Myelodysplastic syndrome

The Pharmaceutical Benefits Scheme subsidises lenalidomide for patients with myelodysplastic syndrome classified as low risk or Intermediate-1.

For patients with myelodysplastic syndrome classified as low risk or Intermediate-1 according to the International Prognostic Scoring System who have a deletion 5q cytogenetic abnormality and who are red blood cell transfusion dependent, treatment with lenalidomide (Revlimid®) can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953.

Section 100

This item is only available to a patient who is attending either:

  • an approved private hospital
  • a public participating hospital or
  • a public hospital
    and is either a
  • day admitted patient
  • non-admitted patient or
  • patient on discharge

This item is not available as a PBS benefit for inpatients of the hospital. The hospital provider number must be included on the application form.

Restriction details

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

Initial treatment

All patients starting treatment with lenalidomide must have myelodysplastic syndrome classified as low risk or Intermediate-1 according to the International Prognostic Scoring System, with a deletion 5q cytogenetic abnormality and be red blood cell transfusion dependent.

If disease progression occurs to acute myeloid leukemia, or if the patient is unable to maintain adequate red blood cell transfusion response, the prescribing doctor must stop treatment with lenalidomide.

Test requirements

All initial applications must include all of the following:

  • a copy of the bone marrow biopsy report demonstrating the patient has myelodysplastic syndrome classified as low risk or Intermediate-1
  • a copy of the pathology report detailing the cytogenetics demonstrating 5q deletion, and
  • a copy of the full blood examination

Continuing treatment

Patients are eligible for continuing treatment until there is evidence of disease progression to acute myeloid leukaemia or if the patient is unable to achieve or maintain adequate red blood cell transfusion response.

The first application for continuing treatment must be submitted in writing to the Complex drugs address on the contact us page. All subsequent applications may be obtained by contacting us on the Complex Drug Enquiry line.

Schedule item details

Dose - Lenalidomide is available as 5 mg and 10 mg capsules in a pack size of 21.

Lenalidomide is a category X medicine and must not be given to pregnant women. Pregnancy must be avoided during treatment.

Initial application

Prescriptions should be written for a sufficient quantity for 4 months of treatment.

Continuing application

Prescriptions should be written for a sufficient quantity for 4 months of treatment.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.

Lodging an application

All initial applications must be submitted in writing to the Complex drugs address on the contact us page.

Further information

For more information contact us on the Complex Drug Enquiry line.

Page last updated: 27 January 2016

This information was printed Wednesday 7 December 2016 from humanservices.gov.au/health-professionals/enablers/myelodysplastic-syndrome 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.