HIV Long-Acting Injectables Face Policy Hurdles After CROI 2025
Amid the political turmoil and public health uncertainties of 2025, a remarkable scientific success story continues to unfold. The Conference on Retroviruses and Opportunistic Infections (CROI 2025) showcased significant advancements in HIV long-acting injectables for prevention and treatment—with new formulations requiring as few as one intervention per year. These latest innovations build on the promise of existing long-acting therapies while dramatically extending their duration and effectiveness.
These advancements represent more than scientific achievements; they're testaments to the HIV community's persistent demand for better options. After decades of daily pills, these innovations offer liberation from medication schedules, reduced visibility for those who face stigma, and new hope for those who struggle with adherence. The HIV community has always adapted and persevered, and these breakthroughs are the latest chapter in that ongoing story of resilience.
Yet, as we celebrate these scientific milestones, we face a familiar challenge: ensuring innovations translate into accessible care for all who need it. While researchers present promising data in conference halls, Republican-led attempts to slash Medicaid funding and legal challenges to preventive care coverage threaten to limit who benefits from these breakthroughs. It's a jarring disconnect between scientific progress and political reality that the HIV community knows all too well.
Still, if history has taught us anything, it's that the HIV community has never backed down from a fight for access. So we'll toast to the science, roll up our sleeves, and get to work on the policy—because breakthrough treatments mean little if they're out of reach for those who need them most.
Scientific Breakthroughs in HIV Prevention
The most notable announcement from CROI 2025 was Gilead's presentation of first clinical data for once-yearly lenacapavir formulations for HIV prevention. The Phase 1 study data showed that both intramuscular formulations maintained plasma concentrations well above protective thresholds for a full year, with median trough concentrations at Week 52 significantly higher than those observed with twice-yearly lenacapavir at Week 26.
This represents a substantial advance beyond current options like daily oral PrEP and bimonthly injectable cabotegravir, potentially reducing interventions to just once annually. The PURPOSE trials have already demonstrated the impressive efficacy of lenacapavir, with PURPOSE 1 showing 100% protection in women in South Africa and Uganda, and PURPOSE 2 finding a 96% lower acquisition rate compared to background incidence across diverse populations.
Advancements in Long-Acting HIV Treatment
Treatment options for people living with HIV are seeing similar progress. The combination of lenacapavir with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab maintained viral suppression in 96% of participants at Week 26, comparable to daily oral treatment. This regimen, which gained FDA Breakthrough Therapy Designation in January 2025, could offer a complete twice-yearly treatment option.
ViiV Healthcare's EMBRACE study of N6LS, administered every four months with monthly cabotegravir, showed similarly high rates of viral suppression. A UCSF study further confirmed the value of long-acting injectables, with 98% viral suppression after 48 weeks among patients who previously struggled with oral medication.
Diverse Patient Preferences
Research confirms that preferences for HIV treatment vary significantly. A recent study identified three distinct preference groups: those preferring implants (29%), those preferring long-acting oral or injectable options (35%), and those preferring daily or long-acting oral treatments (36%). These preferences correlated with factors like age, education, injection aversion, and adherence to current therapy.
This heterogeneity underscores that "the failure of current daily oral ART to achieve viral suppression for all people living with HIV has shown that there is no one-size-fits-all in HIV care." Offering a range of options will be essential to address diverse needs and preferences, potentially improving both adherence and outcomes.
Access Barriers and Coverage Challenges
Despite the promising scientific advances in long-acting treatment and prevention therapies, significant structural barriers threaten to limit their reach to the communities that need them most. The complex distribution and administration requirements for these medications create unique challenges not seen with oral HIV medications.
According to data from NASTAD, the Wholesale Acquisition Cost (WAC) for Apretude (cabotegravir for PrEP) is $3,700 per dosing kit, translating to approximately $22,200 annually for maintenance doses, or about $25,900 for the first year with initiation doses. This cost, while lower than the $40,000 often cited for Cabenuva (the treatment version), remains substantially higher than generic oral PrEP. Unlike oral medications, these injectable options also require additional costs for clinic visits and administration fees, further complicating access.
