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Across the globe, people will mark World Hepatitis Day on July 28 to raise awareness about viral hepatitis, call for better access to prevention and treatment programs, and advocate for greater government action. Here in the United States that includes bringing to light the hundreds of thousands of people living with hepatitis C (HCV) who could be cured of their disease in as little as two months by a pill taken just once a day. However, most state Medicaid programs are refusing to pay for their treatment. Claiming high drug costs, these states are restricting access to only those with severe liver damage or who have abstained from substance use. This forces people to become sicker than necessary, violates current Medicaid law, and will cost state Medicaid programs more in the long run. This rationing of treatment needs to be stopped.
HCV is a deadly infectious disease. Left untreated, it can cause liver damage, cirrhosis, and is a leading cause of liver cancer. Every year, nearly 20,000 people in the United States die from HCV and its complications, and HCV-associated deaths now exceed the number of deaths from 60 other nationally notifiable diseases, including HIV, combined. More than one-third of the estimated 3.5 million people living with HCV in the United States are expected to die from HCV-related complications that could be averted by a simple treatment over a matter of weeks if they have access to the drugs. With the number of new HCV cases having tripled since 2010, an increase fueled by the opioid epidemic, something needs to be done now.
Instead, states are making it harder to access treatment. Currently, 33 states plus the District of Columbia are restricting access to the HCV cure to patients with a Fibrosis Score of F2 or higher, and 15 of those states require a score of F3 or above. Translated into layman’s terms, a score of F2 means moderate liver scarring while F3 means severe fibrosis. Additionally, 38 states require patients to attest to or be tested for sobriety from drugs and/or alcohol, or to be assessed or enrolled in a substance use treatment program, before HCV treatment can begin. These restrictions violate Medicaid law, is against what the FDA decided when they approved the drugs and run counter to current HCV treatment guidelines.
In reaction to this growing trend, the Centers for Medicare and Medicaid Services took a step that it almost never does and sent a State Notice in November 2015 warning states they cannot restrict access to approved HCV drugs for non-medical reasons and reminded them that they must cover every prescription drug by every manufacturer that participates in the Medicaid rebate program. Since that Notice, several states have expanded access, but mostly as a result of or the threat of litigation. Patients should not have to rely on a long, arduous, and costly legal process in each state to ensure access to a drug that can cure them of a life-threatening infectious disease.
The restrictions are also contrary to treatment guidelines developed by expert panels that conclude treatment of nearly all patients diagnosed with HCV should be encouraged, regardless of Fibrosis Score or abstinence length. Additionally, the National Academies of Science, Engineering, and Medicine in a report on how to eliminate hepatitis recently recommended that health plans, including Medicaid, “remove restrictions that are not medically [necessary] and offer direct-acting antivirals to all chronic hepatitis C patients.” If states won’t voluntarily lift the restrictions, then the Trump administration should take steps to enforce the Medicaid law and force states to provide these cures without unnecessary restrictions.
While states and others continue to claim that the price of the drugs are high, they seem to be focusing on the original list price for the drugs, and living in the past with headlines of a $1,000 per day drug. Since then prices have dropped tremendously as new treatments with lower list prices have been approved, creating a very competitive market allowing states and other purchasers to receive substantial discounts.
By law, state Medicaid programs receive an automatic 23 percent rebate from a drug’s price, so they never pay the list price. Pharmaceutical companies provide additional discounts and the federal government bears a large part of a state’s Medicaid costs. So now, based on treatment costs of $28,000, one state Medicaid program is estimating their share would only be $8,300 to cure a patient. Despite this, Louisiana is considering asking the federal government to take emergency action and break patent laws in order to obtain the drug at even lower costs.
States’ continued false statements about the real price of the cure and scary cost scenarios based on faulty claims that all people with HCV in their state will seek treatment in one year, inject untruths into the debate around drug pricing, while distracting from the fact that real people need treatment and are being kept from it. If state Medicaid programs really want to save money, they should loosen their restrictions. Numerous studies have found that it is cost-effective to treat HCV early because, if left untreated, HCV can lead to health outcomes that require long-term care at high costs and additional infections.
Modern medicine has given us a way to cure a widespread and deadly infectious disease. State Medicaid programs spend just a fraction of their money on prescription drugs and an even smaller amount on HCV. We fail to understand why states are only focusing on people with HCV and their one-time drug costs. States and other payers must provide access to the HCV cure for those who need it. If states aren’t willing to do it, the Trump administration should use its authority to force states to comply with the law. It’s time for us to do the right thing for those living with HCV, and cure them.
Michael Ruppal is the executive director of The AIDS Institute.
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