PBS listings update 2022

From 1 December 2022, the temporary PBS listings that allowed patients to transition off tocilizumab onto another biological disease modifying drug (bDMARD) due to a shortage of tocilizumab, will be changed to ‘Supply Only’ for 6 months and then removed completely.

These changes are in response to a resolution of the tocilizumab shortage on 15 July 2022. For more details, including the affected item codes and information for prescribers, pharmacists and consumers, see this PBS news item.

 

Key points

  • On 1 December 2021 listings were added to the PBS General Schedule and Highly Specialised Drug (HSD) Program for tocilizumab.

    These new temporary listings have been added to provide a pathway for the return to tocilizumab treatment once the global shortage has resolved.

 

What’s changed?

On 1 December 2021 additional listings for tocilizumab became available on the PBS General Schedule and the HSD program for private and public hospitals.1 All arrangements are Authority Required and temporary, having been introduced due to global shortages of tocilizumab.

A previously published RADAR detailing the current tocilizumab shortage and outlining guidance for prescribers, patients and carers is available here.

The new listings cover patients with severe active rheumatoid arthritis or severe active juvenile idiopathic arthritis who switched from PBS-subsidised tocilizumab treatment to another biological medicine due to the current global tocilizumab shortage. The new listings ensure a supported transition back to tocilizumab once the shortage crisis has resolved.

 

Temporary listings for tocilizumab – General Schedule

Item

Active ingredient (Brand name)

Condition

Treatment criteria

Temporary listing

12761P

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (Actemra ACTPen)

Severe active juvenile idiopathic arthritis

Must be treated by a rheumatologist;

OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

Treatment Phase: Initial treatment – Initial 4 (Temporary listing – change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab).

12762Q

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (Actemra Subcutaneous Injection)

12767Y

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (Actemra ACTPen)

Severe active juvenile idiopathic arthritis

Must be treated by a paediatric rheumatologist;

OR

Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.

Treatment Phase: Initial treatment – Initial 4 (Temporary listing – change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab).

12768B

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL syringes (Actemra Subcutaneous Injection)

12792G

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (Actemra ACTPen)

Severe active rheumatoid arthritis

Must be treated by a rheumatologist;

OR

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.

Treatment Phase: Initial treatment – Initial 4 (Temporary listing – change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab).

12806B

TOCILIZUMAB, tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL syringes (Actemra Subcutaneous Injection)

 

Temporary listings for tocilizumab – HSD (private and public)

The listings under the S100 HSD program settings (private and public hospitals) relate to the following tocilizumab products:

  • 80 mg/4 mL injection, 4 mL vial (Actemra)
  • 200 mg/10 mL injection, 10 mL vial (Actemra)
  • 400 mg/20 mL injection, 20 mL vial (Actemra).

For complete details, including specific item numbers, treatment and clinical criteria see the PBS Schedule.