Novel models of care allow expansion of HCV treatment
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With the availability of simple and effective treatment for hepatitis C, specialists are seeking to expand the base of clinicians caring for patients with HCV by exploring new models of care.
These models, which primarily center around a test-and-treat approach to HCV, seek to streamline the diagnostic and treatment process in hopes of keeping patients from falling off the cascade of care. Although a number of approaches are being used, the concept of moving diagnosis and treatment to the primary care realm has been a major focus.
In an interview with Healio, Norah Terrault, MD, MPH, professor of medicine and chief of gastroenterology and liver at the Keck School of Medicine at USC, discussed some of these novel care models, the benefits and potential concerns of these programs, how specialists can support their implementation and more.
Healio: What are the benefits of shifting HCV treatment outside of the specialty clinic?
Terrault: First, there are data that show if you have individuals who can be tested and treated in the same setting rather than testing and then referring for treatment, you have more individuals who can complete treatment and achieve sustained virologic response. The more steps you add to a patient going from screening to getting treated, the greater the possibility that they will fall off. This is one of key benefits — it improves our ability to complete the cascade of care from diagnosis to cure.
The second reason, however, is that there are individuals who are uninsured, underinsured or followed in safety-net settings, for example, where it is more difficult to get access to a specialist. In these situations, a primary care setting where patients can get diagnosed and treated would be a benefit.
The third reason is that we just need more treaters. There are many people in the United States who are both unaware of their diagnosis and need treatment, and our capacity to have all of those individuals funneled through a specialist’s office also will decrease the pace with which we can do diagnosis and cure.
All those reasons are behind the rationale to move treatment away from the specialist. Of course, patients should still see specialists if possible, but we want to broaden that base of treaters and certainly engage the primary care providers because they are the screeners. As a specialist, I don’t do screening, so the person doing the screening is really the ideal individual to continue to manage HCV and usher the patient through treatment. I see the ideal model as primary care serving at the forefront of doing HCV diagnosis and treatment with a specialist there to provide support as well as be available to see more complex patients, such as those with advanced liver disease and treatment failure. However, most patients with HCV could and should be treated in the primary care setting.
Healio: What models for delivering care in these other settings have been studied?
Terrault: Several different models have been studied, but the one that has probably received the most attention is the Extension for Community Healthcare Outcomes (ECHO) model. This was originally started by Sanjeev Arora, MD, MACP, FACG, at the University of New Mexico, more than a decade ago. He initiated this hub-and-spoke model in which there are a hub of specialists who connect with primary care providers in more rural settings in a sort of virtual clinic where they do case-based learning. That’s basically the premise behind it. And it was a model that was shown back in the day — when HCV treatment was much more complex — to improve care and increase the number of patients who were getting active treatment. It also showed that these primary care providers could do treatment with equivalent success.
Project ECHO has continued and there are now many ECHO programs around the U.S. and around the globe. I also started a Project ECHO when I was at UCSF to reach out to the more rural areas of northern California. Since I have moved to southern California, I’m using the same model to serve the greater Los Angeles area, especially in terms of Federally Qualified Health Centers (FQHCs) and reaching out to patient populations served by FQHCs. So, the hub-and-spoke model, where you can really provide education and support to primary care providers, works.
There are other models in which they have gone directly into primary care practices and basically conducted very abbreviated training and then provided individuals with backup from specialists. These have also been shown to be effective, which demonstrates that you can do relatively short periods of training and have many primary care providers at least manage diagnosis, staging and treatment of uncomplicated patients.
Now, models are also shifting to include other kinds of providers. There are data from the U.K. looking at pharmacist-led programs, where pharmacists are doing both diagnosis and treatment, which is an interesting idea.
Also, co-localization of therapy has been shown to be highly effective. Because many of our HCV cases are among individuals who inject drugs, there is a lot of interest in co-localizing treatment of substance use disorders with HCV. The idea is to have those individuals who head up clinics for managing substance abuse, such as opioid substitution therapy or methadone clinics, also be trained in treating HCV so they can co-localize the management of those two diseases. That is a very important strategy.
Finally, we also have some evidence from programs that are taking it to the streets, so to speak. There are programs in which they are doing point-of-care testing for people who are unstably housed, for example, or may not have access to a primary care provider on a regular basis. This kind of “street medicine” approach has been undertaken in Boston and San Francisco, and they are starting to do that here in Los Angeles as well. They’re primarily trying these in large urban areas where you can have a van that moves around or have people who go to individuals who are in these less conventional settings to do diagnostics and/or treatment.
Healio: Which models of care appear to be most effective?
Terrault: Effective is partially defined by what has actually been studied and published. Project ECHO has evidence that it can certainly increase capacity to do treatment and move it from the specialist to primary care and the care that is delivered is excellent. Co-localization, primarily the evaluation or treatment of patients in the setting of an opioid substitution therapy clinic or methadone clinic, is also well studied and shown to improve the cascade of care. Not much has been published yet on the street medicine approaches, but data have been presented and early evidence shows that this approach could be beneficial, which we think is important. For the pharmacist-led intervention, I have only seen data from the U.K., but it could be an effective model as well.
