New natalizumab PBS listing for RRMS


By Geir O'Rourke

7 Feb 2024

Patients on natalizumab for RRMS will now be able to take their medication without an IV infusion, with the drug now available on the PBS as a pre-filled syringe for SC administration.

Eligibility will be open under the same criteria as the existing listing for the drug, branded Tysabri (Biogen), including that patients must be ambulatory and have at least two documented attacks in the preceding two years of commencing MS therapy.

As with the IV infusions, dosing is every four weeks, but the new form will allow more convenience, with injections able to be given by any health practitioner, according to the company.

It was approved by the Pharmaceutical Benefits Advisory Committee last March (link here).

“The submission states that natalizumab SC is less invasive, reduces the time required for drug administration, reduces post administration observation time and allows for administration to occur outside of the hospital setting,” the PBAC noted in its decision summary.

“The submission suggested that natalizumab SC would be administered by a general practitioner at consulting rooms.”

PBAC supports therapy for amyloidosis with polyneuropathy

Meanwhile, the PBAC has come out in favour of a listing for patisiran for the treatment of patients with (hereditary transthyretin-mediated) hATTR amyloidosis with polyneuropathy.

Branded Onpattro (Alnylam), patisiran is formulated as an IV infusion to be given every three weeks in addition to best supportive care.

The recommendation reflected a “high clinical need for effective treatment” in this population, PBAC noted in an outcomes statement following its December intracycle meeting (link here).

The therapy had also shown clinical benefits in terms of delaying disease progression, reducing neuropathy symptoms, and improving health-related quality of life compared to placebo, based on the primary and secondary outcomes in the APOLLO trial over its 18-month trial period, the committee said.

Based on this trial, patisiran is dosed by weight at 0.3 mg per kg of body weight, although for patients weighing 100 kg or more, the recommended dose is fixed at 30 mg.

Patients with a body weight over 66.7 kg will require the maximum quantity of 3 vials per dose (corresponding to approximately 40% of the APOLLO trial population).

According to the PBS application, the requested restriction would be consistent with the TGA indication, hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (FAP stage 1 or 2, or PND score I, II, IIIA or IIIB), however the requested restriction would also require the hATTR amyloidosis to be confirmed by genetic testing.

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