For people relying on AIDS Drug Assistance Programs (ADAPs), coverage remains inconsistent. According to the International Association of Providers of AIDS Care (IAPAC), six states (Missouri, Kentucky, Louisiana, Oklahoma, Texas, and South Dakota) and some U.S. territories do not cover injectable HIV medications through their ADAP programs. Even in states that do provide coverage, the distribution system for these medications differs significantly from oral medications. As NASTAD explains, long-acting injectables are distributed through "buy-and-bill," "white bagging," or "clear bagging" mechanisms involving specialty distributors or pharmacies rather than traditional retail pharmacies, creating additional logistical barriers.
While the Biden Administration issued updated guidance in October 2024 requiring health insurers to cover all three FDA-approved forms of PrEP without cost-sharing, this mandate faces legal challenges. The Supreme Court has agreed to hear a lawsuit challenging the Affordable Care Act's preventive services provision, with arguments commencing in spring 2025 and a decision expected by July. This case could potentially eliminate the requirement for insurance plans to cover preventive services like PrEP without cost-sharing.
These access challenges disproportionately affect those at highest risk for HIV. Despite the recommendations for PrEP that now include newer formulations, PrEP uptake remains unequal. The Centers for Disease Control and Prevention (CDC) has estimated that the proportion of persons with indications for PrEP who received it was 60.5% among White persons vs 7.9% in Black persons and 13.8% in Hispanic/Latino persons. Without policy intervention to address these barriers, the remarkable scientific progress in HIV prevention and treatment risks benefiting only those with privileged access to healthcare while leaving behind the communities with the greatest need.
Political Context and Threats to Progress
The current political landscape presents additional challenges to expanding access to long-acting injectables for HIV treatment and prevention. The Republican-led Congress is considering plans to cut Medicaid by potentially $880 billion or more to help pay for tax cuts, according to a Kaiser Family Foundation report. Such reductions would likely impact access to these innovative but costly treatments.
At the international level, the Trump administration's pause on PEPFAR-funded prevention services threatens to reverse progress in global HIV prevention efforts. As Jirair Ratevosian writes in his CROI analysis, "The Trump administration now faces a choice: either let PEPFAR's legacy crumble or seize this opportunity to lead the next phase of HIV prevention."
It's worth noting that Medicaid enrollees across the political spectrum express concerns about potential program cuts. KFF focus groups found that "both Trump and Harris voters valued their Medicaid coverage and the access to health care services, mental health services, and medications for themselves and their children it provides." Participants described losing Medicaid as potentially "devastating" and likely to lead to serious consequences for their physical and mental health.
Bridging the Gap
To ensure equitable access to these breakthrough HIV prevention and treatment options, several policy approaches should be considered:
Strengthen CMS Guidance on Long-Acting Injectables: The Centers for Medicare & Medicaid Services should update its informational bulletins on HIV prevention and care delivery to reflect the latest advancements in longer-acting therapies and issue specific policy guidance on Medicaid's role in supporting PrEP uptake and persistence.
Defend Preventive Service Coverage: Advocacy efforts should focus on defending the ACA's preventive services mandate as the Supreme Court considers challenges to this provision.
Expand ADAP Coverage: State ADAP programs that do not currently cover long-acting injectables should be encouraged to add these medications to their formularies, potentially with additional federal support to offset costs.
Engage in Value Assessment: Payers, including Medicaid and Medicare, should evaluate the long-term clinical and economic benefits of these options, including reduced transmission, improved quality of life, and potentially fewer hospitalizations due to better adherence.
Conclusion
The scientific advancements presented at CROI 2025 offer unprecedented opportunities to transform HIV prevention and treatment. Once-yearly prevention therapies and twice-yearly treatment regimens could dramatically improve adherence, reduce transmission, and enhance quality of life for millions of people living with or at risk for HIV.
