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Practical Implications for the Use of Targeted Treatment in Atopic Diseases - A Q&A With Neal Jain, MD

Other logistical questions include: Should these agents be administered in the office versus at home, and what are the caveats of administering at home in a population of severe patients? Will patients fall off therapy? Will falling off therapy lead to other adverse outcomes, such as nonresponsiveness to the medication down the road, because you could have a situation in which you take the medicine for period of time and then you stop taking it because you feel good and then it loses effect upon recapture when you put someone on it? Do you see exacerbations leading to hospitalizations with these medications if [patients] are nonadherent and they are getting them at home? Also, what is the value to the physician who’s prescribing or administering these medications? It takes a lot of time, staff, and money for us to take care of patients with severe disease, and the cost to practitioners is high to take care of these patients without any real monetary benefit by putting patients on these therapies. In fact, in the era of managed and capitated care, if we are high prescribers of these therapeutics, we may be at a disadvantage for taking care of these patients. Reimbursements could go down and practitioners could be penalized by virtue of the fact that we are seeing a higher population of patients with severe disease who require these costly therapies.

I have a severe asthma clinic, and I may be perceived by payers as a high prescriber of biologics because I take care of patients with severe disease. That may affect my reimbursements and my overall ability to continue to provide quality care to these individuals. How does that coexist in a healthcare system as it is structured right now, in which many practitioners and specialists do not work for hospital systems or integrated health systems, whereby you have contained costs and you can afford to do that. That is a big question that we just don’t know the answer to. It is unfortunate that there are already practices who discourage practitioners’ prescribing of therapies that are costly from an administrative standpoint or alternatively may have concerns about payers grading the practice as a high utilizer of such therapies and in turn leading to decreased reimbursements due to capitation and risk-sharing strategies.

AJMC®: Can you talk about evolving treatment guidelines and the managed care implications of a growing treatment spectrum?

Jain: Treatment guidelines often take a pure clinical approach or science approach, without taking into account costs. As we move beyond the simple paradigm of inhaled steroids, inhaled steroids with long-acting beta agonists, to therapies that are new and target type 2 inflammation but do not fall into the categories that we currently have, a question that must be answered is where do we put these in the our guidelines, and how do we use them? One important aspect is to consider cost, in addition to efficacy. Including managed care stakeholders in the process may make sense. We are unlikely to have head-to-head clinical trials to help answer the questions, and we don’t have the science or resources to know the long-term ramifications of choosing different therapies over other therapies. Where do you intervene with a biologic versus other therapeutics, and how does this work from the standpoint of reimbursements, not only for the therapeutics, but also for the physicians who are caring for these patients? It is a big question.

AJMC®: How do you see the treatment landscape evolving over the next 5 years, and what would you like to see emphasized among various stakeholders?

Jain: There are several factors that are sometimes moving together and sometimes moving in opposite directions that are going to better shape how we use these therapeutics in the future. Amongst those are obviously the managed care side of things, as well as the flip side of that. Where does the pharmaceutical industry see this going? Obviously, from trying to maximize profits and penetration into the market, pushing the fee, does this work in different populations with different comorbid conditions? Does this work in a milder population, and when is it appropriate to use expensive therapeutics, such as biologics, in a more moderate or even mild population? I think that the other question becomes, do you use these earlier in the course of disease with the hopes of impacting the natural history and long-term outcomes associated with this disease in patients [who] have, not only severe disease, but also more moderate disease? Then, are we going to also see increasing step therapy, as other small-molecule therapeutics become available to manage this condition over time? The closest we have come in the past, after the use of inhaled corticosteroids [ICS], and ICS/LABAs, was montelukast, which unfortunately did not have as significant an impact as we initially hoped. There are other therapeutics that are coming down the pipeline that are going to have potential for limited side effects and high efficacy that are significantly different from what we have now. How these will fit in to the equation will be interesting to see and will largely depend on how the ongoing trials evaluating the efficacy of these agents turn out.

AJMC®: What are the practical implications of the current treatment spectrum, particularly when it comes to access?

Jain: The cost implications of the current treatment spectrum must be considered when we start to think about the ability of the healthcare system to pay for these newer biologic therapeutics. The recent GINA Pocket Guide to the Identification and Management of Difficult-to-Treat and Severe Asthma nicely outlines when biologic therapy should be considered and instituted. Patients [who] require high-dose ICS/LABA therapy or oral steroids to maintain control or who are uncontrolled despite such therapy should be considered as candidates for biologic add-on therapy. Certainly, when you get to a point where you have systemic effects from steroids that are unintended consequences and sometimes underappreciated, you should start to think about implementing biologic therapy. In these individuals, the unintended and underappreciated consequences have a lot of long-term negative cost consequences associated with them. I have seen patients [who] come in [who] are resigned to the fact that they have bad asthma; they are on their high-dose ICS/LABA agents plus their oral steroid 3 times a year. Some of these patients have had cataract surgery, have osteoporosis, or uncontrolled diabetes, hypertension, and other unintended consequences that may, in part, result from their chronic asthma therapy. We, as practitioners, need to consider these potential consequences when making decisions about simply continuing their therapies or instituting biologic therapies.

Another aspect of this, of course, is the overutilization of these therapies in individuals who do not really require or will not benefit from such therapies. This is where we really need better education of our patients about the importance of being adherent with prescribed therapies, as well as utilization of diagnostic tools, such as biomarkers, to identify the appropriate patients for such therapies. 

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