LENIOLISIB

Information current as at: 1 July 2026

PBAC meeting date: November 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: Joenja®
Form and strength:: Tablet 70 mg
Submission sponsor:: PHARMING AUSTRALIA PTY LTD
Condition/indication: (therapeutic use): Activated PI3K delta syndrome (APDS)
Listing requested:: To consider the sponsor's revised proposal for listing leniolisib for the treatment of symptomatic APDS in adults and adolescents aged 12 years and older. This item was previously recommended by the PBAC at its July 2025 meeting. The revised proposal specifically requests that the PBAC reconsider its recommendation for a Section 100 listing and instead recommend funding via the Life Saving Drugs Program (LSDP).
Funding program:: PBS Section 100 (Highly Specialised Drugs Program)
Request authority level:: Authority Required (Written) for initial treatment Authority Required (Telephone/Online) for continuing treatment
PBAC Submission type:: New PBS listing (–)
Comment:: --
Other PBAC consideration:: LENIOLISIB

Submission received for:: November 2026 PBAC meeting
2Opportunity for consumer comment:: Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
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 Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

a1291

Page last updated

23 July 2026

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