Lynn Taylor, a Rhode Island-based infectious disease doctor, was quick to start prescribing the wonder-drug Sovaldi (sofosbuvir) when it was approved in 2013 as a cure for hepatitis C. Yet her state's Medicaid system started sending her strange requests. The Rhode Island health care system wanted her to certify that her patients were not drug and alcohol users -- an essential step before Medicaid would agree to pay for the drug.
Frankly, Taylor found this request bizarre. Medicaid had never made this request for patients with HIV, for example. She started to investigate, and found that colleagues in different states were experiencing similar reimbursement obstacles for Medicaid-covered hepatitis C patients. However, there was nothing in Sovaldi's label (or in the labels of subsequently approved drugs Harvoni or Viekira Pak) to indicate that drug and alcohol users should not receive treatment.
Even though this policy seemed strange, Taylor wasn't sure it was against the rules, so to speak. To answer this question, she teamed up with a legal expert, Robert Greenwald, J.D., director of Harvard Law School's Center for Health Law and Policy Innovation, and other researchers from the Kirby Institute of Australia and Brown University.
What they found was alarming. While most states are permitted to set their own respective Medicaid policies, there is a federal Medicaid policy to which all the states must adhere. According to the team's findings, most states are violating federal laws by denying coverage for Sovaldi.
Of the 42 state Medicaid programs with data available, 88% include some kind of eligibility criteria concerning drug and alcohol use. Taylor pointed out that this policy is particularly alarming because injection drug use is a leading cause of hepatitis C transmission. Therefore, curing these patients also eliminates their risk of transmission of hepatitis C to others, bringing substantial benefits on both an individual and community level.
But drug and alcohol use wasn't the only restriction Medicaid programs used to dictate Sovaldi coverage. Another common criteria was the extent of liver damage (scarring). Of those 42 programs, 74% had policies that limited treatment to patients with advanced fibrosis or even cirrhosis. Patients who are hepatitis C positive, but still have a relatively healthy liver, are typically not eligible.
In addition, there are significant provider limitations. Only a select few specialists are allowed to prescribe Sovaldi. Yet some states have too few of these specialists to address the needs of the entire state, Taylor noted. She added that these policies need to be revisited, and perhaps expanded to include nurse practitioners and other infectious disease specialists to the list of qualified prescribers.
There is no doubt that Sovaldi and other direct acting antivirals are extremely expensive. Sovaldi famously costs USD $84,000, or USD $1,000 per pill. Therefore, it makes sense that a budget-strapped state Medicaid system would try to limit coverage in any way possible.
The high price of hepatitis C medication turns prescribing choices into an ethical conundrum. Society has to choose which patients "deserve" to be treated, because not everyone can be treated right away. Yet there is a big difference between "rationing" and "prioritizing" treatment, Taylor said.
The only appropriate solution is to lean heavily on national and international guidelines to determine coverage policy, according to Taylor. But the research team found that most state Medicaid restrictions were not based on scientific evidence, treatment guidelines or clinical data. For example, most major federal agencies and medical associations recommend treatment for people who inject drugs, including the National Institutes of Health, the American Association for the Study of Liver Diseases/Infectious Diseases Society of America, the European Association for the Study of the Liver, the International Network for Hepatitis in Substance Users and the World Health Organization.
From a prioritization perspective, Taylor admits that there is logic to the policy of treating patients with cirrhosis and fibrosis first, as these patients are the most sick. But restricting treatment for drug and alcohol users is discriminatory and doesn't make a lot of sense, she said.
She hopes that her team's findings, published in the Annals of Internal Medicine, will encourage state Medicaid programs to change their coverage policies. As it stands, these policies deny lifesaving medication to patients who should qualify under federal rules.