“Provider restrictions compound the problem, as access to subspecialty care can be nonexistent in healthcare systems that care for medically marginalized persons,” Sylvestre said. “Treating hepatitis C is easier and less costly and more effective than treating HIV, diabetes, hypertension, and so many other things, and thus treatment restrictions are very hard to rationalize without invoking prejudice and stigma as their root cause.”
The report reveals that the status of Medicaid access to hepatitis C treatment is not closely correlated with geographic region or “red” versus “blue” political leanings. Alaska, Connecticut, Massachusetts, Nevada, and Washington merited an “A” rating, while Arkansas, Louisiana, Montana, Oregon, and South Dakota warranted an “F.” Just over half the states got a grade of “D” or worse.
In some states lawsuits have been filed to remove restrictions on hepatitis C treatment. In November 2015, the Centers for Medicare & Medicaid Services (CMS) issued a bulletin advising states that limitations on coverage “should not result in the denial of access to effective, clinically appropriate, and medically necessary treatments using DAA drugs for beneficiaries with chronic HCV infections.” CMS also urged drug manufacturers to do their part to ensure access and affordability.
But advocates argue that states are still not doing enough to make sure that everyone who could benefit from hepatitis C treatment has access to it — especially in light of falling drug prices and the recent approval of AbbVie’s Mavyret (glecaprevir/pibrentasvir), which substantially undercuts other regimens on the market.
“As the findings of our report illustrate, many state Medicaid programs are violating federal law by imposing discriminatory restrictions that keep people from getting lifesaving medical care and treatment,” CHLPI director and Harvard Law professor Robert Greenwald told MedPage Today.
“Restrictions to treatment based on disease severity and sobriety have no basis in the medically accepted standard of care and serve only to cut cost and increase stigma surrounding hepatitis C. While the cost of treatment certainly presented challenges initially, now states are hiding behind costs and ignoring the fact that the cost has actually decreased 75% over the past 3 years and will decrease even further as new treatment options enter into the marketplace.”
- Gilead’s generic hep C drugs may increase access through Medicaid
- Hepatitis C Meds and Medicaid: Take These Steps to Get Covered
- Why Medicaid Denied More Hepatitis C Patients
- Why Early Treatment Is More Cost Effective
- What to Do if Medicaid Denies Coverage for Hepatitis C
- Hepatitis C Drug’s Lower Cost Paves Way For Medicaid, Prisons To Expand Treatment
Gilead’s generic hep C drugs may increase access through Medicaid
Approximately 700,000 Medicaid beneficiaries are living with hepatitis C, yet less than 3% receive treatment each year, according to a May policy brief by the Brookings Institution. An estimated 3.5 million people in the U.S. carry the virus, according to Brookings, while approximately 1 in 3 of the U.S.’ 2.2 million prisoners are living with hepatitis C, according to the Centers for Disease Control and Prevention. Survey results published by Kaiser Health News found that 97% of inmates across the country are not getting hepatitis C treatment
Matt Salo, executive director for the National Association of Medicaid Directors, said many states never saw the expected influx of Medicaid enrollees seeking treatment, likely discouraged by the restrictions that states adopted. But states have improved access to hepatitis C treatments for their Medicaid populations in recent years, he said. Al Juboori said he too has seen an improvement the past two years in Missouri’s Medicaid coverage for hepatitis C medication.
Missouri is one of a handful of states without any of the three major access restrictions to hepatitis C medication. In 2016 a court injunction barred the state’s Medicaid program from enforcing its limits on hepatitis C medications based on sobriety, which required patients to abstain from alcohol or substance use for three months prior to starting treatment.
Missouri also limited access to hepatitis C drugs to those in at least Stage 3 of liver disease. By 2017, both limits were eliminated, earning the state a grade of A from Harvard Law School’s Center for Health Law and Policy Innovation in its 2017 hepatitis C Medicaid Access Report.
