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Have your say on PBS listings for IBD medications – September 2020

The Pharmaceutical Benefits Advisory Committee (PBAC) is seeking consumer feedback on submissions relating to some IBD medications on the Pharmaceutical Benefits Scheme (PBS).

This meeting there is applications for oral and injectable biologics. You may like to provide feedback if you have interest in or experience taking:
Adalimumab biosimilars Idacio® or Hadlima®;
Infliximab injectable Remsima®;
Mesalazine tablet Asacol®;
Tofacitinib tablet Xeljanz®;
Vedolizumab injectable Entyvio®
.


Submission type
(new listing, change to listing)

Drug Name, form(s), strength(s) and Sponsor
(Drug name, form, strength, Trade name®, Sponsor)
Drug Type and Use
(What is the drug used to treat?)
Listing requested by Sponsor / Purpose of Submission
(Includes type of listing requested (unrestricted, restricted benefit, authority required) and restriction wording.  If restriction is lengthy it may be paraphrased.)

New listing

(Minor Submission)

ADALIMUMAB

Injection 40 mg pre-filled pen
Injection 40 mg pre-filled syringe
Injection 40 mg vial

Idacio®

Fresenius Kabi Australia Pty Limited

Severe Crohn disease; moderate to severe ulcerative colitis; complex refractory fistulising Crohn disease;

To request an Authority Required (STREAMLINED) listing of a new biosimilar adalimumab under the same conditions as the reference biologic.

Change to listing

(Minor Submission)

ADALIMUMAB

Injection 40 mg pre-filled syringe
Injection 40 mg auto-injector

Hadlima®

Merck Sharp & Dohme (Australia) Pty Ltd

Severe Crohn disease; complex refractory fistulising Crohn disease; moderate to severe ulcerative colitis;

To request an Authority Required (STREAMLINED) listing for the biosimilar in the continuing treatment phase; to request an Authority Required (telephone) for the biosimilar in the initial treatment phase; and to request that use of the biosimilar not count as treatment failure.

New listing

(Major Submission)

INFLIXIMAB

Injection 120 mg in 1 mL pre-filled syringe
Injection 120 mg in 1 mL pre-filled pen

Remsima® SC

Celltrion Healthcare Australia Pty Ltd

Crohn’s disease

Complex refractory fistulising Crohn’s disease

Ulcerative colitis

To request Section 100 (Highly Specialised Drugs Program) and Authority Required listings under the same conditions as infliximab powder for I.V. infusion 100 mg.

New listing

(Minor Submission)

MESALAZINE

Tablet 1600 mg

Asacol®

Chiesi Australia Pty Ltd

Ulcerative colitis

To request a Restricted Benefit listing of mesalazine for the treatment of mild to moderate ulcerative colitis and maintenance of remission in adults.

Change to listing

(Major Submission)

TOFACITINIB

Tablet 5 mg
Tablet 10 mg

Xeljanz®

Pfizer Australia Pty Ltd

Ulcerative colitis

Resubmission to request an Authority Required (Written) listing for the treatment of moderate to severe ulcerative colitis and to consider interchangeability advice.

New listing

(Major Submission)

VEDOLIZUMAB

Injection 108 mg in 0.68 mL pre-filled syringe
Injection 108 mg in 0.68 mL pre-filled pen

Entyvio®

Takeda Pharmaceuticals Australia Pty Ltd

Ulcerative colitis

Crohn’s disease

To request Authority Required listings under the same conditions as vedolizumab powder for injection 300 mg.


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 4 October 2020.

Have your say to support the PBS listings of Adalimumab biosimilar – Hadlima®.

Submissions closed

Have your say to support the PBS listings of Adalimumab biosimilar – Hyrimoz®, Mesalazine suppositories and granules – Pentasa®, protein formula – Modulen IBD® or Tofacitinib – Xeljanz®.

Submissions closed

Have your say to support the PBS listing of Stelara for treatment of Crohn’s disease in adults

Submissions closed

Have  your say and let the PBS know your needs for treatment of ulcerative colitis

Submissions closed

Have  your say and support the PBS listing of Humira for treatment of Ulcerative Colitis

Submissions closed

Have your say about getting Vedolizumab on the PBS listing for treatment of Crohn’s disease and ulcerative colitis! 

Submissions closed

Have your say and support the PBS listing of Humira for treatment of paediatric Crohn’s!

Submissions closed