However, without concerted policy action to address access barriers, these innovations risk becoming available only to those with privileged access to healthcare, potentially widening rather than narrowing health disparities. As long-acting HIV therapies move closer to widespread availability, advocates, policymakers, healthcare providers, and industry partners must work together to ensure that these scientific breakthroughs translate into public health impact for all communities affected by HIV.
The gap between what's scientifically possible and what's accessible represents both a policy failure and a moral challenge. Bridging this gap requires political will, innovative financing approaches, and a commitment to health equity that matches the remarkable scientific progress we've witnessed.
Equitable Access to Long-Acting HIV Treatment
For people living with HIV (PLWH), adherence to antiretroviral therapy (ART) is crucial. Achieving and maintaining viral suppression, the primary goal of HIV treatment, depends on taking medication as prescribed. Yet, consistent adherence can be challenging due to busy schedules, pill fatigue, stigma, and side effects. Suboptimal adherence has serious consequences, including increased viral load rebound, drug resistance, and disease progression. It also hinders public health efforts to control the HIV epidemic. Long-acting injectable (LAIs) antiretroviral therapies offer a promising alternative by providing sustained viral suppression with less frequent dosing. However, a significant barrier remains: equitable access. Some State AIDS Drug Assistance Programs (ADAPs), designed to support low-income PLWH, do not adequately cover these medications due to cost concerns .
This limited coverage is a public health issue and a moral failing. State ADAPs must provide equitable access to the most effective HIV treatments available that meet the unique needs of the patient, regardless of cost. While the initial expense of LAIs may be high, their potential to improve adherence, viral suppression, and long-term health outcomes far outweighs the financial investment. It's time for ADAPs to prioritize the health of PLWH by ensuring access to LAIs and supporting efforts to end the HIV epidemic.
The Promise of LAIs
LAIs represent a major advancement in HIV treatment. Unlike daily oral ART, which requires daily ingestion and absorption, LAIs are administered as intramuscular injections, typically once a month or every two months. These injections provide a steady release of medication, ensuring consistent drug levels and effective viral suppression.
The benefits of LAIs are significant. The MOCHA study found that adolescents overwhelmingly favored LAIs due to the convenience of less frequent dosing . This reduces the daily burden of remembering to take pills, leading to improved adherence rates—a key factor for successful HIV treatment.
Improved adherence through LAIs also enhances long-term health outcomes and reduces the risk of HIV transmission. When the virus is undetectable, it cannot be sexually transmitted, a concept known as Undetectable = Untransmittable (U=U). By promoting optimal adherence and sustained viral suppression, LAIs become a powerful tool in the fight against the HIV epidemic.
Evidence of Effectiveness
The effectiveness of LAIs is supported by considerable scientific evidence. The MOCHA study found that after 24 weeks of treatment with long-acting cabotegravir/rilpivirine, none of the nearly 150 participants experienced virological failure. This highlights the potential of LAIs to achieve durable viral suppression, especially among younger populations who often struggle with adherence to daily oral regimens.
The LATITUDE study, focusing on PLWH with a history of suboptimal adherence to oral ART, found that long-acting injectable therapy was superior in suppressing HIV replication compared to daily oral medication . The compelling results led the National Institutes of Health Data and Safety Monitoring Board to recommend offering the long-acting medication to all eligible participants.
These studies, along with a growing body of research, show that LAIs are effective in achieving viral suppression and are particularly beneficial for those who struggle with adherence to traditional oral ART. This makes LAIs a critical tool for addressing disparities in HIV treatment outcomes and advancing health equity among PLWH.
Impact on the HIV Epidemic
The effectiveness of LAIs in maintaining viral suppression has significant implications for public health, especially the Ending the HIV Epidemic (EHE) initiative, which aims to reduce new HIV infections in the United States by 90% by 2030. Achieving this goal requires expanding access to effective prevention and treatment options.
