Tofersen
========

Solution for intrathecal injection 100 mg in 15 mL

SavePrivate hospital

PBS item code15533MMaximum quantity1 units

Repeats2

More detailsProgramHS

AdministrationINJECTION

Benefit typeA

Brands

- Qalsody[TGA record](https://www.tga.gov.au/resources/artg/467305 "TGA ARTG record 467305")[CMI (PDF)](https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2026-CMI-01448-1 "Consumer Medicine Information (PDF)")[PI (PDF)](https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2026-PI-01439-1 "Product Information (PDF)")

Dispensed price for maximum quantity (DPMQ)2 pricesQalsody · s90-cp-s100$28672.24

Qalsody · s94-private-s100$28449.24

Restrictions & indications
------------------------------

AUTHORITY REQUIRED

Amyotrophic Lateral Sclerosis - Extended first continuing treatment (additional 3 doses)

Show full PBS criteriaHide full PBS criteriaAmyotrophic lateral sclerosis

Extended first continuing treatment (additional 3 doses)

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must not have demonstrated an adequate response to treatment with this drug for this condition; AND

Patient must not have undergone a tracheostomy; AND

Patient must not have experienced respiratory failure; AND

Patient must not be receiving palliative (end of life) care; AND

The treatment must be given concomitantly with best supportive care (including riluzole where appropriate) for this condition; AND

Patient must not be receiving concomitant treatment with edaravone for this condition; AND

Must be treated by a specialist with expertise in the diagnosis and management of amyotrophic lateral sclerosis.

Reassessment of response must be conducted after the additional three months of therapy to determine the patient's eligibility for further treatment.

If this reassessment is not undertaken, the patient will not be eligible for ongoing treatment.

All the assessments of response must be documented in the patient's medical records.

Patient may qualify for this treatment phase once only.

Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R.

Notes (5)Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.

The ALS Functional Rating Scale - Revised (ALSFRS-R) can be accessed online at:

www.mdcalc.com/calc/10166/revised-amyotrophic-lateral-sclerosis-functional-rating-scale-alsfrs-r or https://neurotoolkit.com/alsfrs-r/

No increase in the maximum quantity or number of units may be authorised.

No increase in the maximum number of repeats may be authorised.

Special Pricing Arrangements apply.

Prescribing notes (5)No increase in the maximum quantity or number of units may be authorised.

No increase in the maximum number of repeats may be authorised.

Special Pricing Arrangements apply.

Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.

The ALS Functional Rating Scale - Revised (ALSFRS-R) can be accessed online at: www.mdcalc.com/calc/10166/revised-amyotrophic-lateral-sclerosis-functional-rating-scale-alsfrs-r or https://neurotoolkit.com/alsfrs-r/

Other listings for Tofersen Solution for intrathecal injection 100 mg in 15 mL
------------------------------------------------------------------------------

[Public15528GMaximum 1 units · 2 repeats

- Amyotrophic Lateral Sclerosis - Extended first continuing treatment (additional 3 doses)](/p/15528G)[Public15532LMaximum 1 units · 5 repeats

- Amyotrophic Lateral Sclerosis - Subsequent continuing treatment
- Amyotrophic Lateral Sclerosis - Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment](/p/15532L)[Public15538TMaximum 1 units · 6 repeats

- Amyotrophic Lateral Sclerosis - First continuing treatment
- Amyotrophic Lateral Sclerosis - Initial treatment](/p/15538T)

Data source: [Australian Government PBS Schedule](https://www.pbs.gov.au/info/browse/download) · Record updated 30 September 2026. Verify current listing and prescribing requirements on the [official PBS website](https://www.pbs.gov.au/).