Covering Single-Tablet vs Multi-Tablet Regimens for HIV

In this interview, Ed Pezalla, MD, MPH, chief executive officer, Enlightenment Bioconsult, LLC, discusses payer strategies for covering various treatment regimens for HIV.

Can you discuss the prevalence of HIV in the United States?

Right now, there are just over 1.2 million people living with HIV in the United States. About 34,000 people are newly infected every year. Importantly, 1 of 8 people living with HIV do not know they have HIV. They have not yet been tested and do not know they are infected, and of course, that creates a pool of people who might transmit the virus unknowingly to other people. That is an important statistic from a public health point of view, as it is one of the reasons we have so many new infections.

The other thing that is surprising but also, in some ways, rather sad is about 55% to 60% of people with known HIV are virally suppressed with medications, but this leaves us with 40% of this patient population who are not virally suppressed.

Either they are not on medication at all or they are inadequately treated. That is another missed opportunity to get patients onto therapy and help us reduce the rate of transmission, as well as to improve the lives of those people so their HIV does not progress, potentially to AIDS.

That is a cost issue as well, because we know HIV is pretty costly. Most of the cost is due to antiretroviral therapies. The estimate is over $420,000 for a lifetime of treatment, but if a patient is deferred therapy for 3 years, that more than doubles to over $1 million for a lifetime of treatment because of complications and other problems that come up, not to mention the social impact of that on other people.

Finally, there are over 1 million people who are eligible for PrEP or pre-exposure prophylaxis, but only about 78,000-80,000 of those people are filling prescriptions even though we have more than a couple of medications that are indicated for that, including some that are lower cost because they are generic.

We have a ways to go in the treatment of patients and screening for HIV.

You mentioned the number of patients receiving vs not receiving care. Would you like to add anything else about the gaps in care?

Part of the gaps is those patients who do not know they have HIV. That is a public health issue, and an issue of partners being realistic. It also means you need to protect yourself. That is where PrEP and barrier methods come in. Those things are important.

We also must reiterate that it is a public health issue to have people not share needles because that is a way of transmitting HIV. If we do not know who has it, people may inadvertently be infected. 

One of the questions is, what can payers do about this? Well, the commercial payers in the United States are not involved much in public health because they have a limited number of people in various patient populations.

What payers do is make the tools available to doctors, patients, and the clinics. They pay for testing. There is no payer who does not cover an HIV test. They do not ask questions. You get the request for this test, and they pay it.

The payers also cover PrEP therapies. They may have rules around which PrEP therapy you can get, because there are some differences in costs, but they all work. Payers do help to make access available for those. Also, they make the treatments for HIV accessible.

Now, we know these drugs are expensive. They can have copays or coinsurances, and that can add up, so we do need to think about how we cover the costs of HIV generally for patients.

In the past, I have been involved in some polling with patients who are receiving treatment for HIV, and we found it is not just the drug costs. We tend to look at costs as whether there is a major direct cost the payers are paying for. But the patients not only have deductibles and out-of-pocket expenses for those medicines; they also have doctor office visits and laboratory tests, both to monitor for HIV breakthrough as well as side effects. We need to take the patient cost of HIV into account.

If we are going to create any nationwide or statewide programs, we need to think about how people get their care covered and paid for. State Medicaid programs do cover PrEP therapy and HIV treatments, in addition to commercial plans covering them.

How do payers approach coverage for single-tablet vs multi-tablet regimens for PrEP?

It is unpredictable who needs which combination of antiretroviral therapies. Sometimes patients have to switch them because of the emergence of drug-resistant strains or because they're having difficulty tolerating something.

Single-tablets are generally available. If a multi-tablet regimen is comprised of the same drugs as a single-tablet regimen, then payers would like to try to move the patient toward whichever regimen is least expensive. The multi-tablet regimen might be less expensive, but that is not always the case.

We do sometimes see payers trying to encourage patients to go one direction or the other to get to the lower cost. If the single-tablet regimens are on a copay tier, if there is a flat copay, then that is beneficial to the patient as opposed to the multi-tablet regimen which would have multiple copays. So single-tablet regimens can be helpful in keeping the cost down for patients. We need to keep that in mind.

If the situation is coinsurance or calculated as a percentage, then the multi-tablet regimen could end up being less expensive for the patient, because we are going to be looking at the costs of each of the ingredients separately.

With new treatments coming out, what are some challenges payers face when it comes to covering them?

The big challenge payers will tell you, of course, is that new treatments tend to be more expensive than older treatments. There is always some additional, new cost as drugs enter the marketplace.

The challenge here is to ensure access to the medicines that patients need, and at the same time, to ensure the benefits are not becoming overly expensive for everyone, including patients with HIV or patients who need to take PrEP. They must balance cost vs what a new treatment offers.

The new treatments are going to be approved and added almost across the board. There are very few times we see a plan not cover new treatments by adding these things to the formulary. It happens occasionally, but there are also ways for patients to get exceptions if that treatment is the only one or the best one for that particular patient.

What should payers keep in mind as new longer-acting drugs are approved?

Oftentimes, payers feel, "Well, adherence is the problem of the patient, and it should be encouraged by the doctor." But lack of adherence and persistence on the medicine over time contributes to increased costs in HIV, as well as increased transmission, morbidity, and sometimes mortality for patients.

It is not just a matter of convenience. In this case, it is also a matter of making sure patients are adequately treated, and if we are paying for treatments, we want them to work.

We are not talking about the difference between taking something 3 times a day and 2 times a day. We are talking about longer-acting therapies that last for a period of time. This can be helpful for patients in general, but it is especially helpful for patients who have challenges in their life preventing adherence.

These patients may not have a permanent address, or they may be challenged to take medications every day because of their life circumstances. Being able to go to a clinic and get an injection can be extremely helpful for those patients because then they do not have to think, "Where's my medicine? Do I have it? Do I need to get a new prescription?"

There can be some patients who really need longer-acting treatments, and there are other patients who are doing fine taking their pills several times a day. As with any other disease, we have patients in many different circumstances. The longer-acting treatments should be evaluated in terms of whether we can reach patients having difficulty adhering to current treatments.

Is there anything else you'd like to add?

We have made strides in creating the medications, but it is the delivery mechanism we need to focus on now. It is making sure patients have affordable access to care. We might need action beyond commercial payers, because they create benefits for a wide variety of people taking a variety of medicines for different medical conditions.

Perhaps we need to do something additional to make coverage more affordable for HIV to help reduce the public health burden. The cost of HIV in the United States is big enough that some augmentation of patients' insurance and coverage could really be helpful.

About Dr Pezalla

Edmund Pezalla, MD, MPH, is a physician and chief executive officer of Enlightenment Bioconsult, LLC. He holds a degree in public health and was formerly vice president of pharmaceutical policy and strategy for Aetna.