LAIs support this effort by fostering optimal adherence and sustained viral suppression. By ensuring that PLWH have access to medications that effectively suppress the virus, we improve health outcomes and reduce the likelihood of transmission, moving closer to the EHE goal.
LAIs also align with the 95-95-95 targets set by UNAIDS, adopted by the EHE initiative, which aim to ensure that 95% of PLWH know their status, 95% of those diagnosed receive sustained ART, and 95% of those on treatment achieve viral suppression. By improving adherence and facilitating viral suppression, LAIs contribute to achieving these targets and reducing new cases.
The International Association of Providers of AIDS Care (IAPAC) emphasized the importance of LAI access for supporting the goals of the Fast-Track Cities initiative . This initiative aims to accelerate progress towards ending the HIV epidemic at the local level. IAPAC argues that providing PLWH with access to effective ART options like LAIs is essential for achieving these ambitious targets.
The Cost Conundrum
The benefits of LAIs are often overshadowed by concerns about cost. Critics, including some state ADAP administrators, point to the high upfront price of these medications compared to generic oral ART options. A 2023 article on AIDSmap highlighted that the price of long-acting cabotegravir would need to drop considerably to be cost-effective compared to daily oral PrEP . This concern about cost is echoed in discussions surrounding LAIs for treatment, with some stakeholders questioning whether the potential benefits justify the higher price tag.
A recent article in TheBody revealed that the annual cost of Cabenuva, a commonly prescribed LAI, is approximately $40,000. This figure highlights the need for careful consideration of drug pricing within ADAP formularies. For comparison, the annual retail cost of the popular oral ART treatment Biktarvy is just over $50,000. However, as of January 2023, only 78% of state ADAPs covered Cabenuva.
This gap in coverage disproportionately affects the most vulnerable PLWH. In states without Cabenuva coverage, nearly two-thirds of ADAP clients live at or below the federal poverty level, compared to 43% in states with coverage. Additionally, ADAP clients in states lacking Cabenuva coverage are more likely to be Black or Hispanic .
While cost is a valid concern, focusing solely on upfront expenses overlooks the potential for long-term savings. ADAPs can negotiate lower drug prices and must consider the broader economic and public health benefits of LAIs.
A Holistic Cost-Benefit Analysis
A comprehensive cost-benefit analysis must consider the long-term impact on healthcare expenditures and public health outcomes. A narrow focus on upfront costs ignores the potential of LAIs to generate significant savings over time.
The HIV+Hepatitis Policy Institute modeled the impact of long-acting PrEP on HIV case aversion and medical cost savings, concluding that improved adherence leads to better health outcomes and reduced transmission, ultimately saving costs for the healthcare system. They projected that increased uptake of long-acting PrEP would avert 139,296 person-years of HIV treatment over ten years, saving $4.25 billion .
Preventing new HIV infections through improved adherence not only saves on direct treatment costs but also reduces the need for costly interventions related to managing complications and comorbidities of advanced HIV. By minimizing the risk of transmission, LAIs contribute to a decrease in HIV prevalence, further reducing long-term healthcare costs and saving lives in the process.
Intangible Benefits
The benefits of LAIs extend beyond economics. These medications significantly improve the quality of life and overall well-being of PLWH.
The MOCHA study highlighted that young people preferred LAIs due to reduced treatment anxiety and fatigue. They appreciated the increased privacy, as they no longer needed to take daily pills that might disclose their HIV status.
ADAP Advocacy emphasizes the importance of patient empowerment and choice in HIV care. LAIs provide PLWH with greater autonomy in managing their health, aligning treatment with their personal needs and lifestyles. This sense of control improves mental health, self-esteem, and quality of life.
By reducing the frequency of medication-related tasks, LAIs help minimize the stigma associated with HIV. Daily pill-taking can serve as a constant reminder of one's HIV status, triggering feelings of shame or fear of disclosure. LAIs, with less frequent dosing, allow PLWH to integrate their care more seamlessly into their lives, reducing the psychological burden.
