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

Multiple myeloma

Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease

The condition must be confirmed by a histological diagnosis; AND

The treatment must be as monotherapy; or

The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND

Patient must have progressive disease after at least one prior therapy; AND

Patient must have undergone or be ineligible for a primary stem cell transplant.

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.

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

(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and

(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and

(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and

(4) details of the basis of the diagnosis of progressive disease or failure to respond; and

(5) nomination of which disease activity parameters will be used to assess response.

To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:

(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 - the percentage of plasma cells; 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 will be used to determine response, results for either (a) or (b) or (c) should be provided 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) should be stated/declared. 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 held in the patient's medical records.

All reports must be documented in the patient's medical records.

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

(i) A completed authority prescription form; 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

Multiple myeloma

Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease

Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND

The treatment must be as monotherapy; or

The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.