CANNABIDIOL
Information current as at: 1 July 2026
Submission Details
- Brand name:
-
- Epidyolex®
- Form and strength:
-
Please search for and view the meeting agenda from the relevant meeting for more information
- Submission sponsor:
- JAZZ PHARMACEUTICALS ANZ PTY LTD
- Condition/indication:
(therapeutic use) -
- Severe myoclonic epilepsy in infancy (Dravet syndrome)
- Listing requested:
- Please see meeting agenda for more information
- Funding program:
- PBS General Schedule
- Request authority level:
- Please see meeting agenda for more information
- PBAC Submission type:
- Other business (Category 3)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended amending the authority requirements for cannabidiol for the treatment
of seizures associated with Dravet syndrome (DS) from Authority Required (Telephone/online
PBS Authorities system) to Authority Required (STREAMLINED). The PBAC also recommended
amendments to the current PBS criteria for cannabidiol to improve access for patients
with DS, including allowing prescribing by paediatricians for both initial and continuing
treatment.
The PBAC advised that changes to the cannabidiol listing should flow on to fenfluramine
and stiripentol.
The PBAC noted and welcomed input from neurologists, Epilepsy Action Australia, the
Epilepsy Foundation and Pharmaceutical Society of Australia. The PBAC noted that all
inputs described that the recommended amendments to the restriction would improve
access to cannabidiol and enhance the efficiency of the prescribing process.
The PBAC noted that there was a small population that benefits from this treatment
and advised that the estimated nil net financial impact to the PBS/RPBS was appropriate.