Home infusion within the larger ambulatory infusion setting poses some specific advantages and disadvantages in relation to the other location options available.
The delivery of intravenous cancer therapies in the home has been a topic of great importance since the start of the COVID-19 pandemic, explained Stephanie Kang, PharmD, MS, BCPS, a clinical manager from University of North Carolina (UNC) Homecare Specialists at UNC Health, during a session at the Hematology/Oncology Pharmacy Association 2021 Virtual Annual Conference.
Currently, home infusion within the larger ambulatory infusion setting poses some specific advantages and disadvantages in relation to the other location options available. There are 3 main ambulatory infusion locations that are used for intravenous cancer therapies: hospital-based clinics, freestanding infusion clinics, and the patient’s home.
Of the 3 locations, hospital-based clinics have the advantage over the others 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.
The disadvantages presented in hospital-based clinics include price, as they are the most expensive location option for infusion, as well as their inconvenience for patients. Inconvenience may especially be a factor if the clinic’s hours of operations are limited, which may also contribute to longer wait times for scheduling treatments.
Alternatively, freestanding infusion clinics may be slightly more convenient because they are dispersed around the community, while also providing a lower cost than hospital-based clinics. However, if not affiliated with the patient’s primary oncology team, these location options can cause issues regarding fragmented care due to difficulties around communication between each care team involved.
Within the home infusion setting options, the lower cost of this setting in relation to hospital-based clinics poses specific advantages, although the cost remains about the same as the cost of freestanding infusion clinics. However, the convenience of the infusion location being in the patient’s home makes this option more advantageous for the patient than freestanding infusion clinics, which will still require transportation considerations.
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 in the home infusion setting. Additionally, concerns regarding the patient’s limited access to their care team may pose problems, since removing the need to visit the clinic for each infusion limits patients' interaction with their provider. There are also other problems that may arise around the patient’s potential limited access to emergency services if a negative reaction or adverse event (AE) occurs during the infusion.
Currently, there are 2 issues that have caused a shift in focus toward the home infusion setting, according to Kang. The first issue is the payer’s side of care mandates, which has arisen as a point of interest due to the lower cost of home infusion and freestanding infusions, bringing about a shift among payers toward requiring that patients receive treatments in either of these settings, rather than in the hospital-based clinic setting.
The second issue that has caused a shift toward the home infusion setting is the COVID-19 pandemic, which led to an overall push for home infusions as a way of mitigating the spread of COVID-19 among patients and health care professionals.
In light of this, the Centers for Medicare and 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 to reduce COVID-19 transmission concerns. As a result of this interim final rule, CMS made it easier for patients to receive home infusions of a wider variety of medications, including cancer therapies.
Within the past 2 years, several national oncology organizations have released position statements related to home infusion of cancer therapies. For example, in the position statement of the American Society of Clinical Oncology (ASCO), the organization explained several concerns around safety, which included the lack of double checks prior to administration, the risk of life-threatening AEs, the potential for chemotherapy spills or exposure to non-cancer patients in the home, the question of liability if there was an error in the drug preparation, and the lack of oncology-trained nurses going out into the home.
However, ASCO also acknowledged some advantages to patients being able to receive infusions in the home, such as increased participation in clinical trials, as well as increased access to care, specifically for patients located in rural regions.
In light of these advantages to the home infusion setting, ASCO made 6 recommendations for administering cancer therapies in the home. The first recommendation was to use public funds to formally research the safety and efficacy of cancer therapies because there is currently not significant primary literature on this topic.
ASCO’s second recommendation was for CMS to not extend the interim final rule established during the pandemic that makes available a wide variety of therapies for infusion in the home. The third recommendation was that CMS looks to work closely with oncology experts to ensure that the provider and patient agree to the home setting as the most appropriate setting for care.
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 due to the lack of available data in these areas.
ASCO’s fourth recommendation was to limit cancer therapies to exceptional circumstances in which the benefit to that patient would outweigh the risk, while the fifth recommendation was to require a consultation with the oncologist before allowing any delivery of pre-prepared cancer therapies. Lastly, ASCO recommended that payers require proof of safety protocols and precautions for home infusion providers.
Conversely, the Community Oncology Alliance (COA) released a position statement stating that they fundamentally oppose the home infusion of chemotherapy, cancer immunotherapy, and supportive drugs for cancer treatment due to serious patient safety concerns.
COA’s specific reasoning for their opposition was that patient’s need face-to-face, high-touch evaluation with each treatment cycle, that the number of treatments increases incidence of AEs and interactions, that the specialty care-trained team is not available in the home, and that home infusions have limited access to emergency medications, equipment, and personnel.
Based on these observations and recommendations from prominent oncology organizations, Kang explained that there are clearly benefits for the home infusion setting, but there remain barriers to this setting that need to be addressed for this to be a successful site of care.
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.
“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, the right resources to the patient, as well as the right level of communication across care teams,” Kang said during the session.
Kang S. Intravenous Cancer Therapies in the Home - Innovative or Dangerous? Presented at: Hematology/Oncology Pharmacy Association 2021 Virtual Annual Conference; April 14, 2021; virtual. Accessed April 14, 2021.