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Dear {{accTitle}} {{accLname}},

I am writing to provide clarification regarding the Pharmaceutical Benefits Scheme (PBS) subsidy for once-weekly dosing of HADLIMA (adalimumab) for patients with Crohn’s Disease and Ulcerative Colitis.1

For your HADLIMA patients who are in the subsequent continuing phase (fortnightly dosing) you are able to utilise the streamlined authority codes, meaning you can give your patients a prescription on the spot. For patients currently prescribed Hadlima 40mg/0.4mL fortnightly who require escalation to 40mg/0.4mL weekly, this adjustment is subsidised under the PBS.2

The submission process is outlined below:

1 Submit an authority request

To access this subsidy, a written Authority PBS approval can be sought online via HPOS in accordance with PBS requirements.

  • Crohn’s Disease: Apply online via HPOS using the Crohn’s Disease adult - continuing authority form (PB088)
  • Ulcerative Colitis: Apply online via HPOS or by phone 1800 700 270 (option 4).
2 Provide a brief justification

A short written clinical rationale must be provided on the form. Please see suggested example for guidance.

Eg. "I am requesting approval to prescribe Hadlima 40 mg/0.4 mL weekly for this patient, in line with the Australian Hadlima Product Information. The attached application and prescription (quantity 4, repeats 5) follow Services Australia advice that increased quantities and repeats may be requested via an Authority PBS form when clinically required."

3 Update quantity and repeats
Adjust the quantity from 2 to 4 with 5 repeats to reflect the weekly dosing schedule and include supporting clinical documentation to facilitate approval.
4 Update the prescription
Once the authority is approved, update the patient's prescription to reflect the new dosing regimen, including the correct quantity, repeats, and authority script number.

HADLIMA PBS Item Code
PBS Listed Indication Streamline Code/Authority Auto Injector Pre-Filled Syringe
Severe Crohn’s Disease Escalated Dosing/Weekly Written 12389C 12410E
Complex Refractory Fistulising Crohn’s Disease Escalated Dosing/Weekly Compassionate (Organon sponsored access program) n/a n/a
Moderate to Severe Ulcerative Colitis Escalated Dosing/Weekly Phone/Online Approval 12358K 12391E


Kind regards,

{{userName}}
Organon Australia Professional Representative
Email: {{userEmailAddress}}
Phone: {{user.Phone}}
www.organon.com/australia



Before prescribing, please review the Product Information, available at www.organoninfo.com.au/hadlimapi.

HADLIMA 40 mg/0.4 mL presentations are PBS-listed. Please refer to the PBS Schedule for full authority information: www.pbs.gov.au.

Considerations for prescribing HADLIMA (adalimumab) Pre-filled syringe and PushTouch™ auto-injector.
Contraindications: Hypersensitivity to HADLIMA or any of its excipients; severe infections including sepsis, active tuberculosis and opportunistic infections; concurrent administration of HADLIMA and anakinra (interleukin-1 receptor antagonist); moderate to severe heart failure (NYHA class III/IV).
Precautions: Record trade name and batch number on patient file; serious infections; reactivation of hepatitis B virus in chronic carriers; tuberculosis including reactivation and new onset of tuberculosis; other opportunistic infections; new onset or exacerbation of neurologic events; hypersensitivity reactions; adverse events of the haematologic system; immunosuppression; live vaccines are not recommended with concomitant HADLIMA therapy; worsening congestive heart failure; malignancies; concurrent administration of etanercept and anakinra or other systemic agents/ phototherapy used to treat psoriasis; autoantibody formation; surgery; use in elderly and children; use in pregnancy - Category C, lactation, fertility effects have not been investigated.
Common adverse effects: Injection site reactions; respiratory tract infections, leukopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, headache, abdominal pain, nausea and vomiting, liver enzymes elevated, rash, musculoskeletal pain; new onset psoriasis; others (including post-marketing see full PI).
References: 1. HADLIMA (adalimumab). Australian Product Information. Organon.
2. Australian Government, Department of Health, Disability and Ageing. The Pharmaceutical Benefits Scheme. Available at www.pbs.gov.au. Accessed September 2025. 3. Australian Government, Department of Health, Disability and Ageing. Biosimilar Uptake Drivers. Available at: https://www.pbs.gov.au/general/biosimilars/biosimilar-uptake-drivers-q-and-a.pdf . Accessed September 2025.
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Copyright © 2025 Organon Group of Companies. All rights reserved. ORGANON and HADLIMA and their respective Logos are trademarks of the Organon group of companies. Organon Pharma Pty Ltd (Organon). Sydney NSW 2000. Medical Information: 1800 023 135.
AU-ADA-110367. Date of preparation: September 2025. ORG038

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