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

Paroxysmal nocturnal haemoglobinuria (PNH)

Return from PBS-subsidised eculizumab post pregnancy or from one of the PBS-subsidised therapies for this condition, for reasons other than post pregnancy

Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND

Patient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan or iptacopan for pregnancy (induction doses)' criteria; or

Patient must have received prior PBS-subsidised treatment with at least one drug listed for this condition and must be returning to pegcetacoplan treatment for reasons other than post pregnancy; AND

Patient must have experienced clinical improvement as a result of treatment with this drug; or

Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND

The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND

Must be treated by a haematologist; or

Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details; AND

Patient must be at least 18 years of age.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); and

(2) 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).

At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.

At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:

(i) Haemoglobin (g/L)

(ii) Platelets (x10⁹/L)

(iii) White Cell Count (x10⁹/L)

(iv) Reticulocytes (x10⁹/L)

(v) Neutrophils (x10⁹/L)

(vi) Granulocyte clone size (%)

(vii) Lactate Dehydrogenase (LDH)

(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory

(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)

For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan.