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Have your say on PBS listings for IBD medications – Jan/Feb 2020

The Pharmaceutical Benefits Advisory Committee (PBAC) is seeking consumer feedback on submissions relating to some IBD medications on the Pharmaceutical Benefits Scheme. You may like to provide feedback if you have experience taking: Adalimumab biosimilar – Hyrimoz®, Mesalazine suppositories and granules – Pentasa®, protein formula – Modulen IBD® or Tofacitinib – Xeljanz®.


Submission Type: New listing – (Minor Submission)

Drug Name: ADALIMUMAB

Form(s) & strength(s): Injection 40 mg in 0.8 mL pre-filled syringe, 2
Injection 40 mg in 0.8 mL pre-filled pen, 2
Injection 40 mg in 0.8 mL pre-filled syringe, 6
Injection 40 mg in 0.8 mL pre-filled pen, 6

Trade Name: Hyrimoz®

Sponsor: Sandoz Pty Ltd

Drug Type & Use:
Crohn disease
Ulcerative colitis
Juvenile idiopathic arthritis
Fistulising Crohn disease
Rheumatoid arthritis
Psoriatic arthritis
Ankylosing spondylitis
Chronic plaque psoriasis
Hidradenitis suppurativa

Listing requested by Sponsor / Purpose of Submission: To request an Authority Required listing of a biosimilar adalimumab under the same conditions as the reference biologic.


Submission Type: Change to listing – (Minor Submission)

Drug Name: MESALAZINE

Form(s) & strength(s): Suppository 1 g
Sachet containing granules, 1 g per sachet

Trade Name: Pentasa®

Sponsor: Ferring Pharmaceuticals Pty Ltd

Drug Type & Use:
Ulcerative procitis
Ulcerative colitis
Crohn disease

Listing requested by Sponsor / Purpose of Submission: To request a change to the maximum quantity for the 1 g suppository (from 30 to 28 units) and 1 g sachet containing granules (from 120 to 100 sachets) forms of the Pentasa® brand of mesalazine, in line with changes to the pack sizes.


Submission Type: New listing – (Minor Submission)

Drug Name: PROTEIN FORMULA WITH CARBOHYDRATE, FAT, VITAMINS, MINERALS AND TRANSFORMING GROWTH FACTOR BETA-2

Form(s) & strength(s): Powder for oral liquid, 400 g, 12

Trade Name: Modulen IBD®

Sponsor: Nestle Health Science

Drug Type & Use:
Crohn disease

Listing requested by Sponsor / Purpose of Submission: To request a Restricted Benefit listing of Modulen IBD for the dietary management of Crohn disease in patients aged 5 years or older in the active or remission phase of disease.


Submission Type: Change to recommended listing – (Minor Submission)

Drug Name: TOFACITINIB

Form(s) & strength(s): Tablet 5 mg

Trade Name: Xeljanz®

Sponsor: Pfizer Australia Pty Ltd

Drug Type & Use:
Chronic plaque psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis

Listing requested by Sponsor / Purpose of Submission: To request that the PBAC review its advice on the interchangeability of tofacitinib on an individual patient basis with other biological disease modifying antirheumatic drugs under Section 101(3BA) of the National Health
Act 1953.


The full document can be accessed on the PBS website here.

If you would like to provide information on the impact of proposed changes you can email [email protected] and CCA will forward your comments grouped with those of others to PBAC.

The closing date for comments to CCA is 10 February 2020.

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