Home-Based Intravenous Cancer Therapies: The Benefits and Disadvantages

The delivery of intravenous (IV) cancer therapies in the home has been a topic of great importance since the start of the COVID-19 pandemic, Stephanie Kang, PharmD, MS, BCPS, a clinical manager from University of North Carolina (UNC) Homecare Specialists at UNC Health, said during a session at the virtual Hematology/Oncology Pharmacy Association Annual Conference 2021.¹

Three main ambulatory infusion locations are used for IV cancer therapies: hospital-based clinics, freestanding infusion clinics, and the patient’s home. Currently, home infusion within the larger ambulatory infusion setting poses specific advantages and disadvantages in relation to the other available options.¹

Of the 3 locations, hospital-based clinics have the advantage of being held to the highest regulatory standards, especially in terms of United States Pharmacopeia compliance, according to Kang. Additionally, the hospital affiliation of these clinics provides the greatest level of access to specialized care.¹

The disadvantages presented in hospital-based clinics include price, because they are the most expensive option for infusion, as well as inconvenience for patients. Inconvenience may especially be a factor if a clinic’s hours of operation are limited, which may also contribute to longer wait times for scheduling treatments.¹

Alternatively, freestanding infusion clinics may be slightly more convenient because they are dispersed around the community and also cost less than hospital-based clinics. However, if not affiliated with the patient’s primary oncology team, these location options can lead to fragmented care because of difficulties around communication between care teams.¹

Within the home infusion setting option, lower cost compared with hospital-based clinics poses a specific advantage, although the cost is about the same as that of freestanding infusion clinics. The convenience of being at home makes this option more advantageous for the patient than freestanding infusion clinics, which require transportation considerations.¹

However, if the home infusion provider is a third-party company that is external to the patient’s primary care team, the issue of fragmented care may also arise. Additionally, there are concerns regarding the patient’s limited access to their care team because removing the need to visit the clinic for each infusion reduces patients’ interactions with their provider. Another potential problem: limited access to emergency services if a negative reaction or adverse event (AE) occurs during the infusion.¹

Currently, 2 issues have shifted the focus toward the home infusion setting, according to Kang. First, there is the payer’s side of care mandates, which have arisen as a point of interest because of the lower cost of home infusion and freestanding infusions, moving payers toward requiring patients to receive treatments in either of these settings rather than in the hospital-based clinic setting.¹

Second, the COVID-19 pandemic has led to an overall push for home infusion as a way of mitigating the spread of the virus among patients and health care professionals.¹

To reduce COVID-19 transmission concerns, the Centers for Medicare & Medicaid Services (CMS) issued a new interim final rule during the pandemic that was intended to allow additional beneficiaries, particularly among high-risk patients, to receive home infusions. As a result, CMS made it easier for patients to receive home infusions of a wider variety of medications, including cancer therapies.¹

Within the past 2 years, several national oncology organizations have released position statements related to home infusion of cancer therapies.¹ For example, in the position statement of the American Society of Clinical Oncology (ASCO), the organization described several safety concerns, including the lack of double checks prior to administration, the risk of life-threatening AEs, the potential for chemotherapy spills or exposure to patients without cancer in the home, the question of liability if there were an error in the drug preparation, and the lack of oncology-trained nurses going to the home.²

ASCO also acknowledged some advantages to home infusion, such as increased participation in clinical trials and increased access to care, specifically for patients in rural regions.²

The organization made 6 recommendations for administering cancer therapies in the home. The first advised using public funds to formally research the safety and efficacy of cancer therapies because there is currently no significant primary literature on this topic.²

Second, ASCO recommended that CMS not extend the interim final rule established during the pandemic that makes available a wide variety of therapies for infusion in the home. Third, ASCO suggested that CMS work closely with oncology experts to ensure that the provider and patient agree to the home as the most appropriate setting for care.²

Upon the agreement of this setting, ASCO recommended that CMS require quality reporting of oncology-specific measures to further evaluate safety and efficacy outcomes, primarily because of the lack of available data in these areas.²

ASCO’s fourth recommendation would limit cancer therapies to exceptional circumstances in which the benefit to that patient outweighs the risk; the fifth would require a consultation with the oncologist before allowing delivery of preprepared cancer therapies. Lastly, ASCO recommended that payers require proof of safety protocols and precautions for home infusion providers.²

Conversely, the Community Oncology Alliance (COA) released a position statement that said it fundamentally opposes the home infusion of chemotherapy, cancer immunotherapy, and supportive drugs for cancer treatment because of serious patient safety concerns.³

COA gave these reasons for their opposition: Patients need face-to-face, high-touch evaluation with each treatment cycle; the number of treatments increases incidence of AEs and interactions; the specialty care-trained team is not available in the home; and home infusions have limited access to emergency medications, equipment, and personnel.³

Based on these observations and recommendations from prominent oncology organizations, Kang explained that there are clearly benefits for the home infusion setting, but remaining barriers to this setting need to be addressed for this to be a successful site of care.¹

In light of this, the Gorski Model for Safe Home Infusion Therapy outlines 4 factors that are required for safe care in the home, although this model is more generally intended for home infusion for all medications. The requirements include appropriate patient selection, comprehensive assessment and monitoring, appropriate patient education, and interprofessional communication and collaboration.¹

“If I put this into my own words, I would say the safe model for home infusion therapy requires the right patient, the right regimen, [and] the right resources to the patient, as well as the right level of communication across care teams,” Kang said during the session.¹

REFERENCES

1. Kang S. Intravenous cancer therapies in the home - innovative or dangerous? Presented at: Hematology/Oncology Pharmacy Association 2021 Virtual Annual Conference; April 14, 2021.
2. American Society of Clinical Oncology Position Statement Home Infusion of Anticancer Therapy. American Society of Clinical Oncology. June 23, 2020. Accessed May 14, 2021. asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020_Home-Infusion-Position-Statement.pdf
3. COA’s position statement on home infusion. Community Oncology Alliance. April 9, 2020. Accessed May 14, 2021. communityoncology.org/coas-position-statement-on-home-infusion/