Written Authority Required Drugs

Spinal Muscular Atrophy

The Pharmaceutical Benefits Scheme (PBS) subsidises nusinersen for patients with spinal muscular atrophy (SMA).

Patient eligibility

The PBS subsidises treatment with nusinersen under the National Health Act 1953, section 100 for patients with SMA.

Patients must be eligible for the PBS and meet the relevant restrictions criteria.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing nusinersen.

Section 100 arrangements

Nusinersen is only available for day admitted patients, non-admitted patients, or patients on discharge who are attending either:

  • an approved private hospital
  • a public participating hospital
  • a public hospital.

Nusinersen isn't PBS subsidised for hospital in-patients. You must include the hospital name and provider number on the authority application form.

Treatment specifics

All applications must be completed by or in consultation with a specialist medical practitioner who is both:

  • experienced in diagnosing and managing SMA
  • affiliated with a neuromuscular clinic of a hospital that's recognised for managing SMA.

Hospitals recognised for managing SMA are:

  • Lady Cilento Children’s Hospital - Brisbane
  • Royal Children’s Hospital - Melbourne
  • Monash Children’s Hospital - Melbourne
  • John Hunter Hospital - Newcastle
  • Sydney Children’s Hospital - Randwick
  • Children’s Hospital at Westmead
  • Adelaide Women and Children’s Hospital
  • Perth Children’s Hospital - formerly known as Princess Margaret Hospital.

Applications

Initial treatment

Apply for initial authority approval to prescribe PBS subsidised nusinersen to treat SMA in writing and either:

All applications must include the completed:

Initial grandfather treatment

For patients who received non-PBS subsidised nusinersen before 1 June 2018 for SMA, apply for initial grandfather authority approval in writing and either:

All applications must include the completed:

Patients only qualify for PBS subsidised treatment under this restriction once only. For continuing PBS subsidised treatment, a grandfathered patient must qualify under the continuing treatment criteria.

Continuing treatment

To apply for continuing PBS subsidised treatment with nusinersen call the PBS Complex Drugs Programs enquiry line.

More information

Call the PBS Complex Drugs Programs enquiry line for more information.

Page last updated: 22 February 2019