Carl Schmid, MBA and Ian Frank, MD discuss the process of initiating HIV PrEP beginning with a clinical patient evaluation.
Neil Minkoff, MD: When a patient is undergoing initial clinical evaluation, what are the different components that should go into that evaluation to make determinations about the use of PrEP [pre-exposure prophylaxis]? Mr. Schmid, I see you jumping in already.
Carl Schmid, MBA: Just like HIV treatment, which is a daily commitment for the rest of your life, PrEP is also a commitment, and its daily use right now. Usually, you take a drug because you’re sick, but in this instance, you’re not sick. Thus, you’re convincing the person to take a drug to prevent illness, which is great that we have it. But it’s a commitment, and the clinician has to assess if that person is willing to do it and adhere to it. Then also, PrEP is not just a drug. It is associated laboratory services. Even before you begin initiation of PrEP, you have to make sure you’re HIV negative. Thus, you have to have an HIV test, an STI [sexually transmitted infection] test, and a hepatitis B test. Then there’s monitoring work as well, for renal function and bone density, and it’s ongoing. Right now, the guidelines from the CDC [Centers for Disease Control and Prevention] are every 3 months for some of these tests. Again, it’s not just a drug, it’s an ongoing commitment, and adherence becomes an issue as well. There are ways we’re trying to address that, through telehealth, and doing consultations and counseling through telehealth, and there are even some advanced new lab services, where you can tell if a patient is adherent or not, perhaps in the future. Thus, it’s not just the drug, and it’s a long-term commitment as well.
Neil Minkoff, MD: I’ve made a little note to circle back around some of these things around adherence, persistence, and so on. But before we get into that, the process of initiation is not necessarily a simple process. There’s the discussion with the patient, there’s the discussion potentially around coverage issues, and so on. Maybe we could get some guidance from our panelists here in terms of what the initiation process can look like between working with the patient and working with the payer, and the PBM [pharmacy benefit manager], for example, in terms of getting the right drug to the right patient, and how you’re making those determinations, and how you help them start that process.
Ian Frank, MD: The first step in this process is taking a good sexual history and being able to do that in a way that isn’t judgmental, and helps promote trust between the provider and the patient. Let’s say we’ve done that, and we’ve assessed somebody’s risk for potential HIV acquisition, then there needs to be some discussion about that. Then, there needs to be some discussion about current symptoms, and whether individuals may have any symptoms that could suggest active HIV infection, newly acquired HIV infection, or a history of active sexually transmitted disease. One wants to understand if somebody has been exposed to hepatitis in the past, if they’ve been vaccinated against hepatitis, other general medical history types of questions. Thus, a good history, and then a good physical examination is a component of the process. Then, as Carl suggested, there’s a conversation about not just prescribing the medicine, but the entire spectrum of management that is required.
Then, ultimately, there is a conversation about 1 of 2 drugs, or some may even consider it the same drug. There’s not that much choice among the agents that are FDA approved for PrEP. It’s emtricitabine plus 1 of 2 different forms of tenofovir: the older tenofovir disoproxil fumarate or the newer tenofovir alafenamide. Those are the choices of agents. Then, I think there is the conversation about how we can get this for you. I work at a large university hospital. Nobody walks in the door without either having insurance or being qualified to get HIV treatment or prevention services. Thus, I pretty much know that I’ll be able to get either of those agents for the patient if he or she elects to take it. If you live in different parts of the country, access may be less readily available. Maybe some of the other panelists could talk about some of the complexities about delivering care in different parts of the country. I feel lucky to be in a Northeast coast state, where public health programs and insurance are a little more generous than other parts of the country.
Transcript edited for clarity.