BOSTON – State Medicaid programs have begun to loosen restrictions and improve transparency around access to direct-acting antiviral agents to treat hepatitis C virus infection, but inconsistencies are still the norm nationwide.
“Far too many states continue to restrict access in defiance to their obligations under the law,” said Robert Greenwald, clinical professor of law at Harvard University Center for Health Law and Policy Innovation (CHLPI), Boston.
Since 2014, the number of states that do not publish their access criteria for direct-acting antiviral agents (DAA) has dropped from 17 to 7, according to a report from CHLPI and the National Viral Hepatitis Roundtable (NVHR). Also during that period, 16 states relaxed or dropped fibrosis levels to qualify for access, and 7 decreased sobriety restrictions. The number of states that publish prescriber limitations has increased from 28 to 35. Because cost restrictions vary across insurance plans, some patients who need access get it, and others don’t, even if they have coverage, said Mr. Greenwald and Ryan Clary, NVHR executive director, who presented the report at the annual meeting of the American Association for the Study of Liver Diseases.
NVHR is a coalition of advocacy groups and local governmental agencies with interests in HCV, HIV, and infectious diseases. Its sponsors include AbbVie, Gilead Sciences, Merck, Bristol-Myers Squibb, Janssen, OraSure Technologies, Quest Diagnostics, and Walgreens. CHLPI is supported in part by Gilead, BMS, Johnson & Johnson, and ViiV Health Care.
In November 2015, the Centers for Medicaid & Medicare Services issued guidance to states, noting that while the cost of DAAs is prohibitive, states should use “sound clinical judgment” when determining access, and to “not unreasonably restrict coverage.” Varied interpretation of the guidance by state Medicaid directors means there is still a great deal of inconsistency in coverage.
Robert W. Zavoski, MD, Connecticut medical director of social services, noted that his state is making gains on balancing patient and taxpayer interests by emphasizing prevention, curbing reinfection rates, and using predictive modeling to determine the cost of HCV comorbidities.
Whitney McKnight/Frontline Medical News
Dr. Robert W. Zavoski (left) and Robert Greenwald
Aligning incentives between institutions and payers that are based on long-term patient outcomes would mean not just lowered costs, but actual savings said Doug Dieterich, MD, professor of medicine at Mount Sinai Hospital in New York.
“It’s incredibly effective to treat hepatitis C virtually independent of the price of the drug. If patients remain in the same [health insurance] plan for 3-5 years after treatment, then the cost of treatment is very effective because the cost of health care drops precipitously – about 300% per patient – as soon as you cure hepatitis C,” Dr. Dieterich said.
Reducing the cost of treatments does not automatically result in better access, according John McHutchison, MD, executive vice president of clinical research at Gilead Sciences. Gilead’s DAAs (sofosbuvir and ledipasvir/sofosbuvir) were priced to the standard of care; however, miscalculations of demand drove up costs and “blew up” budgets, he said at the meeting.
Rebates to payers, discounts to patients, and the influx of new treatments to market are helping to drive down costs, Dr. McHutchison said, but while industry “wants to develop curative therapies, our system promotes chronic therapies from the financial perspective.”
The situation is compounded by the fact that state Medicaid programs negotiate individually with pharmaceutical companies and do not make their dealings public, said Brian Edlin, MD, chief medical officer for the CDC National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. He called for more transparency regarding actual thresholds for profit and cure so that all restrictions could be dropped, and everyone could benefit. “How can much can we expect people to pay, what can we afford? All of that is out of the public domain,” he said.
Further dismantling of the barriers to care caused by high cost could be in the works if a recent proposal by FDA Commissioner Robert Califf, MD, gains traction. In an editorial published in JAMA, Dr. Califf called for collaboration between federal agencies to hasten and clarify public notification of the necessary criteria for a drug’s approval, coverage, and payment.
In the meantime, Mr. Greenwald said he and other advocates “are putting Medicaid directors on notice.”
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