This article was original written by Ed Silverman and published by STAT News on May 19, 2021.
Over the past few years, state Medicaid programs have done a better job of disclosing information about access to expensive hepatitis C medicines and fewer are restricting treatments to patients, according to a new analysis.
For the first time, each state program has released treatment criteria. And since 2017, 32 states have either removed or eliminated restrictions based on a patient’s stage of liver disease, 21 have loosened rules that required patients to demonstrate they have not abused or drug or alcohol for a period of time before starting treatment, and 25 state scaled back prescribing restrictions for health care providers.
Moreover, seven states have removed all treatment restrictions and also eliminated requirements for prior authorization, according to the latest survey of Medicaid programs by the Center for Health Law and Policy Innovation at Harvard Law School and the National Viral Hepatitis Roundtable. Prior authorization refers to obtaining approval before a medicine can be prescribed.
“Overall, we see restrictions far less frequently than we had,” said Phil Waters, a staff attorney at the CHLPI, which had filed lawsuits against two state Medicaid programs over the issue and also receives pharmaceutical industry backing. “But the momentum has kind of stopped since we launched this project in 2017. It seems that the states that are going to remove restrictions have removed them.”
The progress has been tracked by the organizations since the Centers for Medicare and Medicaid Services warned state Medicaid programs in 2015 that they may be violating federal law by restricting access to hepatitis C medicines, which were described as “medically necessary.” The warning was issued as the states struggled with the high cost of new hepatitis C treatments.
The continued restrictions in so many states prompted both groups, along with two other organizations, two years ago to write CMS to complain about “egregious” barriers posed by so many states. At the time, they urged the agency to force the state programs to “comply with federal law and open access to curative hepatitis C therapy.”
The advocacy groups complain there is no medically necessary reason to implement restrictions, which run counter to guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. “But they have to balance their budgets, right?” said Waters.
In a statement Craig Kennedy, who heads Medicaid Health Plans of America, which represents managed care organizations that contract with state programs, said the organization is “pleased by the significant progress concerning access to hepatitis C drugs. We know this life-threatening condition places a disproportionate financial burden on state Medicaid programs.”
We also asked the National Association of Medicaid Directors for comment and will update you accordingly.
As noted previously, a new generation of medicines was initially celebrated by physicians and patients, thanks to high cure rates that exceed 90%. But at the same time, the medicines caused a furor. When Gilead Sciences (GILD) introduced its groundbreaking Sovaldi treatment nearly eight years ago, the medicine was priced at $1,000 a pill, or an $84,000 annual cost for a 12-week regimen.
Despite arguments that these newest medicines would lower long-term health care costs, the near-term expense for treating a surge of people quickly strained budgets. Many state Medicaid directors responded by implementing restrictions which in turn prompted the CMS warning and, later, lawsuits against a few states.
Since then, however, a growing number of hepatitis C medicines have become available. That has led to falling prices, although some states continue to complain that the cumulative cost remains daunting. For this reason, state officials in Louisiana and Washington pursued a so-called Netflix pricing model in which a company provides a guaranteed net unit price for Medicaid beneficiaries. The Louisiana program also covers patients incarcerated in state prisons.
Nonetheless, there has been a steady increase in hepatitis C infections, according to the Centers for Disease Control and Prevention. From 2014 to 2018, the number of cases rose by 65%, from 30,000 to 50,300. During the same period, however, there was a 26% drop in the number of deaths attributed to the infection.
Meanwhile, there is concern that infections and deaths will continue to increase due to the Covid-19 pandemic, which saw a drop in the number of people who might normally have scheduled routine visits with physicians or delayed treatment over the past year.
Earlier this year, the Department of Health and Human Services issued a five-year plan to eliminate hepatitis A, B, and C, the three most common forms of the virus. Elimination is defined by the World Health Organization as a 90% reduction in new chronic infections and a 65% reduction in mortality, compared to a 2015 baseline. There were an estimated 33,900 new infections that year.
“This is the first time ever the federal government released a plan to eliminate hepatitis C in the U.S. It’s a follow up response to the World Health Organization, which asked its members states to eliminate the virus by 2030,” said Adrienne Simmons program director at the NVHR. “But the ability to implement this requires funding. So the real question is will the funding come along with it?”
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