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.
The Future is Now: Welcome to the Age of Injectables
For years, HIV advocates have anticipated injectable antiretroviral therapies (ART) – often with a level of excitement. I recall listening to robust discussions between advocates and officials in statewide meetings, reviewing candidate treatments, discussing labor and staffing needs for providers, potential regulatory changes needed to ensure programs could cover the actual syringes associated with injectable ART, given state-based restrictions. The excitement extended from a sense of no longer needing daily tablets (pills) in order to maintain adherence and thus an undetectable viral load, extend quality of life for those experiencing barriers to care like homelessness, and otherwise welcome a new age of treatment – if only by new method of delivery.
In late 2019, we seemed on the edge of such an accomplishment. ART focused pharmaceutical manufacturers Glaxo Smith Kline subsidiary, ViiV, and Johnson & Johnson subsidiary, Janssen, had paired up in an effort to provide the world with its first long-acting ART via injection. However, the Food and Drug Administration (FDA) refused to grant the companies an approval for the dual shot regimen of cabotegravir and rilpivirine (together, “Cabenuva”) due to concerns related to “Chemistry Manufacturing and Controls”. Thirteen months later, on January 21, 2021, Janssen and ViiV announced FDA approval of Cabenuva.
ViiV Healthcare understands the transformative nature of Cabenuva and the many “firsts” associated with a provider-administered injectable therapy for HIV. We will be educating HCPs on how to identify appropriate patients who may prefer or benefit from an option other than daily, oral therapy. Two key considerations are that patients agree to the required monthly dosing schedule and understand the importance of adherence to scheduled dosing visits. We also will be helping educate people living with HIV about Cabenuva and these commitments. - ViiV
According to the product monograph, Cabenuva is a dual intramuscular injection protocol (requiring one shot of cabotegravir and one shot of rilpivirine) monthly, administered by a health care provider. Prior to starting the monthly injections, providers should test tolerability via “oral lead-in” via once daily tablets of both cabotegravir and rilpivirine with a meal. If consumers expect to miss a monthly injection by more than 7 days, once daily oral tablets of cabotegravir and rilpivirine may be used to replace the injections for up to two injection cycles (or 2 months). Contraindictions include any known or suspected resistance to either or both drugs and any intolerability of components of either or both drugs. The injections cannot, at this time, be self-administered.
Despite all of the antici…pation and data showing a higher level of satisfaction than with current regimens among trial participants, some advocates are still cautious and concerns remain regarding logistical accessibility. Regarding financial accessibility, ViiV has already launched its patient assistance program for Cabenuva through ViiVConnect. Florida advocates and members of Florida HIV/AIDS Advocacy Network, Ken Barger, Joey Wynn, and David Brakebill, discussed in…spirited detail varying perspectives on rural access.
Wynn advocated for diversifying public funds, if rural health departments couldn’t meet the demand of a once monthly injection protocol, “If a rural health department can’t do a monthly injection [for ART], when they do injections for all sorts of other disease states, they need to give their money to providers who can.” Barger and Brakebill pointed out that for many rural counties, the health department may be the only provider in the area that’s accessible, with a highlight on concern regarding capacity. Wynn suggested the need for investment in better planning and preparation – not just for injectables, but for situations of natural disasters which have been known to disrupt access to medications and care in the state regularly.
When asked about these concerns, ViiV acknowledged the challenges and provided the following commitment to invest in ensuring more equitable access to care: ViiV Healthcare is also dedicated to improving how HIV treatment and care are delivered in the “real-world” environment through our Implementation Science program. One example of this focus is a study evaluating how improvements in transportation and use of digital tools can help get people living with HIV to their healthcare providers on a regular basis, which if successful we’ll look to implement on a broader scale
This week’s HEAL blog wouldn’t have been possible without the coverage of and reporting on treatment developments in this and other therapeutic areas by Liz Highleyman.
Quotes attributed to ViiV Healthcare are direct and were provided by Robin Gaitens, Product Communications Director.