IBD PBS forms and links to compassionate access resources (Australia)

PBS FORMS FOR TREATING INFLAMMATORY BOWEL DISEASE IN AUSTRALIA, AND LINKS TO COMPASSIONATE ACCESS PORTALS

Forms from the Services Australia website pertaining to treatment of patients with inflammatory bowel disease with biological agents (infliximab, adalimumab, golimumab, ustekinumab and vedolizumab) and small molecule agents (ozanimod, tofacitinib, upatacitinib, etrasimod). Also contact details for compassionate access to dose intensification etc.

Disclaimer: the author makes absolutely no claims for the accuracy of anything on this page. Use at your own discretion. These resources pertain to resources for patients with IBD in Australia only.

ULCERATIVE COLITIS

Partial mayo score form (click to download pdf. No hospital branding on this one)
Further info re the Mayo score “complete and partial Mayo score – points to remember”
IBD standard weight calculator spreadsheet (for calculating CDAI)
this form has now been updated and uploaded to “google sheets” so download is no longer required

Overview (Services Australia website)
Ulcerative colitis adult – initial authority application form (PB127)

Continuing Treatment

Approval for continuing treatment for ulcerative colitis is via streamline authority for biosimiliar agents (not including Remsima) or via telephone authority from the PBS Complex Drugs Programs enquiry line (1800 700 270 Monday to Friday, 8 am to 5 pm local time). A partial Mayo score will be required. Note that for the latter, an application can alternatively be submitted via PRODA (see below)

Ulcerative colitis adult – change or recommencement authority application form (PB245)
Ulcerative colitis toxicity and severity descriptors
Ulcerative colitis – paediatric – initial authority application form (PB215)

CROHN’S DISEASE

Overview (Services Australia website)
Crohn’s disease adult – initial authority application form (PB087)
Crohn’s disease adult – continuing authority application form (PB088)
Crohn’s disease – fistulising Crohn’s disease
Crohn’s disease adult – change, recommencement or demonstration of response authority application form (PB235)
Crohn’s disease toxicity and severity descriptor

As opposed to ulcerative colitis, application for continuing treatment requires filling in a form and submitting this to Medicare (see above).

Urban legend states that the patient can have fulfilled the immunomodulator and corticosteroid criteria in the past, however the application is more likely to be approved if the patient is still currently taking one of these medications. YMMV

OTHER RESOURCES

Vedolizumab – digital prescribing guide from Takeda

Note that if the patient is not sure whether to continue on subcutaneous or intravenous vedolizumab, the first three induction doses can be applied for then the remainder or either subcut or IV can be dispensed under the “balance of supply” PBS number. Note that this does require authority approval, however can also easily be submitted via PRODA.

Review article: guide to tofacitinib dosing in patients with ulcerative colitis

“PRODA” i.e. “PROvider Digital Access”

https://proda.humanservices.gov.au/

A very helpful online resource which enables applications for biologicals to be submitted electronically, avoiding the situation of mailing in applications and waiting for the approval (or rejection) to return in the mail. Note that a nurse can be set up as a “delegate” to enable to them to send in applications and receive correspondence with respect to these applications.

An important feature is to set up email notifications so that you are notified when you receive incoming messages or alerts from Medicare (such as PBS approvals or rejections). Please see “setting up notifications” and “changing notification settings” under this link.

Edit: PRODA seems to have a few glitches logging in or accessing the messaging section (or form upload section) within PRODA. I was advised by Services Australia to use “incognito mode” on google chrome or “private window” on Mozilla Firefox. This opens a window without “cookies” and seems to often resolve these browser gremlins. Alternatively, you can also periodically clear the “cache” in your browser.

COMPASSIONATE ACCESS WEBSITES

Takeda Pro and Entyvio Pathway (vedolizumab, note dose intensification is available for IV only, not subcut). VARSITY study (2019)

Janssen Pro (Remicade, Stelara and Simponi aka golimumab) SEAVUE STUDY (2022)

Abbvie Pro (Humira and upatacitinib aka Rinvoq) note: updated to correct link. From website:
WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients:
• With history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long time smokers).
• With malignancy risk factors (e.g. current malignancy or history of malignancy).
• Who are 65 years of age and older

Celltrion care (subcutaneous Remsima or Yuflyma, biosimiliar adalimumab) Remsima product brochure. Note that there seems to be some evidence that subcutaneous infliximab maintains therapeutic drug levels more effectively than intravenous dosing, possibly improving efficacy. See this article, amongst many others. Anecdotally, it does not seem that measuring infliximab levels or dose escalation plays an important role in using Remsima.

Pfizer ixtend program (Inflectra – biosimiliar infliximab) Biosimiliar fact sheet

Celgene Australia (Zeposia aka ozanimod) Zeposia website re common side effects

Organon Pro (Hadlima i.e. biosimiliar adalimumab) PBS item codes and streamline authority numbers for Hadlima

Adalimumab biosimiliars – ~~Amgevita (Arrotex)~~, Hadlima (see above), Hyrimoz (Sandoz), Idacio (Fresenius Kabi).

addit: new portal for Arrotex biologicals which now covers both Amgevita and Hadlima. It seems they have a scheme where they train pharmacists to show patients how the injection pens work, though the pharmacists are not able to actually inject the product as they are not nurses… online video support is available from nurses only (not in person).

(note: streamline authority generally available for continuing supply for biosimiliar adalimumab preparations)