These intangible benefits, while difficult to quantify economically, should weighed equally when making decisions that affect patient care and access. They highlight the profound impact of LAIs on the lives of PLWH, extending beyond viral suppression to encompass improved quality of life, reduced stigma, and increased autonomy.
Ethical Considerations
Equitable access to LAIs is an ethical imperative. State ADAPs, as safety-net programs for low-income PLWH, have a moral duty to provide access to the most effective HIV treatments, regardless of cost. Denying access based on price perpetuates health disparities and undermines equity.
IAPAC argues that access to innovative treatments like LAI-ART should not depend on socioeconomic status. Providing ADAP coverage for LAIs is crucial for equitable healthcare.
Restricting LAI access disproportionately impacts those already facing systemic barriers, including people of color, those with low income, and those in rural areas. These populations are more likely to have adherence challenges due to social, economic, and structural factors. Denying them access to LAIs further entrenches health inequities.
A commitment to health equity demands prioritizing the needs of the most vulnerable. Cost concerns, while valid, cannot justify denying essential healthcare to those who need it most. State ADAPs must ensure all PLWH can benefit from LAIs, regardless of financial circumstances.
Addressing Barriers and Implementing Solutions
Ensuring equitable access to LAIs requires a multi-faceted approach, addressing cost concerns and systemic barriers. Policy changes at federal and state levels are necessary for creating a more just healthcare system for PLWH.
Policy Recommendations for ADAPs
Mandate LAI Coverage: State legislatures should require ADAPs to cover all FDA-approved LAIs for HIV treatment. This would ensure all eligible PLWH have access to these medications.
Streamline Prior Authorization: ADAPs should streamline prior authorization processes for LAIs, minimizing delays and ensuring timely access to treatment. This could include standardized approval criteria, expedited review processes, and clear communication between providers and ADAP administrators.
Increase Funding Allocations: State and federal governments must prioritize increased funding for ADAPs, recognizing the growing demand for LAIs and their long-term cost savings potential.
Provider Education and Training
The ADAP Advocacy Association underscores the need for robust provider education and training on LAIs. They advocate for targeted education about providing LAIs within a modified clinic flow model.
Ongoing education initiatives should focus on:
LAI Pharmacology and Administration: Providers need a thorough understanding of LAIs, including dosing schedules, potential side effects, and proper administration techniques.
Patient Selection and Counseling: Training should equip providers to identify appropriate candidates for LAIs, considering personalized patient needs and potential adherence barriers. Effective counseling strategies are necessary for addressing concerns and ensuring informed decisions.
Addressing Provider Bias: Some providers may hold misconceptions about LAIs, such as concerns about patient acceptance or injection-related anxiety. Training programs should address these biases, providing evidence-based information and dispelling myths.
By investing in comprehensive provider education and training, we can empower healthcare professionals to embrace LAIs confidently, facilitating broader access and improved health outcomes for PLWH.
Patient Advocacy and Support
Community activism has been a hallmark of the U.S. HIV response, and PLWH should work with clinicians to advocate for state ADAPs to prioritize patient choice and treatment preferences.
PLWH and community organizations can play a powerful role by:
Sharing Their Stories: Personal narratives are powerful tools for raising awareness and influencing policy change. PLWH who have benefited from LAIs can highlight the positive impact, while those denied access can shed light on the challenges and the need for equitable coverage.
Engaging with ADAP Advisory Committees: Many state ADAPs have advisory committees of stakeholders, including PLWH. Participating in these committees provides an opportunity to voice concerns and advocate for policy changes.
Collaborating with Advocacy Organizations: Partnering with national and local organizations can amplify voices, provide resources, and facilitate collective action for policy changes.
Educating Their Peers: PLWH can educate peers about LAIs, dispelling myths and sharing information about the benefits and potential challenges. Peer-to-peer support can empower people to advocate for their health and make informed treatment decisions.
By raising voices, sharing experiences, and engaging in collective action, we can drive progress towards equitable LAI access, ensuring all can benefit from these transformative medications.
