№ files_lp_4_process_3_120265
File format: docx
Character count: 74394
File size: 163 KB
Summary of a pharmaceutical reimbursement submission to the Pharmaceutical Benefits Advisory Committee describing clinical evidence, comparative outcomes, pricing framework, and proposed PBS listing conditions for pembrolizumab in advanced urothelial cancer following platinum therapy failure.
Year:
2017
Country:
Australia
Region:
Australia
Subject:
Oncology; Pharmaceutical reimbursement policy
Document type:
Pharmaceutical reimbursement submission summary
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Program:
Pharmaceutical Benefits Scheme (PBS) Section 100 Efficient Funding of Chemotherapy
Medication:
Pembrolizumab (Keytruda®)
Manufacturer:
Merck Sharp & Dohme (Australia) Pty Ltd
Medical condition:
Urothelial cancer
Disease stage:
Locally advanced (Stage III) or metastatic (Stage IV)
Target population:
Patients with urothelial cancer after failure of a platinum-containing regimen
Comparator treatments:
Paclitaxel; Docetaxel
Clinical trial referenced:
KEYNOTE-045 (KN045)
Primary outcomes:
Overall survival; Progression-free survival
Secondary outcomes:
Objective response rate; Duration of response; Health-related quality of life; Safety
Treatment regimen:
Pembrolizumab 200 mg intravenous infusion every 3 weeks
Requested listing category:
Authority Required listing under PBS
Pricing context:
Published PBS dispensed price for maximum amount provided for public and private hospitals
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
Not specified
Region / City:
Not specified
Topic:
Cancer research, Urothelial carcinoma
Document type:
Research methodology
Institution:
Not specified
Author:
Not specified
Target audience:
Researchers in oncology and immunology
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Medical treatment approval and submission for pembrolizumab and lenvatinib
Document type:
Submission for drug listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Therapeutic Goods Administration (TGA)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical professionals, health regulators
Period of validity:
2022 onward
Approval date:
August 10, 2021
Amendment date:
Not specified
Year:
2023
Region / City:
Australia
Theme:
Oncology, Pharmaceutical
Document Type:
Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, policymakers
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Oncology / Colorectal Cancer Treatment
Document Type:
Medical submission
Agency / Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Medical practitioners
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Revision:
Not provided
Year:
2024
Region / City:
Australia
Topic:
Oncology / Cancer Treatment
Document Type:
Pharmaceutical Submission
Organization:
Merck Sharp & Dohme
Author:
Merck Sharp & Dohme
Target Audience:
Healthcare professionals, regulatory bodies, pharmaceutical industry
Effective Period:
From September 2024
Approval Date:
Pending
Date of Changes:
September 2024
Context:
A submission by Merck Sharp & Dohme to request a multi-indication listing for pembrolizumab to treat advanced or metastatic cancers under the Pharmaceutical Benefits Scheme in Australia.
Year:
2022
Region / City:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Addendum
Organ / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Indication approved on February 7, 2022
Approval Date:
07 February 2022
Change Date:
Not specified
Year:
2022
Region / city:
Australia
Topic:
Early-stage triple negative breast cancer treatment
Document type:
Pharmaceutical submission
Organization / institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target audience:
Medical professionals, healthcare providers
Effective period:
From September 2022
Approval date:
2 September 2022
Modification date:
Not specified
Registration status:
Approved by TGA
Background:
Pembrolizumab was approved by the TGA for the treatment of early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and as monotherapy post-surgery.
Condition:
Triple negative breast cancer
Indication:
Early stage triple negative breast cancer
Restriction:
Section 100 (Efficient funding of chemotherapy), Authority Required – Streamlined
Treatment initiation criteria:
Hormone receptor negative, HER2 negative, preparing for surgery, ECOG status 1 or less, treatment combined with chemotherapy, no previous treatment, not exceeding 24 weeks of therapy
Continuation criteria:
Must have undergone surgery, ECOG status 1 or less, monotherapy for adjuvant phase, no more than 27 weeks of therapy
Grandfathering criteria:
Must have previously received non-PBS subsidised treatment
Price:
$7,881.87 private, $7,733.78 public for neoadjuvant; private and public prices for adjuvant not specified
Number of doses:
7 for neoadjuvant, 8 for adjuvant
Source:
Table 1.1-1, pp12-14
Context description:
A pharmaceutical submission for the approval of pembrolizumab as a treatment for early-stage triple-negative breast cancer, including neoadjuvant and adjuvant therapy details and pricing for PBS listing.
Year:
2017
Region / city:
Australia
Theme:
Oncology, Immunotherapy
Document type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme
Target audience:
Healthcare professionals, medical practitioners
Effective period:
Ongoing
Approval date:
March 2017
Changes date:
Not specified
Context:
A pharmaceutical submission for the listing of pembrolizumab for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients, detailing proposed PBS listings, treatment phases, and clinical criteria.
