Tofersen ======== Solution for intrathecal injection 100 mg in 15 mL SavePublic hospital PBS item code15532LMaximum quantity1 units Repeats5 More detailsProgramHB 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-public-s100$28400.00 Restrictions & indications ------------------------------ AUTHORITY REQUIRED Amyotrophic Lateral Sclerosis - Subsequent continuing treatment Show full PBS criteriaHide full PBS criteriaAmyotrophic lateral sclerosis Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the first continuing treatment, the extended first continuing treatment or the grandfather treatment restriction; AND Patient must have demonstrated an adequate response to treatment defined as any improvement or stabilisation in the ALSFRS-R score (i.e. no more than a 20% decline from the baseline ALSFRS-R score), if they have received treatment under the first continuing or extended first continuing restriction; or Patient must have demonstrated a clinical benefit from treatment, based on clinician judgment, within 12 months of treatment initiation, if they have received treatment under the grandfather listing; 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. AUTHORITY REQUIRED Amyotrophic Lateral Sclerosis - Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment Show full PBS criteriaHide full PBS criteriaAmyotrophic lateral sclerosis Grandfather arrangements - Transitioning from non-PBS to PBS-subsidised treatment Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2026; AND Patient must have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing non-PBS-subsidised treatment with this drug; AND The condition must have been diagnosed by a neurologist; AND The condition must have a confirmed pathogenic (class 5) or likely pathogenic (class 4) superoxide dismutase 1 (SOD1) gene variant; 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. The date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant must be documented in the patient's medical records. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a grandfathered patient must qualify under the Subsequent continuing treatment criteria. 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)[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/).