Monday, May 9, 2016
What price a miracle? Limited access to hepatitis-C drug sparks debate
WASHINGTON – Jose Robles is the picture of health. And because of that, he has to remain sick, even though new drugs would likely cure him of the disease he’s had since birth.
Robles, born with hepatitis C, is currently asymptomatic, but when he tried to enlist in the Marines, they turned him down because his ailment made him a “liability.” Determined to make good on a promise to his honorably discharged brother, Robles spoke with his doctor who quickly prescribed Harvoni.
The drug – approved by the FDA in 2014 – has a 95 percent chance of curing hepatitis C within three months – and an estimated $94,500 price tag. Arizona’s Medicaid program will pay for the drugs, but Robles does not meet its strict restrictions on who qualifies for the costly drugs.
Because he’s not really sick, Robles will have to stay a little sick. And that makes him angry.
“Since I don’t show any signs of liver inflammation and I don’t have HIV or AIDS, they told me I couldn’t be processed until my symptoms got worse,” said Robles, 18, of Flagstaff. “At first, I didn’t feel anything about it, but now I’m angry.”
He’s not the only one: From doctors and patients to ethicists and actuaries, the debate over access to wonder drugs like Harvoni and Sovaldi for hepatitis C has spurred investigations, lawsuits and conversations about the restrictions that leave some patients without access to the newest treatments.
Dr. Anita Kohli of St. Joseph’s Hospital in Phoenix is all too familiar with that conflict. As an infectious disease specialist, she is used to prescribing treatments for hepatitis C that took up to 48 weeks to work and left patients “exhausted, like they had been through chemotherapy.”
She can prescribe drugs like Harvoni, but said “outdated” and “unprecedented” restrictions imposed by insurance companies keep “90 percent – maybe more” of her hepatitis C patients from being cured.
“The Medicaid guidelines are a little problematic … and need to be remedied,” Kohli said in a phone interview. “It’s all just an artificial barrier to treating the disease.”
But Matt Salo, the executive director for the National Association of Medicaid Directors, said that opening up access to everyone might work – but would dry up every state’s Medicaid budget in the process.
“We don’t want there to be access problems,” Salo said. “But if we open it up, what’s going to give?”
Salo said that before insurance companies can loosen restrictions on the new class of drug, the manufacturers have to stop being “opaque” in their pricing.
The National Academies of Sciences, Engineering and Medicine (NASEM) said hepatitis C affects an estimated 2.7 million to 4.7 million Americans – the number is hard to pin down because many people don’t know they have it – with about 29,700 new cases reported every year. The disease is usually transmitted through injection, either by shared or unsterilized equipment, but can be transmitted through sex, blood transfusion or, as in Robles’s case, at birth.
The report said hepatitis B and hepatitis C together cause 15,000 deaths a year in the U.S. Those two diseases kill 1 million a year globally, passing HIV and AIDS to become the seventh-leading cause of death in the world.
The prevalence of the disease is part of the reason the FDA’s approval of Harvoni and Sovaldi garnered so much attention. But when people saw the costs of the drugs – Sovaldi treatment costs an estimated $80,000 – the attention turned negative.
A Senate Finance Committee investigation of Gilead, the manufacturer of Harvoni, accused the company of pursuing a “calculated scheme” of “maximizing revenue, regardless of human consequences.” Officials at Gilead did not respond to requests for comment for this story.
The Senate report, released in December, found that only around 1.5 percent of hepatitis C patients insured by Medicaid in Arizona had access to new drugs in 2014. That’s about 266 patients out of the state’s nearly 18,000 Medicaid beneficiaries who had hepatitis C.
Dr. Matthew DeCamp of the Johns Hopkins Berman Institute of Bioethics said that while patients on all types of insurance can face access issues, Medicaid beneficiaries in particular have fewer options. And the NASEM and Senate reports said the people most likely to be on Medicaid – the old and low-income – have a slightly higher chance of contracting hepatitis C than those insured by private companies.
“That is clearly a question of fairness as to whether barriers to that population are different than barriers for other populations,” DeCamp said.
He suspects that private insurers may also restrict access to the new drugs, but has not been able to collect that data from the insurance companies.
In Arizona, as in many states, hepatitis C patients have to meet strict requirements that show a heightened level of sickness before Medicaid will pay for the new treatments. Arizona patients, for example, must show advanced liver scarring and prove that they have been sober for at least six months, for those with a history of substance abuse. Other requirements to get the drug include prescriber limitations and HIV co-infection restrictions.
-Click on the map for prescription restrictions by state. (Cronkite News graphic by Sara Weber)
A study published in the Annals of Internal Medicine in August said most states have a similar list of criteria and that many of those restrictions “violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration labels.”
The NASEM report came to a similar conclusion and accused pharmaceutical companies of putting profit before patient, creating costs high enough to make insurers “reluctant to provide unrestricted access.”
“The restrictions are not supported by current treatment guidelines, and appear motivated entirely by cost,” the NASEM report said.
Blue Cross Blue Shield of Arizona recently dropped one of the requirements in the state’s Medicaid system that calls for patients to have liver fibrosis before they can get Harvoni, according to a statement from Dr. Daniel Aspery, the insurer’s medical director.
But while it removed liver fibrosis as a criterion “months ago,” the statement went on to say that it “has pharmacy guidelines in place that manage the use of Harvoni and other new Hepatitis C agents. There are multiple medically necessary criteria that must be met before a drug is approved.”
Cost and restrictions have prompted lawsuits in a handful of states, and Salo said he thinks it’s “just a matter of time” before other states end up in court.
“If the lawsuit that is currently in play in Indiana goes … against the state, then what I think you will see is similar lawsuits in all the other states literally overnight,” he said.
Salo also said, however, that he believes the price of drugs like Sovaldi and Harvoni will decrease as new drugs enter the market.
“We’ll figure out this hepatitis C situation,” Salo said. “Over time, we’ll slowly chip away at everybody or the federal government will be forced to step in and help do this. But we’ll figure it out.”
The NASEM report suggested that could take a long time, writing that “eliminating hepatitis C would require near-universal access to treatment, something that appears unfeasible given the current pricing and policy environment.”
Kohli said there’s no time to sit and wait.
“It’s urgent,” she said. “Some of these patients are very sick, and we can’t wait decades to treat them.”
As for Robles, he plans to look for mechanic work in Flagstaff until he can get treatment and apply to the Marines again. He said he’s not too nervous about his condition yet.
“They said I would start getting sick, and that eventually when I get older I would start to forget people, but I haven’t started yet,” he said.
“Everything is an eventuality, but I’m still young,” he said. “Other people get older and get dementia all the time. I just hope I’d be in the military before that happens.”