Panel urges expanded access to hepatitis C drugs

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More people may be eligible for hepatitis C treatment under a recent proposal.

Low-income Vermonters will find it easier in the future to get live-savings drugs to cure hepatitis C.

The board that decides which drugs are available to Medicaid patients has recommended that the state lift almost all of its restrictions on access to expensive hepatitis C medications.

The recommendation from the advisory board came after more than two years of advocacy from the Vermont Coalition for Access to HCV Treatment, led by Vermont Legal Aid's Office of the Health Care Advocate.

However, the expanded treatment program could be expensive. One estimate put the cost to the Medicaid program at more than $10 million.

The advocates have argued for more than two years that the state's restrictions on the drugs are bad for patients' health, cause more spending on hepatitis C-related diseases, and violate federal Medicaid law.

Historically, Vermont Medicaid had required that patients have stage 3 or stage 4 liver damage before Medicaid would allow them access to drugs like Harvoni and Sovaldi, some of the most expensive drugs on the market.

Vermont runs its Medicaid program similarly to a health maintenance organization, or HMO, and has extensive criteria that must be reached for patients to get certain specialty drugs and procedures. The criteria are designed to keep Medicaid from spending too much money.

In December, the Medicaid Drug Utilization Review Board voted to loosen that restriction, allowing people with stage 2 liver damage to access the drugs. In February, the Department of Vermont Health Access, which runs Medicaid, started allowing people with stage 2 liver damage to get the drugs.

On Oct. 16, the coalition sent a letter to the Drug Utilization Review Board asking for "all people" with chronic hepatitis C to get treatment, regardless of the stage of liver damage. Doing so would "protect the health of Vermonters, maintain fiscal responsibility, and prevent unnecessary litigation," the coalition said.

The coalition cited a new drug, Mavyret, that came on the market in August at a maximum price of $20,000 per course of treatment—about one-quarter of the price of Harvoni or Sovaldi, according to the coalition.

"We recently learned that Mavyret is highly likely to be available at a steeply discounted price to states with no (liver damage) restrictions on HCV treatment," the coalition said.

"This type of discount is unlikely to remain available to Vermont if the state's treatment restrictions are removed via the courts or the Legislature rather than by the (Drug Utilization Review Board) and the Department of Vermont Health Access," the coalition said.

Julia Shaw, a health policy analyst with the Office of the Health Care Advocate, said the Department of Vermont Health Access still needs to implement the change so that many more people will have access to hepatitis C treatment.

Dr. Jonathan Strenio, the chief medical officer for the Department of Vermont Health Access, said the Medicaid program would recommend lifting the liver damage restrictions.

"It's the right thing to do, clinically," Strenio said. "If we can cure the disease, then we should. And secondly, there is a new medication that is available now that is significantly less expensive, so I think those are the biggest reasons for going forward with this."

However, Strenio said the state would like to work with the Legislature and policymakers before implementing the change. That's because it could cost the Medicaid program at least $10 million to treat people's hepatitis C, he said.

"I just know the Legislature has a pretty big stake in the budget and what's covered and not covered for Medicaid members across the state," Strenio said. "Since this has such a significant potential impact, it was a wise thing to do to include them in the decision-making process."

Shaw disagrees.

"There is no medical basis for the (liver damage) criterion, and until DVHA implements this change, the agency is keeping a discriminatory policy in place and ignoring its own advisory board's decision," she said. "This is unacceptable."

Strenio contends that, with the Legislature's input, the change could be implemented in the first quarter or first half of 2018. He said the amount of wait time is small in comparison to the benefit.

"We're talking about somewhere between three to five months, and I think that's a lesser concern than if we were talking about five years," he said.

Once the liver damage restrictions are lifted, according to Shaw, there will only be one remaining restriction on access to hepatitis C drugs: the patient must be treated in consultation with a specialist, and cannot have the condition treated solely by a primary care doctor.

Next, Shaw said her office would advocate for lifting that restriction so that primary care doctors can treat hepatitis C.

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