AUSTIN, Texas — New or soon-to-be approved drugs for conditions that require infusions, such as postpartum depression and thyroid eye disease, along with the potential for an infusible drug for Alzheimer's disease in the near future, threaten to overwhelm the capacity of nononcology office-based infusion centers.
"The rubber band is pretty tight, but it would snap if an infusible drug for Alzheimer's was approved," Reece Norris, JD, cofounder of the National Infusion Center Association (NICA), told Medscape Medical News.
"Encouraging results from clinical trials offer hope that one or more therapies will become available as early as 2020," according to a 2017 report published by the RAND Corporation.
In an analysis of the ability of the health system in the United States to handle the influx of patients if an infusible Alzheimer's drug is granted approval, the report authors note that about 15 million Americans with mild cognitive impairment, which could be an early sign of Alzheimer's, would need evaluation, testing, and treatment.
Their simulation showed that "patients would have to wait an average of 18.6 months for treatment in 2020. Approximately 2.1 million patients would develop Alzheimer's dementia between 2020 and 2040 while on waiting lists."
The capacity at current infusion centers is listed as a contributor to wait times, according to the report.
Sensitivities must be considered in the treatment of patients with Alzheimer's disease, said Norris. For example, accommodations would need to be made for the caregivers who would likely accompany these patients.
"We're seeing new treatments coming to market that will serve previously untreated or undertreated populations," Brian Nyquist, MPH, executive director of NICA, said here at the organization's inaugural annual meeting.
Accepting New Patients
Anticipating an exploding pipeline is a priority for us. "It's imperative that we look at building capacity," he explained. Current services will have to be optimized to "make sure these patients, who haven't had a viable treatment option, have access to care once it hits the market."
The first treatment for postpartum depression was approved in March by the US Food and Drug Administration (FDA), as reported by Medscape Medical News. Brexanolone infusion (Zulresso, Sage Therapeutics) is administered under medical supervision as a continuous infusion over 60 hours.
And teprotumumab (Horizon), an infusion for active thyroid eye disease currently in phase 3 trials, has been granted breakthrough therapy, orphan drug, and fast track designations by the FDA. This is the first FDA-approved therapy for the condition.
"Ophthalmologists and retina specialists typically don't infuse in their offices today, so they have to send those patients outside," Norris pointed out.
Obstacles to Expansion
Federal and state regulatory requirements can be barriers to the expansion of infusion services. And infusion drugs are expensive, so the prior authorization process is extensive.
Because the cost of infusions is lower at outpatient centers, as previously reported by Medscape Medical News, insurers are moving away from hospitals. However, they are narrowing their networks to centers that already have patients, which makes it hard for centers just starting out, Norris explained.
"It's a little bit of a chicken-and-egg game. You have to articulate your value to the payer," he said.
And some insurers might not know where to refer patients, if not to a hospital. To help, the NICA has added an infusion center locator to their website.
Although the newly approved and coming drugs present challenges for infusion centers, they also confirm the need for services that are not easily replicated, said Bryan Johnson, cofounder of NICA.
"The need for what you're doing is not going anywhere," he said during the meeting's closing session. "This requires a very personal activity. You have to have a nurse right next to a patient putting a needle in their vein."
Norris, Nyquist, and Johnson have disclosed no relevant financial relationships.
National Infusion Center Association (NICA) 2019 Meeting.
Medscape Medical News © 2019
Cite this: New Drugs Could Overwhelm Infusion Centers' Capacity - Medscape - Jun 25, 2019.