Al Juboori questions, however, whether his state’s effort to improve access to hepatitis C drugs resulted from cost reductions since he has not seen much of a drop in the price of hepatitis C medications over the past four years, even with the entry of at least six new drugs following Sovaldi’s release.
Many analysts see Gilead’s plan as a direct response to the approval last year of AbbVie’s hepatitis C drug Mavyret, which entered the market at a list price of $26,400.
Al Juboori was hopeful Gilead’s actions would lead to significant cuts in the cost of all hepatitis C treatments. But even a $24,000 price point might discourage some poorer states from deciding to expand access, he said. “We’re still paying more than the whole entire world for one treatment for a hepatitis C patient.”
He said there is now greater awareness of the public health and economic benefits of providing hepatitis C drugs when compared to the long-term healthcare burden related to chronic hepatitis, which occurs in up to 85% of cases and is one of the most common reasons for liver transplant.
Even if Gilead’s launch of generic versions of its drugs sparks significant price drops for the other hepatitis C medications now on the market, both Al Juboori and Salo agreed that ultimately stigma will play a big role in determining whether state lawmakers are motivated to provide Medicaid agencies with the funds needed to provide such treatments to their vulnerable populations.
“It’s 2018, and unfortunately we still judge people for what they do, and it should be totally separate from the issue of their healthcare,” Al Juboori said.
Originally published by Vice on December 21, 2017. Written by Sony Salzman.
As a liver disease doctor in Chicago, Illinois, Nancy Reau treats patients with hepatitis C, a viral infection that kills more people in the United States than 60 other infectious diseases combined, including HIV. Her practice has changed dramatically since 2013, when a flurry of miracle “cures” for hepatitis C were approved. Since then, Reau has successfully treated a majority of her hepatitis C-positive patients.
However, Reau still has about 30 patients who are waiting for treatment. These patients have one trait in common—they’re covered by Medicaid. Across the country, Medicaid programs continue to triage curative treatment, even as most other insurance providers have adopted a treat-all approach. Some Medicaid restrictions include sobriety tests and proof of extensive liver damage, which run counter to medical consensus.
Treatment denial “is a hard message for patients to stomach, especially a patient who has finally invested in taking care of themselves,” Raeu says. Often, she adds, “they fall out of the system.” For many state Medicaid programs, restricting access softens the financial blow of expensive hepatitis C cures. But for doctors, these restrictions are a nightmare, as they block access for their most vulnerable patients.
In recent years, the price of hepatitis C medications has dropped dramatically, yet more than half of state Medicaid programs were given a “D” or an “F” in recent report card compiled by Harvard’s Center for Health Law and Policy Innovation (CHLPI). With this report card in hand, lawyers at CHLPI and other advocacy groups have a new weapon in their legal battle on behalf of low-income people seeking a cure for hepatitis C.
The fracas over hepatitis C medication began in 2013 when the first curative treatment, Sovaldi, was priced at a headline-grabbing $1,000 per pill, prompting outcry from public and private insurance programs alike. Over time, however, market competition slashed wholesale prices and behind-closed-door negotiations between pharmaceutical companies and insurance providers lowered the real cost even further.
Today, treatment restrictions have been lifted by most insurance providers, and even by Medicare, a federally-funded program for the elderly. In part, that’s because number crunching revealed that treatment is cost-effective in the long run.
But Medicaid, a program designed for the poor, is different. Medicaid programs rely on budget allotments from policy makers in Washington DC, making them highly sensitive to short-term expenses. One analysis found that two hepatitis C drugs—Sovaldi and Harvoni—comprised nearly 5 percent of the total budget for drug expenditures in 2015.
However, since 2015, six new drugs have been approved at dramatic discounts. One such drug, Mavyret, was priced at $26,400, a 72 percent discount to Harvoni’s wholesale price. In theory, that means the net cost of treating a Medicaid patient with HCV would go down, according to Anna Kaltenboeck, program director at the Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, and member of the Drug Pricing Lab team.
