Should pricey new treatments for the hepatitis C virus (HCV) be limited to the sickest patients, or should we immediately treat everyone who wants the drugs? Such is the question posed by Julie Appleby at Kaiser Health News, who teamed up with The Washington Post for a story on the financial implications of using new hep C treatments in the United States.

The story noted that different advisory groups are putting out different guidelines. For example, early this year, a panel from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America said the new drugs should be the preferred treatments for most of those living with hep C. The 28-member group, a majority of whom received drug-industry financing directly or through their research institutions, did not set any criteria for which patients should get the treatment first.

But in April, a panel for the Department of Veterans Affairs--none of whose members reported financial ties with the drug industry--offered a different take, suggesting that doctors prescribe the drugs mostly for patients with advanced liver disease, including those awaiting transplants. The VA panel said most patients at earlier stages of the disease should consider waiting for drugs now in development that may prove superior. Analysts expect those drugs to be available within the next year or two.

Then, the Kaiser story noted, there’s the issue of what constitutes “fair” pricing. Sovaldi costs $84,000 for a 12-week treatment, although some people will need to take the drugs for 24 weeks. Olysio rings up at about $66,000 for a 12-week treatment, but is approved for fewer types of patients. In some cases, a combo of both meds is prescribed; plus, other drugs may be included in the treatment, further driving up the cost.

Drugmakers defend the pricing, saying the treatments are curative and can prevent the need for other costly care, such as liver transplants. Insurers and consumer advocates hope increased competition will result in lower prices for the next round of hepatitis C drugs expected out later this year and next, but that is by no means guaranteed.

Also not guaranteed? A cap on the hep C population; the number of people living with HCV could balloon in the years ahead. At present, most people with the virus don’t even know they have it--that’s one of the reasons why fewer than 20 percent have sought treatment with the older regimens. However, more people are expected to be diagnosed as health officials urge baby boomers to get tested.The blood-borne virus is spread mainly by intravenous drug use, although many people were unknowingly infected by blood transfusions, organ transplants and poorly sterilized medical equipment before 1992, which is when widespread screening of the blood supply began.

Policymakers say the cost of treating even half of those infected could raise premiums for everyone with private insurance.
And for those without private insurance? Uh-oh. In an era of limited resources, notes the story, the prices pose a particular dilemma for public programs.

“For the price of Sovaldi for one patient, we could provide health insurance through Medicaid for [up to] 26 people for an entire year,” said J. Mario Molina, chief executive of Molina Healthcare, which has Medicaid plans in 10 states.

“There’s no question it is a very efficacious drug. But it’s just [a question of] who gets it and when.”

It’s also a question of whether there’s harm in waiting to treat. That’s not unusual for people with hep C. In the past, many chose to delay treatment because the available options were complex to administer, had to be taken for longer periods, were less effective and came with strong side effects. So demand for the new drugs is pent up, although some may still want to wait for interferon-free alternatives.
But once again, the cost factor cannot be ignored. “There’s no safety issue, so ’Does it cost too much’ is the only question left,” said David Thomas, MD, MPH, director of the infectious diseases division at Johns Hopkins University School of Medicine.

Speaking for himself, rather than the panel, he said that cost questions need to be debated “with all the vested parties at the table, not just the doctor sitting down with a patient.”

To read Appleby’s full article, click here.

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