Updated label for Tysabri SC (natalizumab) may result in increased flexibility
By introducing TYSABRI (natalizumab) subcutaneous (SC) outside of a clinical setting (OCS), Biogen aims to change the way relapsing remitting multiple sclerosis (RRMS) is managed, focusing on flexibility for patients and healthcare professionals. (1)
The label for Tysabri SC (subcutaneous natalizumab) was updated December 2023 and this has resulted in increased flexibility within the treatment of RRMS. With the new label, it is now possible to administer Tysabri SC outside of the traditional clinical setting. This change implies not only increased flexibility, but also time saving for both patients and healthcare professionals. (7) Tysabri SC outside of a clinical setting must be administered by healthcare professionals and may be considered for patients, who have previously tolerated at least 6 doses of natalizumab well, i.e. have not experienced hypersensitivity reactions. (1)
For healthcare professionals, this update means adapting to new protocols and possibly providing additional patient education to ensure that the transition to OCS is smooth and that patients understand the importance of adhering to treatment schedules and monitoring requirements. It is essential for healthcare professionals to adhere to the updated guidelines and ensure that patients receive the same level of care and monitoring, as would be the case in a clinical setting.
Updated educational materials – A new Checklist
As part of the label change, educational materials in the risk minimization program have been updated and a new pre-administration checklist has been developed. The introduction of a new checklist for Tysabri SC is an important step in ensuring the safe administration of Tysabri. The checklist includes a decision tree and should be referred to by the healthcare professional for each patient prior to each administration.
Download the new pre-administration checklist here.
Time and cost savings
The ability to treat patients in an out of clinical setting may reduce the burden on healthcare facilities and minimize patients' travel and waiting times. This represents an opportunity for clinicians to manage operational challenges in their practice, while tailoring treatment to the needs of the individual patient. (1,2,3,5) As care can be moved outside of a hospital setting, it may also result in cost savings. (REF) This has been demonstrated in a number of studies across Europe. (6,7)
REFERENCES
1. TYSABRI (natalizumab) Summary of Product Characteristics.
2. Santus P, Ferrando M, Baiardini I, et al. Patients beliefs on intravenous and subcutaneous routes of administration of biologics for severe asthma treatment: A cross sectional observational survey study. World Allergy Organ J. 2019;12(4):100030.
3. Tetteh EK, Moriss S. Evaluating the administration costs of biologic drugs: development of a cost algorithm. Health Economics Review. 2014;4(26).
4. Rummel M, Kim TM, Aversa F, et al. Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-84.
5. Bittner B, Richter W and Schmidt J. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs. 2018;32:425-440.
6. Alonso AM, Arévalo AG, Becerril N et al. Cost-Analysis of Subcutaneous vs Intravenous Administration of Natalizumab Based on Patient Care Pathway in Multiple Sclerosis in Spain. Pharmacoecon Open. 2023 May;7(3):431-441.
7. Filippi M, Grimaldi L, Conte A et al. EASIER Study Working Group. Intravenous or subcutaneous natalizumab in patients with relapsing-remitting multiple sclerosis: investigation on efficiency and savings-the EASIER study. J Neurol. 2024 Jan;271(1):340-354.