Conclusion
Long-acting injectable antiretroviral therapies (LAIs) represent a major advancement in HIV treatment, offering a powerful tool for improving adherence, achieving sustained viral suppression, and ending the HIV epidemic. While cost concerns are valid, a holistic cost-benefit analysis shows that the long-term benefits of LAIs far outweigh the initial investment.
The time for action is now. Contact your state legislators, ADAP representatives, and other stakeholders. Demand equitable LAI coverage and support policies that prioritize the health and well-being of all PLWH. Together, we can dismantle barriers to access and ensure no one is left behind in the fight to end the HIV epidemic.
European Commission Approves Once Every 6 Month Supplemental HIV-Treatment
Last week, the European Commission (EC) approved use of Gilead Sciences’ investigational medication, lenacapavir (branded as Sunlenca), for use in treatment for people whose HIV is highly treatment resistant. Lenacapvir has been closely watched by advocates because of great anticipation regarding injectable and otherwise long-acting agents (LAAs) and because of its exceptionally long half-life in the body, providing efficacy for about 6 months from just one subcutaneous injection, providing a potential for the longest acting agent to hit the market thus far.
Lenacapavir also stands out as a first-in-class product because it works in a way that no other antiretroviral medication works. Offering a novel mechanism of action, binding the shell (capsid) surrounding viral genetic material that highjacks our own cells in HIV reproduction, capsid inhibitors will work against HIV in multiple areas of the virus’ life cycle. And because this is a tool we’ve never used before, it’s ideal for meeting the treatment needs of people living with highly resistance HIV – the virus doesn’t recognize the medication and has not yet found a way around it. Because HIV is highly adaptable, that lack of resistance may be short-lived once broad reach of the product is made available but excitement remains for a novel product, especially for people who have developed such resistance that options of effective care have diminished to near zero.
Gilead Sciences is awaiting a decision from the United States’ Food and Drug Administration (FDA) on its recently resubmitted “New Drug Application” (NDA), after the agency declined to accept the NDA due to issues with the glass vials used for the injectable form of the medication. The vial issue has since been fixed and research resumed for use of lenacapavir as a supplement to “background” treatment, first-line treatment, and as pre-exposure prophylaxis (PrEP). At the end of July, the FDA provided Gilead with a December 27, 2022 prescription drug user fee date. This is one of the final steps in an initial new drug approval. (Briefly, the Prescription Drug User Fee Act funds a massive portion of the FDA and those medications which pose potential benefit to public health may receive an expedited fee date; HIV advocates historically championed the act as a massive “win” in the early 90’s when introducing this funding scheme sped up their processes to make oncology and HIV medications more readily accessible.)
Patients who may hear about “once every 6-month treatment) should be kindly reminded lenacapavir will serve only as a supplement to other therapies – administering the medication is required to be done by a provider and patients will still need to remain adherent to their existing treatment regimen. HIV medications for treatment need between 2 and 3 different combinations of medications and PrEP only needs 1. As such, there may be a disparity in lenacapavir as PrEP and Sunlenca as treatment in terms of uptake because, while lenacapavir won’t require maintenance of other medications, Sunlenca as treatment will require patients to continue to take the oral medications that are “optimized” with Sunlenca acting almost like a “soft reset” for patients.
Operationalizing will remain an issue, especially for state ADAP Program’s that have not fully implemented access to cabotegravir, in terms of injectable medication management and for arguments that frame investing in successful patient care as something that requires a “cost consideration”. Patient advocates should be well-prepared to defend a desire to see this product come to their patients as those patients so desire it.
Institutional Barriers Still Stand in the Way to Equity
On July 28, 2022, the World Health Organization (WHO) released new guidelines on the use of long-acting, injectable cabotegravir (branded as Apretude) as pre-exposure prophylaxis (PrEP), just ahead of the 24th International AIDS Conference (AIDS2022) in Montreal. On the same day, ViiV Healthcare announced a voluntary licensing agreement with Medicines Patent Pool in an effort to extend access to the medication to middle- and low-income countries, particularly sub-Saharan African countries.
