High risk and intermediate-2 risk myelofibrosis

Treatment Phase: Initial treatment

Clinical criteria:

  • The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report,

AND

  • The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.

Details of the following must be documented in the patient's medical records:

(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and

(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.

Note

A patient may only qualify for PBS-subsidised treatment under this restriction twice in a lifetime. Patients reinitiating PBS-subsidised treatment following pregnancy are exempt from this rule.

Note

Risk of myelofibrosis is defined in accordance with the Myelofibrosis International Prognostic Scoring System (IPSS) or the Dynamic International Prognostic Scoring System (DIPSS) or the Age-Adjusted DIPSS.

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.

Note

Special Pricing Arrangements apply.

Intermediate-1 risk myelofibrosis

Treatment Phase: Initial treatment

Clinical criteria:

  • The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report,

AND

  • Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; OR

  • Patient must have intolerance to prior treatment with a JAK inhibitor for this condition,

AND

  • The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition.

Details of the following must be documented in the patient's medical records:

(a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and

(b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.

Note

A patient may only qualify for PBS-subsidised treatment under this restriction twice in a lifetime. Patients reinitiating PBS-subsidised treatment following pregnancy are exempt from this rule.

Note

Risk of myelofibrosis is defined in accordance with the Myelofibrosis International Prognostic Scoring System (IPSS) or the Dynamic International Prognostic Scoring System (DIPSS) or the Age-Adjusted DIPSS.

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.

Note

Special Pricing Arrangements apply.