IBD PBS FORMS AND COMPASSIONATE ACCESS

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). Also contact details for compassionate access to dose intensification etc. Latest update 22/2/2024

PARTIAL MAYO SCORE FORM FOR 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

ULCERATIVE COLITIS

Overview (Services Australia website)

Ulcerative colitis adult – initial authority application form (PB127)

Ulcerative colitis adult – initial grandfather authority application form (PB350)

Ulcerative colitis – continuing treatment is generally either via streamline authority (some biosimiliar agents) or telephone authority with a partial Mayo score. Note that for the latter, the details (including scan of prescription) can be uploaded via PRODA (authority prescription + partial Mayo score) with a brief cover note requesting ongoing supply (i.e. no PBS form required). This might be more convenient than calling Services Australia. They will generally reply within a few days (in the “messages” section) with an “approval code” which you enter onto your prescription. Note that you can change the settings on PRODA to notify you when a new message comes in for you.

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

Urban legend states that the patient can have tried 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

Crohn’s disease adult – upadacitinib – initial grandfather authority application form (PB357) seems to be a new form for upadacitinib only. Telephone conversation with PBS – advised to complete both initial form (using retrospective data) and continuation form for “grandfathering” patient on infliximab. Suggest confirm this with PBS if needed – ag 22.2.24

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.

Those people having difficulties accessing the messaging section (or form upload section) on PRODA are encouraged to use google chrome “incognito mode” or “private window” on mozilla firefox. This opens a window without “cookies” and seems to often resolve these browser gremlins. Clinicians can provide “delegate” access to a trusted third party such as an IBD nurse to help facilitate PBS applications.

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

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

Pfizer ixtend program (Inflectra – biosimiliar infliximab, also ??tofacitinib) 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)