitri Barua and colleagues looked at Medicaid policies in 50 states and Washington, D.C.

Though there are now many new hepatitis-C antivirals on the market and still more in the FDA approval pipeline, the team looked only at Medicaid policies regarding prescriptions for sofosbuvir (Sovaldi/Gilead).

Federal law requires traditional Medicaid programs to “cover drugs consistent with their US Food and Drug Administration labels,” Barua wrote, as long as their manufacturers participate in Medicaid’s prescription drug rebate program. According to federal websites, 600 drug manufacturers participate, including Gilead.

But in state Medicaid programs, the $1,000-a-day medications are generally prescribed according to limits set by individual states. Even 25% discounts obtained from pharma companies have not changed those policies, the team wrote.

“Although some payers have negotiated ample rebates, they have not altered their reimbursement restrictions,” the researchers noted.

The researchers did not attempt to learn policies in states that have expanded their Medicaid coverage under the Affordable Care Act, where newly available coverage sometimes has still more restrictions on the available of sofosbuvir, such as not considering it a “preferred drug.”

The research was limited to online information. The team was unable to get information for 9 states.

State Medicaid officials have been balking at the idea of offering the pricey antivirals to Medicaid recipients ever since they came on the market.

In California, for instance, Kaiser Health estimated that would cost the state $6.3 billion. That would be just for patients with advanced disease—not the 75% of people with the hepatitis-C virus who do not know they have it.

But the pharma companies and many physicians defend the costs as far cheaper than those of treating patients with advanced disease, particularly those who will end up needing liver transplants.

In the Annals study, the researchers catalogued the various restrictions Medicaid programs are currently setting as barriers to treatment. They include limiting the drugs to patients who do not use injection drugs, do not misuse alcohol, already have advanced fibrosis or cirrhosis, are patients co-infected with HIV, and to those patients who agree to have a liver biopsy to confirm that their liver disease is advanced.

Two thirds of the states also set limits on who can prescribe sofosbuvir, such as requiring that it be a liver transplant surgeon or other specialist.

Nevada is the only state that does not require prior authorization for sofosbuvir.

Addressing price concerns, the authors note that making sofosbuvir widely available to Medicaid recipients would not necessarily cause a stampede for the drug.

That has not happened in Massachusetts, they wrote.

“Despite relatively unrestricted access to sofosbuvir in its Medicaid fee-for-service program, recent data indicate that only 14% of Massachusetts' Medicaid enrollees known to be diagnosed with HCV are engaged in treatment.”

The authors call for revision of states’ Medicaid policies to make sure they are “in line with national clinical recommendations.”

earlier studies have documented that insurers also differ widely in coverage policies.