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

Relapsed or refractory multiple myeloma

Continuing treatment

Patient must have previously received treatment with this drug for this condition; AND

Patient must have had progressive disease after receiving at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, and (iii) an anti-CD38 monoclonal antibody; or

Patient must have been refractory to, at least 3 prior lines of therapy, including each of the following therapies: (i) a proteasome inhibitor, (ii) an immunomodulatory agent, (iii) an anti-CD38 monoclonal antibody; AND

Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition; AND

Patient must have a WHO performance status of 2 or less prior to initiating treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Progressive disease is defined as at least 1 of the following:

(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or

(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 2

Prescribers may request the number of vials in line with the dosing requirement for each stage of treatment with the intention of providing the number of vials for each 4-weeks of treatment (24-weeks of treatment including repeats). Up to 4 vials with 5 repeats may be requested for a patient undergoing treatment in weeks 2-26. Up to 2 vials with 5 repeats may be requested for a patient undergoing treatment from week 27 onwards. Requests beyond what is listed in the TGA approved product information will not be approved.