Changeflow GovPing Government & Legislation Highly Specialised Drugs Program Amendment
Routine Rule Amended Final

Highly Specialised Drugs Program Amendment

Favicon for www.legislation.gov.au AU Federal Legislative Instruments (7-day)
Published March 31st, 2026
Detected March 31st, 2026
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Summary

The Australian Department of Health and Aged Care issued Legislative Instrument F2026L00403 amending the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021). This April update modifies Schedule 1 of the existing special arrangement governing highly specialised drugs access under the Pharmaceutical Benefits Scheme. The amendment takes effect on 31 March 2026 and is authorised under the National Health Act 1953.

What changed

The Department of Health and Aged Care made amendments to the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) via Legislative Instrument F2026L00403. Schedule 1 of the arrangement contains the specific amendments, which typically include updates to listed drugs, indications, or associated conditions under the HSD program. This is an 'April Update' amendment to the existing program framework.

Healthcare providers, pharmacies, and prescribers participating in the Highly Specialised Drugs Program should review the updated Schedule 1 amendments to ensure compliance with any modified drug listings, indications, or conditions. Patients accessing HSD program medicines should be informed of any changes that may affect their treatment arrangements. The amendment is effective from 31 March 2026.

What to do next

  1. Review Schedule 1 amendments to identify any changes affecting prescribed drugs or indications
  2. Update dispensing and prescribing procedures for affected highly specialised drugs
  3. Inform patients of any relevant changes to their HSD program medications

Source document (simplified)

- Interactions

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (April Update) Instrument 2026

In force Administered by
- Department of Health, Disability and Ageing
This item is authorised by the following title:


View document Legislative instrument Explanatory statement Filter active Table of contents
- 1. Name
- 2. Commencement
- 3. Authority
- 4. Schedules
- Schedule 1—Amendments
- National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

Named provisions

Schedule 1—Amendments National Health (Highly Specialised Drugs Program) Special Arrangement 2021

Classification

Agency
DoH
Published
March 31st, 2026
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
F2026L00403
Supersedes
National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

Who this affects

Applies to
Healthcare providers Pharmaceutical companies Patients
Industry sector
6211 Healthcare Providers 3254 Pharmaceutical Manufacturing
Activity scope
Drug Benefits Pharmaceutical Prescribing Healthcare Supply
Geographic scope
Australia AU

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Pharmaceuticals Consumer Protection

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