ACR: Infusions belong in a facility, not at home
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The American College of Rheumatology has released an updated position statement declaring biologic infusions should be administered in a monitored health care setting rather than in the patient’s home, as some insurers have mandated.
“It is becoming more frequent that rheumatologists are having insurers mandate the location of infusions,” Marcus Snow, MD, chair of the ACR’s Committee on Rheumatologic Care (CORC), said in a press release. “Requiring patients to do infusions at home for the sole purpose of cost-cutting jeopardizes their safety.”
“Biologics are complex therapies often used when patients have failed to respond to less potent medications, and they can cause adverse reactions that must be promptly evaluated and treated,” Snow added. “Effective clinical monitoring and mitigation of risk is best accomplished when these drugs are infused in medical facilities supervised by on-site trained physicians.”
According to the ACR, the updated position statement “strengthens” the group’s opinion that the infusion setting should be decided jointly by the patient and provider. Although biologics have shown to be highly effective in treating patients with rheumatic disease, and in reducing disability, hospitalizations, costs and mortality risk, they can also cause a range of reactions. These reactions can include mild rashes, myalgia, hypertension, shortness of breath, headaches and life-threatening anaphylaxis, all of which can occur during or after the infusion, the ACR said.
In addition, the position statement argues that home infusions fail to allow for “rigorous maintenance of conditions,” including recommended temperature, storage away from sunlight and proper reconstitution or dosing.
“The ACR believes having patients monitored in a health care facility by a provider who is actively involved in their care with access to their medical record helps ensure patients’ safety,” the ACR said in the press release.
The update follows a recent study published in JAMA Network Open suggesting that home infusions are associated with a 25% increased risk for hospital admission the same or next day, and a 28% higher risk for permanent discontinuation, compared with facility-given infusions.
“Increasingly, biologic infusions are being administered at home instead of at a facility,” Matthew C. Baker, MD, MS, of Stanford University, and colleagues wrote. “Biologics are expensive; they accounted for 38% of the total prescription drug spending in the U.S. in 2015 and 70% of the growth in drug spending between 2010 and 2015. Infliximab, one of the most commonly prescribed biologics, costs approximately $6,500 per facility-based infusion. Up to 16% of the costs associated with biologics can be attributed to facility overhead.”
“Hence, there is an economic incentive to administer biologics at home instead of at a facility,” they added. “In addition, home infusions are often more convenient for patients and caregivers. Currently, because of sheltering-in-place and social distancing during the COVID-19 pandemic, a further increase in home infusions is expected. However, the safety implications of administering biologic infusions at home remain unclear.”
Baker told Healio Rheumatology that their data show a recent increase in the proportion of biologic infusions administered at home. He added that although some of the increase in home infusions may be due to patient preference, he and his fellow researchers believe it is mainly driven by insurers.
“We think that when issues arise in the home setting, there is a lower threshold for escalation of care,” Baker said. “Thus, it is not surprising that we found an increased risk of emergency department visit or hospital admission within 24 hours of home infusions compared to facility infusions. This highlights the need for more research in this area so that we can better understand which infusion setting is most appropriate for any individual patient.”
In the ACR press release, Snow said patients are best served in facilities where their individual health records are known, and where professionals understand the drugs involved.
The full ACR positions statement can be viewed here.
“Making sure our patients are getting their medication in the safest environment is a big concern,” Snow said in the release. “While the risk of infusion reaction is small overall, it can be severe. We feel that if infusions are given where the patient is known by health care providers who understand the drugs given, the risk of adverse event to the patient is lower. Experienced providers, available on site, can decide whether it is safe to continue therapy if mild reactions occur and provide prompt treatment for moderate or severe reactions.”
Perspective
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David A. McLain, MD, MACR, FACP, FRCP
In 2017 study published in Healthcare, Polinski and colleagues found that adverse events were no more common with home infusions than those performed in a medical setting. The researchers cited only one study — among patients with hemophilia — that showed reduced hospitalizations for patients receiving home infusion.
Home infusion has grown significantly, with a worldwide market size of $15 billion in 2015 and a projected increase to $28.3 billion by 2024. It is hardly limited to our world of rheumatology. Home infusion therapy is used to deliver antimicrobials, hydration solutions, parenteral nutrition, antineoplastic drugs, analgesics, cardiac infusion therapies for heart failure, immunoglobulins, and many biologics and other specialty drugs. With the shift from fee-for-service to value-based global payment models, the use of less costly alternatives as place of service is expected to grow.
However, there is a lack of outcome data with home infusion therapy, with literature searches finding few articles with hard data. A recent large retrospective database study by Baker and colleagues demonstrated an increase in ED and hospital admissions after biologic infusions in the home vs. a medical setting. The ACR statement on biologic infusions is reasonable and necessary given the lack of data to refute it and the new study.
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