Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Polycythemia vera

Initial treatment

Patient must be resistant to hydroxycarbamide (hydroxyurea); or

Patient must have an intolerance to hydroxycarbamide (hydroxyurea) of a severity necessitating permanent treatment withdrawal; or

Patient must have developed a clinically important adverse event/contraindication to hydroxycarbamide (hydroxyurea) as defined in the TGA-approved Product Information necessitating permanent treatment withdrawal; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must be at least 18 years of age.

Hydroxycarbamide (hydroxyurea) resistance is defined as a minimum of 12 consecutive weeks treatment at a dose of at least 1.5 grams/day or at the maximum tolerated that still results in one of the following:

(i) the need to reduce haematocrit levels to below 45% through phlebotomy; or

(ii) a platelet count greater than 400 x 10⁹/L and a white blood cell count greater than 10 x 10⁹/L

If applicable, details of prior systemic treatment with hydroxycarbamide (hydroxyurea) that caused either (i) an intolerance, (ii) an adverse event as listed in the TGA-approved Product Information, or (iii) a contraindication as listed in the TGA-approved Product Information necessitating permanent treatment withdrawal should be documented in the patient's medical records.

If the application is submitted through HPOS form upload or mail, it must include:

(i) details of the proposed prescription; and

(ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Polycythemia vera

Balance of Initial treatment - up to 48 weeks

Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must be at least 18 years of age.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Polycythemia vera

First continuing treatment

Patient must have received this drug as their most recent course of PBS-subsidised treatment for this condition; AND

Patient must have achieved and maintained a response to treatment with this drug for this condition; AND

Patient must be at least 18 years of age.

A response to treatment is defined as:

(i) Maintaining a haematocrit level of less than 45% without relying on phlebotomy and which was measured at least 12 weeks after the most recent phlebotomy procedure (if performed to reduce red blood cell levels); or

(ii) Ability to demonstrate or maintain a normal platelet count of less than or equal to 400 x 10⁹/L; or

(iii) The absence of palpable splenomegaly.

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

(a) details (dates, unique identifying number/code, or provider number) of the pathology report confirming the patient has achieved and maintained a response within 48 weeks of treatment initiation; or

(b) confirmation that the patient does not have palpable splenomegaly.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Polycythemia vera

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have achieved and maintained a response to treatment with this drug for this condition; AND

Patient must be at least 18 years of age.