Myelofibrosis

The Pharmaceutical Benefits Scheme (PBS) subsidises ruxolitinib (Jakavi®) for patients with myelofibrosis.

Treatment with ruxolitinib (Jakavi®) is subsidised through the PBS under Section 85 of the National Health Act 1953.

This item is available for patients with primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis who are classified as:

  • high risk or intermediate–2 risk, or
  • intermediate–1 risk with severe disease related symptoms that are resistant, refractory or intolerant to available therapy

Restriction details

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing ruxolitinib (Jakavi®) to patients.

Test requirements

All initial applications must include a copy of the bone marrow biopsy report which confirms the diagnosis of myelofibrosis.

Classification of risk of myelofibrosis must be provided in accordance with either the:

  • Myelofibrosis International Prognostic Scoring System (IPSS)or
  • Dynamic International Prognostic Scoring System (DIPSS), or
  • Age Adjusted DIPSS

Patients who have been treated with non PBS subsidised ruxolitinib (Jakavi®) before 1 February 2016 must submit details of the previous treatment. The details are to include:

  • the date when treatment with ruxolitinib (Jakavi®) was initiated
  • a bone marrow biopsy report which confirms the diagnosis of myelofibrosis,
  • confirmation the PBS restriction criteria for the relevant risk category was met at the time of initiation, and
  • the method by which ruxolitinib (Jakavi®) treatment was accessed at the time of initiation, such as through a compassionate use program

Schedule item details

Dose – ruxolitinib (Jakavi®) is available as:

  • 5 mg tablets in a pack size of 56
  • 15 mg tablets in a pack size of 56
  • 20 mg tablets in a pack size of 56

The recommended starting dose of ruxolitinib (Jakavi®) is based on platelet count:

Platelet Count Starting Dose

50 - 100 x 109/L

5 mg twice daily

100 - 200 x 109/L

15 mg twice daily

200 x 109/L

20 mg twice daily

No increase in the maximum quantity may be authorised for the 15 mg and 20 mg dose strengths.

Lodging an application

All initial application requests must:

Send all written applications to the Complex Drugs address on the contact us page.

Continuing treatment

Authority applications for continuing treatment may be made in writing or by calling the Complex Drugs enquiry line on the contact us page

Further information

For more information contact us on the Complex Drugs enquiry line.

Page last updated: 26 May 2016

This information was printed Monday 26 September 2016 from humanservices.gov.au/health-professionals/enablers/myelofibrosis It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.