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Multiple myeloma (MM) Program in Pharmaceutical Benefits Scheme (PBS) 012-18051124



MM restriction and item codes

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\\INTERNAL.DEPT.LOCAL\Shared\NAT\SERDELEXCEL\WORKPRODIMP\Operation Blueprint Migration\RDT Release Icons\32w\icon-hidden-attachment.pngPBS MM restriction and item codes

Contact details

PBS Complex Drugs Programs

PBS authority approvals

Services Australia website

FAQs from Service Officers

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item

Description

1

How does a prescriber request an initial authority approval for their patient with newly diagnosed MM?

Prescribers can make a request:

The exception is daratumumab triple therapy, which is available by phone or in real time using the Online PBS Authorities system.

2

How many days in each cycle are acceptable for triple therapy for newly diagnosed MM with lenalidomide?

Either:

  • 21 days for 8 cycles, or
  • 28 days for 6 cycles

3

How to proceed if a prescriber calls requesting the approval of initial treatment with selinexor?

Effective 1 October 2025, selinexor for the treatment of relapsed and/or refractory multiple myeloma (MM) has transitioned to the General Schedule. Service Officers should make prescribers should be made aware of this change.

Service officers should confirm the weekly dose with the prescriber to make sure the correct item codes are selected to proceed.

4

A prescriber calls requesting to change the treatment of a patient from triple therapy with selinexor+dexamethasone+bortezomib to dual therapy with selinexor+dexamethasone.

Is an initial application for dual therapy required?

No, patients can switch between dual therapy and triple therapy without an initial application form.

5

Can the 160 mg dose of selinexor be approved for triple therapy?

No, the 160 mg per week dosing can only be approved for dual therapy.

6

Can public hospital approved selinexor scripts written after 1 October 2025 be dispensed in a community pharmacy?

No, as of 1 October 2025 selinexor is a general schedule S100 item. This means that only scripts approved under private hospital item codes can be dispensed in a community pharmacy.

7

Can daratumumab be approved as a single therapy?

No, the treatment must be part of a triple combination therapy limited only to daratumumab+lenalidomide+dexamethasone.

8

Can prescribers request daratumumub for a different PBS indication if diagnosis has been changed or reclassified?

No, patients can only access daratumumab once per lifetime, irrespective of whether the diagnosis has been re-classified or changed from multiple myeloma to amyloidosis or vice versa.

9

Can prescribers request daratumumub for relapsed/refractory Multiple Myeloma if they have received treatment for untreated first line Multiple Myeloma?

No, patients can only access daratumumab once per lifetime.