WILSONVILLE, Ore. – An Oregon Medicaid committee on Thursday significantly scaled back access to an effective — but expensive — new drug used to treat hepatitis C.
The decision allows only a narrow set of Medicaid patients to be treated with the $1,000-per-pill drug known as Sovaldi, made by Gilead Sciences Inc.
Medical experts on Oregon’s pharmaceutical review committee question whether the drug is worth the price tag, and officials worry it would break the bank. They say treating all Medicaid patients with the liver-wasting disease would cost almost as much as last year’s entire drug bill.
Oregon’s guidelines would allow the drug to be used only for patients with later stages of liver damage who have been drug-free for at least six months. The drug could only be prescribed by a liver or gastrointestinal specialist, which often requires months of waiting for an appointment.
The moved drew an angry reaction from hepatitis patients and groups that work with them. Lorren Sandt, director of Caring Ambassadors, a hepatitis C resource group based in the Portland suburb of Oregon City, called the guidelines “horrific.”
“Can you imagine if you were a cancer patient and they said, ‘We’re going to wait until you’re Stage 4 before we’ll treat you?'” Sandt told The Associated Press. “That’s what they’re doing.”
Allowing liver damage to advance to late stages puts patients at a high risk for cancer and lowers their quality of life, she said.
The cost of a 12-week regimen of Sovaldi along with two companion medications that patients must also take is around $100,000. Competing regimens with other drugs cost in the mid- to high five figures, and some are far less effective and harder to tolerate.
Oregon took up the issue a day after Illinois’ Medicaid program put in place tight restrictions on the use of the drug, including requiring patients to meet 25 criteria and get prior approval before the government program will pay.
A separate Oregon panel could go even further next month, removing Sovaldi from the list of treatments covered under Medicaid and requiring doctors to make an individualized appeal to obtain the coverage. Oregon can take such a strong stance because of a federal waiver that allows the state to prioritize treatments for medical conditions based on their cost-effectiveness.
Tom Burns, director of pharmacy programs at the Oregon Health Authority, said it’s impossible to know how many patients will make it over the hurdles officials are establishing.
Hepatitis develops slowly over years or decades. Oregon officials say that while they wait for the price to drop or for new treatments to come on the market, they want the drug available only to those who face imminent severe liver problems.
Medicaid officials are used to covering expensive treatments, but they’re usually for relatively rare conditions, said Matt Salo, director of the National Association of Medicaid Directors.
“It’s always been 50 people or 500 people or 1,000 people, not hundreds of thousands like we’re seeing (with Sovaldi),” Salo said. “So this is kind of a game-changer.”
In a statement, Gregg Alton, executive vice-president at drugmaker Gilead, did not directly address Oregon’s decision but said regimens containing Sovaldi reduce total treatment costs for hepatitis C, including medication costs for dealing with side effects from alternative drugs and managing advanced liver disease.
Oregon had about 5,600 Medicaid patients with hepatitis C at the end of 2013, before 300,000 people joined the system under the federal health care overhaul. State officials say it would cost $360 million to treat all of them with Sovaldi, and total Medicaid drug spending was $377 million in 2013.
Hepatitis C surpassed AIDS as a cause of death in the U.S. in 2007, claiming an estimated 15,000 lives that year. The illness is complex, with distinct virus types requiring different treatments. While it advances gradually, it can ultimately destroy the liver, and transplants cost an average of $577,000 each.
Hepatitis C is a public health concern because the disease can be transmitted by contact with infected blood, by drug users sharing needles, and sometimes through sexual activity. Many people are unaware that they carry the virus. Health officials advise all baby boomers to get tested.
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