These are very exciting developments as the innovative products (Cabenuva for the treatment of HIV and Apretude for the prevention of HIV) represented the most recent of biomedical interventions around HIV with the potential for dramatic changes for the better. Expanding options, allowing for patients to choose between a daily tablet or once-every-two-months provider administered injection, gives patients the choice to pick between highly effective regimens to suit their comfort and lifestyles. While that may sound like a sales pitch for a phone, it’s not – it’s the effort to make life-saving medications appealing and easy. Frankly, they should be.
But in the long fight to make these medications available, we should be reminded that “available” and “accessible” are two, very different things. The difference is big – so big – that it can be measured in the 4,000 new diagnoses a day and 650,000 AIDS-related illness deaths in 2021.
That gulf, the pit in your stomach reading that data, the silence at the end of the hope and joy you had reading those first two paragraphs – that’s the space between “available” and “accessible”.
In order to fully appreciate the extraordinary efforts to improve living with and life for people living with HIV, we must also fully appreciate the barriers to care patients face every day. From housing to transportation to stigma to food – clean water and food – patients have consistently been blamed by policymakers, both foreign and domestic, for failing a moment in which patients aren’t the ones with institutional power to change the circumstances of their journey to care.
A large portion of AIDS2022 is dedicated to highlighting these disparities, the specific policy mechanisms countries should consider implement* in order to create a more equitable world for all and to ultimately End the HIV Pandemic. From discussing discordances in criminal laws and public health best practices (sex work, harm reduction) to practical investments in education and health care systems to very direct conversations on how political opportunism finds readiness in villainizing people and communities highly affected by HIV, the International AIDS Conference is a dedication in love, spanning thousands of years of lived experiences and expertise. The lessons learned from the collaborative and sometimes confrontational efforts highlighted at this event are lessons we ultimately should also appreciate here, in the United States.
At home, though, the disconnect between federal authorization of innovative medical products and state-based policies to ensure access is the representation of that engulfing silence from earlier. Patients, especially low-income patients, are still struggling to realize the benefits and flexibilities of the biomedical innovations. Medicaid programs were slow to appreciate the need to cover Cabenuva and Apretude (some still don’t). A national coverage determination has not yet been made to ensure Medicare patients have access. And even if every last corner of these public payers covered these medications, private payers still maintain the power over a patient’s choice by simply refusing to pay for them – instead forcing patients to suck up whatever the payer determines is acceptable.
Of all the systemic and institutional barriers to care patients face domestically, payers remain some of the least regulated, least accountable, and most profitable – of the top 12 most profitable companies in the US, 3 are or own pharmacy benefit managers. Food, housing, transportation all take many, many layers of work to dig into. But changing what patients pay at the pharmacy counter, relieving that stress and making patients less fearful of having to choose between those necessities and their medications? That takes one layer, one set of actors, to be held accountable to everyone who pays them to stay in business – including and especially the United States government. Advocates would do well, as federal legislators prepare to go elbow deep in “drug pricing” legislation, to readily ask “lower prices for whom?” The difference in the answers can be measured as the difference between “available” and “accessible.”
*The strikethrough and italics is the author’s commentary on language used by politicized entities to urge necessary policy changes.
Cabenuva Approved for 2 Month Injections; Insurers Remain a Barrier to Access
In late January of 2021, ViiV Healthcare and Janssen Pharmseutical Companies announced the Food and Drug Administration’s (FDA) approval of the first extended-release injectable medication regimen for the treatment of HIV as a once-monthly administration, branded as Cabenuva. Eleven (11) months later, the FDA approved cabotegravir as an extended-release injectable suspension for the prevention of HIV as a once-every-two-month administration, branded as Apretude. Again, on February 1, 2022, the FDA expanded Cabenuva’s administration to be a once-every-two-month administration. Near overnight, people living with HIV-related medication therapy and prevention efforts went from a burdensome three-hundred sixty-five (365) pills to six (6) injections.
