Has Louisiana Cracked The Code to Treating Hepatitis C?
Louisiana isn't usually considered a trailblazer when it comes to public health policy, but the state's novel plan to treat and cure the vast majority of Hepatitis C cases through an innovative payment structure is being closely watched by other states and health officials around the world.
This summer, the Louisiana Department of Health struck a deal with a Asegua Therapeutics, a subsidiary of pharmaceutical company Gilead Sciences Inc., to get unlimited access to a generic drug called Epclusa that cures 98 percent of Hepatitis C cases. The state will use the drug to treat patients in Medicare and in the Department of Corrections. In return, Louisiana will pay a set fee -- $260 million -- for access to the drug over a five-year period.
For Louisiana, the goals under the deal are ambitious: treat and cure 90 percent of those living with chronic Hepatitis C. And the stakes are high too: Hepatitis C is the leading infectious disease killer in the U.S. and the world.
'Often Hepatitis C is asymptomatic until you develop liver disease, so it can be a very silent killer.' - Kimberly Hood, the Hepatitis C Elimination Program Manager for Louisiana’s Office of Public Health
“Often Hepatitis C is asymptomatic until you develop liver disease, so it can be a very silent killer," says Kimberly Hood, the Hepatitis C Elimination Program Manager for Louisiana’s Office of Public Health. “By the time you develop liver disease, you're going to have complications. You may have fibrosis or cirrhosis, which has to do with scarring in the liver.”
Hood oversaw the the creation of the Asegua partnership and manages it today. She says the negotiations with the drug company started with one question: “How will you give us unrestricted access to drug at a fixed cost?”
How The Deal Came About
The drugs used to treat and cure Hepatitis C are expensive -- typically $24,000 for a single treatment. What Louisiana needed was predictability of cost, a way to ensure that spending on this one disease doesn’t overshadow the budget.
In 2016, the state’s health department formed a quote to treat everyone on Medicaid and in the Department of Corrections living with Hepatitis C through the conventional payment model. The cost was roughly $760 million —which amounted to roughly the entire K-12 budget and then some. The solution was to seek a non-volume based payment structure, not tied to how many pills you buy or sell. The benefits are financial, but also make sense in combating the virus which can spread quickly. This plan would require a special agreement between the state and a private manufacturer, and there are only three pharmaceutical companies in the country with patents for Hepatitis C drugs.
“We didn't ask the pharmaceutical companies for some firesale price. We didn't say, ‘Come in and give us the lowest possible price you can on this drug,’” says Hood.
Because no other state health department has ever enacted a model like this, Louisiana had to solve for the best price of the medication with the manufacturer also knowing they could set a standard for other states to follow.
Hood continues: “So we said, ‘Look this is what we spent in 2019. We can commit to spending this amount across these two populations for five years, but in order to get out ahead of this epidemic we need unrestricted access to drug on day one.”
The Louisiana Department of Health -- LDH -- brokered two separate agreements, one for Medicaid and one for the Department of Corrections, which combined cost roughly $60 million.
'How will you give us unrestricted access to drug at a fixed cost?' - Kimberly Hood.
For Hood, the deal gave Louisiana exactly what it needed -- “unrestricted access at a predictable cost. And the pharmaceutical partner is getting guaranteed revenue for five years over the life of the model which is fantastic.”
La. Hopes To Treat 90 % Of Cases
Over the course of five years, Louisiana seeks to test and treat approximately 39,000 people with Hepatitis C across Medicaid and the Department of Corrections. In this model, the burden is on the state’s health department to identify people living with Hepatitis C, connect them with trained providers, and ensure medication is dispensed. Planning for that, the health department worked with a team of hepatologists and other doctors to create a streamlined Test and Treat algorithm this past May.
“We convened in New Orleans,” says Hood. “We walked through what the existing guidelines are for screening, testing, and treatment and confirming that someone's been cured. And we sat down and wrote through an algorithm that really eliminates any step that's not absolutely necessary for this program. So providers can now be trained on this algorithm in about an hour.”
The drug manufacturer, Asegua, and Louisiana’s health department are collaborating to create promotional campaigns and access programs for patients to seek treatment through the next five years. This includes focus groups with people who inject drugs, who’ve been treated for their Hepatitis C, and people who are classified at risk to determine effective programming with those communities. The partnership has also overhauled the state’s previous surveillance system for Hepatitis C, which is key to getting a clear picture of how well the program is working.
