With the approval听this month of two drugs to treat hepatitis C in children, these often overlooked victims of the opioid epidemic have a better chance at a cure. Kids may have an easier time than adults getting treatment approved, some experts say.
Medicaid programs and private insurers have often balked at paying for the pricey drugs for adults, but stricter Medicaid guidelines for kids may make coverage more routine.
The two drugs by the Food and Drug Administration,听Harvoni and Sovaldi, both have been听highly effective in treating adults with the disease. In two clinical trials of children ages 12 to 17, the drugs eliminated all traces of the virus in 97 to 100 percent of patients, generally in 12 weeks. Trials that test the effectiveness of the drugs in younger children are ongoing.
鈥淚t鈥檚 great news for our kids,鈥� said Dr. Jessica Wen, medical director for the viral hepatitis clinical care听program Children鈥檚 Hospital of Philadelphia, which had more than a dozen kids participating in the trials. 鈥淗istorically every new medication that鈥檚 approved for adults, there鈥檚 always a lag for pediatrics,鈥� she said, noting that the wait can be as long as a decade.
The FDA approved Sovaldi in 2013 and Harvoni in 2014 for adults, and the drugs were widely hailed听because they cured nearly everyone with minimal side effects, typically in 12 weeks. Earlier treatment regimens that required interferon injections and antiviral pills for six months or more were less effective and frequently caused severe side effects.
But until the FDA approved the drugs for pediatric use, many doctors were delaying treatment. Because the FDA approval applies to children 12 and older who weigh at least 77 pounds, this group would require an adult dose.
Researchers estimate that听听in the United States are infected with ,听a blood-borne infection that causes inflammation of the liver and can lead to liver failure, cancer and death. Most of the estimated 2.7 million to 3.9 million people overall that have chronic hepatitis C in the U.S. got it from or sharing needles and other equipment while injecting illicit drugs. But only about 20 percent of children get it听from drug use. The majority of kids become infected by their mom during pregnancy. A baby has about a 6 percent chance of contracting hepatitis C if their mother has it.
Since neither adults nor children are routinely screened for hepatitis C and many don鈥檛 develop any symptoms after becoming infected, people may have the disease for years before learning they鈥檙e sick.
Children often come to clinicians鈥� attention when their regular pediatrician learns the mother is infected, said Dr. Karen Murray, a professor of pediatrics at University of Washington medical school who works at Seattle Children鈥檚 Hospital, which had several children in the trials.听听
Children who contract hepatitis C may suffer less liver damage over time than those who contract it as adults, Murray said.
Still, 鈥渢here are all these social and biological events that may happen like marriage and childbirth, and it would be nice if they were cleared of the virus before then,鈥� she said.
When the new drugs were introduced a few years ago, insurers often balked at the price tag, which typically approached $100,000 for a course of treatment. Medicaid programs, in particular, restricted access to the drugs for adults, often requiring that and/or prove that they鈥檇 been drug- and alcohol-free for several months before they would approve treatment. (Because the drugs weren鈥檛 approved for children, many pediatricians said they didn鈥檛 attempt to prescribe them.)
Increased competition from the introduction of new drugs has somewhat in recent years, and insurers aren鈥檛 creating quite as many obstacles to treatment now,听said Ryan Clary, executive director of the National Viral Hepatitis Roundtable, an advocacy group.
However, 鈥渃overage is still a very significant problem,鈥� Clary said.
Insurance coverage may be less problematic for children, experts say. Under federal law, state Medicaid programs must cover 鈥溾�� for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses.
鈥淭he short answer is that [Medicaid]听will likely require coverage for all kids regardless of whatever the coverage policies for adults may be,鈥� said Matt Salo, executive director of the National Association of Medicaid Directors.
State Medicaid programs have leeway with adults to decide that a treatment isn鈥檛 medically necessary unless the person鈥檚 liver is damaged, said Kelly Whitener, an associate professor听at Georgetown鈥檚 Center for Children and Families.
鈥淏ut for kids, the federal standard 鈥� is broader, so medical necessity could not be linked to severity of illness/liver disease,鈥� she said.
It鈥檚 unclear what private insurers will do regarding coverage for kids.
鈥淕iven these are recently approved drugs, we expect plans will follow their normal practices,鈥� said Kristine Grow, a spokeswoman for America鈥檚 Health Insurance Plans, a trade group. 鈥淭his includes evaluating the evidence, systematic review of the medication鈥檚 effectiveness, considering any federal or state mandates, and updating their policies as new evidence is available.鈥�
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