This kind of innovation has been long anticipated and while advocates and patients recognize not every patient will desire to switch to injectable medications and resistance profiles may require some people living with HIV to maintain their tablet regimens, injectables offer yet another tool in the tool box. The extended-release nature of injectables offer an opportunity to overcome “treatment fatigue”, reduce opportunities for missed doses and subsequent treatment resistance, and even address safety in storing medications at-home – especially for those people living with and at risk for acquiring HIV that may also be experiencing houselessness. This becomes even more of an astounding tool, in addressing disruptions in care when patients live in areas prone to natural disasters, as seen in Florida during Hurricane Michael when the state’s central pharmacy operations came to a halt, forcing the state to rely on a private-public partnership with CVS, and in Puerto Rico after Hurricane Maria, in which patients lost access to life-saving medications. The issue of natural disasters interrupting care is not new and will likely be something providers and patients need to have plans for as every indication exists climate change will produce more and more powerful hurricanes. Indeed, despite the lessons learned from Hurricane Katrina, I personally witnessed multiple calls across social media channels among people living with HIV seeking additional medication in order to manage loss of their anti-retrovirals in 2021, during Hurricane Ida. Despite the state of Louisiana and the department of Health and Human Services declaring a public health emergency and activating the Emergency Prescription Assistance Program for uninsured and underinsured patients, anecdotal reports found the program hard to manage for those who needed daily administration of medications.
Yet and still, despite these incredible advancements at our finger tips, both public and private insurance programs remain reticent to allow patient and provider choice to guide what therapies patients actually have access to. Indeed, one of the largest payers in both the public and private spaces is CVS Health, who, on December 16, 2021, published priorities in “weighing cost” versus clinical benefit while specifically naming cabotegravir as an active agent in Cabenuva and Apretude. The payer outlines tactics known as “utilization management” to include initially blocking coverage of new drugs, “strongly favor[ing] generic use”, and “select[ing a] preferred agent generating lowest net cost option in category”. Even some AIDS Drug Assistance Programs (ADAPs) are delaying adding the innovative therapy to their coverage formularies. All of which creates a system of care where people living with HIV are experiencing limitations on their access to effective therapies based on their income, rather than their need as determined by them, as patients, and their provider. Deny-first utilization management practices risk losing people to care by creating unnecessary and burdensome administrative process and delays.
When Cabenuva was first approved, advocates in the community and among public services stressed concern about getting patients to return for monthly shots and the logistics of administering the shots. The concern on costs to public programs also raised its head and has done so even more recently as a limited study concluded Apretude wasn’t “cost-effective”. However, in the time since these initial discussions, tens of millions of people have received their COVID-19 vaccines, which are situated a mere 3 weeks apart and variant development has left many experts expecting the need for annual boosters of the same. The logistics of administering shots have clearly been addressed. As for the “cost-effectiveness” study, the limitation the authors cite is one that’s patently…ridiculous: “Uncertain clinical and economic benefits of averting future transmissions.” We well know the clinical benefits of preventing transmissions means fewer HIV diagnoses, a goal outlined by the United States’ federal government in the Ending the HIV Epidemic initiative, and the economic realities of preventing new transmissions is as apparent in reducing the costs of care associated with stagnant or even rising transmission rates.
The truth is, long-acting anti-retroviral therapies are the next step in innovation at extending effective care to people at risk of acquiring and living with HIV. These advancements will come with a cost that is significantly outweighed by improvements in patient quality of life, retention in care, and reduction in new transmissions. If we aren’t careful in ensuring equitable access to these innovations, existing health disparities will only grow. Barriers to care originating from payer processes, from formulary inclusion to co-pay accumulator programs, should be well-documented by providers and advocates need to be forceful in seeking access to these innovations for all patients, regardless of income or economic status. Policymakers, lawmakers, and regulators need to move quickly to address these barriers. Innovation waits for no one and that which exists in the balance between these interests are people’s quality of life and their very lives.