№ files_lp_4_process_2_55381
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Template for collecting structured feedback on PBAC’s consideration of PD-1 and PD-L1 checkpoint inhibitor immunotherapies, including detailed questions for stakeholders on clinical, economic, and regulatory aspects of multi-tumour subsidy applications.
Year: 2018
Region: Australia
Subject: PD-1 and PD-L1 checkpoint inhibitor immunotherapies
Document Type: Submission Template
Organization: Pharmaceutical Benefits Advisory Committee (PBAC)
Intended Audience: Patients, healthcare providers, researchers, pharmaceutical industry, government bodies
Submission Deadline: 29 June 2018
Contact Information Required: Yes
Confidentiality Note: Commercial-in-confidence or personal information to be redacted before publication
Format: Electronic submission in Microsoft Word or text-based format
Questions Covered: Advantages, disadvantages, unmet clinical need, evidence requirements, cost-effectiveness, subsidy pricing, biomarker considerations, extrapolation across medicines and cancer types, rare cancers, follow-up actions, clinical trials, international models
Price: 8 / 10 USD
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Synergy between EphA2-ILs-DTXp, a novel EphA2 targeted nanoliposomal taxane, and PD-1 inhibitors in preclinical tumor models
Year: 2026
Region / City: N/A
Topic: Cancer research, Immunotherapy
Document Type: Research article
Organization / Institution: N/A
Author: Walid S. Kamoun, Anne-Sophie Dugast, James J. Suchy, Stephanie Grabow, Ross B. Fulton, James F. Sampson, Lia Luus, Michael Santiago, Alexander Koshkaryev, Gang Sun, Vasileios Askoxylakis, Eric Tam, Zhaohua Richard Huang, Daryl C. Drummond, Andrew J. Sawyer
Target Audience: Researchers, Oncology professionals
Period of Action: N/A
Approval Date: N/A
Modification Date: N/A
Supplementary Results for Intra-tumoral Injection of Caerin 1.1 and 1.9 Peptides in Vaccinated TC-1 Tumour Bearing Mice with PD-1 Blockade
Year: 2026
Research Area: Immunology, Cancer Biology
Document Type: Scientific Article Supplementary Data
Authors: Guoying Ni et al.
Organ / Institution: Not specified
Experimental Model: TC-1 tumour-bearing mice
Treatments: Caerin 1.1/1.9 peptides, P3, PD-1 blockade
Cell Types Studied: Macrophages, B cells, NK cells, Dendritic cells, T cells
Methods: Single-cell RNA sequencing, GO and KEGG enrichment analysis
Key Findings: Modulation of immune cell populations and activation pathways in tumour microenvironment
Supplementary Figures: 13A-F, 14A-F
PD-(L)1 checkpoint inhibitor stakeholder meeting 08 February 2019
Year: 2019
Region / City: Australia
Topic: Pharmaceutical Benefits Scheme, PD-(L)1 inhibitors, non-small cell lung cancer (NSCLC)
Document type: Meeting minutes
Organization: Pharmaceutical Benefits Advisory Committee (PBAC)
Author: Professor Andrew Wilson (PBAC Chair)
Target audience: Stakeholders in the healthcare and pharmaceutical industry
Period of validity: 2019 and onwards
Date of approval: February 2019
Date of amendments: Not specified
Supplementary Tables S1–S3 and Figures S1–S2: Baseline Characteristics, Tumor Mutation Burden, PD-L1 Expression, and Overall Survival in Renal Cell Carcinoma Cohort
Document Type: Supplementary appendix
Subject Area: Oncology
Disease Focus: Renal cell carcinoma
Content Type: Tables and figures
Population: Patients with renal cell carcinoma
Sample Size: 43 patients (baseline characteristics), 19 patients (tumor mutation burden), 8 patients (PD-L1 expression)
Variables: Age, sex, ECOG performance status, histology, sarcomatoid/rhabdoid differentiation, IMDC risk group, metastases, prior nephrectomy, therapy line
Biomarkers: Tumor mutation burden, PD-L1 expression
Outcomes: Best overall response, overall survival
