Non-Interchangeable & Unique

One-size-fits-all policies are unsuitable for plasma protein therapies and endanger patient health. Each therapy is unique due to the pharmacologic and manufacturing differences that exist across different brands and patients’ unique response to the treatments. Plasma protein therapies are non-interchangeable, sole-source biologics, therefore it is essential that patients have access to their medically justifiable therapy.

Expert Clinical Guidelines on Non-Interchangeability

“It is unacceptable to limit availability of augmentation therapy in any way and especially to a single product.” 1

“IVIG is not a generic drug and IVIG products are not interchangeable. A specific IVIG product needs to be matched to patient characteristics to insure patient safety.” 2

“Given the variable nature of these diseases, individualized treatments depending on patient need and physician judgment are important.” 3

“HAE management plans must be individualized to each patient's needs due to wide variability in HAE symptoms, response to and tolerance of various HAE medications, and numerous factors impacting clinical course and quality of life. Treatment plans should be monitored regularly and adjusted based on the needs of the patient.” 4

“It is critical that the bleeding disorder community has access to a diverse range of therapies and that prescriptions for specific clotting factor concentrates are respected and reimbursed.” 5

"It may take a considerable time to find the right IVIG product and individual rate of infusion to optimize tolerability. When a patient changes site of care and the brand of IVIG product is not available, all effort should be taken to find the product that most closely resembles the product the patient is currently receiving, even though it will not be an exact match. In the case when a health-system, specialty pharmacy or home care pharmacy changes products with only cost in mind and not the product matching the tolerability of that individual patient, the patient’s rights and the clinician’s duty related to unnecessary additional adverse reactions need to be considered. Every patient’s biological and physiologic system is unique. This distinction is critical to ensuring that he or she receives the most appropriate IVIG treatment that optimizes clinical outcomes."6

1. Alpha-1 Foundation Medical and Scientific Advisory Committee Clinical Practice Guidelines.
2. American Academy of Allergy Asthma & Immunology Principle #8.
3. American Academy of Neurology Therapeutics & Technology Assessment Subcommittee Evidence-based Guidelines.
4. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema.
5. NHF Medical and Scientific Advisory Council Recommendation #159.
6. Jerry Siegel, PharmD, FASHP. "All IG Products Are Not the Same! A Pharmaceutical, Clinical, and Ethical Deep Dive." Pharmacy Practice News, Feb. 1 2024.

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