Approved in January, 2021, Cabenuva was the first long-acting injectable for treatment of HIV. But in Texas, uninsured people living with HIV (PLWH) still have to pay out of pocket or make do with oral treatments. That’s because the Texas HIV Medication Program (THMP), the state’s AIDS Drug Assistance Program (ADAP), still hasn’t added it to their formulary, and HIV advocates are crying foul.
Texas is one of six states—the others are Missouri, Kentucky Louisiana, Oklahoma and South Dakota—that do not include Cabenuva in their ADAP formularies.
Other Texas payers cover Cabenuva, including private insurers as well as Medicare and Medicaid. Without coverage, injections of cabotegravir plus rilpivirine cost more than $6,000 per treatment, out of pocket. THMP, the payer of last resort for people living with HIV, serves about one-sixth of the people with HIV in Texas, according to its annual report.
THMP does cover two long-acting injectable HIV treatments, Sunlenca (lenacapavir) and Trogarzo, but they’re indicated for heavily treatment-experienced PLWH who have had difficulty finding an optimized functioning regimen, including those with multi-drug resistance.
Dora Martinez, a physician with Valley AIDS Council in south Texas and regional medical director at ViiV Healthcare, the maker of Cabenuva, has about 60 patients on a waiting list for Cabenuva. Martinez, who recommended adding Cabenuva to the Texas formulary when she served on the THMP Advisory Council, said that Texas is the only state with no avenue for uninsured PLWH to get the medication. “Many folks can’t get on Medicaid and there’s really no other program here,” she said. “Some of the other states that don’t have [Cabenuva] on their ADAP formulary will essentially pay for the premiums for someone to become insured.”
The current maximum income for a single Texan to be eligible for Medicaid is just under $30,000. Forty states plus the District of Columbia have expanded Medicaid under the Affordable Care Act, providing another avenue of coverage for lower-income people. Texas has not expanded Medicaid, making it even more challenging for people to get covered.
About 4.9 million, or 17% of Texans, are without health insurance, according to 2022 Census data. The number of people with HIV in the state, as of 2019, was near 100,000, with Black and Hispanic/Latinx Texans making up the majority.
“Bottom line, if you’re a Texan with HIV, and you have insurance, you potentially have access to Cabenuva and if you’re uninsured, you don’t,” Martinez said. “You can go to a patient assistance program where otherwise your income would qualify, but because [ADAP] is considered insurance, you don’t qualify.”
‘Specious’ assumptions
THMP has given “specious reasoning” behind not providing Cabenuva, according to Michael Elizabeth, director of public health policy for the HIV advocacy organization Equality Federation. The assumption is that people switching from a less expensive oral medication could potentially bust the budget. But in crunching the numbers, Elizabeth said that assumes every Texan on oral meds would switch to Cabenuva. “ADAP says the number of people switching would add up to $6.4 million a year for Texas, but that assumes 100% of the virally suppressed patients on oral single-tablet regimens would switch to Cabenuva, but we don’t see those [switching] numbers in other states. We’re not seeing an exodus of people on Biktarvy, for example, immediately switching to Cabenuva.”
Martinez agreed that THMP’s assumptions are faulty. “We’ve seen from other states’ ADAPs that maybe 2–5% have switched to Cabenuva.”
“You can’t have resistance to either of the components [in Cabenuva] and there’s going to be individuals who may have developed resistance in their prior treatment history,” she said. “And you have to be someone that actually wants injections. Not everybody is a fan of needles.”
Bottom line, if you’re a Texan with HIV, and you have insurance, you potentially have access to Cabenuva and if you’re uninsured, you don’t.
Recent data from the LATITUDE Phase 3 trial, presented at CROI in March, indicate that long-acting injectables may be better than daily pills for people who have difficulty with adherence. The Transgender Network of Texas (TENT), in a letter to the Texas Department of State Health Services (DSHS), the organization that oversees THMP, emphasized that trans Texans would benefit from Cabenuva.
“Due to the prevalence of housing instability, employment discrimination and other social determinants of health, many transgender Texans fluctuate between Medicaid and THMP based on income and other eligibility factors,” TENT wrote. “Open and full formulary access to all FDA-approved HIV medications should not be made more difficult, especially for those most deeply affected by this epidemic.”
Martinez added that a potential groundswell of PLWH switching to Cabenuva shouldn’t break the state’s budget. “The cost is on par [with oral medication], within the ballpark, and there was a good faith effort negotiation between ViiV and ADAPs to make Cabenuva cost neutral.”
