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

Untreated multiple myeloma

Transitioning from non-PBS to PBS-subsided treatment - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025; AND

Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; AND

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

Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.

Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:

(a) the level of serum monoclonal protein; or

(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or

(c) the serum level of free kappa and lambda light chains; or

(d) bone marrow aspirate or trephine; or

(e) if present, the size and location of lytic bone lesions (not including compression fractures); or

(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or

(g) if present, the level of hypercalcaemia, corrected for albumin concentration.

As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.

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).

Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.