Colorado lifts Medicaid restrictions for treating hepatitis C

Originally published by STAT on December 4, 2017. Written by Ed Silverman.

Amid ongoing criticism that some states continue to curb access to hepatitis C drugs, Colorado officials have lifted restrictions that determined when patients could receive treatment. Going forward, Medicaid beneficiaries will no longer have to demonstrate an advanced stage of liver disease to be treated.

In explaining their decision, state officials pointed to declining costs for the medicines, which have dropped in price recently as more new drugs become available. Over the summer, AbbVie (ABBV) introduced a treatment that costs $26,400, before rebates and discounts, for an eight-week regimen, which is significantly less than the $84,000 that Gilead Sciences (GILD) charged for 12 weeks of treatment for Sovaldi when it was first marketed four years ago.

“Over the past two years, there are more choices among these drugs, which has driven their cost down substantially,” said Dr. Judy Zerzan, the chief medical officer at the Colorado Department of Health Care Policy and Financing, in a statement issued on Friday. The department reportedly spent nearly $27 million treating 326 hepatitis C patients last year, or about $82,000 per person.

The move also comes a year after the American Civil Liberties Union and Center for Health Law and Policy Innovation at Harvard Law School filed a lawsuit accusing the state Medicaid program of “illegally” providing the medicines only to people with the most advanced stages of liver disease, such as cirrhosis. The state was also accused of violating standard medical care and disregarding federal warnings.

“Were a cure for cancer … discovered, no one would tolerate insurance providers telling patients: ‘We need to wait until you get really sick before we treat you.’ But that’s what patients in Colorado with hepatitis C were being told, and what patients in other states are still being told,” said Kevin Costello, the litigation director at CHLPI, in his own statement. “It’s unconscionable.”

The new generation of hepatitis C medicines, which first became available in early 2014, offered cure rates exceeding 90 percent and fewer side effects than less effective drugs that had been the standard of care. This quickly prompted many physicians to write prescriptions, even though the initial price for Sovaldi—and for subsequent medicines—was a budget buster for many private and public payers.

Drug makers and their supporters, however, argued that near-term spending would save money down the road on treating liver failure or liver cancer, and on liver transplants. But many state Medicaid programs responded by instituting coverage restrictions, despite warnings from the Centers for Medicare and Medicaid Services in 2015 not to do so because such moves may run afoul of the law.

Placing restrictions may be “contrary to the statutory requirements” of a federal law that requires state Medicaid programs to pay for all medically necessary treatments, CMS officials wrote in their notice to the state programs. And the agency warned state officials to monitor managed care organizations, which run Medicaid programs, to ensure they provide patient access to the medicines.

At the same time, the American Association for the Study for Liver Diseases and the Infectious Diseases Society of America issued guidelines that counseled physicians to “treat all patients as promptly as feasible.” However, the groups acknowledged that physicians may have to take into account the cost of the hepatitis C medicines when deciding whom to treat first.

A recent analysis by the CHLPI found that, over the past three years, state Medicaid programs have, in fact, done a much better job of disclosing information about access to hepatitis C medicines and fewer are restricting treatment to patients. Nonetheless, over 65 percent of states continue to have liver disease restrictions, and nearly one in four states still require patients to have advanced liver disease before treatment.

The move by Colorado officials will not automatically end the lawsuit, though. It’s “definitely a major step forward,” Mark Silverstein, legal director at the ACLU in Colorado, wrote us. But “since there’s now a class certified by the court, it’s not resolved just by getting coverage for our individual plaintiffs. For one thing, we need to make sure that everyone in the class gets notice that they are now eligible.”