Year:
2021
Region / City:
Australia
Topic:
Cancer treatment
Document Type:
Clinical submission
Organization:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of Validity:
Ongoing (TGA approval received September 28, 2021)
Approval Date:
September 28, 2021
Date of Changes:
None specified
Year:
2019
Region / city:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Not specified
Approval Date:
16 October 2019
Date of Revisions:
Not specified
PBS Code:
10424P, 10436G, 10475H, 10493G, 11492W, 11494Y
Requested Dose Regimen:
400 mg Q6W
Indications:
Unresectable Stage III or Stage IV malignant melanoma, metastatic non-small cell lung cancer (NSCLC)
Price:
Private $17,434.92, Public $17,118.12
PBAC Outcome:
March 2020 meeting
Regulatory Status:
TGA approval
Clinical Evidence:
Pharmacokinetic modelling data
Clinical Trials:
Not presented for 400 mg Q6W, PK data used
Economic Analysis:
None provided
Year:
2026
Region / City:
Not specified
Subject:
Electroplating, Platinum Coating, Surface Treatment
Document Type:
Technical Process Description
Institution:
Meyer Tool
Author:
Not specified
Target Audience:
Manufacturers, Engineers, Aerospace Industry
Duration:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2022
Region / City:
Eastampton, NJ
Topic:
Gymnastics competition schedule
Document Type:
Event schedule
Organization:
EnVision Gymnastics, LLC
Author:
EnVision Gymnastics, LLC
Target Audience:
Athletes, coaches, judges, spectators
Period of Action:
April 2–3, 2022
Date of Approval:
N/A
Date of Changes:
N/A
Year:
2026
Occasion:
Wedding anniversaries
Date of Celebration:
14 February 2026
Liturgical Season:
Before Lent or as chosen
Type of Document:
Liturgical service plan / Mass program
Location:
Parish or church setting
Author / Contributor:
Father Pat McManus (resources and inspiration)
Musical Works:
A Joy for All the Earth (Ephrem Feeley), Gloria (Bernard Sexton), Críost Liom (Bernard Sexton), The Servant Song (Richard Gillard), others
Target Audience:
Married couples celebrating significant anniversaries, parish community
Scripture References:
Ecclesiasticus 15:15-20, I Corinthians 2:6-10, Matthew 5:17-37
Rituals Included:
Renewal of marriage vows, Penitential Rite, Eucharist, Prayers of the Faithful
Special Notes:
Material adapted from World Meeting of Families 2018, Saint Gabriel’s Church, Dollymount
Year:
2025
Company:
Platinum Elite Holdings Ltd
Acquired Company:
Equip Rasen Ltd
New Company Name:
Equip Global Supplies Ltd
Location:
Market Rasen, Lincolnshire, United Kingdom
Industry:
Industrial Supplies, Automotive, Agricultural, Battery Division
CEO:
John Richards
Managing Director:
Ray Hildred
Document Type:
Press Release
Contact Information:
[email protected], +44 01673 844814
Operational Changes:
Introduction of new global battery division EGS, investment in state-of-the-art computer system
Period of Effect:
From June 2025
Target Audience:
Customers and suppliers
Historical Note:
Ray Hildred was John Richards’ first battery customer 30 years ago
Year:
2022
Region / City:
Durham, United Kingdom
Subject:
Street party organization for Platinum Jubilee
Document type:
Application form
Issuing authority:
Durham County Council, Highway Network Management Section
Target audience:
Event organisers planning street parties
Application deadline:
30 April 2022
Event dates:
02 June 2022 – 05 June 2022
Legal basis:
Town Police Clauses Act 1847
Requirements:
Public consultation, risk assessment, public liability insurance, signage and barrier setup
Submission method:
Email to [email protected]
Year:
2004
Region / City:
Jena, Germany
Theme:
Fire-rated materials
Document Type:
Technical specification
Organization / Institution:
SCHOTT Technical Glass Solutions GmbH
Author:
Not specified
Target Audience:
Architects, contractors, and glaziers
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2026
Region / City:
Various locations
Theme:
Golf
Document Type:
Offer
Organization / Institution:
Various golf courses
Author:
Not specified
Target Audience:
Golf enthusiasts, Passport holders
Period of validity:
2026 season
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2022
Region / City:
Davlyn House
Topic:
Special events, Platinum Jubilee, Father’s Day celebration
Document type:
Event report
Organization / Institution:
Davlyn House
Author:
Not specified
Target Audience:
Residents, relatives, and staff of Davlyn House
Event Date:
June 2022
Approval Date:
Not specified
Date of Last Revision:
Not specified
Year:
2024
Region / City:
Cologne
Topic:
Sustainability, Human Rights, Procurement
Document Type:
Press Release
Organization:
TÜV Rheinland
Author:
TÜV Rheinland
Target Audience:
Stakeholders, Business Partners, Sustainability Advocates
Validity Period:
2024 and ongoing
Approval Date:
25 January 2024
Date of Changes:
Not specified