Proven therapy can help thousands more patients with rare diseases

The innovative advances we've seen over the past few decades have conditioned many of us in the healthcare industry to look toward exciting new therapies as a panacea for patients suffering today. But not every disease will need an expensive, cutting-edge treatment, and sometimes the tools to improve patient health are here today, hiding in plain sight.

One such instance is what's known as therapeutic apheresis. Apheresis is the process of simultaneously separating blood components, isolating certain parts, and returning the rest to the donor or patient. The technology for doing this is commonly found at hospitals, blood centers, and specialized clinics, for several uses. While blood therapies are finally starting to gain recognition as essential medicines within the medical community, therapeutic apheresis has largely flown below the radar until now.

Increasingly, apheresis is used to isolate components that can be used as starting material for cell-based therapies, one-time treatments like those curing patients with blood cancers today – and those on the horizon for rare disorders like sickle cell disease (SCD), expected in the coming months. But it is also deployed as a therapeutic option to manage disease symptoms by directly removing disease mediators or inflammatory elements in the blood. It has applications for patients with autoimmune, neurology, rheumatology, dermatology, cardiology, nephrology, and other diseases.

About 75% of therapeutic apheresis procedures are therapeutic plasma exchanges (TPEs). TPE is used for patients with over 187 diseases and indications¹, including many that are rare or orphan – rapidly removing disease mediators in the plasma such as the antibodies that interfere with muscle function in myasthenia gravis.

Today, most U.S. patients access therapeutic apheresis only in hospitals, even for many chronic conditions – despite the fact that the technology can generally be safely deployed in settings outside the hospital for maintenance or preventive therapy. As healthcare increasingly moves toward local settings, reimbursement is not keeping pace for this well-established therapy.

Patient access is effectively limited by inertia, with only a small number of community facilities offering therapeutic apheresis. These practices must operate on a cash-pay basis because Medicare, Medicaid, and private insurance companies reimburse them at a much lower rate than inpatient facilities. State regulations can further limit payments. However, the therapy has been established for 40 years and is safe to be performed routinely in outpatient clinics, doctor's offices, blood centers, or even mobile apheresis units – a potential boon especially for patients with chronic diseases needing routine treatment.

This fall, the Center for Medicare and Medicaid Services (CMS) is considering an adjustment to reimbursement for community therapeutic apheresis, supplies, and staff. Today, CMS has reimbursement for the procedure misvalued, and is paying community healthcare facilities about 42% less than hospitals. As part of the overall current procedure value, CMS only reimburses three-quarters of the cost of necessary inventory like tubing sets. It also reimburses less than half of the salary for nurses with specialized apheresis training, even though hospitals themselves often access these experts by contracting with local blood centers.

What would the impact be if CMS increased reimbursement to make it feasible for local practices to offer therapeutic apheresis? Especially given the tendency for insurers to follow the lead of CMS, it could expand treatment opportunities for the more than 25 million Americans living with a rare disease – and potentially even more, given the growing evidence for TPE to treat chronic diseases like long-COVID². There is already clinical evidence of the impact of maintenance TPE for autoimmune³, neurological⁴, and hematological⁵ diseases, with economic benefits expected as better-controlled diseases lead to fewer acute flares – and those acute flares can be addressed without a hospital admission.

The gold standard for rare disease treatment will always be a cure, and new therapeutic approaches are bringing some within reaching distance – but it will be a long time before patients can access them. CMS's leadership can change the lives of patients suffering with chronic diseases tomorrow.

About the Authors
Tina Ipe is the Chief Medical Officer, Our Blood Institute, and a consultant for Terumo Blood and Cell Technologies. Joy Duemke is the Director of Marketing – North America, Terumo Blood and Cell Technologies.

About Terumo Blood and Cell Technologies
Terumo Blood and Cell Technologies is a medical technology company. Our products, software and services enable customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees worldwide believe in the potential of blood and cells to do even more for patients than they do today. This belief inspires our innovation and strengthens our collaboration with customers.

Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 150 countries across the globe. We have 750+ granted patents, with more than 150 additionally pending.

We have global headquarters in Lakewood, Colorado, U.S.A., along with five regional headquarters, seven manufacturing sites and six innovation and development centers across the globe. Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology.

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Proven therapy can help thousands more patients with rare diseases – if they can access it