In an email, Douglas Loveday, a spokesperson for DSHS, said the department’s estimate was based on an assumption that only 80 percent of THMP clients, not 100, would switch to Cabenuva (the estimated percentage of THMP clients virally suppressed and eligible to switch).
“The addition of Cabenuva will also require increased office and injection-only visits for clients,” Loveday wrote. “The cost of an injection ranges from $25 as part of a nursing visit to $75 as part of a medical provider visit. The average cost for injection visits ranges from $75 to $125 per client per year. This will result in a projected increase of $857,175 to $1,428,625 annually.”
The projected cost of office visits plus the medication would increase the cost to THMP up to $6.4 million annually, Loveday wrote. “DSHS is experiencing an increase in THMP enrollment which, if it continues, will exceed program funds. DSHS is completing further analysis to see how to best resolve this projected program shortfall.”
The Texas legislature could apply pressure on the agency to add Cabenuva to the formulary, but the lawmakers meet only every other year, and the next session starts in January. Elizabeth adds that expecting the legislature to take up the issue, despite some advocates in the chamber, is dubious.
Any legislative effort to put Cabenuva on the THMP formulary will face strong headwinds, Elizabeth said. “Anything that tends to even remotely support marginalized communities has a hard fight ahead of it,” he said. “The legislature is one of the drivers behind all the anti-LGBTQ bills that we’re seeing across the nation… and have generally been anti- anything that can be seen as supportive of these communities.”
Martinez said that the failure to provide Cabenuva for uninsured Texans could have consequences for ending the HIV epidemic, noting that five jurisdictions—Bexar, Dallas, Harris, Tarrant and Travis counties—are in the U.S. Ending the Epidemic (EHE) initiative.
The overall HIV viral suppression rate in Texas is estimated to be 63%, well below the state’s goal of 75% by 2025.
“More data is coming out that long-acting injectables are potentially a means of getting folks to undetectable,” Martinez said. “We’re nowhere close to ending the HIV epidemic and meeting those goals, the 90-90-90 goals and we’re especially not going to get there with this glaring disparity. We have to think about who are the folks that tend to have more challenges, and folks without insurance already tend to have more challenges.”
A VITAL gap in Puerto Rico?
Puerto Rico, unlike Texas, has government-funded healthcare for people who need it. But a recent change to the plan has HIV advocates worried that people living with HIV (PLWH) will see gaps in coverage for all HIV meds.
As with Texas and other states, Puerto Rico provides ADAP coverage for PLWH who are not insured through a government health plan called VITAL. But as of July 1, people who relied on VITAL for meds were switched to a Medicaid Drug Rebate Program (MDRP), affecting about 7,000 Puerto Ricans on the island who are living with HIV, and possibly not for the better, advocates say.
Under the MDRP, pharmacies and clinics that provide meds will have to upfront the cost of meds then get reimbursed by the government. But some of the pharmacies and clinics do not have the cash flow to pay for medications for all their patients, according to Pedro Julio Serrano, manager of development and public policy at Waves Ahead, a San Juan-based LGBTQ+ services organization. “So this means pharmacies and clinics might not be able to buy medications in advance,” he said.
To head off unintended roadblocks to getting meds, Waves Ahead and other advocates met with Mellado López, the Secretary of Health of Puerto Rico, and asked that HIV meds be excluded from the MDRP and make them available through ADAP instead, but they were unsuccessful.
“The government is saying that this allows for more pharmacies to be able to provide the meds, but in reality, some people can’t be going to pharmacies or other places to get their meds because they can only afford one ride, to go to the clinic to get their meds and their labs,” Serrano said. “This endangers people who are adherent to their medications.”
The government did provide a temporary patch to make sure that the pharmacists and clinics have a sufficient allocation of medication through December. “But we don’t know what will happen after January,” he said. “That’s why I worry.”
Adding to the uncertainty are the November elections. Serrano fears that a wave of new right-wing candidates “fostering a climate of hate that is inciting violence against LGBTQ+ people” may be voted into office.
“Some candidates are jockeying for votes from the right-wing sector that is proposing things that are dangerous for [people with HIV]. So we’re worried that some of the successes that we’ve had in terms of adherence in Puerto Rico, and services and projects, might be in jeopardy if more candidates from the right wing are elected.”
So far there’s been no disruption in obtaining HIV meds on the island, Serrano said.
—Larry Buhl