№ lp_1_12411
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Detailed submission for the inclusion of Nirsevimab in the National Immunisation Program for the prevention of respiratory syncytial virus (RSV) in infants and children under 24 months of age in Australia.
Year:
2024
Region / City:
Australia
Topic:
Immunization, Respiratory Syncytial Virus (RSV), Vaccines
Document Type:
Submission
Organization:
SANOFI-AVENTIS AUSTRALIA PTY LTD
Author:
Not specified
Target Audience:
Healthcare professionals, policy makers, immunization program administrators
Period of validity:
From 2024
Approval Date:
24 November 2023
Date of Changes:
17 January 2025
Date of Submission:
7 March 2024
Note:
Contextual Description
Price: 8 / 10 USD
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Year:
2025
Region / City:
Victoria, Australia
Topic:
Respiratory Syncytial Virus (RSV) Immunisation
Document Type:
Informational Leaflet
Organ / Institution:
Victorian Government, Department of Health
Author:
Victorian Government
Target Audience:
Parents and carers of infants and young children
Period of Action:
1 April 2025 to 30 September 2025
Approval Date:
February 2025
Date of Changes:
February 2025
Contextual Description:
A government-issued informational leaflet detailing RSV, its risks to infants, and the nirsevimab immunisation, including eligibility, administration, and availability.
DUPILUMAB, 300 mg in 2 mL single use pre-filled syringe, Dupixent®, Sanofi-Aventis Australia Pty Ltd
Year:
2023
Region / City:
Australia
Subject:
Atopic dermatitis treatment
Document type:
Application resubmission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Type of document:
Pharmaceutical Benefits Advisory Committee (PBAC) submission and assessment report
Medicine:
Aripiprazole long-acting injectable (AOM)
Dosage forms/strengths:
Powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe; Powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe
Brand:
Abilify Maintena
Sponsor:
Lundbeck Australia Pty Ltd
Purpose of submission:
Request for General Schedule Authority Required (STREAMLINED) PBS listing of AOM pre-filled syringe dose form
Indication:
Treatment of schizophrenia
Comparator:
AOM modified release injection vial kit (therapeutic vial kits)
Regulatory status:
TGA registered 7 May 2018 for acute and maintenance treatment of schizophrenia in adults and maintenance treatment of bipolar I disorder (monotherapy)
Previous PBAC consideration:
400 mg AOM PFS recommended July 2018; recommendation rescinded March 2023
Pricing basis:
Cost-minimisation versus AOM vial kit with equivalent pricing (no price premium)
Price levels referenced:
DPMQ, PTP, AEMP (current as of 1 June 2025)
Estimated PBS usage:
400,000 to <500,000 scripts over first six years (Year 1 10,000–<20,000; Year 6 100,457)
Indication listing conditions:
Authority Required (Streamlined); prescriber types include medical practitioners and nurse practitioners; general schedule (Code GE)
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical Submission
Document Type:
Regulatory Submission
Agency / Institution:
PBAC
Author:
CELLTRION HEALTHCARE AUSTRALIA PTY LTD
Target Audience:
Healthcare professionals, regulatory authorities
Effective Period:
2021 and ongoing
Approval Date:
25 August 2021
Date of Changes:
March 2022
Year:
2024
Region / City:
Australia
Topic:
Medical submission for listing of Aripiprazole 2-monthly injection
Document Type:
Submission for drug listing
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Lundbeck Australia Pty Ltd
Target Audience:
Healthcare professionals, regulatory bodies
Period of validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Year
Background:
The submission requested a General Schedule Authority Required (Telephone/Online) listing of a new form of adrenaline (epinephrine) acid tartrate 150 micrograms/0.15 mL autoinjector (AI) (Jext® Junior (Jr)) and 300 micrograms/0.3 mL AI (Jext®) under the same circumstances as the currently listed adrenaline (epinephrine) 150 microgram/0.3 mL AI (EpiPen® Jr and Anapen® Jr 150) and 300 microgram/0.3 mL AI (EpiPen® and Anapen® 300).
Year:
2022
Region / city:
Australia
Theme:
Rheumatoid Arthritis, Pharmaceutical submission
Document type:
Submission for PBS listing
Organization / institution:
Celltrion Healthcare Australia Pty Ltd
Author:
Celltrion Healthcare Australia Pty Ltd
Target audience:
Health professionals, regulators
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Medicinal Product Submission
Document Type:
Submission for Pharmaceutical Listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Healthcare professionals, policy makers
Period of Validity:
Not specified
Approval Date:
10 August 2022
Date of Changes:
Not specified
Year:
2021
Region / City:
Australia
Topic:
Atopic dermatitis treatment, medication submission
Document Type:
Submission report
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Medical professionals, regulatory authorities
Action Period:
Ongoing treatment evaluation
Approval Date:
17 August 2021
Modification Date:
Not specified
Background:
Dupilumab registration history
Clinical Claim:
Dupilumab has superior efficacy compared to standard care for children with severe atopic dermatitis
Episodicity:
Chronic
Severity:
Severe
Condition:
Atopic dermatitis
PBS Indication:
Chronic severe atopic dermatitis
Prescriber Type:
Medical practitioners, dermatologists, clinical immunologists
Treatment Phase:
Initial, continuing
Population Criteria:
Children aged 6 to 11 years, specific weight ranges
Comparator:
Placebo
Outcomes:
EASI-75, IGA 0 or 1 at Week 16, improvement in itch score
Dosing:
Tiered by body weight
Cost:
$1,754.28–$3,380.91
Price:
Published price for maximum quantity
Form:
Pre-filled syringe
Medical Information:
Dupilumab 300 mg/2 mL, 200 mg/1.14 mL
Note:
Comparator
Standard of care (Placebo)
Source:
PBAC submission
Year:
2022
Region / City:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission
Agency / Institution:
PBAC
Author:
Janssen-Cilag Pty Ltd
Target audience:
Healthcare professionals, pharmaceutical regulators
Period of validity:
N/A
Approval date:
May 2020
Date of last update:
March 2022
Context:
This document is a pharmaceutical submission requesting PBS listing for ustekinumab in the treatment of moderate to severe ulcerative colitis.