If you look at the published studies, though, you still see a significant drop-off from diagnosis to cure. Although these are all methods to increase the proportion of patients who complete the cascade of care, there are still reasons why people fall off. None of these care models is perfect in terms of guaranteeing that a patient is getting screened and taken all the way through the cascade of care. But each of these models improves upon the old model, which involved someone making the diagnosis and then referring the patient to a specialist. In any study in which these novel approaches were compared with referral to a specialist, the data showed improvement.
Healio: Are there any drawbacks to these novel models of care?
Terrault: I do not think there are drawbacks per se. One concern that I have is that, as we expand this base of treaters, we must do a good job educating them about knowing the stage of disease in the person whom they are treating.
As a hepatologist, when I’m doing education with this extended group of providers, I emphasize the need to know if the patient has cirrhosis. If they do, they really need ongoing care because they can still be at risk for liver complications in the future, including liver cancer. For example, those with cirrhosis should undergo screening for liver cancer every 6 months, whereas patients without cirrhosis or advanced liver disease basically just require counseling on good liver health.
Healio: How has technology helped overcome barriers to care?
Terrault: HCV management is ideally suited for telehealth, actually, because once the diagnosis is made and you have staged the patient, taking them through treatment and assessment for cure can all be done via telemedicine for the most part. You can check in with the patient to see if they are tolerating the treatment and being adherent and then follow up with them to make sure they are getting the appropriate testing. All of that can be done without coming into the office, which can lessen the burden for patients.
Telemedicine can also be useful in some of those settings in which they are co-localizing care. For example, there was a study in which patients in a methadone clinic underwent HCV testing and those who were positive were able to have a telemedicine visit with a specialist right in the methadone clinic. That specialist could do assessment, come up with a treatment plan and that plan would be executed by individuals working in the methadone clinic. That’s a very effective use of technology to co-localize the care to where the patient is and a good example of how to use telehealth to provide ease of linkage between primary care or frontline care providers and specialists.
Looking to the future, technological advances, such as improved point-of-care testing or devices that can easily assess liver disease in a mobile setting, are also of interest because these would allow us to bring the care and the procedure to the patient as opposed to having them go to a health system. Additionally, telehealth has also promoted the use of devices to support patient monitoring at home. That type of technological advance would be helpful for consideration in HCV, for example, where they could do testing at home. The patient would then not have to come into the office for any testing or monitoring.
Healio: How does funding and reimbursement work within these novel models of care?
Terrault: It is tricky, and this is a major challenge. Most Project ECHOs, for example, have no funding. Often, they have external sources of funding or state-level funding, but it really is driven by the individuals who have those programs. The problem with Project ECHO is that it involves providers interacting with each other, not with patients, so there is no mechanism for billing. There is an effort to try to have this type of activity become reimbursable, but that has yet to go through. This is the major problem with the hub-and-spoke models, at least in the United States. The co-localization of care model is easier because a physician is actually seeing a patient, so those services could be billed. The street medicine programs are largely funded by organizations or health systems that are interested in providing that type of care.
In general, the challenge with some of these new models is if there is not a patient per se at the center of it, it is hard to reimburse.
Healio: Is there ongoing research on specific models that allow expansion of HCV testing and treatment outside the specialty clinic?
Terrault: There are funded projects either through the Patient-Centered Outcomes Research Institute or the NIH that are ongoing and do inform models of care. They are still ongoing, with many having been presented and some having been published. I would definitely expect more to come because no one has a perfect answer and there is not a one-size-fits-all approach to HCV treatment. You have to adapt the test-, stage-and-treat model to different populations, so it is appropriate that a lot has been done in specific settings or patient populations.
Healio: What advice would you give to a provider who would like to start an ECHO or expand care?
Terrault: There is a shifting role for specialists here. We continue to be individuals who are happy to see patients in consultation and most of us are still doing HCV treatment in clinics, but increasingly our role is in supporting others in doing treatment and to advocate for treatment in the primary care setting. So, what can we do?
First, we can be educators and get the word out that treatment is now highly curative and simple, and treatments are available that can be appropriately managed by primary care providers. It is important to convey that HCV treatment is now really quite simple. Also, many primary care providers view HCV as a specialist disease. We need to assure them that it appropriately belongs in primary care and that there are simple treatment algorithms and tools that can be used to support primary care providers as they undertake treatment. We also need to assure them that we as specialists are available in that capacity to guide and educate.
Additionally, I advise providers to be open to models of co-management. For example, primary care providers seeing patients with HCV would have a specialist available to answer tough questions or to refer patients to if they are uncertain. Similarly, co-localizing care in places such as methadone clinics or other places where there is a high prevalence of HCV would be important.
Basically, as I said, our role has shifted. We really have to be advocates for this concept of broadening the base of treaters and reassuring individuals that they can learn and become skilled at managing these patients. After all, HCV is easier to manage than diabetes or hypertension, which many primary care providers do in clinic every day. If you can manage the many other diseases that fall under your umbrella, I’m suggesting HCV should be added because it is actually simpler.
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Healio Interview
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