Tofersen ======== Solution for intrathecal injection 100 mg in 15 mL SavePrivate hospital PBS item code15540XMaximum quantity1 units Repeats6 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 - First continuing treatment Show full PBS criteriaHide full PBS criteriaAmyotrophic lateral sclerosis First continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; 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. Assessment of response must be conducted after 6 months of the first continuing treatment (i.e. at 12 months from treatment initiation). If a response to treatment cannot be demonstrated at this assessment, prescribers may apply for up to a maximum of three months (i.e. 2 repeats) of additional continuing treatment under the extended first continuing treatment phase to verify non-response. 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. Adequate response to treatment is defined as any improvement or stabilisation (no more than 20% decline) from baseline score of ALSFRS-R. AUTHORITY REQUIRED Amyotrophic Lateral Sclerosis - Initial treatment Show full PBS criteriaHide full PBS criteriaAmyotrophic lateral sclerosis Initial treatment Patient must have/have had one or more clinical symptoms of amyotrophic lateral sclerosis prior to commencing 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 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 following must be documented in the patient's medical records: a) date and details of the patient's genetic testing confirming the presence of the SOD1 pathogenic gene variant; and b) baseline score of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) at treatment initiation. 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/).