Year:
2021
Region / City:
Australia
Topic:
Pneumococcal vaccine submission
Document type:
Submission for listing on the National Immunisation Program
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Health professionals, regulatory bodies, policy makers
Period of validity:
Ongoing
Approval date:
16 July 2021 (FDA approval), 14 October 2021 (EMA recommendation)
Date of changes:
Not specified
Context:
A clinical submission for the inclusion of a 15-valent pneumococcal conjugate vaccine (PCV15) on the National Immunisation Program for adults at risk of pneumococcal disease.
Year:
2020
Region / City:
Australia
Theme:
Pharmaceutical submission, medical treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Medical practitioners, gastroenterologists
Period of Validity:
Not specified
Approval Date:
12 May 2020
Modification Date:
Not specified
Registration Status:
Registered by TGA
Clinical Claim:
VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications:
Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings:
PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions:
Specific guidelines for initiating subcutaneous therapy
Administrative Advice:
Applications for authorisation under PBS can be made online or by phone
Contextual Description:
A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Note:
Year
Topic:
Treatment of severe atopic dermatitis
Document Type:
Authority Required listing
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Target Audience:
Healthcare professionals
Year:
2017
Region / City:
Australia
Theme:
Pharmaceutical application
Document type:
Resubmission for Authority Required listing
Organ / Institution:
PBAC
Author:
Janssen-Cilag Pty Ltd
Target audience:
Medical professionals, regulatory bodies
Validity period:
Ongoing
Approval date:
November 2017
Modification date:
Not specified
Year:
2015
Region / City:
Australia
Topic:
Immunization, HPV Vaccine
Document Type:
Health Policy
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
PBAC
Target Audience:
Health professionals, policymakers, researchers
Period of validity:
Ongoing from 2015
Date of approval:
June 29, 2015
Date of amendments:
January 2017
Year:
2015
Region / city:
Australia
Topic:
Pharmacoeconomic Evaluation, Pharmaceutical Policy
Document Type:
Submission
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Shire Australia Pty Ltd
Author:
Shire Australia Pty Ltd
Target Audience:
Healthcare professionals, policymakers
Period of Effectiveness:
2015-2020
Approval Date:
July 2015
Revision Date:
None indicated
Year:
2020
Region / city:
Australia
Topic:
Biosimilar medicine submission
Document type:
Pharmaceutical submission
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Maxx Pharma Pty Ltd
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
Ongoing
Approval date:
November 2022
Modification date:
November 2022
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
DUPILUMAB, 300 mg in 2 mL single use pre-filled syringe, Dupixent®, Sanofi-Aventis Australia Pty Ltd
Year:
2023
Region / City:
Australia
Subject:
Atopic dermatitis treatment
Document type:
Application resubmission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target audience:
Healthcare professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Type of document:
Pharmaceutical Benefits Advisory Committee (PBAC) submission and assessment report
Medicine:
Aripiprazole long-acting injectable (AOM)
Dosage forms/strengths:
Powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe; Powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe
Brand:
Abilify Maintena
Sponsor:
Lundbeck Australia Pty Ltd
Purpose of submission:
Request for General Schedule Authority Required (STREAMLINED) PBS listing of AOM pre-filled syringe dose form
Indication:
Treatment of schizophrenia
Comparator:
AOM modified release injection vial kit (therapeutic vial kits)
Regulatory status:
TGA registered 7 May 2018 for acute and maintenance treatment of schizophrenia in adults and maintenance treatment of bipolar I disorder (monotherapy)
Previous PBAC consideration:
400 mg AOM PFS recommended July 2018; recommendation rescinded March 2023
Pricing basis:
Cost-minimisation versus AOM vial kit with equivalent pricing (no price premium)
Price levels referenced:
DPMQ, PTP, AEMP (current as of 1 June 2025)
Estimated PBS usage:
400,000 to <500,000 scripts over first six years (Year 1 10,000–<20,000; Year 6 100,457)
Indication listing conditions:
Authority Required (Streamlined); prescriber types include medical practitioners and nurse practitioners; general schedule (Code GE)