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

Untreated multiple myeloma

Initial treatment as first-line drug therapy from week 0 to week 24

The condition must be newly diagnosed; AND

The condition must be confirmed by a histological diagnosis; AND

Patient must be ineligible for a primary stem cell transplantation; AND

The treatment must form part of triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, and (iii) dexamethasone; AND

Patient must not be receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide; 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.