For Reau, the dramatic price drop, but relatively unchanged policies means ongoing treatment restrictions have “nothing to do with price.” Instead, she says, they’re about stigma, as hepatitis C is associated with injection drug use. That’s part of the argument lawyers are making in a growing number of lawsuits levied against state Medicaid programs across the country.
“I think states are hiding behind cost at this point,” says Phil Waters, clinical fellow at Harvard’s CHLPI. Regardless of budget considerations, Medicaid’s restrictions are illegal, Waters argues. In 2015, the Centers for Medicare & Medicaid Services warned states that treatment restrictions violated federal rules. A spokesperson for the National Association of Medicaid Directors did not respond to request for comment.
Over the past several years, litigation has been initiated in Indiana, Washington, Colorado, and Missouri specifically on the Medicaid issue, Waters says. In Washington and Colorado, judges sided with patients, forcing Medicaid programs to drop treatment restrictions. Facing public pressure and mounting lawsuits, some states have voluntarily eased restrictions, he says.
Today, the people being infected with hepatitis C are young, injection drug users. With a cure in hand, countries like Australia and Georgia are well on their way to eradicating hepatitis C by targeting high-risk populations.
Meanwhile, the booming opioid addiction crisis has contributed to a three-foldincrease in the number of new infections in the United States. Although most of the 3.5 million Americans with hepatitis C are members of so-called “Baby Boomer Birth Cohort”—a generation of people who were infected before the virus was discovered in 1989—hepatitis C is spreading rapidly among 20-29-year-olds.
With current treatment restrictions in place, “you are just building your next birth cohort,” Reau says.
Hepatitis C Meds and Medicaid: Take These Steps to Get Covered
If you have hepatitis C and you’re on Medicaid, chances are you may have been denied coverage for expensive new drugs for the liver disease.
Recent research finds that Medicaid patients with hepatitis C are more often denied coverage for these drugs than people covered by private insurers, risking liver damage from the chronic infection.
A study by Vincent Lo Re III, MD, assistant professor of medicine and epidemiology at the University of Pennsylvania’s Perelman School of Medicine in Philadephia, and others, looked at more than 2,300 prescriptions for patients with chronic hepatitis C, and found that nearly half of those on Medicaid were denied coverage for the pricey, life-saving anti-viral meds. “We didn’t expect the magnitude of the denial to be that high,” says Dr. Lo Re. He presented the findings in November at the annual meeting of the American Association for the Study of Liver Diseases in San Francisco.
Why Medicaid Denied More Hepatitis C Patients
Lo Re and his colleagues analyzed prescriptions from November 1, 2014, and April 20, 2015, for Medicaid, Medicare, and private insurance. The scripts, for newer direct-acting antiviral drugs such as Sovaldi (sofosbuvir) and Harvoni (ledipasvir), had been submitted to a specialty pharmacy operating in Pennsylvania, New Jersey, Delaware, and Maryland. In all, 377 patients, or 16 percent of those seeking care, were denied coverage for the hepatitis C medications. When the researchers looked at denial by coverage, they found that 46 percent of those on Medicaid were denied, while just 5 percent of those on Medicare and 10 percent of those on private plans were denied.
Why the denials? Most often, the insurer said there was insufficient information to evaluate “medical need.” Other reasons included a lack of medical necessity and positive alcohol or drug screens.
When Medicaid patients were approved, they waited 10 days longer, on average, to have the prescription filled than did those on other plans, the researchers found.
Other studies have found issues with denials, Lo Re says, but his research approach was unique. “No one has really looked at the outcomes of prescriptions to date,” he says. “That’s where I think this study fills a major knowledge gap.”
Why Early Treatment Is More Cost Effective
The real cost for hepatitis C treatment with these newer meds can reach or exceed $100,000 per patient. While patient assistant programs are available through drug makers, the price tag may still be too steep for someone without insurance coverage, and even with coverage, out-of-pocket costs can be high.
But the newer drugs are much more effective than previous treatments, with higher cure rates. And they also cost less than complications that require transplants.