Response Categories: Partial response, stable disease, progressive disease
Institutions Referenced: Eastern Cooperative Oncology Group, International Metastatic RCC Database Consortium
Language: English
Data Presentation: Quantitative tabular data with percentages and counts
Evaluation of potential herb-drug interactions between Bojungikki-tang and PD-L1 immunotherapy
Year: 2022
Region / City: Daejeon, Republic of Korea
Subject: Pharmacology, Immunotherapy, Herbal Medicine
Document Type: Supplementary Research Document
Institution: Chungnam National University, Korea Institute of Oriental Medicine
Authors: Sung-yoon Yang, Jin-Mu Yi, Jaemoo Chun, Seongwon Park, Tham Thi Bui, Hwi-yeol Yun, Jung-woo Chae, Mi-Kyung Jeong
Target Audience: Researchers in pharmacology and immunotherapy
Methodologies: LC-MS/MS, ELISA, Cytokine Assay
Compounds Analyzed: Bojungikki-tang components, anti-PD-L1 antibody
Study Model: Mouse serum samples
Purpose: Assessment of pharmacokinetic interactions and biomarker quantification
Amendment to MBS item 72814 for programmed death ligand 1 (PD-L1) immunohistochemistry (IHC) testing to include testing for advanced triple negative breast cancer (TNBC) patients
Year: 2023
Region / City: Australia
Subject: Health / Oncology
Document Type: Official Announcement
Organization: Department of Health and Aged Care
Author: Medical Services Advisory Committee (MSAC), Pharmaceutical Benefits Advisory Committee (PBAC)
Target Audience: Healthcare providers, specialists
Effective Date: 1 September 2023
Approval Date: 10 August 2023
Changes Date: 1 September 2023
Clinical Category: Pathology Services
Procedure Type: Type C
Private Health Insurance Classification: Support List (pathology)
MBS Item: 72814
PBS Listing: pembrolizumab (Keytruda®)
Eligibility Criteria: Advanced TNBC, PD-L1 Combined Positive Score (CPS) ≥10
Consulted Stakeholders: Clinical experts, providers, consumer health representatives
Review and Monitoring: Compliance audits
More Information: www.mbsonline.gov.au
Description: Official update on the inclusion of PD-L1 immunohistochemistry testing for advanced triple negative breast cancer (TNBC) patients under the Medicare Benefits Schedule (MBS) effective 1 September 2023, aligned with PBS listing for pembrolizumab.
Melanoma specimens analyzed for PD-L1 expression, BRAF mutation, and inflammatory infiltrate
Year: 2026
Region/Location: Not specified
Subject: Melanoma research
Document type: Supplementary data tables
Institution: Research laboratory / academic study
Author: Not specified
Sample size: NEVI (14), Primary Malignant Melanoma (23), Metastatic Melanoma (15)
Methods: Immunohistochemistry for PD-L1, BRAF codon 600 genotyping, inflammatory scoring
Cell lines: Human melanoma cultured cells
Treatment: IFN-gamma induction
Data metrics: %PD-L1 expression, inflammation score, ∆MFI for PD-L1 and MHC I
Context: Archival melanoma tissue samples and cultured melanoma cell lines analyzed for PD-L1 expression, BRAF mutation status, and immune response markers in experimental study
Landscape of CD8 densities and PD-L1 expression in small cell and esophageal carcinomas
Year: 2026
Region / City: Not specified
Subject: Oncology, Immunology
Document type: Supplementary Figure
Institution: Not specified
Authors: Not specified
Target audience: Researchers, Clinicians
Study focus: CD8 densities and PD-L1 expression in small cell and esophageal carcinomas
Data type: Quantitative immunohistochemical analysis
Tumor types: Small cell lung carcinoma, small cell carcinoma of the prostate, small cell carcinoma of the bladder, small cell carcinoma of the esophagus, esophageal squamous cell carcinoma, esophageal adenocarcinoma
Measurement methods: Immunohistochemistry, Tumor-infiltrating immune cells analysis
Topics: Immunotherapies PD-1 PD-L1