Xpovio (Selinexor)

selinexor 20 mg tablet, 16 · ORAL · PBS code 13085Q

AUTHORITY_REQUIRED

What it costs

AU$9360 PBS-determined price per 16 units

Most patients pay only the standard PBS co-payment, not the full price above — up to AU$25.00 per script (general) or AU$7.70 (concession/Safety Net) in 2026. The figure above is what the PBS pays the pharmacy; the Australian Government subsidises the rest. Always confirm the current amount with your pharmacist.

• First listed on the PBS: 2022-09-01.
• Repeats: 2.
• PBS program: HB.

Eligibility criteria for subsidised access

The following is the government's own wording from the PBS Schedule, shown unchanged.

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

Relapsed and/or refractory multiple myeloma

Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week

The condition must be confirmed by a histological diagnosis; AND

Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or

Patient must be undergoing 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 not have previously received this drug 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).

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

Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.

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

(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.

Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy

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

Relapsed and/or refractory multiple myeloma

Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week

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

Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; or

Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND

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