RELATED: How to Pay for Costly Hepatitis C Drugs
About 3 million Americans are infected with hepatitis C, including a large proportion of baby boomers. Left untreated, hepatitis C can lead to chronic hepatitis or liver inflammation, liver failure, liver cancer, and cirrhosis. Chronic hepatitis C is the most common reason for liver transplantations in the United States today.
Hepatitis C expert Harinder Chahal, PharmD, MSc, assistant adjunct professor of pharmacy at the University of California in San Francisco, recently published a study in JAMA Internal Medicine showing the cost effectiveness of early treatment.
“We know approvals are not going through until patients get more advanced disease,” he says. Yet in a computer model he created to look at the value of treating early versus later, he found, “If patients are treated early, at lower levels of liver disease, they have better outcomes down the line.”
Treating early, Chahal says, increases the chances of avoiding the most serious complications like liver cancer, and the need for a liver transplant. That’s critical for the patient and for keeping down costs in the long run, too. As he says, “The sooner we treat patients the better it is for them, and the better it is for the health care system.”
What to Do if Medicaid Denies Coverage for Hepatitis C
If you’re denied by Medicaid or another insurer, there are take steps you can take to increase your chances of approval after an initial denial, say Lo Re and Chahal.
- Be your own advocate. “Patients often wait for their clinician’s decision on when to start treatment,” Chahal says. And some healthcare providers may wait until hepatitis-related liver problems progress to suggest treatment. Better, he says, to seek treatment early and to be sure your healthcare provider knows that’s your wish. Ask about treatment as soon as you’re diagnosed, adds Lo Re.
- Educate yourself. If you’re insured by Medicaid, be aware that it’s state-run, and programs vary from state to state, Lo Re says. Go to Medicaid.gov to learn more about what to expect in your state.
- Promptly fill requests for information or testing. In the study of insurance decisions, Lo Re found that lack of information was a major reason for denial by Medicaid. If your coverage provider requests more information or additional testing, comply promptly, Lo Re says.
- Be persistent. If your request is denied by your insurer, you can appeal, Lo Re adds. He found that those on Medicaid were less likely than the privately insured to file appeals.
Prescription drug spending has been a key driver of the recent increase in Medicaid spending. After many years of low to moderate growth, Medicaid prescription drug spending increased 24.6 percent in 2014 and 13.6 percent in 2015 according to the Centers for Medicare & Medicaid Services, primarily due to increased spending for hepatitis C drugs.
These drugs, which can effectively cure many types of hepatitis C, also come with high list prices. The initial list price for Sovaldi—which has been one of the two most popular hepatitis C treatments along with Harvoni—was about $84,000 for a standard 12-week regimen when it launched in 2013. Before accounting for rebates, Medicaid programs nationwide spent more than $2.8 billion in 2015 on Sovaldi and Harvoni, almost five percent of total drug spending.
To better understand the impact of these hepatitis C drugs on states and managed care plans, MACPAC engaged George Washington University to conduct a series of interviews with 11 states and representatives from Medicaid managed care associations about their experiences in covering these new hepatitis C drugs since their introduction in late 2013. The interviews covered three main topics:
- How states developed coverage and prior authorization policies for the new hepatitis C drugs, starting with Sovaldi in 2013, and how those policies changed as more drugs entered the market and the economic, social, and political landscape evolved.
- How states addressed the effects of the new hepatitis C drugs on Medicaid budgets and the finances of managed care plans serving Medicaid enrollees.
- How their experiences with the new hepatitis C treatments affected state Medicaid officials’ and managed care plan representatives’ thinking about policies for other high-cost drugs.
This report was prepared under contract to the Medicaid and CHIP Payment and Access Commission (MACPAC). The findings, statements, and views expressed in this report are those of the authors and do not necessarily reflect those of MACPAC.
Publication Type: Contractor Reports
From: March 2017 MACPAC Public Meeting
Hepatitis C Drug’s Lower Cost Paves Way For Medicaid, Prisons To Expand Treatment
Valerie Green is still waiting to be cured.
