Hep C Debate: Should the Feds Require States to Cover Drugs for All?

The debate over whether state Medicaid programs are violating federal law by restricting access to pricey new hepatitis-C drugs is getting hotter. The While House is under new pressure to step in.

In recommendations that are likely to turn up the heat on a national debate, President Barack Obama’s Advisory Council on HIV/AIDS yesterday urged the administration to make the costly new hepatitis C antiviral drugs available to all Medicaid patients who need them.

Under federal law, states have leeway in setting Medicaid benefits.

But as MD Magazine reported last month, authors of a Brown University study published in Annals of Internal Medicine have argued that most states are apparently violating federal law by putting restrictions on which Medicaid recipients can get these drugs.

The authors reasoned that federal law also requires traditional Medicaid programs to “cover drugs consistent with their US Food and Drug Administration labels,” lead author Soumitri Barua wrote, as long as their manufacturers participate in Medicaid’s prescription drug rebate program. That would include Gilead, the manufacturer of sofosbuvir (Solvadi) the focus of the Brown study.

Due to the costs of these drugs, which can cost $1,000 for a daily pill, some states are restricting these therapies to patients who can show they have not abused drugs or alcohol for a year. Others are enacting rules on which specialists can prescribe them.

A recent Harvard Law School study also found that medical criteria for prescribing vary. Those include setting fibrosis criteria, and criteria related to HIV status, such as requiring that a patient with HIV co-infection have an undetectable viral load.

The hepatitis C drugs are widely acknowledged to be so effective that they are worth their high price tags compared to the costs of having end-stage liver disease and receiving a liver transplant.

In video interviews with MD Magazine at the 2015 European Association for the Study of the Liver, Fred Poordad, MD, of the Texas Liver Institute discussed the effectiveness of the drugs while Markus Peck, MD, the association’s chairman talked about price and the lack of testing.

The costs to Medicaid programs, as much as $84,000 per patient, would grow if states aggressively tested at-risk populations like prisoners and homeless people.In the interview, Peck said wealthy nations like the US should absorb that cost.

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 the new drugs would cost its state Medicaid program $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.

In a letter to President Obama, reported today by The New York Times, advisory council called on the White House to bar states from restricting the drugs to any Medicaid patient who needs them. The only exception would be patients who clearly have less than a year to live.

Other limits are “unreasonable and discriminatory” and “not supported by medical evidence,” the council's letter noted.