Biogen secures PBS listing for patient-centric formulation in multiple sclerosis

Pharma News: A new formulation of Biogen’s multiple sclerosis (MS) disease-modifying therapy has been included in the Pharmaceutical Benefits Scheme (PBS), heralding flexibility and choice for individuals and their clinicians.

The move to reimburse Tysabri (natalizumab) in subcutaneous (SC) form comes on the heels of phase I and phase II clinical trials, DELIVER and REFINE, which revealed comparable effectiveness between the two dosage forms. With the exception of pain at the injection site occurring in 7.4% of patients with subcutaneous injections, the overall safety profile remained similar.

MS Australia emphasised the significance of the SC option, expanding treatment accessibility beyond traditional infusion centres.

“Many patients may have limited availability to attend infusion centres, where infusion of Tysabri can take up to an hour. The SC option would allow patients to attend their local healthcare professional for administration. In addition, the SC formulation is administered in a shorter timeframe compared to the IV formulation and allows physicians to reduce or remove the post-dose observation period for some patients after six doses as clinically appropriate,” the advocacy group said.

In a recent real-world study named EASIER, which factored in patient travel time, it was found that each intravenous (IV) administration required an average of 5 hours. Healthcare providers (HCPs) dedicated 29 minutes of active working time to each IV administration, with nursing staff contributing to 70% of this time. However, with the adoption of the subcutaneous (SC) route, HCPs estimated a 50% reduction in patient procedure time and a significant 55% decrease in HCP active working time. This translated into an impressive 63% cost reduction for the MS centre per Tysabri administration procedure.

The preference for subcutaneous administration of Tysabri over IV administration was evident in the SISTER real-world study, with nearly 90% of patients expressing a clear choice for the SC route. Patients cited the shorter duration of delivery and enhanced convenience as key factors influencing their preference.

Monique Alves, Head of Medical at Biogen Australia & New Zealand, stated “Tysabri is a therapy with a well-characterised safety profile for patients living with MS with nearly 15 years of real-world experience. This treatment option holds significant importance for individuals with MS who are prescribed Tysabri, offering flexibility in how they receive treatment.”

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