№ lp_1_33379
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This document is a resubmission for a Section 85 Authority Required listing of dupilumab for treating moderate-to-severe atopic dermatitis in adult patients inadequately controlled on topical therapies, comparing it to standard care and ciclosporin A.
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
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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
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:
2024
Region / City:
Australia
Topic:
Severe Atopic Dermatitis Treatment, Pharmaceutical Pricing
Document Type:
Proposal
Organization:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Healthcare professionals, policymakers, pharmaceutical stakeholders
Effective Period:
December 1, 2024 onwards
Approval Date:
11 June 2024
Modification Date:
March 2024
Context:
Proposal to delist dupilumab (Dupixent®) from PBS for severe atopic dermatitis treatment, addressing cost-effectiveness and price reduction negotiations with PBAC.
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
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:
2024
Region / City:
Australia
Topic:
Severe Atopic Dermatitis Treatment, Pharmaceutical Pricing
Document Type:
Proposal
Organization:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Healthcare professionals, policymakers, pharmaceutical stakeholders
Effective Period:
December 1, 2024 onwards
Approval Date:
11 June 2024
Modification Date:
March 2024
Context:
Proposal to delist dupilumab (Dupixent®) from PBS for severe atopic dermatitis treatment, addressing cost-effectiveness and price reduction negotiations with PBAC.
Product Name:
DUPIXENT® (dupilumab)
Dosage Strengths:
200 mg; 300 mg
Document Type:
Sample medical exception letter
Purpose:
Request for coverage and reimbursement exception
Intended Users:
Physicians and healthcare providers
Related Coding System:
International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)
Indications:
Atopic Dermatitis; Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Esophagitis; Prurigo Nodularis; Chronic Obstructive Pulmonary Disease; Chronic Spontaneous Urticaria; Bullous Pemphigoid
Contraindication:
Known hypersensitivity to dupilumab or its excipients
Required Signatories:
Treating Physician; Patient or Legal Representative (if required)
Supporting Documentation:
Chart notes; Diagnostic test results; Treatment history; Prescribing Information; Patient narrative
Safety Information Included:
Contraindications; Warnings and Precautions
Year:
2023
Region / city:
Not specified
Subject:
Medical necessity letter for DUPIXENT® (dupilumab)
Document type:
Medical letter
Institution:
Not specified
Author:
Not specified
Target audience:
Healthcare providers, insurance companies
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2022
Region / City:
Australia
Subject:
Pharmacology, Pharmaceutical Benefits Scheme (PBS)
Document Type:
Submission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Not specified
Approval Date:
3 June 2022
Date of Changes:
Not specified
Contextual Description:
A regulatory submission detailing the request for listing of dupilumab in new forms for treating severe atopic dermatitis and uncontrolled severe asthma in pediatric patients under the PBS.
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
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:
2024
Region / City:
Australia
Topic:
Severe Atopic Dermatitis Treatment, Pharmaceutical Pricing
Document Type:
Proposal
Organization:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Healthcare professionals, policymakers, pharmaceutical stakeholders
Effective Period:
December 1, 2024 onwards
Approval Date:
11 June 2024
Modification Date:
March 2024
Context:
Proposal to delist dupilumab (Dupixent®) from PBS for severe atopic dermatitis treatment, addressing cost-effectiveness and price reduction negotiations with PBAC.
Product Name:
DUPIXENT® (dupilumab)
Dosage Strengths:
200 mg; 300 mg
Document Type:
Sample medical exception letter
Purpose:
Request for coverage and reimbursement exception
Intended Users:
Physicians and healthcare providers
Related Coding System:
International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)
Indications:
Atopic Dermatitis; Asthma; Chronic Rhinosinusitis with Nasal Polyps; Eosinophilic Esophagitis; Prurigo Nodularis; Chronic Obstructive Pulmonary Disease; Chronic Spontaneous Urticaria; Bullous Pemphigoid
Contraindication:
Known hypersensitivity to dupilumab or its excipients
Required Signatories:
Treating Physician; Patient or Legal Representative (if required)
Supporting Documentation:
Chart notes; Diagnostic test results; Treatment history; Prescribing Information; Patient narrative
Safety Information Included:
Contraindications; Warnings and Precautions
Year:
2023
Region / City:
Multiple countries
Topic:
Medical / Asthma Treatment
Document Type:
Research Study
Organization / Institution:
Various research centers and universities
Authors:
Jonathan Corren, David J. Jackson, Thomas B. Casale, Larry Borish, Klaus F. Rabe, William W. Busse, Jorge F. Maspero, Daniel J. Jackson, Nadia Daizadeh, Arman Altincatal, Amr Radwan, Angela Khodzhayev, Michel Djandji, Juby A. Jacob-Nara, Paul J. Rowe, Yamo Deniz
Target Audience:
Medical professionals, researchers
Period of Validity:
Ongoing study
Date of Approval:
N/A
Date of Amendments:
N/A
Year:
2023
Region / city:
Not specified
Subject:
Medical necessity letter for DUPIXENT® (dupilumab)
Document type:
Medical letter
Institution:
Not specified
Author:
Not specified
Target audience:
Healthcare providers, insurance companies
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified