1996 marked the year when “people stopped dying” from HIV due to newly available antiretroviral drugs. Since then, treatment is often as simple as one daily pill that can suppress the virus to undetectable levels. However, this outcome only occurs if patients adhere to oral medications and ensure they never miss a day.
Now, Cabenuva — a new drug that was FDA-approved in 2021 — could improve the HIV treatment landscape by helping those struggling with traditional regimens. What does this mean for medical professionals? How can we best navigate logistical hurdles to ensure patients have access to this new drug?
What is Cabenuva?
Cabenuva is a long-acting injectable HIV regimen. Typically administered via a monthly intramuscular injection, the shot replaces current HIV-1 medicines for those who are doing well on their current medication and are undetectable. But, if Cabenuva is intended for those already virologically suppressed and on a stable antiretroviral regimen (with no history of treatment failure), why should patients switch?
The reality is that Cabenuva still works for those struggling with medication adherence. It has incredible potential for patients with a history of noncompliance since there are fewer patient-level barriers to a monthly injection.
Unfortunately, insurance can often be a barrier for patients who don't meet the requirements of being undetectable. Therefore, the patients who potentially benefit the most from Cabenuva are the same patients struggling to access the regimen.
How can clinicians speak on behalf of their patients and help provide access to this new regimen? At The MetroHealth System, an HIV Specialty Pharmacy initiative advocates for patients, helping bridge the gap between patients and insurance companies.
Persuading insurance: A team game
Alex Nelson, PharmD, a Staff Pharmacist at MetroHealth’s specialty pharmacy, believes the decision to switch to Cabenuva should be between a patient and their physician, with no third parties involved. If the patient advocates for themselves and their doctor agrees that Cabenuva will help them, MetroHealth’s Specialty Pharmacy works to get their case approved by insurance companies.
In the first year since Cabenuva became available, MetroHealth has had nearly a hundred percent success rate with prior authorization outcomes. How have they achieved this? By understanding the need for persistent advocacy on behalf of patients, demonstrating to insurance companies that Cabenuva is in the patient’s best interest.
Many HIV-positive people do not fit the FDA criteria of being undetectable, often through no fault of their own. Some congenitally infected patients have gone years with HIV that was not controlled or virally suppressed. These patients often have significant challenges with treatment adherence, and a switch to Cabenuva could mean they can live without being impacted by HIV. This is supported by research: in a recent pilot study, “80% of people who started Cabenuva with a detectable viral load achieved and maintained viral suppression, some of them for the first time.”
Stories like this are encouraging and help providers-- like MetroHealth-- build a stronger case when discussing the need with insurance companies. From there, it’s about perseverance.
If, at first, you don’t succeed…
Upon a prior authorization denial, certain cases might require the clinician to have a peer-to-peer conversation with the insurance company. Even if those conversations fail, MetroHealth will write a formal appeal to the insurance provider.
Here are a few lessons MetroHealth learned along the way to help improve the odds of success:
- Patient-centered: Don’t get weighed down by trying to tick off every criterion from an insurance company. Instead, focus on the patient by using everything at your disposal, including:
- Patient-specific evidence for issues with taking oral medications
- Patient-specific concerns regarding the stigma accompanying taking daily tablets or privacy worries around carrying a pill bottle
- A patient’s belief that they would benefit from switching to an injection
- Find common ground: Cabenuva is not the first alternative to the daily pill — there are already other approved medications given to patients with adherence issues or HIV drug resistance. Providers can use this to support their case. When patients don’t have access to suitable alternatives, they have the option of a mile-long med list, or no medication at all.
- No can’t be the end: If you and your patient know that Cabenuva is the correct regimen for your patient to be on, insurance shouldn't be getting in the way. Go back to the drawing board, make a stronger case, and find articles to back up what you're saying.
- Avoid frustration: The person at the other end of the phone likely lacks a holistic clinical view of the patient and is simply checking off boxes on behalf of an insurance provider. Help them by framing your communications from the patient’s perspective instead of a ‘health care professional vs. a corporation.’ An adversarial relationship isn’t the best way to advocate for your patient, especially when having a positive attitude may make all the difference.
Approved: What comes next?
Once you have convinced the insurance company to approve Cabenuva, it's up to the medical team to adequately prepare for any logistical hurdles.
- Refrigeration: Cabenuva must be refrigerated, requiring a plan for storing it and designating runners, if needed, to retrieve the medications from the central pharmacy.
- Be prepared: Ensure the medication is in the clinic when the patient arrives.
- Medical or pharmacy benefits: Insurance companies may require Cabenuva to be provided through either medical or pharmacy benefits. Therefore, a plan for two different workflows is necessary. While this varies by facility, MetroHealth's protocol supports a specialty-based practice within a hospital.
- For pharmacy benefits, Cabenuva is dispensed (“clear bagged”) directly to the outpatient clinic via the outpatient pharmacy.
- For medical benefits, doses are dispensed by the infusion pharmacy and delivered through the automated medication vending system.
- Be proactive: Schedule follow-ups for recurring injection appointments. Luckily, there is a large dosing window for Cabenuva (seven days on either side of the target date), which gives patients flexibility when rescheduling appointments. A method of tracking upcoming and missed injections is crucial.
A specialty pharmacy embedded in the HIV clinic
When possible, having a specialty pharmacy embedded in your HIV clinic can make all the difference in providing the proper care for patients. At MetroHealth, a team is invested in each patient's success, encouraging people to remain in care and promoting health advocacy amongst individuals. Within the MetroHealth HIV Specialty Pharmacy are four dedicated pharmacists, a prior authorization specialist, and several patient care coordinators. They reach out to patients and ensure they receive oral medications on time, set up deliveries or pickups, and work with patients for compliance packaging.
Medical professionals should advocate for their patients, even when facing challenges from insurance providers. Ultimately, we must keep the best interests of our patients in mind, and if that means dealing with healthcare corporations and regulatory hurdles, it's the right path forward.
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