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Monday, December 14, 2015

Ind. Gov't. - "Hep C drug fight bitter pill to some: ACLU lawsuit is only a small part of a bigger bipartisan policy battle"

That is the heading to the lead story in this week's issue of $$$ Indiana Legislative Insight. The story begins:

In Jackson et al., v. Sec’y of the Indiana Family and Social Services Admin., No. 1:15-cv-01874-SEB-DKL, the American Civil Liberties Union of Indiana files suit against the Family and Social Services Administration challenging FSSA’s new policy – just implemented in October – of denying Harvoni, a life-saving drug, to certain Medicaid recipients who have early-stage Hepatitis C, allegedly in contravention of federal Medicaid law ... and this is a bigger can of worms than you might think, extending well beyond FSSA and the friendly confines of Indiana. Indeed, FSSA and the State of Indiana may find themselves in an untenable position as they try to accommodate growing human needs – and the costs and the lawsuit – which had gone largely overlooked until late last week – has major fiscal and public policy implications.
ILB: Here is a copy of the lawsuit, filed Nov. 25, 2015.

The Indianapolis Star had a related story on Friday, by Shari Rudavsky, headed "A new drug can cure Hepatitis C, but Indiana won't always pay for it under Medicaid." A quote:

Indiana, like most other states, refuses to pay for the drug for her or any other Medicaid recipient until they have entered a later stage of the disease.

The American Civil Liberties Union of Indiana recently sued Indiana’s Family and Social Services Administration on behalf of [Sarah Jackson] and others like her, asking the state to reverse its policy and provide at least some of these expensive drugs now.

“What we have here is a drug that can cure Hepatitis C, and it is being denied to people with Hepatitis C,” said Gavin Rose, a senior staff attorney with the Indiana ACLU.

Hepatitis C, a chronic condition, long evaded treatment. A viral liver infection, it is spread through sexual contact, sharing drugs and needles, or from mother to child.

In recent years, however, a number of new drugs have hit the market that offer cure rates of 90 percent or greater. But these drugs are costly, running as much as $1,000 for each pill that must be taken daily for 12 weeks.

For now, Jackson, a 34-year-old Fort Wayne florist who has no symptoms of the disease, must wait until her disease worsens to start treatment, hoping that the state changes its policy before she winds up with liver damage that could lead to cirrhosis, cancer or death.

More from the story:
Indiana is far from alone in its decision to restrict access.

Earlier this month the U.S. Senate Finance Committee released the results of an 18-month investigation into how one company, Gilead Sciences, priced its two drugs. The drug company, according to the report, set prices with an eye toward maximizing revenue, even though its own analysis showed more patients could be treated if the drug cost less.

The report found that at least 27 states said they would pay for only the sickest of their Medicaid patients to receive the Gilead drugs.

Not one state Medicaid program makes the drug available to everyone who could benefit from it, said Matt Salo, executive director of the National Association of Medicaid Directors.

Price governs those decisions, Salo said. While Medicaid programs do approve expensive drugs for many other rare conditions, such as hemophilia or cystic fibrosis, none of those diseases affect as many people as hepatitis C. An estimated 1 million people on Medicaid in this country have hepatitis C and approving these drugs for all would "explode the budget," potentially leaving those on Medicaid with other diseases in the lurch, he said.

"This has clearly been priced to prioritize profit margins and not cures. Effectively what they have done is priced this drug so it is unavailable for everyone who needs it," Salo said. "We often talk about an unwritten social contract that has existed in Medicaid that orphan drugs can have orphan drug prices. ... But when you have something that’s treating a mainstream condition, it violates the social contract."

The long Indiana Legislative Insight story concludes:
As for the overarching policy implications, Sen. Wyden [Senate Finance Committee Ranking Democrat Ron Wyden (D-OR)] explained that “The reason that a Democrat and a Republican came together to investigate into what happened in this case is because of the serious challenge that could be on the horizon. Very quickly after [Gilead’s Harvoni predecessor drug] rollout, the alarming consequences of the price became clear. It was a huge medical breakthrough, and it was overtaken almost immediately by the price. Now, consider where medicine is headed in the future. America needs a cure for cancer. It needs a cure for Alzheimer’s. It needs a cure for diabetes. And it’s important to note on World AIDS Day, it needs a cure for HIV. If those cures are unaffordable and out of reach to millions who need them, the Congress will not have met its responsibilities to the American people.”

Posted by Marcia Oddi on December 14, 2015 09:06 AM
Posted to Indiana Government