Amyotrophic lateral sclerosis

Treatment Phase: Initial treatment

Clinical criteria:

  • The condition must be/have been diagnosed by a neurologist,

AND

  • Patient must not have had symptoms for more than 2 years prior to commencing therapy with this drug,

AND

  • Patient must have at least 80 percent of predicted forced vital capacity (FVC) or slow vital capacity (SVC) within the 2 months prior to commencing therapy with this drug,

AND

  • Patient must not require assistance with eating or ambulation,

AND

  • Patient must have at least two points on each individual item of the ALS Functional Rating Scale - Revised (ALSFRS-R) score prior to commencing therapy with this drug,

AND

  • Patient must not have undergone a tracheostomy,

AND

  • Patient must not have experienced respiratory failure.

The date of diagnosis, the date and results of spirometry (in terms of percent of predicted forced vital capacity or slow vital capacity) must be supplied with the initial authority application.

Note

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/

Note

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.

Note

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

Note

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