The COVID-19 pandemic has had a major effect on our lives and has altered the world immeasurably. In particular, it has changed the way we access our healthcare. While millions of Americans were contracting the virus in the US, millions of others began changing their lifestyles and adopting precautions to protect themselves and those at risk. For people already living with chronic disease, visiting doctors and clinics for treatments became difficult and, in some cases, risky. This caused a major shift in behavior with people across the country opting for telehealth visits and in-home care, including home infusion services to manage their conditions. If nothing else, the pandemic has reshaped our perspectives on risk versus access to healthcare and in the ‘new normal’. In-home healthcare services such as home infusion will only continue to gain acceptance and popularity.
Home infusion therapy, an important part of some home healthcare regimens, allows patients with diseases requiring regular infusions of intravenous medications to be treated in the comfort of their homes. This has been proven to be a cost-effective, safe, and efficacious alternative to inpatient care for a variety of therapies and disease states, both acute and chronic.
The National Home Infusion Association (NHIA) estimates that home and specialty infusion has grown by more than 400% during 2010-20191. Key drivers of this growth include:
Home infusion gives patients better control of their treatment schedules and more time for themselves, their families, their jobs, and other activities. The NHIA estimates that across the United States, there are now nearly 1,000 providers of home and specialty infusion serving more than 3.2 million patients each year2.
Notably, patients are pleased with services and outcomes: In the largest study to date of patient satisfaction in home infusion, the NHIA found that more than 97% of patients agreed or strongly agreed with the statement, "I was satisfied with the overall quality of the services provided." Providers also scored extremely well in specific tasks such as patient instruction with learning to administer the IV medication3.
Iron deficiency is very common and affects more people than one would think. Approximately 10 million people are iron deficient in the United States. Inadequate iron intake due to poor or restrictive diets can lead to iron deficiency, as can numerous other underlying diseases and risk factors, particularly inflammation, which can decrease iron transport and absorption. Iron deficiency is the most common cause of anemia worldwide, afflicting several hundred million people. Left untreated, it may put patients at an increased risk of Iron Deficiency Anemia (IDA) which can result in serious health risks and symptoms: poor immune function, heart failure, extreme fatigue, weakness, chest pain, shortness of breath, to name a few.
If IDA is diagnosed, ongoing care is necessary, however not all treatment options are the same.
Healthcare providers may recommend an oral iron supplement. Oral iron is considered inexpensive, safe, and may be effective at helping to treat IDA. However, it is frequently not well tolerated and in many diseases is insufficiently adsorbed due to inflammation, leading to iron deficiency anemia even with good compliance. Use of currently approved IV iron products at home may also not be an option due to infrequent, yet serious side effects4 requiring medical supervision or multiple clinic visits. Left untreated, patients may require blood transfusions and/or suffer end-organ damage resultant from insufficiently treated anemia. Access is also an issue: Patients might be required to visit an outpatient infusion center to receive IV iron, and many patients in the wake of the pandemic are looking for more convenient, less risky alternatives to in-person care.
Many patients that receive home infusion therapy to treat chronic disease may be particularly at risk for severe iron deficiency and anemia. Therapeutic options are also limited. Home infusion use of traditional IV iron is somewhat limited due to the requirement for health care provider supervision and uncertainties about compatibility with other infused drugs. An office visit for infusion of IV iron is costly, inconvenient, and is very disruptive to a patient’s quality of life or physician practice care models5. Limitations with the current approach can lead to a vicious cycle of late diagnosis and treatment, inconsistent follow-up, and increased risk of more office visits or even the need for a red blood cell transfusions. A viable, well-tolerated iron infusion therapy suitable for use in the home could potentially benefit patients with convenience of administration, improvement in quality of life and avoidance of additional trips to the clinic.
Should we be thinking bigger? NHIA is. They have been effective in helping to drive change. During the height of the pandemic, in support of providers’ efforts to prevent the spread of COVID-19, the Center for Medicare & Medicaid Services (CMS) increased their payment rates for both health care and home setting infusions of monoclonal antibodies, a proven beneficial treatment for early stages of COVID-19 illness. Interestingly, the rationale for increased care was “to ensure that the agency is supporting beneficiary access to care.”
Access to medications best infused at home is the new frontier for healthcare, and treatment of IDA through a safe, at-home, iron infusion therapeutic option may be an opportunity to benefit a significant patient population. Rockwell Medical is on a mission to improve the treatment of iron deficiency anemia, and this year we will be starting our Phase 2 clinical study of ferric pyrophosphate citrate (FPC) in the home infusion setting. This will be the first clinical trial of its kind in the home infusion setting for the treatment of IDA.