Should We Be Rationing Hepatitis Drugs? Obama Pressured to End Restrictions

Eric Pianin

Amid mounting evidence that federal and state authorities are rationing costly new wonder drugs for treating people with the potentially lethal hepatitis C virus, public health experts have begun pressing the White House to intervene to expand the use of Sovaldi and other new medications.

An estimated 3.2 million adults are chronically infected with hepatitis C while an estimated 20,000 people die from the serious liver ailment every year, including many military veterans.

Related: The Life-Saving Drug That Almost No State Can Afford

The New York Times reported on Tuesday that a group of experts from the Public Health Service and President Obama’s Advisory Council on H.I.V./AIDS wrote a letter to the White House complaining that restrictions on the use of these drugs by many states are inconsistent with prudent and sound medical practices.

The advisory group members said that the federal government should order states to either relax or eliminate restrictions that delay or deny treatment to low-income Medicaid beneficiaries. They did not address who would pay for such a move.

The cost of the new state-of-the art hepatitis C medications – as much as $1,000 a pill or $84,000 for a 12-week treatment – has become a major budget concern for the Department of Veterans Affairs, the federal prison system, Medicare and state Medicaid officials across the country.

The VA and many state Medicaid programs have negotiated deep discounts of as much as 40 percent with California-based Gilead Sciences, the manufacturer, for the purchase of Sovaldi and Harvoni, a similarly effective new drug. Yet their overall pharmaceutical costs continue to skyrocket as more and more people seek the treatment, which has an astounding 90 percent success rate and eliminates the need for long-term treatment.

Related: Cash-Strapped VA May Start Rationing Some Treatments

While VA and Medicaid officials have denied they are intentionally rationing the drugs to save money, two new studies published in late June by the Annals of Internal Medicine found that most states in fact are picking and choosing which Medicaid patients will be granted access to Sovaldi.

According to one of those studies by Lauren A. Canary, an epidemiologist with the Centers for Disease Control and Prevention in Atlanta, 31 states have designated Sovaldi as a “non-preferred” drug. That frequently means that health officials should look to cheaper, less effective alternative drugs.

Meanwhile, 17 states designated the wonder drug as “preferred.” And while providers do not necessarily have to prove medical necessity in those states in order to gain access to Sovaldi, all but two of those states require clinicians to seek “prior authorization” from Medicaid before prescribing it.

The criteria used in prior authorization varies widely from state to state. For example, doctors are expected to evaluate the extent of the liver disease, and only those deemed to have advanced stages of liver disease can receive the new drug. Others with less severe but still debilitating cases do not qualify.

Related: Medicare’s Budget Busting $4.5 Billion for Hep-C Drugs

Moreover, prior authorization criteria frequently demand that the patients abstain from alcohol, illicit drugs or both for periods of up to 12 months before treatment may begin.  A second study by Soumitri Barua, a Brown University researcher, and others concluded that these and other restrictions are in violation of federal Medicaid law.

“This listing of prior approval criteria by state Medicaid offices provides insight into the pressure that approval of new, costly HCV treatments places on state Medicaid programs and the resultant warehousing policies that limit access to lifesaving treatment,” Canary wrote in her report.

She said these widespread practices also highlights a decision-making process being used by state Medicaid review boards that are “choosing approval criteria on the basis of a mix of medical evidence, cost considerations, and perhaps-unmeasured preferences.”

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