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New form of Tysabri® under PBAC consideration

  • Tysabri® (natalizumab) is currently available for the treatment of relapsing remitting MS and is provided as a monthly intravenous (IV or drip) infusion.
  • The Pharmaceutical Benefits Advisory Committee (PBAC) will be meeting in March to consider the inclusion of a subcutaneous (under the skin) injection form of Tysabri® on the Pharmaceutical Benefits Scheme (PBS).
  • The addition of subcutaneous Tysabri® would expand the clinical settings where people can be treated, would be delivered in a shorter timeframe and would be a convenient option for people who live remotely.

The Pharmaceutical Benefits Advisory Committee (PBAC) will be meeting in March to consider the inclusion of a new form of Tysabri® (natalizumab) on the Pharmaceutical Benefits Scheme (PBS).

Tysabri® is a monoclonal antibody that locks onto certain immune cells, called T cells. Once Tysabri® is attached to the T cells, they cannot cross the blood-brain barrier to attack the myelin or nerves of the brain and spinal cord.

Tysabri® has been available for the treatment of relapsing remitting MS since 2006 and is provided as a monthly intravenous (IV or drip) infusion. The new form of Tysabri® under consideration would be provided as a monthly subcutaneous injection (under the skin) at the same dose.

What did the clinical trials comparing both forms of Tysabri show?

The phase I and phase II clinical trials, DELIVER and REFINE, compared subcutaneous and intravenous forms of Tysabri® and showed the effectiveness was similar for both forms. The way in which the drug moved around the body (pharmacodynamics) and how it affected the body (pharmacokinetics) were also comparable. The safety profile between the two forms was also similar, with the exception of pain at the injection site, which can occur with subcutaneous injections.

What are the benefits of subcutaneous Tysabri®?

This option would expand the clinical settings beyond infusion centres, where people can be treated. In addition, the subcutaneous form is delivered in a shorter timeframe compared to the intravenous formulation and, if it is appropriate, allows clinicians to reduce or remove the post-dose observation period for some people after six doses, resulting in a faster process for the patient.

The addition of the subcutaneous delivery also offers people living with MS another option at a time when they are being encouraged to minimise the risk of COVID-19 exposure at large healthcare settings. This treatment route provides a potentially convenient option for people with relapsing remitting MS, particularly for those living remotely.

In 2021, the European Commission (EC) approved the subcutaneous delivery of Tysabri® for the treatment of relapsing remitting MS. This now provides two routes of administration and enables flexibility to meet patients’ needs and preferences.

What does the PBAC need to consider when making a recommendation?

The PBAC is required to consider several factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines and the cost to the government of a new listing. The decision of the PBAC is the first step in a process where final approval is given by the Federal Government. If approved, it will then allow people with relapsing remitting MS across Australia to access this new form of treatment under the PBS.

MS Australia will be making a submission advocating for the subcutaneous form of Tysabri® to be listed on the PBS, as we welcome affordable access to all treatment options that have been shown in clinical trials to provide safe and effective treatment for MS.

The MS community are also invited to provide comments in support of this application. Consumer comments to the PBAC are due by 25 January and can be submitted here.

For helpful tips for submitting consumer comments to the PBAC, please see here.

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New form of Tysabri® under PBAC consideration