Allergists, Pulmonologists Face Rising Tide of Patients with Better Tools

October 1, 2020

This edition from the 10 Year Plan features perspective from leadership at AAAAI and ACAAI, as well as survey results from allergists and pulmonologists.

The rate of allergic and immunologic patients has been on a steady climb in the US for most of recent memory. The chronic conditions, from asthma to allergies, are being driven by a multitude of factors generally outside the realm of feasible prevention: rising pollution and urbanization, lesser early endotoxin exposure, more use of acetaminophens and antibiotics, and equally climbing rates of obesity.

Allergy and respiratory care teams enter the 2020s with heightened responsibilities and fuller patient schedules. But they also come in with resources that welcome the challenge of more work—both in treatment and diagnosis.

For as many certain new cases he and his colleagues face, David M. Lang, MD, faces an equal challenge in addressing the unknown among patients. Lang, President of the American Academy of Allergy, Asthma & Immunology (AAAAI), told HCPLive® more and more asthma- and allergy-risk patients come in with no diagnosis—just symptoms.

The great challenge of rising diagnoses is the interplaying symptoms among the atopic and immunologic diseases.

“We can clarify particular conditions, or at least rule out other conditions,” Lang said. “And our ability to do that will grow. It has grown in recent years, and will grow even more, based on improved understanding of those conditions.”

What the field has headed into this decade is advanced protocols in diagnosis; the sensitivity, validity, and reliability of blood tests, as well as more informed understanding of disease phenotypes and endotypes, makes the rising tide of allergic and asthmatic disease nothing overwhelming.

It is more so the potential to uncover endotypes than phenotypes which excite Lang for the future of his field. While phenotypes have set sound parameters between clinical characteristics of differing allergic disease and severity, it is endotypes that have begun to inform previously inexplicable shortcomings in therapeutic response. But more work is needed.

“The challenge we have is that a lot of the endotypes right now, we can't recognize them,” Lang explained. “So we give patients a standard kind of treatment. And based on the type they have, they may or may not respond.”

What more greatly exacerbates this issue is the cost of tailored allergic or asthmatic care: biologic agents, a drug class first introduced to the US market with omalizumab more than 15 years ago, have been indicated or at least researched in late-stage trials for practically every prominent allergic or asthmatic patient population. But as the agents became more available in the last 5 years, their significant price tags have changed little.

“With the patients who go on biologic agents, not all respond,” Lang said. “And they cost about $35,000 per year.”

What’s needed is even more bolstered baseline testing and understanding of endotypes to distinguish the patients who would—and more importantly, would not—respond to these very pricey yet specifically efficacious therapies. Sadly, a proposal to simply reduce the cost of these agents is not something experts have stock in right now.

J. Allen Meadows, President of the American College of Allergy, Asthma & Immunology (ACAAI), recalled to HCPLive the experience of visiting a manufacturing plant for a prominent allergic-asthmatic biologic drug. He described the process as labor-intensive, and requiring work be done in much smaller doses than is standard for most drugs.

“It was like they were making wine or distilling fine bourbon,” he said.

Until innovation reaches that manufacturing process, Meadows sees the drug cost issue being continually burdened by the influence of pharmacy benefit managers (PBMs).

“We’ve got biologics now that are costing $50,000 a year,” he said. “The next one that comes out, it's going have to be $65,000 or they won't get picked up on any managed care than the one after that. You know, eventually after that, it will be over $100,000 a year. It's just completely unsustainable.”

By Meadows’ estimation, the fields of allergy and asthma are about 3 years away from a major therapeutic breakthrough. The introduction of anti-thymic stromal lymphopoietin (TSLP) and anti-interleukin 33 and 35 (IL-33; IL-35) therapies, plus the continued advances in phenotype and endotype characteristics, could result in once-monthly targeted injection therapy which could essentially subdue the chronic conditions of a disease like asthma.

But those trio of options—which Meadows fondly recalls a fellow investigator describing as the “Three Horsemen of the Asthma Apocalypse” in a presentation—would be largely unavailable to the growing patient population so as long as prices continue to rise.

“We need to see Congress act, and I believe they will,” Meadows said about PBM regulation.

As for care teams, Meadows foresees this decade becoming the time when allergists and respiratory specialists become largely associated with conglomerate systems. He predicted that, in the next 5-7 years, up to 80% of US allergists will be working for one of a dozen-plus entities.

“Federal regulations have just gotten so onerous, it's probably not possible for a mom and pop operation to fulfill those needs,” Meadows said. “Companies have just gotten so powerful, you know, as with the CVS-Aetna merger.”

That said, going bigger may have some perks for the next generation. Meadows cited reduced diagnostic supply costs and better access to specialty-unique equipment during a time when patient demands will be increasing. Fewer and fewer allergists will be tasked with patient data management, and can focus more so on patient care.

Such benefits align with the interests of the newest generation of allergists and respiratory clinicians, Meadows argued. He believes the new wave of physicians are less interested in entrepreneurship, with running a business; their passion is strictly reserved for the clinical work.

Lang seconded the prospect of specialists moving toward larger healthcare systems, albeit at a pace that fits their position in the patient care experience.

“I think that there are some specialties, particularly those that are more hospital-based, in which that trend has accelerated more rapidly than in our field,” Lang said. “Or I think we and other specialists, like dermatologists and ophthalmologists, are still at a substantial proportion in community practice—rather than places like the Cleveland Clinic, where I am.”

Overall, Lang projects US healthcare to increasingly shift from volume-based to value-based reimbursement priority over this next decade. He feels confident his field is well-positioned for that shift. Much of what has developed in allergic and respiratory care has brought value to the patient market place.

“We can employ care for a number of the conditions that we treat, with enhanced quality of life and improved outcomes,” Lang said.

Lang conceded the challenge that’s been repeated for years on end now: asthma, drug allergy, food allergy, and immunologic disorders are still on the rise in the US. “But our growth potential remains robust,” he argued.

Despite enjoying their field more currently, pulmonologists were on average less optimistic (6.75/10) than allergists (7.13/10) for the future advancement of their field.