“The elimination goal that we are following is the [World Health Organization’s] elimination goal and it says that 90 percent of the people in this state living with chronic HCV will be identified by the end of five years and 80 percent of those folks will be treated,” says Hood. “That's a really high bar.”
For Patients, Waiting For Treatment Can Be ‘Unbearable’
To reach this elimination goal, the health department included major changes in their Hepatitis C elimination plan. Most notably, prior-authorizations for treatment of Hepatitis C for people on Medicaid and in the Department of Corrections have been waived.
Previously, Louisiana had some of the most strict prior-authorization requirements in the country, requiring the patient to be sober from drugs and alcohol and present considerable liver damage from the infection.
For patients living with Hepatitis C, those strict rules surrounding prior-authorization for treatment added to the stress -- and caused delays in treatment.
“You had to go through so much and your levels had to be high. [Often people] weren't eligible for it,” says Bryan Domange, a Baton Rouge resident was diagnosed with Hepatitis C more than a year ago.
“It was really like, ‘Am I even worthy enough to deserve this medication?’ So, the waiting process was just... it was unbearable,” says Domange.
“It's like ‘Is this ever even going to happen?,’” he added.
Domangue wanted to get on treatment as soon as possible, and he had insurance through Medicaid. But, due to the high cost of even generic treatments of Hepatitis C, he didn’t meet the prior authorization requirements.
Domange appealed the decision, and eventually he was approved for treatment.
“I got the call I was jumping up for joy. I told like 5 different people I was happy as all get up.”
'I got the call I was jumping up for joy.' - Bryan Domange, a Baton Rouge resident
Health officials hope that with prior-authorization restrictions waived under the new plan, there will be more cases like Domange.
In The Jails, More Testing, More Treatment
Similar to the impact of assuring treatment for the most financially in-need through Medicare, treatment of the incarcerated population is key to eliminating the virus. Risk of transmission, progression of the virus, and developing another condition is higher for incarcerated people than the general population.
And, issues of bottlenecking in the Louisiana Department of Corrections health system has specifically impacted Hepatitis C treatment in the past. For example, before this summer, there was only one Hepatitis doctor for the corrections department. Now all eight all DOC facilities have providers who are trained to use generic Epclusa.
“In the past you may have someone, ‘Yes I have [Hepatitis] C but I'm going home in two years. And so therefore I don't meet the qualifications.’ So I have to wait to get this care when I go home.’ Whereas now we can test and treat and cure,” says Jean Schexnayder, the Corrections Specialist for the Louisiana Department of Health.
In addition to waiving prior-authorization restrictions in the Department of Corrections, health officials are also launching a major push for more surveillance of infectious diseases -- including population-level testing for HIV, Syphilis, and Hepatitis C.
Schexnayder says Louisiana is in the testing phase of its plan to treat the state’s incarcerated population.
“Right now we have a mobile phlebotomist team which I supervise and we have two individuals and we are basically going from DOC facility to DOC facility and we are testing what we call the existing population -- individuals who are currently in that facility,” says Schexnayder, who adds that testing will also be done at parish-level DOC facilities.
As Treatment Program Takes Off, Potential Roadblocks Appear
Once testing is completed at the Department of Corrections, health officials say they will begin treating incarcerated Hepatitis C patients in December.
But already, some roadblocks are emerging. There is currently no mechanism for purchasing medication to dispense in DOC facilities. The channels simply don’t exist as they do for people on Medicaid. State health officials, like Hood and Schexnayder, say they are aware of the issue and working on currently working on a fix. .
On the Medicaid side -- which has already enacted the treatment phase of the program -- patients and providers have also run into minor problems. For example, while prior authorizations are waived, individual pharmacies can still request authorization information from the provider. These pharmacy authorizations have confused some providers as to whether authorizations have been waived or not. Hood says the health department is aware of this issue and are now including it in their training of providers and pharmacists.
For Hood, Schexnayder and others working on this novel Hepatitis C program, it’s not surprising that there are challenges that have arisen. But they say the ability to actively solve problems and innovate will go along way in determining the effectiveness of the program -- and whether other states follow Louisiana’s lead in combating this infectious disease.