The Delaware resident was diagnosed with hepatitis C more than two years ago, but she doesn’t qualify yet for the Medicaid program’s criteria for treatment with a new class of highly effective but pricey drugs. The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment.
The drug, Mavyret, is the first to be approved by the Food and Drug Administration that can cure all six genetic types of hepatitis C in about two months in patients who haven’t previously been treated. Other approved drugs generally require 12 weeks to treat the disease and often aren’t effective for all types of hepatitis C.
In addition, Mavyret’s price tag of $26,400 for a course of treatment is significantly below that of other hepatitis C drugs whose sticker price ranges from about $55,000 to $95,000 to beat the disease. Patients and insurers often pay less, however, through negotiated insurance discounts and rebates.
“It certainly stands to reason that the continual march downwards on cost would lead to continual opening up of criteria,” said Matt Salo, executive director of the National Association of Medicaid Directors.
Hepatitis C is a viral liver infection spread through blood that affects an estimated 3.5 million people in the United States. It can take years to cause problems. Many baby boomers who contracted it decades ago before blood was screened for the virus don’t realize they have it until they develop liver disease. In addition, the growing heroin epidemic is adding to the problem as people become infected by sharing contaminated needles.
“Direct acting antiviral” therapies like Harvoni, a once-a-day pill introduced in 2014 that generally cured hepatitis C in 12 weeks, are much more effective than earlier treatments that required weekly interferon injections and multiple daily pills for nearly a year. But the newer regimens came at a price: $94,500, in Harvoni’s case.
State Medicaid programs, which cover a high proportion of people with hepatitis C, balked at the high prices, even with the 23 percent drug discount the programs typically receive. Many threw up roadblocks to limit drug approval until the disease was advanced. Some required people to be drug- and alcohol-free for six months or more before treatment would be approved.
Those moves prompted advocates to push for better access, in some cases filing suit to force the programs to cover more people.
Faced with a lawsuit in Delaware, the state Medicaid program began loosening up treatment criteria this year, and in January will begin approving enrollees regardless of the severity of their disease.
The state joins more than a dozen others that no longer (or never did) restrict hepatitis C treatment based on disease severity, said Kevin Costello, director of litigation at Harvard Law School’s Center for Health Law and Policy Innovation, which has been a key player in litigation in Delaware and other states.
It can’t happen soon enough, said Green, 58, who believes she contracted the disease 31 years ago when she suffered complications during childbirth and required a blood transfusion. Although her liver isn’t damaged, Green said, she’s suffered with abdominal and joint pain, weight loss and fatigue for decades, symptoms that doctors attribute to the hepatitis C virus.
“It’s been a difficult fight for us Medicaid patients,” she said.
People who are incarcerated face an even tougher battle to get treatment for hepatitis C. Roughly 17 percent of prisoners are infected with hepatitis C, compared with about 1 percent of the general population.
Prisons have a duty not to be deliberately indifferent to the medical needs of incarcerated people. Prisons don’t get the price discounts that the Medicaid programs have, and their budgets are fixed.
“Administrators have to make do with what is there,” said Dr. Anne Spaulding, an associate professor at Emory University’s public health school who has worked as a medical director in corrections and published research on hepatitis C among prisoners.
Lawyers in a handful of states are pursuing class action lawsuits to force prisons to provide hepatitis C treatment. Mavyret may make a difference, said David Rudovsky, a civil rights lawyer who’s litigating a class action lawsuit against the Pennsylvania Department of Corrections.
“Everyone recognizes that it’s going to make it easier to cover people,” he said.
People with regular private insurance may face some obstacles to coverage of hepatitis C, but coverage is typically less problematic. For example, Mavyret is one of seven hepatitis C drugs that are included in the 2018 national preferred formulary by Express Scripts, which manages the pharmacy benefits for 83 million people.
“The benefit to patients and payers is the additional competition, which brings down costs across the class, thus resulting in greater access and affordability,” said Jennifer Luddy, director of corporate communications at Express Scripts.
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KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
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